Food 12345

Food Regulatory Guide
Food Safety & Compliance with

High Performance Weighing & Inspection
Table of Contents
Table of Contents
Chapfer 1 Food Safety & Quality – The Trend Towards Certification 06
Chapter 2 Traceability for Standard Compliance and Process Improvement 14
Chapfer 3 Improved Production Yield Through Process Oriented Recipe Management 20
Chapter 4 Food Safety – Fresh Products in Grocery Retail 26
Chapter 5 Package Quality Control – Net Content Control 34
Chapter 6 In-line Checkweighing – Aspects of a Key Technology 40
Chapter 7 Vision Inspection – Driving Quality and Process Security 46
Chapter 8 Foreign Body Detection – Metal 52
Chapter 9 Foreign Body Detection – X-ray Inspection 58
Chapter 10 Hygienic Designed Food Scales – Less Contamination, Enhanced Profits 64
Chapter 11 7 Considerations for Cleaning Production Equipment 70
Chapter 12 Efficient Quality Management in a Regulated Environment 76
Chapter 13 Meeting Legal Metrology Standards 84
Chapter 14 Reaching Specified Food Attributes with Compliant Analytical Instruments 92
Chapter 15 Moisture Analyzer Routine Performance Testing 98
Chapter 16 Intrinsically Safe Solutions – Accurate Weighing in Hazardous Areas 104
2 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 3

Prepare to Improve Safety Select Your Focus Topics
Topics
Ensure High-Quality Food Consider your area of interest and see to which regulatory standard chapter
they correspond.
Consumers deserve high-quality and safe food. However, maintaining an effective Topic / Chapter BRC FSSC 22000 IFS SQF Page
food-quality control system that fulfills all food-safety requirements and standards Food Safety & BRC Global Standard FSSC 22000 International Food SQF Code, Edition 7,
Standards
Quality Standards (Version 7) (Version 3) Standard (Version 6) Module 2
is challenging. This guide offers know-how in 16 different areas, where weighing 6
and foreign-body control helps to ensure your products are compliant while achiev-
Traceability / • 3.9 Traceability • 7.9 Traceability • 4.18 Traceability • 2.6 Product
ing the level of safety and quality your customers demand.
Traceability
Product Identification • 3.11 Management system • 4.2 Specifications identification, 14
of incidents, prod- and formulas trace, withdrawal
Formulation / uct withdrawal and and recall
Recipe Weihing product recall
20
Quality Data Man- • 6.3 Quantity • Net content • 5.5 Quantity • 2.4.1 Food
Food producers are under constant pressure to deliver • BRC Global Standard agement / Net Content control legislations checking legislation 34
Control / SQC (quality control/ • 2.5.6 Product
high quality food and to comply with national laws • FSSC 22000 filling quantities) sampling inspec-
In-line Checkweighing 40
and global food safety and quality standards. • IFS International Featured Standard tion and analysis
Quality Control Assured

• SQF Code Vision Inspection • 3.9 Traceability • 7.6.4 System for • 4.5 Product • 2.3.2 Raw and
• 6.2 Labeling the monitoring packaging packaging materi-
In addition to existing quality standards such as and pack control of critical control • 4.18 Traceability als
ISO9001, GMP or FDA’s Food Modernization Act This expanded and updated second edition of the points • 5.5 Quantity • 2.5.6 Product sam-
• 7.9 Traceability checking pling inspection 46
(FSMA) it is becoming increasingly important for a Food Safety Guide offers guidance to fulfill global system and analysis
food manufacturer or retailer to be certified according food safety and quality standards without harming • 17 Product infor- • 2.6.1 Product
mation / consumer identification
to a food-specific, GFSI-accepted standard. production efficiency. awareness • 2.6.2 Product trace
Food Labeling • 5.2 Product • 17 Product infor- • 4.5 Product • 2.6.1 Product
The Global Food Safety Initiative (GFSI) benchmarks There are 16 areas where weighing equipment, foreign labeling mation / consumer packaging identification 26
awareness
existing food standards against food safety criteria body detection, or quality control solutions can be
Metal Detection • 4.10 Foreign body • 7.6.4 System for • 4.12 Risk of foreign • Detection of
Foreign Body
with a goal of standardizing certifications and elimi- critical for achieving compliance and efficiency. detection and re- the monitoring bodies, metal, foreign objects 52
Detection
nating multiple audits. moval equipment of critical control broken glass and
X-ray Inspection points wood
This guide helps to ensure your products reach your • 10.4 Physical 58
contamination
In 2016 the following GFSI-accepted standards rank customers exactly as they should – no more, no less,
Hygienically Designed • 4.6 Equipment • 8.2 Hygienic • 4.17 Equipment • Vehicles, equipment
as the most-often used worldwide. correct, complete, and safe, inside and out. Equipment design and utensils 64
Hygiene
Cleaning • 4.11 Housekeeping • 8. Equipment suit- • 4.10 Cleaning and • Cleaning and
and hygiene ability, cleaning disinfection sanitation 70
and maintenance
Management of • 4.7 Maintenance • 8.3 Control of • 5.4 Calibration • Calibration of
Quality in a Regulated • 6.1 Control of oper- monitoring and and checking of equipment 76
Environment ations measuring measuring and
Calibration
Equipment
• 6.4 Calibration and monitoring devices
Legal Metrology control of measur- 84
ing and monitoring
GP Good Practices
devices
92
Moisture Analysis 98
Safety Safety in Explosive ATEX Directive / OSHA Law & Regulations

Atmosphere 104
4 METTLER TOLEDO © 06/2017 – Food Regulatory Guide METTLER TOLEDO © 06/2017 – Food Regulatory Guide 5
Food Safety & Quality For this reason, work to gain conformity among stan- may want to consider when deciding which standard
Food Safety dards – and help manufacturers decide which one is to adopt. Finally, it gives an outlook on trends – such
best for their purposes – is underway, mainly driven as the need for manufacturers and suppliers to take
The Trend Towards Certification by the Global Food Safety Initiative (GFSI), a retailer/
manufacturer non-profit foundation. This paper high-
a more active role in certification to ensure future
profitability – in food safety & quality discussions
Food Safety
lights four of the most-used standards. It also offers a worldwide.
short comparison of each, providing points producers
Consumers, retailers and food manufacturers today are increasingly focused on

food safety and quality. In fact, an annually-repeated industry survey conducted
by the Consumer Goods Forum found that food and product safety remain among 1 Certification: Oversight, Responsibilities & Benefits
the top concerns of manufacturers and retailers.
At its most basic, certification can be defined as a pro- The Global Food Safety Initiative (GFSI)
cedure by which an accredited certification body gives The GFSI is run by the Consumer Goods Forum, which
The only thing on retailers’ and manufacturers’ minds written assurance that a product or a process is in brings together CEOs and senior management from
more than safety? The economy and consumer de- conformity with the respective standard. Standards 650 retailers, manufacturers, service providers and
mand, which translates to profitability. In a competitive can be set up by the public sector (governmental insti- other stakeholders across the food industry. The initia-
world market made even tougher by recent legislation tution) or by the private sector (retailer/industry associ- tive was set up in 2000 against the backdrop of vari-
in major markets such as the U.S. and China to reas- ation). ous food safety crises, including BSE, with the inten-
sure consumers, producers at every point in the supply tion of ensuring worldwide consumer confidence in
chain are carefully watching margins while seeking Benefits of certification food safety.
new strategies to protect market share. In addition to existing quality standards such as
ISO9001, GMP or HACCP, it is becoming increasingly GFSI benchmarks existing food standards against food
In addition to general food safety, other industry issues important for food manufacturers and retailers to be safety criteria with a goal of standardizing certifica-
such as healthy or organic/biologically-grown foods – certified according to a food-specific, GFSI-accepted tions and eliminating multiple audits. Preferred imple-
as well as animal welfare – are also gaining impor- standard. Benefits include: mentation places the GFSI just above Third Parties/Ac-
tance. Addressing these issues in addition to food • Improved customer confidence creditation Bodies, as referenced in the following
safety & quality basics via certification by a globally- • Enhanced brand protection graphic. Key elements and further requirements are
accepted food standard – which helps ensure con- • A standard process/quality measure summarized in the GFSI Benchmarking Requirements/
sumers get what they pay for – is one way manufac- • Minimized costs through not having to “clean up” Guidance Document (found via the links at the end of
turers have begun to carve out niches for themselves after distribution of nonconforming products this paper).
in the global food arena. Specialization aside, with the Contents
broader adoption of global food standards, retailers 1 Certification: Oversight,
and manufacturers are now able to favor purchasing Responsibilities & Benefits International Accreditation Forum
from certified suppliers and sub-suppliers. The Consumer Forum
2 Choosing a Standard (IAF)
3 GFSI-Accepted Standards
4 Comparing the Standards
5 Sample Audit Procedure Accreditation bodies GFSI
6 Outlook
7 Summary
8 Additional Resources Certification bodies GFSI-recognized standards
SGS, Intertek, DNV, SAI Global… BRC, SQF, IFS, FSSC 22000…
Producer/supplier

2 Choosing a Standard It was accepted by GFSI in 2010 and lists over 11,000
FSSC 22000 certified organizations from 149 coun-
ISO/TS 22002-4 or PAS222 and any additional re-
quirements to ensure they receive this GFSI-approved
tries. This includes public and private companies that certification. This may be the easiest certification route
As a result of their ongoing work to ensure each certifi- Before deciding on a standard or a set of standards, manufacture perishable animal or vegetable products, for companies who are already ISO 22000-compliant.
cation method is sound, GFSI promotes the equal ac- check with customers to determine which standard products with a long shelf life, food ingredients, and/or
Food Safety
Food Safety
ceptance of all approved standards: “Once certified, they accept – and which ones they prefer. Understand- food additives. Other standards are largely industry specific (red
accepted everywhere.” Actual practice proves, howev- ing these preferences, some certifying bodies offer meat, aquaculture). However, the food safety specifics
er, that retailers, manufacturers and even entire seg- combi-audits (for example, BRC & FSSC 22000) in a Manufacturers who are already ISO 22000-certified of these industries are also covered to a great extent
ments may have strong certification preferences. single, integrated audit process. only need to be reviewed against the ISO/TS 22002-1, by one or more of the major certification schemes.
3 GFSI-Accepted Standards 4 Comparing the Standards
Mid-2016, the following standards are GFSI-recognized The International Featured Standard (IFS) All GFSI-accepted standards, whether for primary or • Companies must demonstrate they have con-
manufacturing schemes. Schemes in bold currently Founded in 2002 by a German retailer association, in secondary production, must meet three main areas of ducted Hazard Analysis and identified the Critical
rank as the most-often used and accepted worldwide. 2011 the IFS represents more than 190 dealers includ- certification requirements: Control Points where warranted in line with
• BRC Global Standard ing 16,800 IFS-certified suppliers in 90 countries. The • Companies must demonstrate they have a food HACCP principles
• FSSC 22000 standard provides a range of integrated checks on safety management system
• Global Aquaculture Alliance (Seafood) safety and quality in food processing companies and • Companies must demonstrate Good Manufacturing Each scheme varies in scope and structure. The fol-
• Global Red Meat Standard offers certification across the whole range of food pro- Practices (GMP), good distribution practices and/or lowing chart analyzes basic differences among the
• IFS International Featured Standard cessing with the exception of agricultural primary pro- good agricultural practices most widely-used standards.
• SQF Code duction.
• PrimusGFS Standard Subject BRC IFS SQF FSSC 22000
The IFS comprises six related standards: IFS Food, IFS System requirements Quality and Quality and Level 2 - HACCP based Food Safety
The most commonly-used, GFSI-accepted food safety Broker, IFS Logistics, IFS Cash & Carry/Wholesale, IFS food safety food safety food safety plans
Level 3 - Comprehensive
and quality standards are overviewed below, ranked in HPC and IFS Global Markets. food safety and quality
order of prevalence in today’s market. management system
Safe Quality Food (SQF) Code System establishment Prescriptive Prescriptive Prescriptive requirements Provide frame-work
and implementation requirements requirements requirements for the
BRC (British Retail Consortium) SQFI has combined the SQF 1000 Code, for primary company to demonstrate
Originally developed in response to the needs of UK producers, and the SQF 2000 Code, for manufactur- how to comply and dem-
members of the British Retail Consortium, BRC Stan- onstrate their food safety
ers, distributors and brokers, to create one standard system
dards have gained use worldwide and are specified as for food safety from farm to fork. Developed in Western Report/ By Certification body and By Certification body and Registration, audit docu- By Certification body and
acceptable by growing numbers of retailers and brand- Australia but now owned by the Food Marketing Insti- data management Standard owner Standard owner ments, reports and certifi- Standard owner
ed manufacturers in the EU, North America and further tute (FMI) in the USA, the scheme aims to meet the cate all managed in the
SQFI database by certifica-
afield. BRC covers the supply chain with four related needs of buyers and suppliers worldwide. The stan- tion body and SQFI
standards: BRC Global Food Standard, BRC Storage dard certifies that a supplier’s food safety and quality Certification process No stage 1; Company No stage 1; Company Document review on-site Stage 1 on-site;
and Distribution, BRC IOP for Food Packaging and management system complies with international and goes directly to an on- can easily go direct to or off-site; Facility certifica- Stage 2 on-site
site certification audit on-site certification audit tion audit on-site
BRC Consumer Products. domestic food safety regulations.
Certificate validity Certificate valid for 1 Certificate valid for Certificate valid for 1 year if Certificate valid for
year; Grade C-Recertifica- 1 year ‘E’ or ‘G’ rating 6 months 3 years
BRC Global Standard for Food Safety was first intro- The only international food certification body head- tion within 6 months Surveillance if ‘C’ rating
duced in 1998 and now has almost 23,000 certificat- quartered outside Europe, SQFI counts more than Integrated audit Recertification depends Does not allow integra- Different management Same management
ed suppliers in over 125 countries. It was developed to on audit result (grade C tion with ISO manage- system structure but system structure as ISO
8,900 companies among adopters of its certification.
needs to be 6 months so ment system standard, possible for integrated standard so it is easy
specify safety, quality and operational criteria required interval or integrated con- allows integration with audit to integrate with other
for food manufacturers to comply with regulations and FSSC 22000 dition will be changed de- product certification management system
pending on result) schemes standards
protect consumers, it was the first standard accepted FSSC 22000 is a food safety certification scheme
Recertification/ Same audit time as Same audit time as Same audit time as Less audit time than
by GFSI in 2000. based on the existing internationally recognized stan- maintenance visit certification visit certification visit Certification audit stage 2 on-site
dard ISO 22000 and complemented by technical stan- Certification mark Not allow to be displayed Not allow to be displayed Level 3 certification can Not allow to be displayed
dards ISO/TS 22002-1, ISO/TS 22002-4 or PAS222 on the product on the product use SQF shield on product on the product
which cover the prerequisites. Source: COMPARING GLOBAL FOOD SAFETY INITIATIVE GFSI RECOGNISED STANDARDS, SGS, 2016
Factors producers may want to consider before apply-
ing for consideration include:
As noted previously, one standard may be easiest to
apply – yet not offer certification’s benefits because it
6 Outlook
• Product characteristics is not considered acceptable among a particular com-
• Company’s position on the supply chain pany’s customers. The trend towards more stringent food safety & quality selves behind bars for up to 15 days. Producers may
• Current management systems regulation continues. New challenges concerning food face fines of up to 30 times the value of their products,
Food Safety
Food Safety
• Company’s historic compliance with existing safety & quality aspects are created through develop- up from 10 times.
regulations ments such as GMOs (Genetically Modified Organ-
• Customer/industry preferences isms), nanotechnology and the increase in internation- Baby formula
al sourcing/trade of food/feed, and actions such as Producers are required to register powdered baby milk
these are expected to propel this trend forward even formula with the food and drug regulator, and have to
more strongly. test every batch of their product, conduct regular inter-
5 Sample Audit Procedure The following food safety issues are expected to gain
nal inspections and submit reports to regulators.
importance in the coming years: Online shopping

The following flow chart illustrates the standard proce- The process can be arduous; however, experts within • Organizations taking even more ownership for food The amendment adds new articles on online shop-
dure for obtaining FSSC 22000 certification. Other pro- the certifying body and industry are available to pro- safety to protect their brands ping, clarifying the liabilities of shopping platforms.
cedures may vary slightly; however, this is an excellent vide necessary guidance to ensure systems are com- • Even tighter controls established to safeguard the They are required to register the real identity of vendors
basic representation of a certification audit. pliant and safe. food supply chain and check their certificates.
• Traceability and integrated management programs
becoming an essential – and perhaps involuntary –
FSSC 2200 & ISO 2200 certification processes part of food production U.S. Food Safety Modernization Act (FSMA)
Assessment Year 1 Year 2 Year 3 The FDA Food Safety Modernization Act (FSMA), signed
With these trends, and corresponding changes in into law by President Obama on Jan. 4, 2011 enables
international and national laws, standards and certifi- the FDA to focus more on preventing food safety prob-
STEP A STEP C STEP D Issue STEP E STEP F cation processes will be subject to regular revision. lems rather than primarily reacting to problems after
Certificate Examples of recent legislation impacting certification they occur. FSMA shifts from a HACCP (Hazard Analy-
after
Agree
Stage 1
Stage 2 Visit Visit Visit Visit Visit Recertification
processes include: sis Critical Control Point) principle to HARPC (Hazard
Certification successful
Contract
Audit
Audit audit 2 3 4 5 6 Visit 1R Analysis Risked Based Preventive Control). The FSMA
China Food Safety Law impacts facilities globally as exports to the US must
The China Food Safety Law launched in 2009 was ad- meet the requirements.
STEP B opted by the country's top legislative body, The Stand-
Visit frequency notes:
ing Committee of China's National People's Congress FSMA requires a written Food Safety Preventive Con-
Annual surveillance – 2 visits;
Optional Twice-yearly surveillance – 5 visits (NPC), and became effective on Oct 1, 2015. trols plan developed by a Preventive Controls Qualified
Pre-Audit With 154 articles, 50 more than were found in the Individual (PCQI) for each food manufacturer and
original law, the revamped Food Safety Law adds new storage facility. This plan must identify certain food
articles and provisions on penalties, baby formula and safety risks associated with their foods and processes
online shopping. and to implement preventive controls that minimize
these risks.
Stiffer penalties
Consumers can demand reparation of three times any The law also provides the FDA with new enforcement
loss they suffer from substandard food. Bigger fines authorities designed to achieve higher rates of compli-
for offenders are also on the menu. Manufacturers ance with prevention- and risk-based food safety stan-
who add inedible substances to food could find them- dards and to better respond to and contain problems
when they do occur. The law also gives the FDA im-
portant new tools to hold imported foods to the same
ensure that certification standards are comprehensive
and widely-accepted, more and more manufacturers
8 Additional Resources
standards as domestic foods and directs the FDA to and suppliers will find themselves seeking certification
build an integrated national food safety system in part- to stay ahead of legislative changes and ensure profit- • METTLER TOLEDO, Meet Global Food Safety Stan- • Safe Quality Food (SQF) Institute
nership with state and local authorities. ability well into the future. dards and Increase Productivity and Profitability www.SQFI.com
Food Safety
Food Safety
www.mt.com/food-regulations
• Global Food Safety Initiative (GFSI)
With these more stringent requirements in mind, and
• SGS – This chapter “Food Safety and the Trend www.mygfsi.com
knowing that global oversight bodies are working to
Towards Certification” contains an extract from
• The Consumer Goods Forum
the paper “COMPARING GLOBAL FOOD SAFETY
www.theconsumergoodsforum.com
INITIATIVE (GFSI) RECOGNISED STANDARDS” and
remains the copyright of the SGS. This white paper • Food Safety System Certification 22000;
7 Summary can be downloaded from the SGS homepage FSSC 22000
www.sgs.com/gfsiwhitepaper www.fssc22000.com
• International Featured Standards (IFS) • FDA Food Safety Modernization Act, FSMA
Consumers – and governments worldwide – are be- on the company’s industry, needs, and customer pref-
www.ifs-certification.com http://www.fda.gov/fsma
coming increasingly concerned about unsafe food. Re- erence remains important, even as GFSI continues to
cent contamination cases are published and distribut- work to create harmony among the approved scheme • British Retail Consortium (BRC)
ed widely via electronic media, which clearly leads to owners and provide a “once certified, accepted every- www.brcglobalstandards.com
reduced income for involved suppliers – and even per- where” approach.
haps the industry segment as a whole.
Knowing and implementing requirements according to
Being certified according to a GFSI accepted standard one of these standards provides a framework for con-
such as IFS, BRC, FSSC 22000 or SQF demonstrate tinually improving production quality processes. This
the company’s engagement in meeting the demand helps to protect and enhance brand reputation and en-
that they focus on safety. sure future profitability in a competitive global market.
While all certifications deal with similar food safety re-

lated concerns, choosing the right certification based
Mettler-Toledo GmbH
Industrial Division
www.mt.com/ind-food-guides
CH-8606 Nänikon, Switzerland For more information
Tel. + 41 44 944 22 11
Local contact: www.mt.com/contacts
Subject to technical changes

© 11/2016 Mettler-Toledo GmbH
MTSI 30364111 / Marcom Industrial
Traceability for Standard Compliance 1 The Importance of Traceability
Traceability
and Process Improvement Traceability is a legal requirement for food, feed and
related products. In addition, it is a basic element in
What is traceability?
Traceability is defined as:
Traceability
safety and quality management schemes such as the ‘Ability to … follow raw materials and components
GFSI accepted standards (BRC, IFS, SQF, and intended to be, or expected to be, incorporated into
FSSC 22000) or in national industry and product spe- a product, through all stages of receipt, production,
Reoccurring incidents such as e-coli in spinach and dioxin in pork emphasize the rising cific regulations (e.g. EU beef labeling regulations). processing and distribution.’
importance of efficient traceability. Tracking & tracing food, feed, and food-producing
Traceability requirements are linked to legislative de- Traceability can also ensure that product safety and
animals through production and distribution stages is proving vital to consumer safety
mands that any product placed on the market shall be quality attributes have been checked (country of origin,
and company reputations. fit for purpose and not injurious to health. As a risk species of animal, whether all components are
management tool, traceability allows businesses and quality-checked and released for production or that
authorities to withdraw products identified as un- products are free of foreign bodies).
Food Safety regulations such as EU178/2002 or US safe. It also:
Bioterrorism Act, as well as retail-driven standards, re-
• Minimizes costs incurred by making recall more
quire food suppliers to assure traceability on a one-up/
effective
one-down principle but do not dictate methods. Some
• Allows targeted action to prevent recurrence
companies comply using paper-based systems; others
• Assists in problem diagnosis, passing on liability
may require full networked computer and bar code
where relevant
systems to effectively meet requirements.
• Promotes customer confidence and brand protection
• Optimizes production efficiency and quality control
This paper focuses on in-plant traceability and dis-
(stock control, material usage, and origin/character-
cusses how good traceability not only helps a manu-
istics of products).
facturer comply with legal and regulatory require-
ments; it also shows how the right systems and
equipment can contribute to production efficiency
through better stock management and minimized
waste.
MES / ERP System

Contents
1 The Importance of Traceability Formulation Software
2 Designing a Traceability System Quality Data Management Software
3 Verifying Product Safety
Retail,
and Quality Attribute Checks Raw Primary Secondary
Packaging
Shipping
Hotels,
Material Processing Processing Stock
4 Documentation Catering
Material Batching Commisioning Distribution &
5 Traceability Testing Receiving & Order Preparation Shipping
6 Traceability Technologies Labelling Labelling
7 Summary QC Formulation
Laboratory Room
Material Analysis Ingredients & Reci-
Batch release pe Control ID Points
Figure 1: Software solutions for ID Points, Formulation Recipe Weighing and Quality Data Management

2 Designing a Traceability System Batches
Unique identity codes such as: delivery date, production
terial must be checked against the amount used in the
resulting finished products, taking process waste and
or run time, batch size, and expiry date should be used. rework into account. Thus:
Legislation generally requires a ‘one up’/‘one down’ Consider where batches merge/diverge and traceability This may consist of an internal system for assigning a A+B+C = processing = X, Y, Z
(raw materials) (yields/waste/rework) (finished products)
approach to traceability. Integration of internal and may be reduced or lost; establish what information is sequential number, or use the supplier’s batch code or
Traceability
Traceability
external systems improves efficiency. Therefore, it is going to be recorded and how. GTIN (Global Trade Identification Number).
worth considering systems operated by raw mate- It is unlikely that the mass balance check will account
rial or component suppliers as well as customers to The system should include documentation of interme- for all materials to 100% accuracy; however, any dis-
Codes should include enough detail to ensure trace-
understand a company’s interaction within the supply diate/semi-processed materials, those that are part- crepancies should be justified (such as ingredient de-
ability back to the production batch.
chain. used, rework, and any rejected materials or those ‘on hydration). A company must demonstrate that it under-
hold’ pending investigation. stands the variance to ensure traceability system
Labeling
effectiveness. Mass balance is a key measure that can
General principles Consider labeling suitability. Traceability is often con-
also highlight areas for improvement.
Some general principles to consider when designing fused if ‘old’ labels are not removed from containers.
or challenging an existing traceability system include Data Integration (e.g. SAP) When implementing a system, investigate alternative
making sure that it: systems of marking, such as:
Timing
• Covers all stages of production, processing and dis- The traceability system must allow actions such as
• Permanent marking pens
tribution isolation of an unsafe batch or recall from a depot to
• Labels aimed at minimizing contamination risk (for
• Identifies raw materials suppliers be taken within an appropriate time frame. This time
example, metal-detectable labels, RFID)
• Identifies which components have been used in frame will relate to product characteristics such as
• Reusable, visually-distinct tags.
which product shelf life, production process/supply chain complexity,
• Identifies supplied customers and consumer risk.
Quantity check
• Identifies which products and intermediates have In order to account for all materials, quantity details
been disposed of (verification of destruction may be IND890 should be included. The amount of incoming raw ma-
required) terminal
• Ensures products supplied to customers are ade-
quately labeled or identified to facilitate traceability
• Provides details to authorities on-demand in a timely Barcode
scanner
3 Verifying Product Safety and Quality Attribute Checks
manner.
An ideal system fits into a company’s normal work A traceability system can be used to confirm that safe- An growing number of consumer products must be
practice and enables quick and easy collection of rele- ty and quality checks have been performed and suffi- supported by an electronic file containing documenta-
vant information. cient records have been retained for verification. This tion that demonstrates the product meets safety stan-
Label printer
is particularly significant when investigating customer dards. This file becomes part of the traceability sys-
Risk assessment complaints and legal compliance. Any test results, tem. It is good practice to use technical files even
Relevant variables such as the nature of products and such as microbiological testing, must also link back to when it is not a specific legal requirement.
Printer original batches.
raw materials must be considered through adequate
risk assessment. Design will depend on on elements Bench or
such as: Floor scale
ale
• Number/nature of raw materials and components
• Criticality and risk of components used 4 Documentation
• Batch/lot sizes and uniformity
• Production processes Figure 2: Weighing Station with METTLER TOLEDO Indicator IND890
• Number of component combinations & lot splits as ID Point
Meaningful documentation provides evidence of pro- Additionally, if traceability is used for confirming that
duction history such as: safety/quality checks have been performed, then the
• Incoming goods records and raw material quality following documentation would also be required:
checks • HACCP or hazard analysis documentation
• Intermediate component records or mix recipes • Process records for manufacturing the finished
• Warehousing and storage records product
• Delivery orders to the final customer • Operator instructions for the recording of batch
• Records of any subcontracted work codes for all raw materials, work in progress
and finished products
• Personnel training records
Legislation dictates traceability record retention time-
frames related to product characteristics. For example,
need to be kept at least six months. Otherwise,
general rules dictate a 5-year retention minimum.
7 Summary
foods with a shelf life of less than three months would
Recent worldwide recall episodes have heightened the Integrated technology can help eliminate manual re-
profile of traceability. Implementing state-of-the-art cord-keeping, save time and eliminate error potential.
Traceability
Traceability
traceability offers: It also improves quality control and supports data inte-
5 Traceability Testing • The ability to perform fast, precise product recalls
• Minimized number and scope/impact of recalls
gration into existing MES or ERP systems. Ultimately,
a well-designed traceability system will provide easier
• Enhanced consumer protection and confidence fulfillment of legislative principles and a wealth of data
The company should determine the method and fre- low system improvements. The company must prove • Improved brand building & protection that can help with internal process improvement.
quency for traceability system checks depending on how quickly information can be collated and corrective • Increased production efficiency and quality control
production process complexity and product criticality. action – such as quarantine – can be taken.
Regular testing will demonstrate effectiveness and al-
6 Traceability Technologies • Directive 2001/95/EC on General Product Safety contains an extract from the BRC Global Standard
(2001) – This European directive requires compa- Best Practice Guideline Traceability and remains the
Regulations and certifications require traceability, but expensive.Intelligent weighing terminals connected to nies to have traceability systems to effect recall of copyright of the BRC. If you wish to purchase a copy
none are prescriptive. A system may be paper- or barcode printers and scanners can clearly mark and dangerous or illegal products from the market. please visit the BRC Bookshop
computer based. The best system fits into the compa- identify raw materials received, semi-finished and final http://eur-lex.europa.eu/LexUriServ/LexUriServ.do www.brcbookshop.com
ny’s normal working practice and enables easy infor- products. For areas with multiple formulation process- ?uri=OJ:L:2002:011:0004:0017:en:PDF
mation access. Weighing scales are often important es such as vitamin premixes or spice kitchen, PC- • RASFF – The Rapid Alert System for Food and Feed
material identification points in a traceability system based recipe weighing can provide seamless docu- • Regulation (EC) No 178/2002 of the European (RASFF) enables the rapid exchange of information
(Figure 1). mentation of how much of what component was Parliament and of the Council of 28 January 2002 whenever a risk to food or feed safety is identified.
weighed when, where and by whom. Benefits include This European regulation lays down the general http://ec.europa.eu/food/safety_en
Paper-based systems material flow transparency, better stock management principles and requirements of food law, establish-
A paper system may be cost-effective for processes and human error reduction. Improved production ing the European Food Safety Authority and proce- • METTLER TOLEDO Formulation / Recipe Weighing
with limited number of materials/components and little follow-through may be guaranteed for some industry dures in matters of food safety. Solution
lot combination/split situations. But documentation segments. www.food.gov.uk/multimedia/ www.mt.com/formulation
practice and form design will need to be reviewed to pdfs/1782002ecregulation.pdf
reduce human error risk. Integrated systems • METTLER TOLEDO Quality Data Management
Integrated solutions that include scales, scanners and • GS1 – Global organisation for design of systems in- Solution
Barcode labeling printers from goods-in to shipment provide the highest cluding traceability standards. www.mt.com/freeweigh
Bar code systems can be more accurate where large level of traceability. All data can be linked and pro- www.gs1.org/productssolutions/traceability/gts/
amounts of data need to be tracked. Internationally cessed in real-time, providing clear identification of • METTLER TOLEDO Traceability Solutions
recognized GS1 Standards can ensure integration of raw materials/intermediate components and ware- • BRC Global Standards – This chapter “Traceability www.mt.com/traceability
information throughout the supply chain matching in- housing/storage records. Genealogy trees allow imme- for Standard Compliance and Process Improvement”
formation flow with physical flow. Because of its ability diate upstream tracing and downstream tracking
to provide globally unique identification of trade items, of potentially faulty components and batches.
assets, logistic units, parties and locations, the GS1 General efficiency improvement through functions
System is particularly well suited to be used for trace- such as yield analysis, line performance comparison
ability purposes. RFID systems provide efficient, inter- and stock optimization help improve productivity.
active data management as well but are typically more
Mettler-Toledo GmbH
Industrial Division
Tel. + 41 44 944 22 11

Improved Production Yield through 1 Increasing Regulatory Pressure Requires Traceability
Formulation
Process Oriented Recipe Management From bird flu to bioterrorism threats, modern reality
has forced both governments and food processors
customer events may require investigation into pro-
duction steps. If defective batches appear, the root
Formulation
to impose new rules for food and allied product man- cause of the problem must be identified and measures
ufacturing. taken to ensure future product quality and safety.
The IFS (International Food Standard) – for example –
Food manufacturing companies are under increased pressure to improve plant productivity, requires producers to guarantee traceability of goods Essentially, food producers must document all pro-
product quality and consumer safety. For all three, ingredient traceability and process flow, as stated in IFS Version 5, paragraph 4.16.1: cesses – without gaps. This includes recipe develop-
Similar requirements are stipulated in BRC (British ment, quality lab, production planning, monitoring,
tracking play central roles.
Retail Consortium) Issue 4, paragraph 2.13 and ISO dispensing and packaging / distribution. A computer-
22000, paragraph 7.9. ized and intelligently networked formulation / weighing
Aside from regulations, unpredictable supply-chain or system is key.
International standards designed to ensure product A traceability system shall be in place which enables the identification of product lots and their relation
safety (EC 178/2002, US Bioterrorism Act, FDA, GMP, to batches in direct contact with food, packaging intended or expected to be in direct contact with food.
BRC, IFS, ISO 22000) are cropping up. A prerequisite
to the traceability required is documentation of all rele- The traceability system shall incorporate all relevant processing and distribution records.
vant formulation and weighing process activities.
A computer-guided and networked, rather than paper-

based, production system provides easily accessible
production data. The resulting documentation and 2 True Traceable Formulation/ Weighing Is Computer-Based
analysis can improve quality, reduce waste and protect
both consumers and brand reputation, providing signif-
Truly gapless traceability requires that all involved par- uct shipment. To be effective, manufacturers must en-
icant bottom-line improvement.
ties feed recipe – relevant data – ingredients, struc- sure systems provide relevant data quickly. Some
tures, work instructions, batch and production order governments request access even within few hours.
This paper will address the benefits of investing in such
information – into a centralized system. A computer-
a system as well as considerations that help ensure the
based system’s advantages over a paper-based sys- For example, in a recall, a manufacturer must identify:
system enhances manufacturing processes.
tem include data consistency, speed of data analysis • Who delivered the spices used in batch XY of meat
Contents and improved recall management. pie Z?
1 Increasing Regulatory Pressure • What quantity was used?
Requires Traceability An electronic system can also document processes, • Who released the recipe?
generate weighing and manufacturing reports, and
2 Traceable Weighing/Formulation
print labels to identify goods-in-process. This brings If end-product taste deviates from recipe expectations:
Is Computer-Based
users one important step closer to compliance with EU • What area of processing needs to be adjusted?
3 System Components/Configuration 178 / 2002; BRC; and Controls Used for Manufactur-
4 Integrated Traceability ing, Processing, Packing, or Holding Dietary Supple- Most critically:
5 Summary ments for FDA 21 CFR Part 111 CGMP Regulations. • How quickly can a manufacturer’s current documen-
This type of system is also vital for transparent manu- tation process answer these questions?
6 Additional Resources facturing processes and providing a proper decision
base for streamlining processes. In an effective and fully networked system, this infor-
mation is immediately available when the system of-
End-to-end documentation fers features such as:
Tracking and tracing demands documentation of all
production actions from goods receiving to end-prod-

Recipe Database Customer Order
ORDER
10,000 pouches
Production
10’000
Swiss pouc
pouches
ches
Mountain
Swiss
Herb Mountain
Mou
untain
Candies
Herbs Candies
100g Cand
dies
100g
Delivery date:
Delivery date:
xx.xx.xxxx
Recipe xx.xx.xxxx
Recipe
Recipe 10,000 Swiss
Recipe
Swiss Mountain Recipe
Mountain Herbs
100g
Raw Material
Herbs Recipe Ingredient #1 Preparation
Ingredient #1 Swiss Apple Ingredient #2
Ingredient #3
Upscaled
Ingredient #2 Taste
Ingredient #3 Ingredient #1 Ingredient #4 Recipe
Formulation
Formulation
Ingredient #4 RecipeIngredient #2 Ingredient #5
Ingredient #5 Swiss Ingredient
Valley
#3 Ingredient #6
Ingredient #6 Fresh Ingredient #4
Ingredient #1
Ingredient #5
Ingredient #2
Ingredient #6
Ingredient #3
Ingredient #4
Ingredient #5
Ingredient #6
Weighing & Mixing

Production Report
Traceability Report
Traceability Report
Final Product
Clearly identified materials via labeling / barcoding. can offer a configurable interface between the solu-
At each stage a label indicating material and status is tions and an ERP system such as SAP.
affixed. Corresponding entries are made in the data-
base. Benefit in terms of ROI User-friendly screens simplify weighing and minimize potential operator errors
Online monitoring. Monitoring functions offer informa- Virtually any company blending different materials in a
tion about exceptional factory situations. well-defined recipe can benefit from a computer based
Industry-standard networking. System components formulation system to streamline procedures. More ex- Specialized weigh stations Seamless data exchange
communicate with a centralized database via Ethernet pensive or higher risk materials will produce the fast- For required formulation activities, the following weigh with ERP/MES systems
LAN. Clients such as dispensing stations and control est return on investment; however, nearly any proces- stations are available: As noted previously, ERP interfaces permit integration
devices such as balances, scales and other peripher- sor should be able to prove ROI on an appropriately • Dispensing – batch components are pre-weighed of an appropriately configured and effectively net-
als exchange production data with the server. Win- scaled system in 12 months or less through: and ready for execution worked weighing system with many ERP and MES
dows-compliant applications use standard resources • Reduced consumer risk • Production – components are verified before mixing systems. Seamless data exchange avoids redundant
such as network printers for reporting. • Enhanced regulatory compliance according to recipe sequence data maintenance:
Expandability and connectivity. System expansions • Less product waste • Dispensing & production – combines both actions, • ERP system data becomes available in the
are possible without disturbing other components un- • Lower disposal / rework / recycling costs used primarily at smaller companies where pre- weighing process.
less software is updated. A dedicated ERP Gateway all leading to substantial bottom-line enhancements. weighing is performed in the production area • Production data is sent back without manual
intervention.
Screens must be designed for optimum readability for
fast information recognition and analysis. Clearly visi- All consumption data are available in the ERP/MES
3 System Components/Configuration ble instructions and color-coded weigh process results system without manual interaction. Based on this data
can help ensure a straightforward and efficient pro- exchange stock levels are automatically adjusted.
cess that increases accurate throughput. Seamless exchange supports batch release in the
A standardized configurable system that has been • Orders MES/ERP system, simplifies data handling and avoids
tuned to manage critical weighing process parameters • Preparation batches Security plays a role here, too: Only trained and autho- manual input errors.
has many advantages over client-specific systems • Warehouse status rized users are be able to manage materials via user
with custom programming. • Containers rights configured to their processor status. Additionally,
Standard interfaces allow a high degree of customiza- • Operators if an ingredient entry scanned and checked against
tion while offering expert system maintenance and • Consumption data the recipe does not match, the system can reject it and
support over the life of equipment and software. The • Exceptions produce an error message, reducing human-error risk.
initial investment better maintains its value and can • Production activities Steps become immediately traceable. Hazardous ma-
secure optimal production performance well into the • Password activities terials precautions can also be clearly indicated when
future. • User connections necessary.
• Database activity log
Master data management • Weighing / calibration Ease-of-use considerations reduce time spent in train-
In a networked system, a master station allows overall • Audit trail ing. Standard log-in/lock-out procedures also reduce
data management and maintenance. This can include • Electronic and hardcopy reporting on the above unproductive downtime between operator shifts and
tracking of: enhance security.
Reliability and security are critical. While processes After successful log-in, planned production orders are presented to
• Materials the operator
• Instructions can be controlled at individual process weigh stations,
• Recipes all process data is gathered at the master station.
5 Summary
In an era of modern threat to food safety as well as ponents flow into the production process timely and
increased regulatory scrutiny, a well-designed, com- that available materials are fully exploited. The results
Formulation
Formulation
puter-guided formulation and weighing process are less waste, less rework, less recycling, and low-
results in straightforward, efficient and fully traceable ered production costs. Productivity is significantly im-
food production. proved at the same time compliance with international
regulations regarding materials traceability is assured.
With easily integrated, standardized weigh stations,
label printers and barcode scanners, materials mix- Enhanced output and higher yield from available raw
ups and wrong quantities become history. The result- materials should result in ROI on initial system invest-
ing active stock management makes sure that com- ment in 12 or fewer months.
Barcodes guarantee simple, fast verification with the connected reader
4 Integrated Traceability • 21 CFR Part 111
Controls Used for Manufacturing, Processing, Packing, or Holding Dietary Supplements for FDA 21 CFR Part
In every production step from goods entry to shipment, • Weighing labels. Dispensed materials for an order 111 CGMP Regulations – www.mastercontrol.com/regulations/21_cfr_part_111.html
database entries correspond to in-process materials. are marked. Order, batch and lot number help guar-
In a computerized system, barcode-reader enabled la- antee processors do not mistake components. • Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002
bels assist with component identification and overall This European regulation lays down the general principles and requirements of food law,
traceability during processing. • Pallet labels. These identify a pallet and its contents, establishing the European Food Safety Authority and procedures in matters of food safety –
particularly when materials are placed on a pallet www.food.gov.uk/multimedia/pdfs/1782002ecregulation.pdf
before they are moved into production.
• www.mt.com/formulation
Scans help avoid confusion as materials are brought
into production and ensure that the right material is
added to a mixture at the right moment. Recorded re-
sults help manage stock, FEFO (first expired, first out),
overall inventory and enhance process transparency.
A newly printed weighing label helps

guarantee component identification
Printers connected to weighing workstations can print

labels at the point of identification that enable fast ma-
terials recognition. Label types include:
• Stock labels. These ensure stock is known upon ar-

rival and becomes traceable. Descriptions, lot num-
bers, quantity, delivery date, expiry and status is en-
tered. The material enters the database and is Company logo and safety / danger symbols, as well as important
Mettler-Toledo GmbH
Industrial Division
available for processing. status information CH-8606 Nänikon, Switzerland For more information
Tel. + 41 44 944 22 11

Food Safety 1 Monitoring Food Safety
Food Safety
Fresh Products in Grocery Retail When it comes to ensuring the safety of food products,
traceability is an important instrument. Food retailers
retailers better food safety, reinforces their brands and
strengthens customer loyalty. New opportunities and
Food Safety
rely on documentation about internal and external pro- optional measures for improving food safety emerge
cesses in order to preclude risks. Traceability offers along the process chain.
Existing legislation, such as the FDA Food Safety Modernization Act (FSMA) and EU
Regulation 1169/2011 on the provision of food information to consumers, is increas- Supermarket
Meat Processing
ingly placing responsibility for food safety on retailers’ shoulders. Such regulations Industry Meat Backroom Service Counter Checkout Back Ofﬁce
stipulate extensive declarations, seamless traceability and effective measures for

$
Software
avoiding product recalls.
Food safety is both a duty and an opportunity. For Farming and Pre-packed goods
meat processing industry • Use the data from the ERP
consumers, it is very important to have access to de-
• Ensure receipt of comprehensive system to print a declaration
tailed additional information about a product. Dietary information from suppliers and on the label or packaging in
plans, allergies and risk awareness all play a part in transfer it into the ERP system accordance with the relevant
regulations
purchasing decisions. Retailers who credibly exemplify
• Label or packaging displays
their food safety with effective measures are rewarded the batch number to ensure
with loyal customers who trust their brand. unambiguous traceability
Existing traceability frameworks form a basis for fur- Supermarket Checkout

Back goods received • System control to check
ther potential improvements to food safety. In cases of
• Compare information from the shelf life when scanning
serious food risk, a well-documented product distribu- suppliers against risk alerts $
the item
tion is required and enables product recalls to be exe- • Allocate internal batch number • System control after any
cuted quickly and consumers to be alerted precisely, if and barcode risk alerts
• Sample analysis such as pH • Additional information will be
necessary on a regional level. An unsafe food product
test as part of quality assurance available online for customers
can be identified and removed at every stage along the
process chain. Parameters can include internal sam-
ples of product quality, dates such as the use-by date Storage and backroom Administration
or external events such as alerts by the RASFF in the Contents • Document further processing • Centralized administration and
steps and responsibilities storage of all data regarding
European Union or by the FDA and USDA in the US. 1 Monitoring Food Safety • Collate product information traceability and labeling
Traceability is therefore a very valuable and effective
Software
2 Food Labeling in the EU such as nutritional values and • System control after any
control instrument for food safety. Food retailers benefit input into ERP system risk alerts
3 Food Labeling in the US • Check use-by date, carry out • Set-up of secure infrastructure
from being able to identify critical or repeatedly prob-
quality controls for uniform and up-to-date
lematic process steps and suppliers. 4 Hygiene: Reducing Health Risks maintenance of all connected
devices
5 Additional Ressources
Service counter
• Register batch number of each
service counter produce
• Ensure all the product informa-
tion is accessible at batch level
through the counter scales
• System comparison to check
the shelf life, for example by
entering the PLU
• Visual check of the product’s
condition
• Print receipt containing product
information and instructions
for use

2 Food Labeling in the EU
EU Regulation 1169/2011 on the provision of food
information extended the scope of what must be
Food Safety
Food Safety
declared for many products. Consumers receive more
information to help them assess the quality of a food
product. In the case of fresh products such as meat
and fish, additional data such as nutritional values
are also mandatory. The information must be provided
not only for pre-packed products but also, with some
modifications, for loose products. This also applies to
products which are further processed on retail pre-
mises.
It is mandatory to indicate substances which can

cause allergies or intolerances even in loose food
products such as those sold at the meat counter. The
way in which these must be listed is determined by
the individual EU Member States at national level. It
For pre-packed products, the label must include:
may suffice to print details of the substances on the
s
uct
d
t
foo
receipt or display the information digitally at the point
ea
rod
dm
red
yp
of sale, for instance. It is therefore advisable to provide
se
nce
pa
ker
ee
at
Pre
Me
Fis
employees with online access to all labeling data at
Ch
Mi
Ba
stituted meat or fish products. This also applies to
the point of sale. frozen foods. In the case of minced meat, the fat Name of the food
Country of origin or place of provenance ** ** ** **
content and collagen/meat protein ratio must be indi-
Allergens: Substances which can cause allergies or Use-by date
cated (-> Art. 17).
Best-before date ***
intolerances must be emphasized on the packaging or
label. This can be done by using bold letters (recom- Information on traceability of beef according to regulation
Date of freezing: The date of freezing must be indi-
EU 1760/2000*
mendation of the BRC). However, an emphasized indicated for both frozen meat and meat-based products
Freezing date**
cation will not be required if the name of the food and for frozen, unprocessed fish (-> Art. 24).
Percentage of fat and collagen/meat protein ratio
clearly refers to the substance concerned (-> Art. 21).
Special storage conditions and/or conditions of use
Nutrition declaration: The amounts of fat, saturates,
Country of Origin: Indication of the country of origin is carbohydrates, sugars, protein, salt and the energy Preparation information if required for safe consumption
mandatory for beef, pork, lamb, goat and poultry. For value must be presented in the prescribed tabular of the food
all other types of food, indicating the country of origin format. The prescribed reference value is 100 grams Instruction for storage and instrutions for use in so far as
is voluntary. If the primary ingredient comes from a or milliliters. Additional information per portion is required for safe consumption of the food
different country than that named for the foodstuff, this permitted. The figures are average values (-> Art. 29).
Net quantity or number of pieces
too must be indicated (-> Art. 26).
Price*
Formal requirements: Mandatory information must be
Name of the food: The name of the food should clearly legible and printed in characters using a font Name and address of the food business operator which
is marketing the product
contain extra descriptive information if it concerns size where the x-height is equal to or greater than 1.2
imitation foodstuffs such as analog cheese or recon- millimeters (-> Art. 13). Barcode*
List of ingredients in the case of more than one ingredient

or if it is not obvious from the name of the product
List of ingredients
Nutrition information
Allergens
Alcohol content – if more than 1.2 percent by volume
* Not required by regulation 1169/2011: please check other regulations

** Mandatory information, depending on the type of product
*** can be omitted for bakery products, which by their nature should be consumed within 24 hours of purchase
3 Food Labeling in the US
Food labeling is controlled by both federal and state
law. From a corporate governance perspective, labe-
Food Safety
Food Safety
ling at a minimum, is essential for foods which are
manufactured by a grocery chain for the following
reasons:
• to avoid an unsuspecting consumer from eating
a food product which contains an unidentified
allergen;
• for ease of use when grocery chains produce labels
on food manufactured at the grocery location which
identify ingredients and
• to ensure that procedures for product traceability
are met.
General guidelines for

nutrition labeling at the meat counter
Effective since March 1, 2012, nutrition information
At a glance: labeling for grocery retailers other carbohydrates, polyunsaturated or mono-
must be provided at retail for raw major cuts of
• A ratio like “85/15” is not a correct statement of the unsaturated fat or potassium. For calories, sugars,
single-ingredient, meat and poultry and for raw
lean and fat percentage. It must read “85 percent total fat, saturated fat, cholesterol and sodium, retai-
ground product on the label or at point-of-purchase.
lean” and “15 percent fat” or “% lean” and “% fat”. lers cannot exceed 20 percent of value declared.
All ground or chopped products are covered by
FSIS rule does not cover advertising. So “85/15” can Otherwise the product can be considered mis-
the FSIS final rule – e.g. ground beef, ground pork
be used for flyers and other promotional items, but branded.
and ground turkey.
signs right in front of the meat have to say “85% • Burgers made in the retail store with diced cheese
lean/15% fat”. The statement of fat percentage must and chopped onions are exempt from nutrition labe-
Muscle cuts: Nutrition information is only required to
be contiguous to, in lettering of the same color, size, ling because they are multi-ingredient products pro-
be provided for the major cuts and the ground pro-
and type as, and on the same color background as, cessed at a retail store, not multi-ingredient ground
duct. Major cuts are determined by regulation, they tions for packaged foods. The simplified format will
the statement of lean percentage. or chopped meat products.
not necessary reflect what consumers are purchasing. apply in many cases.
• The minimum nutritional elements that have to be • If a full service meat counter where none of the meat
Information for muscle cuts may be provided at the
shown on the label are: serving size, servings per is packaged until a customer selects a product, sells
point-of-purchase. Nutrition facts panel: The nutrition facts panel may
container, calories, calories from fat, total fat, satu- the major cuts of single-ingredient, raw meat and
be on the principle display panel or on the information
rated fat, cholesterol, sodium, total carbohydrate, di- poultry products listed in the nutrition labeling final
Signs, posters and pamphlets are all acceptable panel, which often is the back panel or the bottom of
etary fiber, sugars, protein, vitamin A, vitamin C, cal- rule, it will need to provide point-of-purchase mate-
means of providing nutrition information for muscle the package. The panel may either be part of the over-
cium and iron. rials for the “major cuts” it sells.
cuts. Grocery retailers can use the UDSA poster based all printed label or applied as a separate sticker.
• Total carbohydrate is a core nutrient and must be • A “servings per container” statement is required
on the Federal Nutrient Database for Standard Refe-
listed on labels or point-of-purchase materials. For on the labels of ground or chopped products. The
rence to comply with FSIS final rule. The regulation The nutrition facts panel format is regulated. Meat and
meat or poultry, total carbohydrates will generally be service per container may be listed as “varied”,
requires the poster to be placed in close proximity to poultry products qualify to use the simplified format. If
declared as “0”. because ground or chopped products are often
the products, but doesn’t mandate a size for the poster. the total square inches of labeling space for the entire
• Nutrient values are not out of compliance, unless random weight products.
package is less than 40 square inches, the tabular
they are more than 20% above the labeled value. • A “servings per container” statement is not required
Ground product: Ground product must be labeled on format may be used. A side-by-side format may be
That rule applies to the labeled values for vitamins, on the major cuts of single-ingredient, raw meat and
the package. The label does not have to be on the appropriate if the regular Nutrition Facts label does not
minerals, protein, total carbohydrates, dietary fiber, poultry products.
principal display panel. The requirements for labeling fit. But in most circumstances, since grocery retailers
ground products are the same as for other packaged can label on the back, they have to go with the verti-
foods, which means they are subject to USDA regula- cal format.
5 Additional Ressources
• Regulation (EU) 1169/2011 of the European Parliament and of the Council of 25 October 2011
on the provision of food information to consumers
Food Safety
Food Safety
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:EN:PDF
• Regulation (EC) No. 852/2004 of the European Parliament and of the Council of 29 April 2004
on the hygiene of foodstuffs
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:139:0001:0054:en:PDF
• FDA Food Safety Modernization Act
http://www.fda.gov/Food/GuidanceRegulation/FSMA/
• METTLER TOLEDO White Paper: Food Safety Regulations
http://us.mt.com/us/en/home/supportive_content/White_Papers/product-organizations/retail/USfoodsafe-
ty.html
• METTLER TOLEDO Webinar: Key Issues in Labeling and Packaging
http://us.mt.com/us/en/home/events/webinar/ondemand/RET_Labeling_Packaging.html
4 Hygiene: Reducing Health Risks
When preparing or selling fresh food items, the top • Regularly check the cleanliness of the counter and
priority is to provide customers with perfectly safe, temperature in the display cabinets
untainted products. Defining and maintaining good • Implement cleaning and disinfection plans for criti-
hygienic practices guarantees that customers receive cal control points
safe food products. Hygiene measures reduce the
exchange and spread of microorganisms such as Cleaning and disinfection
bacteria to a non-hazardous level. Grocery retailers It is essential to ensure that HACCP rules for cleaning
are required to define processes and set up control and disinfection are followed. Important: cleaning does
mechanisms which ensure adherence to the hygiene not mean disinfection. A proper disinfection needs
measures. These are founded on the basic principles specific products and should be done after each
of HACCP for targeted recognition and prevention of cleaning in order to ensure a high hygienic standard.
hazards. For cleaning and disinfection of the counter, equipment
and backroom, it is highly recommended to only use
Good hygiene practices food safe products. Standard non food safe products
Front-of-store and backroom employees are crucial can contain flavor and colorant agents which may
to the effectiveness of good hygiene practices. Clear contaminate the food with allergic components.
work instructions and responsibilities as well as regu-
lar controls ensure long-term success. The main focus Using spray for cleaning or disinfection should be
is on direct contact with the fresh, unpacked goods: avoided, as the mist could accidentally spread to
• Handle meat, cheese and cooked meats using clean areas where food is stored, which could lead to
forks or tongs whenever possible contamination. Additionally, spraying cleaning prod-
• When removing items for weighing, always place ucts can also be dangerous for employees if they
them immediately on suitable paper or film breathe in the mist. The hygienic condition of work
• Do not use staples – they present a hazard around surfaces, utensils and other equipment used in
food. Instead, seal bags using labels the preparation and sale of fresh food products
Mettler-Toledo (Albstadt) GmbH
Unter dem Malesfelsen 34
• Wash hands and disinfect regularly, e.g. after han- needs to be critically monitored continually. Regular 72458 Albstadt, Germany For more information
Tel. +49 7431 14 0
dling a transaction or before switching to a different cleaning and maintenance is an essential part of
Fax +49 7431 14371
task such as food preparation good hygiene practices.

32 METTLER TOLEDO © 06/2017 – Food Regulatory Guide MTSI 30364125 / Marcom Industrial 33
Package Quality Control 1 Cost Control through Optimized Filling
Quality Control
Net Content Control Filling is subject to a large number of influences that
can cause fluctuations in packaged goods weight.
general overfills can be costly and lower the revenue
considerably. Even with the modest output rate of
Quality Control
However, weight fluctuations must not cause the net smaller companies, corresponding product give-away
weight of even a single package to fall appreciably be- costs are striking.
low stated net weight. Government regulations gen-er-
Billions of packages of all kinds are filled around the world every day. “Package” can ally specify permissible underfill amounts. Accurate monitoring and quality data management
mean bottle, jar, tube, box or can – any container filled with product. All prepackaged provides better results. Giving the process closely con-
Some manufacturers systematically overfill to elimi- trolled limits can help reduce expensive product give-
goods by law display net weight or volume and number of pieces. Today, the value of a
nate risk of consumer and legal complaints. But such away.
product includes more than its assignment. Saleable elements include safety and image
as well. Even simple products include these elements and can influence their perceived
compliance with regulatory requirements and enhance consumer acceptance.
Thorough product inspection includes ensuring pack-

2 Available Methods – Random Sampling and 100% Inspection
ages contain labeled amounts. Statistical Quality Con-
trol (SQC) can help. A quality assurance system based In many countries static scales must be used to verify In-depth understanding of filling machine scatter and
on SQC provides, among other attributes the following compliance with net content legislation and produce package parameters are essential to select the right
core quality data: package tare weight verification reports. Product spe- sampling method, random sampling on static scales
• Production (period) mean value cific parameters and processes, in combination with or 100% checks of all packages using dynamic
• Number of violations of the legally defined tolerance financial and economic factors, usually dictate which Checkweighers.
limits T1- and T2- method is beneficial on a production line.
• Mean standard deviation of the production (period)
• Other quality or safety relevant attributes (CCPs)*
Random sampling control 100% inspection control
with static scales with dynamic checkweighers
A suitable control system must be fast, simple to op-
• Random sampling, • All packages are checked (100%)
erate, reliable and objective and requires an up-front • Rapid product change (size, weight) • Tolerance infringements are automatically
investment. However, the right system can increase Contents • Low space requirements sorted out
productivity and provide a return on investment within • Low system costs • Use in filling processes in which access to the
1 Cost Control through Optimized Filling • Tare weights, component weighing and filling head product is difficult
12 months through:
• Minimized product giveaway caused by excessive 2 Available Methods control • Less control personnel
• Optimum regulation to the nominal fill quantity • Operator errors less probable
and continuous overfilling 3 System Considerations • Allows collecting and analyzing additional quality • Slightly higher deviations
• Prevention of government obstacles to 4 Summary and safety attributes
product distribution • Higher accuracy and repeatability
• Better end-user product acceptance
• Streamlined QA procedures/personnel
• Prevent legal conflicts Process and economic factors to consider when choosing static or dynamic checkweighers include:
• weight fluctuation potential, filling machine repeatability/scatter
This paper addresses the aspects and benefits of • product characteristics (package weight, package size, shape, …)
implementing robust quality data management so- • production line throughput
lutions and systems, such as METTLER TOLEDO’s • trade off between sampling speed and measurement precision
FreeWeigh.Net®, to ensure overall product quality • initial investment budget
and safety improvement. • running costs of ownership
• manual efficiency and personnel costs
SQC delivers good results SQC or 100% depending on speed 100% checks allow to sort out defects
and product

How SQC helps The question of the optimum or lowest, possible fill
To truly quantify and control product fill, an under- quantity can be answered irrespective of the control
standing of Statistical Quality Control (SQC) is re- system used. The goal of the filling process is to attain Product Definition in the
specifications product catalog
quired. SQC takes random sample data and creates optimum mean filling quantity while fulfilling net con-
comprehensive quality control information. tent legislation requirements.
Quality Control
Quality Control
This information helps ensuring that a batch meets
legal requirements.
Product selection
at the test site
Cost effectivness in the filling plant Monitoring Sample/data

and report acquisition
Mean fill weight
Average fill quantity

Declared fill quantity
= Gaining quality information can be broken down to five easy steps with a well-designed solution.
Step 1: Product specification

Tolerance limit T1-
Define declared net content, applicable tolerances, tare management and other quality attributes
Tolerance limit T2-
No packages allowed in this area
Step 2: Catalog definition
Adding product data and test item information to define the quality process
Consumer protection / legal requirements
SQC spot-checks determine batch acceptability Step 3: Product selection

Product is selected on the test scale or terminal in direct dialog with the system
Step 4: Sampling / data acquisition

3 System Considerations Samples are taken, guided by the system according to test plan and quality process
Step 5: Monitoring and reporting

Ideally, a solution should address any needs for quali- Data connectivity Results are automatically analyzed by the system and process deviations lead to immediate, alarm messages to
ty data acquisition throughout the factory and test labs. Industry standard data communication interfaces such
operators and supervisors.
It should be highly configurable and expandable to en- as Ethernet with TCP/IP protocol, help keeping infra-
Printed reports in addition to electronic records can be produced based on documentation requirements
sure an enhanced degree of control with no need for structure costs low when adding and networking in-
software engineering during implementation or daily strumentation such as balances and scales, check-
routine. System design considerations include: weighers, metal detectors, terminals and sensors to a
comprehensive quality-control system, as well as oth- Enhanced compliance
System usability er existing devices to protect given infrastructure and If the process begins deviating from the target, the The US FDA has implemented 21 CFR Part 11 in such
Intuitive user interfaces allow increased setup flexibility, limit investments. chosen solution should ensure that appropriate correc- a way that electronic audit documents become the
ease of operation and more precise control during fill- tive measures can be taken for enhanced compliance original, while paper printouts are non-binding copies.
ing and packaging. Easy and fast data access as well as optimized production. For compliance track- Companies wishing to comply with 21 CFR Part 11
Easy and fast access to production parameters is cru- ing, traceability of all quality and safety relevant data must therefore implement systems that support it.
cial. A key parameter in most cases is fill quantity. is critical over the entire life of ingredients as well as
However, increasingly other parameters such as for- final products. Overall, a well-implemented quality data management
eign body detection, ingredient analysis data (e.g. pH, solution or system reduces user error and subsequent
moisture …), results from visual inspection or any re- Increasing regulatory requirements require food indus- loss of product information. The resulting improved
sults from other critical control points. tries such as infant formula or nutraceuticals to adapt product quality helps a manufacturer reach important
the longer the more to Pharma like practices such as operating targets.
‘audit trail’ or electronic record keeping.
4 Summary 5 Additional Resources
Overfill cost is directly related to raw material costs. Various solutions are available, such as static scales • WELMEC (European Cooperation in Legal Metrology)
But safe-margin overfills are an effective way to en- for offline random sampling, as stand-alone or www.welmec.org
Quality Control
Quality Control
sure compliance with net content legislation. network solutions of net content data or inline check-
Overfills are costly, even with the modest output rate weighers for 100 % data checks. Additional information on METTLER TOLEDO solutions can be found under the following links:
of small companies. Calculated, minimized overfilling
can be very effective at controlling giveaway and its • General SQC information
resulting expense without increasing personnel costs. www.mt.com/sqc
new
• SQC Application Overview
www.mt.com/sqc-application
Package quality Product quality • Quality data management solution FreeWeigh.Net ®

parameters parameters www.mt.com/freeweighnet
Sealing ok? Sensory test
Label ok? Visual appearance (colour …) • Request your free copy of the comprehensive SQC guide
Undamaged? Single piece weight www.mt.com/sqc-guide
Net content ok? Viscosity
Texture i.e. particles size • Asses your potential savings through reduction of overfilling – ROI Calculator
Expiry date ok?
Moisture www.mt.com/sqc-calculator
Batch/lot ID ok?
pH-value
Metal free?
Typical FreeWeigh.Net ® screens

Product quality – a function of countless individual variables and attributes can be processed with FreeWeigh.Net ®
A state of the art quality data management system, at individual workstations can account for unique
such as METTLER TOLEDO’s FreeWeigh.Net® offers company structure and expansion. It also integrates
multiple benefits to food manufacturers. It allows data easily with MES or ERP systems.
collection for important quality attributes from static
scales, in-line Checkweighers, Foreign Body Detectors, An integrated quality data management system is an
pH meters, sensory test panels. It alerts operators to excellent way to achieve better quality control and real
required adjustments almost immediately, thus helps cost-savings. METTLER TOLEDO offers solutions and
preventing failed production batches. Further, central- systems that pay for themselves and provide a full ROI
ized test planning and decentralized data acquisition within 12 months or less.
Mettler-Toledo GmbH
Industrial Division
Tel. + 41 44 944 22 11

In-line Checkweighing 1 Benefits of Checkweighing
In-line Checkweighing
Aspects of a Key Technology As part of overall quality control, checkweighing pro-
tects both manufacturer and consumer. Manufacturers
manually can now be collected in a fraction of the time
by a checkweigher, resulting in the following benefits.
are assured that they use raw materials effectively and
offer compliant products. Their brand and reputation is Improved resource use
protected. Consumers receive a high quality product An accurate checkweigher makes the most of existing
A checkweigher is usually part of a typical quality control system, ensuring that every that includes the correct net content or parts. resources though tighter production tolerances. More
product leaving a production line is the right weight and corresponds to packaging re- items can be created using the same amount of raw
Today’s technology makes checkweighers more reli- materials. Figure 1 shows a simple calculation to un-
quirements. Selling products with incorrect weights causes problems for manufacturers:
able and accurate than ever before. The information derline the savings which can be made by reducing
underweight products can result in companies being fined, whilst overweight products that a quality team would have previously collected overfill by just 1 gram.
generate expensive product giveaway.
Package and production information Savings (1 gram overfill reduction)

Checkweighers systematically weigh 100 per cent of Labelled package weight = 450 grams 0.1 ct savings per package
production line items and provide a complete overview Material cost = 0.1 ct per gram 20 ct savings per minute
Line rate = 200ppm €12 savings per hour
of data such as:
Line utilization = 65% €124 savings per day
• Product counts Shift = 8 hours €28,704 savings per year
• Batch tracking Shifts per day = 2
• Total weights Production days per year = 230
• Good weights The reduction of 1 gram overfill as shown in this example would free enough raw materials to produce an additional 60,000 products
• Rejected weights Figure1: Example Showing the Impact of Reducing Overfill by 1 gram
In an increasingly competitive marketplace, check-

weighers are essential in fulfilling ever-changing
customer needs and in complying with local Weights Enhanced product consistency
& Measures standards, as well as global standards. A line with a throughput of 100 packages per minute
where 15 packages are manually sampled every hour
Different checkweighing approaches and implemen- means only 0.25 percent of total packages are sam-
tation considerations are discussed in this paper. pled. A checkweigher however automatically weighs
Contents 100 percent of all packages on the line. Operators can
react immediately if a problem is detected to ensure
1 Benefits of Checkweighing
results are more uniform.
2 Checkweigher Uses/Statistical Uses
3 Production Phases where Checkweighers Increased overall equipment
Are Used effectiveness (OEE)
4 Static and Dynamic Checkweighers Checkweighers provide real-time monitoring of pro-
5 Integrated or Combination Systems duction processes, including yield statistics and SPC
Figure 2: Real-Time Monitoring of Production Processes
trending all of which can be used for process improve-
6 Summary ments and operating efficiencies (Figure 2). This can
7 Additional Resources result in increased OEE. Better net content
Net content laws and regulations differ from country to
Filler monitoring country. However, an effective checkweigher program
Active monitoring of filler performance minimizes over can minimize risk of non-conformance and eliminate
and underfills by keeping filler heads properly adjust- potential lawsuits and customer complaints.
ed. Checkweighers communicate directly with the filler
control/network and existing factory automation for
seamless feedback control.

Fewer false rejects, less rework Brand/legal protection the next process stage. This eliminates rework • After case packing – specialized checkweighers
and reduced scrap Branding frequently drives repeat purchases and justi- and costly waste in the secondary production called caseweighers ensure short cases are not
An accurate, well-maintained checkweigher improves fies premium product pricing for manufacturers and phase. shipped. They may also transmit case weight data
processes while reducing scrap and reworks. False re- retailers. If a company is investigated after consumer to a manifesting system for shipping. This check-
complaints, checkweigher documentation will provide • Secondary packaging – ensure all components weigher is also used for large bulk product bags
jects are also minimized. Accuracy becomes more
precise as zone settings are refined. invaluable evidence of appropriate quality control. have been included in the final package. such as 25kg bags of dry dog food or flour for net
weight control.
2 Checkweigher Application/Statistical Application
Checkweighers perform a critical range of quality con- • Weight zone or classification analysis
trol functions based on weight. • Monitoring efficiency through total count
and total weight
Manufacturers use checkweighers to:
• Check for under and overweight
• Check volume or density (bread, yogurt) Figure 4: Checkweigher usage in manufacturing operations
• Ensure net content for pre-packaged goods
• Measure raw/unwrapped food prior to packaging
• check for missing components
(labels, instructions, lids, leaflets)
• Verify counts for warehouse or delivery 4 Static and Dynamic Checkweighers
• Check mixes for solid-to-liquid ratio
• Reduce giveaway through filler adjustments
• Classify products for grading or portioning ensure In many countries static scales must be used to usually dictate which system is used on a
customer or agency (USDA, FDA, OIML, FPVO) Figure 3: Monitoring production data
sample product for completion of net contents and production line.
standards are met package tare weight verification reports. Processes,
• Report production line data to drive process im- • Providing SPC for closed loop control and automatic in combination with financial and economic factors, A comparison of static and dynamic checkweighers
provement process adjustments follows.
• Interfacing with business systems, Programmable
Statistical uses include: Logic Controllers (PLC) and SCADA systems that Static checkweigher Dynamic checkweigher
• Weighs stationary objects • All packages are checked (100%)
• Monitoring speed efficiency (packages per minute) link the checkweigher to the production process,
• Requires manual intervention • Tolerance infringements are aretomatically sorted out
• Monitoring standard deviation for out of tolerance including checkweigher remote control
• Sample spot-checking • Use in filling processes in which access to the product
conditions or trends • Target weights/sample tests is difficult
• Keeping and management of regulatory records All of these uses add up to increased quality control • Higher accuracy/repeatability •100% process control
• Analyzing filler head performance and its resultant production line and compliance • Slightly higher deviations
• Accumulating totals for a day, shift, hour, batch or run improvements. It may even lead to reductions in
• Providing Statistical Process Control (SPC) charts for quality control personnel.
manual process adjustments Process and economic factors to consider when • Production line throughput
choosing static or dynamic checkweighers include: • Trade off between sampling speed and
• Initial investment budget measurement precision
• Weight fluctuation potential, filling machine repeat- • Initial investment budget
3 Production Phases where Checkweighers Are Used ability/scatter • Running costs
• Product characteristics (package weight, package • Manual efficiency and personnel costs
size, shape, ...) • Governance of sample rates
Figure 4 shows four distinct areas where checkweigh- a signal to the divider/former to maintain consisten-
ers are typically used in a manufacturing operation. cy and reduce giveaway.
These include:
• Primary packaging – to checkweigh tubes of
• Prior to packaging – such as handling raw dough frosting prior to cartoning to keep fillers tuned and
prior to freezing. The checkweigher could also send prevent non-conforming product from reaching
5 Integrated or Combination Systems Checkweighers are used to:
• Check under- and overweight, volume and density
Both static and dynamic checkweighers have places
on production lines. Decisions about how to imple-
• Ensure net content ment each must be made based on application and
Integration of other inspection devices such as metal Primary benefits of combining devices include: • Check for missing components budget.
detectors, X-ray devices, cameras, scanners, marking • Consolidation of user interfaces • Verify counts
systems or sensors makes the checkweigher part of • Reduced for set-up and line changeover time • Classify products for grading or portioning Integration of other devices such as cameras, scan-
a high performance product inspection solution. • Less opportunity for operator error; shorter training • Ensure customer or agency standards are met ners, metal detectors and X-ray systems add up to
• Reduction in maintenance and cleaning costs • Report production line data to drive process a high performance inspection solution, providing
Integrated systems make it easy to check for a wider • Smaller equipment footprint; maximized production improvement benefits such as a smaller warehouse footprint and
variety of quality control items, such as: space reduced maintenance costs.
• Open flaps, missing caps
• Package orientation and skew detection Using a combination system, rejected products
• Printed information such as batch number, expira- can be quarantined at once for effective management
tion date of non-conforming products.
• Bar code labels and RFID tags 7 Additional Resources
• Contaminants such as metal, stone or glass Integrated systems are easier to install and usually
less expensive than separate systems.
• METTLER TOLEDO Garvens Principles of Checkweighing Guide serves as a definitive checkweighing reference
work with helpful information on everything from basic principles to comprehensive program implementation.
Request your free copy at
www.mt.com/cwguide
• White Paper – Overall Equipment Effectiveness (OEE)

Increasing the productivity of a production line is not just a matter of buying faster equipment. Using the OEE
(Overall Equipment Effectiveness) calculation, companies can become more efficient and utilize their process-
es more effectively. This white paper describes OEE in detail and shows, using the simple calculation, how you
can improve productivity whilst also reducing costs.
www.mt.com/Garvens-OEE
• METTLER TOLEDO On-demand webinars allow 24/7 self-paced learning on a wide range of important process
integration topics
www.mt.com/pi-ondemand
• OIML – International Organization of Legal Metrology OIML R87 Quantity of product in prepackages
www.oiml.org/publications/R/R087-e04.pdf
• NIST – US National Institute of Standards and Technology, Handbook 133, Fourth Edition
Checkweigher combination systems with x-ray or metal detector http://ts.nist.gov/WeightsAndMeasures/upload/Complete-HB133-05-Z-2.doc
6 Summary
Today’s technology makes checkweighers more reli- • Less product giveaway

able and accurate. Information previously collected • Enhanced consistency and operational effectiveness
manually can now be collected in a fraction of the • Better net content
time, resulting in: • Reduced scrap
Mettler-Toledo GmbH
CH-8606 Greifensee, Switzerland
• Improved quality control • Brand/consumer protection Tel: +41-44-944 22 11 For more information
• Better raw materials use rates Local contact: www.mt.com/contacts


Vision Inspection 1 Why Vision Inspection?
Vision Inspection
Driving Quality and Process Security Vision inspection helps to prevent defective product
from being distributed – a very valuable function for
Vision Inspection
manufacturing, assembly and packaging operations.
Research shows that 65 percent of consumers refer to

Vision inspection provides highly specialized and effective quality control. packaging when buying products. If a package's label
It brings together cameras, lights and image processing software in a unified is missing, incorrect or damaged, a customer may be
exposed to an allergen or harmful ingredient unknow-
system which inspects high speed manufactured packaging and labels.
ingly. This exposes the manufacturer to a potential
lawsuit on top of the cost of a product recall and po-
tential lost business. The Canadian Supplier “Packag-
ingWorld.com” confirms that 55 percent of food indus-
Vision systems help to prevent distribution of defective try recalls arise from improper labeling.
products and significantly enhance a manufacturer’s
quality assurance. This reduces the risk of a product In an effort to reduce these label-based product recalls, ability to inspect every product on the line, vision
recall and its associated costs by preventing the distri- manufacturers are turning to vision systems. With the ensures defective products never reach customers.
bution of mislabeled or poor-quality packaging to con-
sumers. They can even lower personnel costs because
fewer employees are required for quality control.
2 Introduction to Machine Vision Systems
Unlike a human inspector, vision systems never blink.
This ensures that every product on the line is inspected
for defects. Machine vision brings together cameras, lighting and ing devices feature the latest in frame-grabbers, soft-
image processing software to create a system that ware, and sensor technology.
This paper seeks to support vision inspection imple- “sees” objects, accurately inspecting them for flaws
mentation by exploring uses, benefits and system at high speeds. The vision software is the brain of the Machine vision systems cost-effectively:
design considerations that assure optimum function Contents system, processing the camera images and comparing • Conduct item inspections
at high line speeds. 1 Why Vision Inspection? them to stored images of how products should look. • Verify accuracy of work-in-process assembly
• Maintain “e-pedigree” records tracking a product
2 Introduction to Machine Vision Machine vision has become more sophisticated and through the production and packaging life. This
3 Uses of Vision Inspection user-friendly since its introduction in the 1980s. Initially, helps demonstrate due diligence as well as maintain
4 Reasons for Establishing Vision Inspection optical character recognition (OCR) systems were used package quality.
in industrial applications to read and verify letters, sym-
5 Designing for Reliability
bols, and numbers. Today’s higher-level image captur-
6 Summary
Light source –
Camera – “Eye of illuminates product
System” – captures being inspected
inspection image
used by system
Product being
inspected
PC – supporting the
HMI, and software

3 Uses of Vision Inspection Customer/consumer protection
Modern manufacturing techniques are constantly im-
While no legal requirement for vision systems exists,
the records and statistics produced by a vision system
proving to eliminate quality defects, although there is can provide evidence of due diligence in the event of a
By inspecting products and packages at production • Identify products /pallets – alpha/numeric & bar always a risk that the processes or procedures can product recall or lawsuit. Additionally, recent legis-
line speeds, a machine vision system can instantly codes are verified; item placement is ensured and break down. Manufacturers have an obligation to min- lation in the United States has placed an even greater
Vision Inspection
Vision Inspection
identify: pallets are identified as correct before shipment imize these instances and ensure consistent quality emphasis on the product labeling process, making
• Damaged or malformed products and packages • Confirm parts – coding verification helps ensure and end-user safety. Vision inspection can protect vision inspection a more attractive proposition.
• Misapplied elements such as crooked caps or proper assembly retailer relations and future business opportunities.
incorrect labeling • Update inventory & maintenance data – Minimizing risk of product recalls/returns
• Missing parts or kit components communicating with an enterprise system to update Brand/reputation protection The consequences of a defective product reaching the
production, inventory and maintenance data; if de- Strong product branding gives retailers and consum- marketplace continue to increase. Consumers may
Such a system can simultaneously check a bottled fects exceed threshold, the line can be shut down for ers assurance of safety and quality, drives repeat pur- take legal action or contact media. In order to protect
liquid product for a misapplied cap, proper neck shape, adjustments chases and justifies premium product pricing. For this themselves, retailers will often fine manufacturers who
foreign material, fill level, and the presence or posi- • Facilitate automatic changeovers – automatically reason, a manufacturer must protect the brand and deliver defective products. This adds to the difficulty of
tioning of the label. The right system will also track adjusting camera position and conveyor speed after company reputation. Documentation provided via a getting fairly priced product on store shelves. The over-
rejects so management can use the information to viewing a new package or programmed puck. vision inspection system can provide evidence of a all result can be devastating to a manufacturer's bot-
further improve processes. sufficient protection program. tom line.
Of course, the level of automation depends on cus-
A vision system can easily: tomer needs and budget. Competing systems offer An effectively managed vision inspection program
Adherence to best practices/
• Reject defective items – some systems even sepa- various feature combinations. METTLER TOLEDO can help keep defective product from reaching retail-
industry standards
rate defective packaging to be recycled from con- CI-Vision, for example, can include all of the features ers. It can inspect one hundred percent of products
Vision inspection systems frequently become the focus
taminated packaging to be scrapped described above and more. coming down a production line at real time, lowering
of audits, especially if they are used as a CCP in a
risk of product recalls, returns, and fines.
HACCP program. They provide evidence of a factory-
wide quality program and can help with:
• Internal food safety and management system audits
• Retailer audits
4 Reasons to Establish a Vision Inspection Program • Quality management system audits e.g.
ISO9001:2000
• HACCP audits, including BRC, IFS, SQF 2000, and
It is important to identify why the program is being selecting a vision system with flexibility in its design
ISO 22000
considered. ROI for a well-designed vision inspection a better long-term investment.
program is achieved through:
• Minimized quality defects Quality assurance
• Enhanced customer/consumer protection Quality problems can cause output loss – particularly
• Protection of company brand and reputation on high-volume automated lines. Such costs can be
• Easier adherence to best practice guidelines and easily overshadowed when customers or consumers
industry standards discover defective product, which can result in product
• Minimized risk and of product recalls and returns recall, damage to the brand, adverse publicity, and
• Staff reductions potential legal action.
• Lowered costs resulting from the above
A thorough vision inspection program reduces internal
When a vision inspection program has been optimized waste, improves output, and all but eliminates cus-
for a manufacturer’s desired inspection capabilities, tomer complaints. This inevitably yields a better return
benefits and cost savings continue year after year. than money lost to additional raw materials, line
Changes to a product's packaging shape or design downtime, consumer response tactics, and lawsuits.
can render a less-flexible system design obsolete, Higher profitability is the result.
which can have a negative impact on ROI. This makes
5 Designing for Reliability 6 Summary
External factors influence reliability in predictable ways. Inspection speed Vision inspection can be a critical element in a system ROI is achieved through:
Accommodations for these external factors must be While conveyor speed is seldom a factor when dis- that prevents distribution of defective product and • Enhanced customer/consumer/brand protection
Vision Inspection
Vision Inspection
considered to ensure: cussing system reliability, the processing power of the can significantly enhance quality assurance. Vision • Best practice and industry standard adherence
• statistical repeatability – detecting the same defect vision system is often the critical factor which will de- inspection systems never blink, detecting virtually • Fewer product recalls/returns
on the same bottle sent through the system multiple termine how quickly inspections can happen. The 100 percent of the defects they are programmed to • Reduced personnel
times to consistently detect defects at production more powerful the processor, the faster the inspection capture, helping to ensure defective and mislabeled • Lowered costs
speed; and system can perform. products never reach consumers.
• measurement repeatability – ensuring measure- Mechanical design, environmental conditions, inspec-
ment differential on a single part measured multiple Lighting Machine vision cost-effectively identifies: tion speed, lighting and product handling must be
times is no greater than a small fraction of tolerance. Optimum set-up requires experimentation so inspected • Damaged or malformed products and packages considered in the system design phase or when com-
features present with maximum contrast. Good set-up • Crooked caps or labeling paring different solutions. Thus, different solutions are
When comparing solutions, ensure that repeatability increases performance and decreases software com- • Correct pallets/parts best considered in their operating environment.
is being measured the same way. In-line simulations plexity. Possibilities include: • Inventory automatic line changeovers
make sure that inspections are repeatable for the in- • Diffuse darkfield, axis, and backlight methods When a vision inspection program has been optimized
tended application and operating environment. Factors • Fluorescence, infrared or ultraviolet light for a manufacturer’s desired inspection capabilities,
that influence repeatability and reliability include the • Spectrum verification for color benefits continue year after year.
following. • Polarization to increase contrast between direct and
diffuse reflection
Mechanical design
As the camera’s lenses, standoff distances and light Multiple illumination set-ups or camera stations might 7 Additional Resources
sources are determined, mechanical setups including be required to avoid interference among inspections.
camera and light mounts must be considered. Devices Different colored lights in combination with colored
must be protected against vibration or shock; isolation camera filters may be another alternative. • METTLER TOLEDO CI-Vision “Building an Effective • METTLER TOLEDO On-demand webinars allow 24/7
might be necessary. Vision Inspection Program” Guide serves as a defini- self-paced learning on a wide range of important
tive reference work and provides detailed insight into process integration topics
Product handling
Cameras and light positions should be adjustable specifying and installing the right vision inspection www.mt.com/pi-ondemand
Product must display in a consistent manner. A well-
independent of each other and include appropriate solution. Request your free copy at
designed solution can handle a certain amount of
lock-down. www.mt.com/ci-vision
variation in product presentation through software or
special optics.
Environmental conditions
Plant vibration, dust, ambient lighting, humidity, and
temperature changes can become acute when running
multiple inspections at high speeds. Consider equip-
ment in factory conditions to avoid undesirable line
speed reductions in production.
Mettler-Toledo GmbH
Tel: +41-44-944 22 11 For more information


Foreign Body Detection 1 The Case for Metal Detection
Metal Detection
Metal Reasons for implementing a professional metal detec-
tion program include the ability to:
No broad-based legal requirement for metal detection
yet exists, though different global HACCP based food
Metal Detection
• Minimize costs safety standards put the burden of establishing reliable
• Increase manufacturing uptime product inspection programs on manufacturers to mi-
• Enhance consumer protection nimise the risk of foreign body contamination within
In order to make informed decisions about metal detection systems, it is important • Maintain brand/company reputation the finished product. In legal proceedings, metal de-
to gain an understanding of the main system components and principles of operation. • Meet certification and compliance standards tection systems help manufacturers prove due dili-
• Demonstrate due diligence gence. Major retailers may also instate their own
This chapter aims to deliver a basic overview and develop an understanding of metal
codes of practice. Increasingly, formal metal detection
detection technology, equipment capabilities and performance. A metal detection program based on effectively de- is expected before supplier approval is granted.
signed and installed technology is critical. It can help
a manufacturer avoid costly contamination errors Metal detection has also become important in safety,
A metal detection system can represent a significant that damage machinery and cause loss of output customer, quality, and regulatory audits such as FSSC
capital investment. Equipment must be designed for in-process or result in a product recall, adverse pub- 22000 and SQF1000/2000 Code, as well as FDA,
the intended application and used in an effective man- licity, and legal action after shipment. USDA, IFS and BRC national/international certification
ner to ensure ROI. A solid metal detection program can standards. Links to more on these standards can be
reduce incidents of broken machinery and resulting found in this paper’s Additional resources.
output loss when metal items are discovered before
processing. Perhaps more importantly, a metal detec-
tion program can reduce litigation risk and mone-
tary / brand image costs when metal contaminated 2 Metal Contamination Sources
products are discovered after delivery.
A well-designed metal detection program must focus Contamination sources include: Good working practices help keep these metal parti-
on good manufacturing practices, correct equipment • raw materials – lead shot in meat, wire in wheat, cles from entering production flow. However, correct
selection, proper installation and consideration of tractor parts in vegetables, hooks in fish metal detection
equipment in a broader foreign body/metal detection • personal effects – buttons, pens, jewelry, coins, equipment selection
program. keys, hair/paper clips and integration maxi-
• mechanical maintenance – screwdrivers, welding mizes product rejec-
This paper will seek to support implementation of an Contents slag/copper wire/metal shavings following repairs tion once metal has
effective program by exploring: 1 The Case for Metal Detection • plant processing – crusher, mixer, blender, slicer entered the produc-
• Reasoning for metal detection and transport system parts including screens, mill- tion stream.
2 Metal Contamination Sources
• Metal contamination sources ing slivers and foil
3 Production Stages where Metal Detection
• System components
• Often-overlooked system design considerations
Is Used
• Additional resources on detection and governing 4 System Components
standards 5 Key Design Elements 3 Production Stages where Metal Detection Is Used
6 Summary
7 Additional Resources Metal detectors are primarily used at two production Finished Product Inspection, which eliminates con-
stages. These are: sumer danger and ensures compliance with retailer
and consumer brand quality standards.
Bulk “In-Process” Inspection, which eliminates metal
before bulk items are broken down to protect machin- A combination of inspection types often provides the
ery (grains/meat before milling/grinding) and reduce best results.
product/packaging waste by eliminating the need to
reject finished product.

4 System Components Metal detector selection should also meet a product’s
hygiene requirements and operating environment. If
Good conveyor design can avoid loops that create
static build up and interference. Fully welded structures
the product is high-risk, such as meat or dairy, the with appropriate metal-free zones, isolated rollers, pul-
A typical system consists of four main parts. plastic chutes mounted on an incline or non-metallic metal detector should be constructed to withstand leys, cross structures and detector head mountings are
pipes mounted horizontally or vertically to inspect deep cleaning and sterilization to avoid expensive re- essential. Belts should be metal-free and manufac-
Metal Detection
Metal Detection
Detector coil/search head powders or liquids. pairs resulting from water/steam ingress. tured with contaminant-free joints. Anti-static materials
The first type of metal detector utilizes a ‘balanced coil’ should be avoided.
search head. Detectors of this design are capable of Automatic rejection system If a metal detection system is to be used in a potential-
detecting all metal contaminant types, including fer- An automatic reject device is often fitted to the trans- ly explosive environment such as a flour mill, system If these precautions are not taken, false rejects gradu-
rous, non-ferrous and stainless steels, in fresh and fro- port system to remove contaminated product without design should be certified and the manufacturer ap- ally increase. The easy solution is to downgrade
zen products. The products being inspected can be ei- manual intervention. Styles include air blast, push proved to sell such systems. equipment sensitivity. However, this can result in con-
ther unwrapped or wrapped, and can include products arm, or drop flap. Reject device type depends on the travention of sensitivity standards and poor perfor-
wrapped in metallised films. inspected product. A more in-depth look at other performance consider- mance.
ations follows.
The second detector type utilises permanent magnets Other components Non-conveyor design
in a ‘Ferrous-In-Foil’ search head. These search heads To enhance total system capacity and support due Balance stability/vibration immunity Similar considerations should be given to metal detec-
are capable of detecting ferrous metals and magnetic diligence extra fail safe and monitoring systems are The majority of metal detectors in use today are bal- tion systems that do not incorporate conveyors such
stainless steels only within fresh or frozen products now widely available and may include: anced coil, so mechanical stability affects perfor- as vertical pipelines for liquids and slurries. Poorly de-
which are packed in an aluminium foil wrapping. • A rejected product collector/container mance. Very small movements, such as temperature signed supports and reject devices reduce metal de-
• A cover between detector and reject device expansion, mechanical shock, or external vibrations tection program effectiveness.
User interface/control panel • A failsafe alarm to signal faulty operation can cause false triggers or balance drift.
The front-end of the control system, the user interface • A sensor to confirm contaminated product is rejected Reject mechanism design
is often mounted on the search head. It can also be • A beacon and/or alarm to signal scheduled tests or Systems that have to be manually balanced on a regu- Reject systems are probably the weakest part of most
remote and connected with cables if the search head full reject bins lar basis or that are prone to vibration are of little value detection systems. As a result, contaminated products
is too small or installed in an inaccessible location. • Reject container secure/locked monitor on an automated production line. Good electronics de- are not reliably rejected. A correctly specified system
• Air failure alarm sign such as automatic balance control and good me- should reject all contaminated product under all cir-
Transport system • Keyless reject container locking facility chanical design such as enhanced potting techniques cumstances independent of contamination frequency
The transport system passes product through the ap- help minimize system failures. or where metal is found within the product.
erture. Conveyors are common. Alternatives include
Conveyor design Hygienics & safety
Metal detectors emit a high frequency signal that cre- Metal detection systems must account for the op-
ate tiny eddy currents. These currents have no effect if erating environment and appropriate sterilization.
5 Key Design Elements they remain constant. However, if the conveyor has in- Good design:
termittent jolts of variable resistance, currents change • Eliminates cavities/bacterial traps
and create interference in the form of eddy current • Seals hollow sections
Reliability is critical. It helps avoid difficult choices tures. However, these “add-ons” will not necessarily loops. • Avoids ledges and horizontal surfaces
such as stopping production when the metal detection contribute to detector effectiveness. A long feature
• Uses open-design, continuous-weld frames for easy
system is down or continuing to operate with contami- checklist and an assumption that the brand with the Metal-to-metal contact points are primary loop sourc- access and cleaning
nation risk. Despite widespread metal detector use, longest list is the best choice can prove a costly error. es. These include: • Allows hygienic electrical cable, trunking and pneu-
few guidelines are available to help users evaluate de- “Which unit is more sensitive?” as a basis of compari- • Bolted assembly supports matic service management
tector reliability. son also does not provide a full picture, as this is only • Pulley shafts and bearings
one of several important factors in a detector’s function. • Chain drives and guards System design should also meet statutory regulations
Factors that help ensure a system’s success include • Reject supports and standards in force at the time of sale. For exam-
ease of set-up, mitigation of drift/erratic detection, and Factors that influence reliability include: • Metal conduit clamps ple, CE markings in machinery standards minimize
elimination of false rejects without constant attention • Stability
employee injury risk, which also reduces costly work-
to maintain sensitivity standards. Ensuring actual, ef- • Electronic drift Joint oxidation or changes in lubrication can cause ers’ compensation claims.
fective “production line” sensitivity means taking the • Repeatability eddy currents to worsen.
following critical elements into account. • Ease of set-up
• Radio frequency immunity (RFI)
Overall detector design • Modular electronics design
Modern metal detectors benefit from advanced micro- • Self-checking/condition monitoring
processor technology, adding a range of appealing fea- • Fail safe operation
Failsafe system design
What happens if a reject device does not remove
Reject confirmation can show when contaminated
product reached the reject bin; built-in condition
contaminated product or a fault occurs within the monitoring can provide early warning of operational
detector? Failsafe features mitigate malfunction risks. state changes. • METTLER TOLEDO Safeline Metal Detection Guide serves as a definitive reference work on building
a cost-effective metal detection program, improving overall production productivity and protecting
Metal Detection
Metal Detection
your brand. Request your free copy at
www.mt.com/metaldetection
• METTLER TOLEDO On-demand webinars allow 24/7 self-paced learning on a wide range of important
process integration topics
www.mt.com/pi-ondemand
Standards increasingly call for food/allied product inspection via metal detection. These resources also offer
additional information on food inspection using metal detection equipment:
• British Retail Consortium (BRC)

www.brcglobalstandards.com
• CIES – International Committee of Food Retail Chains

www.ciesnet.com
• Codex Alimentarius
www.codexalimentarius.net
• Food and Agriculture Organisation (FAO) of the United Nations

6 Summary www.fao.org
• International Food Standard (IFS)

A metal detection system that is capable of consistent, shot, wire, machine parts, personal effects, slivers, www.food-care.info
reliable detection without false rejection will win the shavings and foil. Attention to conveyor and reject sys-
confidence of line operators and management. tem design also helps ensure effective operation by • ISO 22000:2005 – Food Safety Management System Standard
eliminating signal eddy loops that create interference, www.lrqa.co.uk/certification/food/iso22000/
Effectively designed and installed technology is key. increase false rejects and decrease sensitivity.
With it, a manufacturer can avoid costly contamination • Safe Quality Food (SQF) Institute
errors that damage machinery and cause reduced out- No broad-based requirement for metal detection exists www.SQFI.com
put during processing – or worse, loss of reputation, yet. Though to help minimize risk of contamination in
product recall, adverse publicity, and legal action after the finished product, different global HACCP-based • United States Department of Agriculture (USDA)
shipment. food safety standards such as IFS and BRC put the www.usda.gov/wps/portal/usdahome
burden of establishing reliable product inspection pro-
Attention to design before purchase and during instal- gram onto food manufacturers. Metal detection sys- • United States Food and Drug Administration (FDA)
lation will ensure ROI. This includes a review of bal- tems can help manufacturers prove due diligence and www.fda.gov
ance stability to avoid drift so a system can reliably also become important in internal safety, customer,
detect potentially damaging objects such as metal quality, and regulatory audits.
Mettler-Toledo GmbH


Foreign Body Detection 1 The Case for X-ray Inspection
X-ray Inspection
X-ray Inspection With increasing line speeds and growing consumer
expectations, manufacturers are under pressure to
OEE (Operational Equipment Effectiveness) can be
increased through x-ray inspection providing pack
X-ray Inspection
adopt more reliable product inspection methods. integrity and allowing manufacturers to manage
quality control within their supply chain.
A well-designed x-ray inspection programme can help:
X-ray inspection technology is used in food, pharmaceutical and related industries, • Minimise contaminants such as metal, glass, stone, An x-ray inspection system helps manufacturers dem-
to ensure product safety and quality. Manufacturers use x-ray inspection systems bone, high density plastics, and rubber compounds. onstrate their commitment to guidelines and standards
• Reduce costs caused by customer complaints, safe- such as HACCP and to effectively manage process
to detect foreign bodies and perform in-line quality checks to avoid product recalls.
ty scares and product recalls. risks.
• Protect consumers and brand reputation by ensuring
consistent quality and product safety.
X-ray inspection technology not only offers exceptional

ferrous, non-ferrous and stainless steel detection, it is
also extremely good at detecting other foreign bodies 2 How X-ray Inspection Systems Work
such as glass, mineral stone, calcified bone, high
density plastics, and rubber compounds. In addition,
x-ray systems can be used to perform a wide range of X-rays are an invisible form of electromagnetic radia- An x-ray system is essentially a scanning device that
in-line quality checks including: tion like radio waves. Their short wavelength allows captures a grey-scale image of the product which is
• Measuring zoned and gross mass them to pass through materials that are opaque to vis- compared to a predetermined standard (Figure 1).
• Counting components ible light. But they don’t pass through all materials
• Identifying missing or broken products with the same ease. In general, the denser the materi- On the basis of the comparison, the system accepts or
• Monitoring fill levels al, the fewer x-rays that pass through. Hidden contam- rejects the image. If rejected, a rejection signal is sent,
• Inspecting the integrity of a product seal or closure inants, like glass and metal, show up under x-ray in- removing the product from the production line.
• Checking for damaged product and packaging spection because they absorb more x-rays than the
• Detecting agglomerates such as flavour and surrounding product.
powder lumps
• Measuring head space
Food manufacturers are under pressure to adopt Contents

the standards of the Global Food Safety Initiative 1 The Case for X-ray Inspection
(GFSI). Other directives and standards such as HACCP 2 How X-ray Inspection Systems Work
(Hazard Analysis Critical Control Points) and GMP
3 X-ray Inspection System Design
(Good Manufacturing Practice) require food and phar-
maceutical manufacturers to make their processes 4 Summary
as safe and transparent as possible. 5 Additional Resources
This chapter explores why x-ray inspection could be

the solution, how x-ray inspection technology works
and looks at effective x-ray inspection system design.
Figure 1

3 X-ray Inspection System Design Hygienic design products are suited more to beryllium. The lower ener-
gy and softer rays improve detection of medium-densi-
Environment and cleaning regime must be considered
before purchase. Design should: ty contaminants such as glass, mineral and bone and
An x-ray inspection system consists of an x-ray gener- system which is fully described in ISO 13849-1. Power • Eliminate cavities/bacterial traps lend themselves to bulk-flow, small thin-pack and
ator, a detector and a control system encased in a isolators should be lockable and emergency stops • Seal hollow sections product-in-seal inspections.
X-ray Inspection
X-ray Inspection
stainless steel cabinet with a highly visible lamp stack must be fitted at every operator station. Emergency • Avoid ledges/horizontal surfaces,
that signals the system status. stops should be used as a back-up for safeguarding • Use open, continuous-weld, easy-access frames X-ray detector
measures and not a substitute for them. • Allow hygienic electrical cable, trunking and pneu- Various diode sizes are available to suit a diverse
Food and pharmaceutical x-ray inspection systems matic service management range of applications. Product depth, size and pro-
are built for tough environments, can be run at high Cabinet design duction line speed must all be considered during the
line speeds, and detect very small contaminants. X-ray inspection cabinets should be stainless steel Drainage slots in catch trays and easy strip belts selection process.
They should be easy to set up, clean and maintain to sealed to minimum IP65 rating as standard or IP69 should be used whenever possible to ensure thorough
improve quality without reducing efficiency. for harsh wash-down environments with greater in- cleaning in high-risk applications. User-friendly interface
gress risk. Full-colour touch-screen displays with intuitive soft-
Despite widespread use of x-ray inspection, few guide- Pipeline systems should incorporate clean-in-place ware and different user access levels allow quick set-
lines exist to help manufacturers evaluate system fea- Systems should include air conditioning or heat ex- (CIP) procedures, allowing hot fluid flush with no need up and reduce errors. Added displays allow remote
tures or compare machines. Knowing how system de- changers to keep internal electronics safe in a sealed to disassemble the manifold or disconnect pipes. visibility. Multiple language options allow operators
sign affects day-to-day production can help identify cabinet. A basic open fan is not enough as it reduces Aseptic manifolds with double O-ring seals for x-ray to select the most appropriate.
the best system for a particular application. the cabinet’s rating below IP65. Air conditioning elimi- connections allow injected steam to kill microorgan-
nates water use. A built-in gauge should indicate isms in sterile applications. Variable speed
Health and safety overheating. A mains suppressor, filter and UPS (unin- Advanced systems should match scanning speed
X-ray inspection systems must be built to comply with terruptable power supply) should be included to en- Good hygienic design helps HACCP compliance. 3-A, and reject timing to line speed. Image proportions
safety standards to ensure all personnel and produc- able controlled shutdowns during power failures. AMI, EHEDG and NSF machine design standards are and sensitivity should be made for the speed range.
tion staff are safe when operating the equipment. For also highly regarded and offer additional information
example, x-ray inspection systems must meet ionising Conveyor design on this topic. For more information please see the Ad-
Adaptive filtering
radiation regulations for the country where the ma- The conveyor belt should be removable without tools ditional Resources section at the end of this chapter.
For dense-edged containers e.g. glass jars, adaptive
chine is used. and incorporate a quick-release tension roller. Tracking technology allows high-absorption areas to be filtered
must also be simple to adjust. On wide-belt – typically X-ray tube out. Fixed-width filters, by contrast, may let contami-
Some x-ray manufacturers have safety barrier photo- over 800 mm – or very wet/greasy applications, auto- X-ray tubes should match the application. Glass-win- nants pass or cause false rejects.
cells across the machine’s entry points. When the matic tracking should be considered. Misaligned belts dowed tubes are common. Low-density/low-depth
photocell is blocked for an extended period the belt can cause substantial downtime, due to premature
stops. This protection method also may not be accept- wear.
able, for certain countries.
For bulk-flow applications, troughed belts or side-
The requirement for a Category 3 (dual circuit) safety skirted belts retain product, minimise spills and im-
interlock design is driven by a risk assessment scoring prove transport.
Information storage 5 Additional Resources
Many x-ray systems are PC based and record large
amounts of useful information, so the Control Panel
should be specified to provide sufficient processing at • METTLER TOLEDO Safeline X-ray Inspection Guide serves as a definitive reference work for development
all times. Features such as USB and Ethernet ports al- of an effective x-ray inspection program. Request your free copy at
X-ray Inspection
X-ray Inspection
low immediate access to statistical data and the reject www.mt.com/safeline-xray
library. This access helps with reporting, traceability
and HACCP compliance. • METTLER TOLEDO On-demand webinars also allow 24/7 self-paced learning on a wide range of important
process integration topics
Diagnostics www.mt.com/pi-ondemand
Well-designed inspection systems will use self-moni-
toring software that continually checks machine oper- Several regulatory bodies advocate x-ray inspection. For more on emerging standards and other helpful
ation to flag potential problems. It can flag up a poten- information, please visit the following:
tial problem in advance, so as to provide an early Figure 2
warning system, plus a field-based service engineer • 3-A standards organization
can also dial into the machine remotely via Ethernet to www.3-a.org
fix faults or prepare parts for a site visit. The lamp stack also alerts operators that a PVR (Per-
• European Hygienic Engineering & Design Group EHEDG
formance Verification Routine) is required. It can also
www.ehedg.org
Failsafe system indicate activation of any of the failsafe features,
A highly visible lamp stack with a top beacon should namely reject confirmation, bin-full warning and low
• National Sanitation Foundation NSF International
be visible from 360 degrees around the machine air pressure. An audible alarm is usually activated at
www.nsf.org
(Figure 2). It indicates that x-rays are on/off, that the same time.
x-rays are about to start up, that the system is in fault
• American Meat Institute AMI
mode, and that power is on the machine and the
www.meatinstitute.org
system is healthy.
• British Retail Consortium BRC

www.brcglobalstandards.com
4 Summary • International Food Standard IFS
www.food-care.info
X-ray inspection systems involve significant capital in- Food and pharmaceutical x-ray inspection systems
vestment. Equipment must be well-designed to ensure should be easy to set up, clean and maintain to im- • ISO 22000:2005 – Food Safety Management System Standard
ROI (Return on Investment). Cost savings, regulatory prove quality without reducing efficiency. They must www.lrqa.co.uk/certification/food/iso22000
compliance, consumer/brand protection, and en- offer durability and accuracy during high-speed opera-
hanced sales can justify the initial expense. A well tion. Safety, hygiene, cabinet/conveyor/x-ray tube de- • Safe Quality Food (SQF) Institute
specified and reliable installation will also help to sign and data collection capabilities should be consid- www.SQFI.com
maximise OEE (Overall Equipment Effectiveness) on ered for optimised selection.
the line.
The capability of x-ray inspection systems to detect a
The short wavelength of x-rays allows them to pass range of contaminants can help manufacturers prove
through materials opaque to visible light. Because appropriate risk management. X-ray detection can
they do not pass through all densities with similar also be considered the highest level of inspection in a
ease, they detect contaminants, which absorb more x- diligent HACCP program.
rays than surrounding product.
Mettler-Toledo GmbH


Hygienic Designed Food Scales 1 Food Contact Surfaces
Hygienic Design
Less Contamination, Enhanced Profits A food product contact surface is defined as a surface
in "direct contact with food residue, or where food resi-
3A Standards also require that such coatings maintain
corrosion resistance and be free of surface delaminat-
Hygienic Design
due can drip, drain, diffuse, or be drawn" (FDA, 2004). ing, pitting, flaking, chipping, blistering, and distortion
Because contamination of these surfaces can result during the equipment’s intended use. Similarly, if any
in food product contamination directly, rigid sanitary other modification or process is used in fabrication–
In today’s global market, in an effort to ensure safety, weighing equipment construction design criteria must be met. such as welding, bonding, or soldering – it should be
must follow international guidelines based on EHEDG, NSF and 3-A standards. done using appropriate materials and in a manner
Non-product contact surfaces include equipment parts that ensures the final surface meets the same sanitary
These standards encompass issues such as equipment surfaces, materials and design.
such as feet, supports, and housings that do not design criteria.
contact food directly. However, contamination of these
surfaces can cause indirect contamination. They must
also be included when considering sanitary design.
Contaminated food processing equipment has been Risk analysis can help define areas with indirect or
responsible for a number of major food poisoning cross-contamination potential.
outbreaks.It also accounts for innumerable instances
of product spoilage and quality defects. Generally, particularly if a structure is coated with
metal alloy or non-metal (ceramic, plastic, or rubber)
In some cases, these events result from a failure to the final surface must be:
maintain, clean, or operate equipment hygienically;
in others, the fault is found in the design of the equip- • Smooth Terminal:
ment itself. Either way, the results can be catastrophic • Impervious Cross-contamination risk
for consumers and food producers. • Free of cracks and crevices
• Corrosion-resistant
To ensure safe food, equipment used for food pro- • Durable and maintenance-free Platform:
cessing must be designed and installed according • Nontoxic Direct food contact
to sound sanitary design principles. Equipment must • Nonporous

allow efficient cleaning and sanitizing, and surface • Nonabsorbent
materials must resist exposure to corrosive food prod- • Non-contaminant Feet:
• Cleanable Depending on the
ucts and cleaning chemicals.
application (such as
Contents • Nonreactive poultry slaughter)
This paper highlights several of the the most important 1 Food Contact Surfaces feet/threads can be in
direct food contact
food processing equipment aspects that are relevant 2 Materials
to bench- or floor-scale design to ensure food safety,
3 Surface Texture and/or Finish
reduce spoilage, and enhance profits.
4 Functional Requirements
5 Construction and Fabrication
6 Internal Angles/Permanent Joints 2 Materials
7 Testing
8 Summary A variety of materials are used in the construction of tary design features. Depending upon the application,
food equipment. These materials vary in their proper- various metals as well as non-metals such as plastics
ties with regard to workability, compatibility and sani- and rubber are used.

Metals 3 Surface Texture and/or Finish
Stainless steel is the preferred general-use metal for
food contact surfaces because of its corrosion resis-
tance and durability in most food applications. In If a surface is ground, polished, or textured in any
Hygienic design
general, the properties of the stainless steel alloy are way, the final result must be smooth, durable, free of
Hygienic Design
Hygienic Design
related to its relative levels of chromium which offers cracks and crevices, and meet the sanitary design re-
corrosion resistance; and nickel which adds strength. quirements described in the previous section.
Surface
3A Standards also provide specifications regarding Large contact surface areas should have a finish
alloys and other coatings used in fabrication. TQWIJPGUU
4CQHŞOQTDGVVGT*QYGXGT
cleanability strongly depends on the applied finishing
technology, which can affect surface topography. Hygienic risk
Hygienically designed portable bench scale feet: Example of non
metal material in a scale, feet without open threads #TQWIJPGUUQH4C ŞOKUCEEGRVCDNGKHVGUVTGUWNVU Microorganism
have shown that the required cleanability is achieved
through other design features or procedures such as a
ANSI, DIN/EN designations of stainless steels commonly used in the food industry: high-flow cleaning agent rate. Specifically, in the case
Product contact surfaces should have finsih a
of polymeric surfaces, hydrophobicity, wettability and TQWIJPGUUQH4CŞO
ANSI DIN/EN Typical analyses
reactivity may enhance cleanability.
C% Cr% Ni% Mo% Ti% N%
304L e.g.: DIN 1.4307 (EN X2CrNi18-9) < 0,03 18 9
316L e.g.: DIN 1.4435 < 0,03 18 14 3
(EN 2CrNiMo18-14-3)
410 DIN 1.4006 (EN X12Cr13) < 0,12 13 < 0,75
4 Functional Requirements
409 DIN 1.4512 (EN X2CrTi12) < 0,03 11,5 < 0,65
329 DIN 1.4460 (EN X3CrNiMoN27-5-2) < 0,05 27 5,5 1,7 < 0,20 Food processing equipment should be easy to main-
tain. This ensures it will perform as expected and pre-
vent microbiological problems.
Non-metals
A variety of non-metal materials find application in • Paper Poorly designed equipment requires more severe
food contact surfaces such as probes, gaskets, and Has been used over the years as a gasket material cleaning and prolonged cleaning time. This can include
membranes. Non-metal materials used in food contact in piping systems designed for daily disassembly. aggressive chemicals and longer cleaning/decontam-
surfaces include: Paper is considered a single use material. ination cycles which results in higher costs, reduced
production availability and shorter equipment life.
• Plastics, rubber, and rubber-like materials • Wood
These should be food-grade and meet requirements is highly porous and difficult to clean and should Easy-clean equipment, on the other hand, allows
designated under 3A Sanitary Standards or EHEDG. be avoided. More details on polymeric materials, high-pressure washdown, reduces costs, and shortens
Compliance with FDA regulations can be covered elastomers, adhesives, lubricants, and other non- cleaning time.
through Food Contact Notification (FCN) certificates. metallic materials can be found under Chapter 9
“Additional resources”.
• Ceramics/glass • Full stainless-steel construction
Ceramics are used primarily in membrane filtration In general, non-metal surfaces may lack the corrosion • Continuously welded and completely closed column,
systems; glass may be used as a food contact sur- resistance and durability of metal surfaces, so mainte- no disturbing cables
face. These applications are limited due to breakage nance programs should include frequent examination • Platter with smooth surface, brushed (ra < 0.8 mm)
potential. for wear and deterioration and be replace as appropriate. • Ingress protection IP68/IP69k
5 Construction and Fabrication 8 Summary
Food equipment design and fabrication should avoid The primary intent of international standards organiza- Hygienic design and high-quality materials ensure that
sharp corners and crevices. Mated surfaces must tions such as 3-A, EHEDG and NSF, is the application machines can be cleaned quickly and with less costs.
Hygienic Design
Hygienic Design
be continuous and substantially flush. Construction of sanitary principles in food equipment manufacturing This leads to fast shift changes, fewer cleaning agents
should allow for easy disassembly for cleaning and to ensure food safety. Even with subtle differences and an overall reduced food contamination risk.
inspection. among a reputable equipment manufacturer such
as METTLER TOLEDO will implement these principles
when designing bench and floor scales.
Liftable floor scale with easy cleaning access

The following resources provided additional information on hygienically designed equipment specifications.
Floor scale with hinged load plate • European Hygienic Equipment Design Group (EHEDG)
where contamination and corrosion www.ehedg.org
have no chance due to high-quality
material, hermetically seal-welded
tubes and smooth surfaces • HYGIENIC EQUIPMENT DESIGN CRITERIA, Second edition, April 2004
www.food-info.net/uk/eng/docs/doc8.htm
Guideline EHEDG No. 2A - Method for assessing in-place cleanability of food processing equipment
Guideline EHEDG No. 8 - Hygienic equipment design criteria
Guideline EHEDG No. 9 - Welding stainless steel to meet hygienic requirements
6 Internal Angles/Permanent Joints Guideline EHEDG No. 13 - Hygienic design of equipment for open processing
Guideline EHEDG No. 32 - Materials of construction for equipment in contact with food
Internal angles should be coved or rounded with fashion: “Corners should preferably have a radius • The National Sanitation Foundation (NSF)
defined radii as shown in the accompanying figure. equal to or larger than 6 mm; the minimum radius is www.nsf.com
Equipment standards state appropriate radii for specif- OO5JCTREQTPGTU
ŰOWUVDGCXQKFGFq
• 3A Sanitary Standards
ic equipment applications and components.
Hygienic risk Hygienic design www.3-a.org
For example, radii requirements stated in the 3A Sani- • Sanitary Design and Construction of Food Equipment, Ronald H. Schmidt und Daniel J. Erickson,
tary Standards indicate that “all internal angles http://edis.ifas.ufl.edu/fs119
135 degrees or less should have a minimum radius of
1/4 inch (6.35 mm)”. EHEDG defines it in a similar • Meat and Poultry equipment: NSF/ANSI/3-A Standards 14159-1, -2 and -3.
www.nsf.com/business/meat_and_poultry_equipment
Hygienic risk Hygienic design • Food and Drug Administration

www.fda.gov/Food/GuidanceComplianceRegulatoryInformation
• METTLER TOLEDO Hygienedesign

www.mt.com/hygienic-design
7 Testing
Mettler-Toledo GmbH
Industrial Division
Tel. + 41 44 944 22 11
A series of EHEDG test methods for assessing the under Guideline EHEDG No. 2A (Additional re- Local contact: www.mt.com/contacts
hygienic characteristics of equipment is available sources).
7 Considerations for Cleaning Production 1 Choose a Hygienically Designed Scale
Cleaning Production
Equipment in Hygienically Sensitive Environments An effective and efficient cleaning starts with the
right equipment. Available on the market are scales
But what construction elements are relevant if
such an approval is missing? Consider the
Cleaning Production
that have the European Hygienic Engineering and following points when selecting a scale for a
Design Group (EHEDG) and National Sanitation hygienically sensitive environment [3].
Foundation (NSF) approval for hygienic design.
Scales, used in hygienically sensitive industries, such as the meat industry, are often
in direct contact with the product. They are consequently a potential contamination risk. Topic Considerations
Independently, if they are used in a basic weighing application in the goods entrance Cleanable to a microbiological level
or as a checkweighing solution in the packaging area, they are located in hygienically The equipment should be designed to prevent bacte- • All surfaces are accessible for mechanical clean-
sensitive areas that follow strict sanitation procedures. rial ingress, survival, growth and reproduction on ing and treatment to prevent biofilms formation
both product and non-product contact surfaces of
Such an equipment sanitation procedure has to ensure the equipment.
adequate cleaning of product-contact and product Made of compatible materials
non-contact surfaces. A common sanitization standard Construction materials must be completely compat- • All surfaces should be designed to eliminate water
for contamination reduction of food-contact surfaces is ible with the product and environment. Water collec- pooling and should be self- draining
generally accepted as 99.999% achieved in 30 section points have to be avoided. • Product contact surfaces must be made with
onds. The sanitization standard for non-food contact materials which are corrosion resistant e.g. stain-
surfaces is accepted as a reduction of 99.9% [1]. less steel
• Hollow areas must be eliminated
Disinfection, in contrast, must destroy or irreversibly • Equipment parts should be free of niches nooks,
inactivate all specified organisms within a certain time, such as pits or cracks
usually 10 minutes [2]. • Check materials against FDA components list of
food contact materials [8]
To achieve those requirements, the equipment has to Accessible for inspection, maintenance, cleaning and sanitation
be hygienically designed and efficiently treated during All parts of the equipment shall be readily accessible • Bench scale: Lift the platter for cleaning
the sanitation program. This white paper provides for inspection, maintenance, cleaning and sanitation • Floor scale: Easy to lift platter or scale
guidance on where to focus when cleaning equipment, Contents without the use of tools.
such as scales and checkweighers, and provides a 1 Choose a Hygienically Designed Scale Sanitary operational performance
typical example of a sanitation plan. During normal operations, the equipment must per- • Buttons on control panels have to be cleaned and
2 Prepare a Surface for Sanitizing
form so that it does not contribute to unsanitary con- sanitized during operations (risk: microbial har-
3 Cleaning with Detergents
ditions or the harborage and growth of bacteria. borage)
4 Visual Controls Hygienic design of maintenance enclosures
5 Disinfection Maintenance enclosures and human machine inter- • Maintenance enclosures in direct wash-down
6 Final Rinsing faces, such as push buttons, switches and touch- areas must be able to be exposed to water
screens, must be designed to ensure that product • Securing with a plastic bag is not acceptable.
7 Verification of Procedures
residue or water does not penetrate or accumulate in Should be NEMA and IP rated, including high-
8 Summary and on the enclosure or interface. pressure washing
(Scale design principles, adapted from 10 Principles of Sanitary Design, AMI Foundation)

2 Prepare a Surface for Sanitizing 3 Cleaning with Detergents
Preliminary cleaning is an important operation and is substantially reduces the number of other undesir- After removing food debris and rinsing with water, the • Alkalis (sodium,
aimed to achieve visual cleanliness of the equipment. able organisms, and does not adversely affect the standard cleaning procedure with detergents includes potassium, etc.)
Cleaning Production
Cleaning Production
product or its safety for the consumer. Sanitizing the following procedures: are active
Prepare a surface for sanitizing does not affect bacterial spores – that is beyond the against organic
For a sanitizer to be effective, the surface being sani- capability of the process. • Cleaning with alkali detergents soiling, as they
tized must be physically clean. One cannot sanitize a Daily: Application of chlor-alcalic foam with low saponify fats
dirty surface – organic soils will consume the sanitiz- Non-food contact surfaces pressure and dissolve
er. Detergent residues must be rinsed well – they will Non-food contact surfaces shall be free of unneces- Once a week: Application of acid foam proteins. Conse-
neutralize many sanitizers. Spraying a surface with a sary ledges, projections and crevices, and de- Consider the instruction of the detergent supplier re- quently, these
sanitizing solution without first cleaning the surface signed and constructed to allow easy cleaning and garding concentration and temperature, because the products are
properly is a waste of time and money. [2] to facilitate maintenance. Although usually the regu- effectiveness of the detergents depends on the tem- frequently used
lations do not explicitly address potential indirect perature used and duration of application. in the meat and
Sanitation food-contact surfaces food-contact surfaces, such as terminals, these • Rinse with water after the predefined contact time. poultry indus-
Sanitizing of food-contact surfaces aims to mini- surfaces can be an important source of microbial tries.
mize disease producing bacteria and viruses, contaminants. • Acids are used
Which detergent and sanitizer to apply? mainly to eliminate calcium deposits (from hard wa-
This cleaning involves the use of a product with deter- ter) and to restore stainless-steel surfaces.
gent action, approved for cleaning with food-contact • Organic (surface-active) products are often incorpo-
Relevant non-food contact surfaces surfaces. The choice of cleaning product depends on rated into the alkali and acid preparations mentioned
the principal type of soil present and the equipment above. Those products have the ability to reduce the
used. Such products may be divided into the following surface tension of water, inhibiting the tendency for
Bench scale platforms
broad categories: droplets to form on cleaned surfaces. [4]
Remove the platter: The daily cleaning procedure should include all parts under-
neath the platter and the feet. [7]
4 Visual Controls
Floor scales Check visually if all surfaces now look clean and correct if necessary.
Look underneath the platter: Choose floor scales that can easily be cleaned
underneath the platter. Different types of floor scales offer the capability to only lift
the platter or the complete scale. Another good alternative are mobile floor scales. [7]
5 Disinfection
The aim of disinfection is to eliminate the microor- It includes:

Terminals ganisms still present on surfaces, adhering to an-
Buttons on control panels should be cleaned in order to avoid microbial harbor- chorage points. Some bacteria become attached a • Daily: Cleaning with disinfectants
age or biofilm. few nanometers from the surface, while others pro- Contact time and pressure wash-down require-
duce substances that result in an adhesion that is ments depend on the product and are defined
difficult to break down (biofilm) [4]. in the manuals of the suppliers.
Checkweighers
An open construction for cleaning and visual inspection is important, including
a toolless removal of components and high ground clearance.
6 Final Rinsing 7 Verification of Procedures
This is a relevant step to remove all traces of soil, detergents and disinfection substances, Upon completion of sanitation, you need to verify that Further protein residue or microbiological tests can be
which may get in contact with food. the procedures have been effective. The simplest ap- performed using contact plates or swaps. [6]
Cleaning Production
Cleaning Production
proach is a visual assessment that no debris remains.
Sanitation plan
A common sanitation plan for the meat industry is described below:
8 Summary
Production equipment, such as bench and floor scale for such an area and provides guidance on
scales, are often installed in hygienically sensitive en- how to specifically treat food-contact and non-food
SOP Page 1 of 1
vironments in a production plant and should be contact surfaces. It shows most relevant cleaning steps
Version 1 Production (8-10°C) Valuable from:
cleaned according to strict sanitation plans. This paper and contains a detailed sanitation plan for a daily and
04.06.2015
highlights criteria to use when selecting a weighing weekly cleaning procedure in a meat factory.
Document issued by
SealedAir
Cleaning plan Acknowledgement

Machine / object Interval Product Application Remarks
[1]
Official Detergent Sanitizer Test, AOAC International Official Methods of Analysis 2009 AOAC International,
Gaithersburg, MD
Mo / Tues / Wed / Fri
[2]
Alan Parker, Effective cleaning and Sanitation Procedure, University of Maryland and the JohnsonDiversey
After each usage
Corporation, 2007
Time [min.]
Temp. [°C]
Conc. [%]
Thursday
[3]
Sanitary Design Equipment Principle, 10 principles of sanitary design, AMI, 2014
Monthly
Weekly
[4]
G. Salvat & P. Colin, Cleaning and disinfection practice in the meat industries of Europe,
Tables / walls / floor x Water Remove debris, pre-rinse and Rev.sci. tech. Off.int. Epiz., 1995, 14
rinse after foaming [5]
Pratical cleaning guidance for the meat industry, SealedAir, 2015
x Enduro Chlor 3 40 15 Chlor-alcalic foam
www.sealedair.com
x Aciclean VK39 3 40 15 Acid foam
[6]
Developing a Cost-effective Sanitation Plan for Small-to-medium Processors,
Keith Warriner, Ph.D. Food Safety Magazine, 2011
x Suredis VT1 1 20 15 Disinfection [7]
Examples of hygienically designed bench and floor scales
www.mt.com/ind-bench-floor-hygienic
x Water Rinse after each disinfection
[8]
FDA, determining the Regulatory Status of Components of a Food Contact Material,
Scales / equipment x Water Remove debris, pre-rinse and www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/de-
rinse after foaming fault.htm
x Enduro Chlor 3 40 15 Chlor-alcalic foam
x Aciclean VK39 3 40 15 Acid foam
x Suredis VT1 1 20 15 Disinfection
x Water Rinse after each disinfection
Chlor-alcalic
Acid
Alcalic
Neutral
Mettler-Toledo GmbH
Industrial Division
Tel. + 41 44 944 22 11

Efficient Quality Management 1 Putting Quality Management in Perspective
Quality Management
in a Regulated Environment Weighing process quality was once primarily a ques-
tion of accuracy. However, it has become increasingly
Questions left to interpretation include:
• How should verification be made? At what interval?
Quality Management
concerned with risk evaluation and management Using which standard?
and is the daily preoccupation of quality managers • How should validity of results be assessed?
worldwide. Recorded?
Ensuring compliance with quality management and regulatory standards, such • What action should be taken?
as ISO or GMP, requires an understanding of parameters influencing the accuracy Quality assurance complexity often arises from the
regulations themselves. They give only a vague frame- Putting the weighing process itself at the center
of weighing processes. In highly regulated industries where consumer safety
work on performance targets. No concrete implemen- of the quality management equation can help
is at stake – such as food, cosmetics, pharmaceutical or automotive production – tation information is given based on the assumption establish helpful, documentation-ready SOPs that
it can also mean being subjected to frequent audits. that the user knows his or her process best – and can pass audits and improve productivity and profitability.
therefore choose the best solution to any issue. METTLER TOLEDO’s GWP® offers a framework
Before acquiring weighing system and instrument verifi- in nearly any regulatory scenario, regardless of
cation, performing a thorough risk analysis between a weighing system’s manufacturer.
service visits can help put regulatory guidelines into ef-
fective practice, while reducing costs and increasing
productivity and product safety. Helpful actions include:
• Determining required process tolerances For example, take this weighing practices excerpt from ISO 9001:
• Selecting appropriate technology
ISO 9001: 7.6 Control of monitoring and measuring devices
• Documenting compliance
Measuring devices shall be calibrated or verified at specific intervals, or prior to use, against measure-
• Setting adequate testing and calibration schedules ment standards traceable to international or national measurement standards. The organization shall
• Choosing appropriate performance measures assess and record the validity of the previous measuring results when the equipment is found not
to conform to requirements. The organization shall take appropriate action on the equipment and any
Instituting relatively simple weighing tests as part of product affected.
standard operating procedures (SOPs) can help
ensure top quality product and audit results. Good
Weighing Practice™ (GWP®), the global weighing
guideline developed by METTLER TOLEDO, can help,
regardless of the manufacturer of a particular scale
or balance. Contents
1 Putting Quality Management in Perspective
2 Establishing an Appropriate Weighing
Practice
3 Matching Instrument Accuracy to Process
Tolerance
4 Understanding Process Risks
in a Regulatory Context
5 Verifying Equipment Accuracy
6 Summary

2 Establishing an Appropriate Weighing Practice 3 Matching Instrument Accuracy to Required Process Tolerance
METTLER TOLEDO’s GWP® offers a framework to es- A weighing system’s life starts with assessing process Quality will be assured if an instrument’s measure-
tablish a weighing practice that works. The five basic requirements from a metrological perspective. This ment uncertainty is always better than the acceptable
Quality Management
Quality Management
GWP® steps follow: means establishing process parameters such as: process tolerance. For example, measuring 1 kg with
• Weighing range a tolerance of 1% is only possible with a scale provid-
• Smallest net weight ing a measurement uncertainty better than 1% (<1%)
STEP 1: Good evaluation • Process tolerance at the given net load of 1 kg.
Evaluate the process from a metrological perspective Good Evaluation • Applicable regulations
to establish parameters, such as smallest net weight • Need for safety margin The relative measurement uncertainty of any measur-
and required process accuracy. These parameters set ing instrument – particularly a scale – can be assured
expectations for a given instrument. Other important concerns include ruggedness of the by considering the following characteristics.
construction, mechanical stress when loading the
scale, hygiene, connectivity and environmental condi- Minimum weight
STEP 2: Good selection tions, such as humidity, temperature, ingress pro- In the low range, there will be a limit under which any
Select a scale that fulfills the preceding requirements, Good Selection tection, explosion/corrosion protection, hygiene and measurement will have an uncertainty greater than the
or matches the accuracy to the process needs. The connectivity. acceptable tolerance. This is called the ‘minimum
minimum weight concept is used as a basis for selec- weight’ characteristic.
tion.
Relative uncertainty becomes bigger at smaller weights

STEP 3: Good installation
Good Installation
Document that appropriate installation – unpacking,
set-up, configuration, calibration, adjustment and U [kg] = U0 + Constant x Weight
operator training – has taken place and that the equip- Absolute measurement uncertainty [kg]
Uncertainty U [kg or- %]

ment still fulfills selection requirements.
Process tolerance (%)
STEP 4: Good calibration

Calibrate a scale in its operating environment. Docu-
Good Calibration
menting scale performance and issuing applicable Relative measurement uncertainty [%]
certificates at regular intervals is the qualified tech-
nician’s task.
Weight [kg] Max
STEP 5: Good operation

Establish SOPs and test schedules to help guarantee Good Operation For smaller weights, the relative measurement uncertainty can be so high
that weighing process criteria are fulfilled between that the weight cannot be trusted anymore!
service visits.
Each step involves assessment of process parameters

to ensure equipment can meet tolerances and quality
requirements.
Smallest net weight
The smallest net weight of the weighing process
In the example (figure 1), it is obvious that Scale 3 is
not appropriate, because its relative measurement un-
4 Understanding Process Risks in a Regulatory Context
under consideration has to fulfill the required process certainty is greater than the required relative tolerance
tolerance requirement. As each scale will have its at the smallest net weight. Scale 2, taking into account Industrial processes always carry risk. Errors may im- system in good order and document that the equip-
own absolute and relative measurement uncertainty only the minimum weight, could be a candidate. Upon pact the company (increased costs, loss of image, ment will perform the task for which it was selected.
Quality Management
Quality Management
curve (see figure 1 on next page), the only scales further investigation, however, we see that Scale 1 is loss of production time), consumers, the environment However, many users invest large sums in instrumen-
that are appropriate are those where the minimum the proper selection. – or all of the above. Errors as a result of a weighing tation but neglect end-user training. Since the user is
weight characteristic is smaller than the smallest inaccuracy may result in over- or under filling, waste often the biggest source of measurement uncertainty,
net weight of the respective process. of production materials, overpaying for materials, this can be a costly error in terms of lost production
quality issues and customer complaints, which may and audit failures.
lead to financial losses for the company.
Scale 1
Establishing audit proof documentation
Mistakes across complex industrial processes may be Calibrating a scale in its operating environment helps
Scale 2 difficult to detect. Identifying, describing and minimiz- document performance under the influence of environ-
Scale 3 ing operational risks has become the focus of most mental factors. Documenting scale performance at
current regulations and quality systems, such as ISO, regular intervals is the task of an authorized and
GMP, IFS, and HACCP. trained technician. He or she will determine the value
Tolerance (in %)
of the different contributions to the measurement

High risk and a narrow process tolerance may call for uncertainty such as scale sensitivity, weighing repeat-
frequent instrument accuracy verification. Even under a ability, eccentricity deviation and non-linearity. The
Process tolerance (%)
more frequent testing schedule, regulators determine scale will also be serviced so that any deviation from
an instrument’s uncertainty principle based on an as- original specifications is minimized or alleviated.
sumption that proper installation and calibration ac-
tions have been performed. Therefore, proper in-
A calibration certificate establishes links to applicable
stallation and calibration are critical to comply with
standards and proves compliance. For critical instru-
the standards.
ments, documentation demonstrating measurement
Smallest net weight Load [kg] Max. 60 kg uncertainty under additional tolerance and safety fac-
Figure 1 – Relative measurement uncertainty (%) of 3 scales of 60 kg
How operator training impacts audits tors may be valuable. For its clients, METTLER TOLEDO
Installation includes unpacking, set-up, configuration, issues a Minimum Weight Certificate to establish bul-
calibration, adjustment, training – and documentation letproof documentation that helps in passing audits.
of all these actions. The manufacturer can install a
Process tolerance & safety margin A safety factor on the Minimum Weight must be ap-
Instrument performance is strongly influenced by the plied. In other words, the Minimum Weight of a scale
environment. Certain environmental factors, such as air at a given tolerance should be at least half of the
currents, temperature changes and vibrations, can lead smallest net weight to be measured (safety factor >2).
to a reduction in instrument performance, resulting in A safety factor >2 is recommended if risk analysis de-
less accurate weighing. Therefore, some safety margin termines that accuracy is critical. Using these criteria,
must be anticipated in order to prevent external influ- in this example, only Scale 1 can fulfill all process
ences from throwing measurements out of tolerance. requirements.
5 Verifying Equipment Accuracy 6 Summary
Inappropriate use, accidental damage, changes in en- Regulations like ISO, GMP, and GFSI-based standards Efficient quality management helps increase productiv- Service technician calibration establishes national and
vironment conditions or water ingress can alter instru- remain silent on determining these parameters. Here ity and reduces costs. Choosing the right weighing international standards compliance. However, routine
Quality Management
Quality Management
ment accuracy. Since calibration is normally only car- again, concepts developed under the GWP® guideline system, establishing testing frequency based on risk self-testing on an established schedule can help with
ried out once or twice per year, users typically perform work. and tolerance, and training internal personnel to spot- regulatory compliance and improve day-to-day opera-
process-specific verifications between formal service check accuracy can help a manufacturer pass re- tions. If weighing mistakes are low-risk and tolerance
visits themselves. Test frequency should be determined by risk level quired audits, assure quality and keep rejects – or is wide, verification needs are few. However, if issues
and process tolerance, as depicted in the following worse, recalls – to a minimum. such as company reputation or consumer health are
Users determine which tests to perform, taking into ac- diagram. at stake, higher testing frequency is required.
count process risks and tolerances. Ideally, this means Establishing characteristics such as weighing range,
establishing: smallest net weight, process tolerance and safety mar- Testing costs and operator experience are integrated
• A test list (sensitivity, repeatability, eccentricity) gin helps guide weighing system selection. Other im- into METTLER TOLEDO’s Good Weighing Practice™
• Testing frequency portant concerns include ingress protection, explosion/ (GWP®), a reality-based weighing practice model that
• Weights used corrosion protection, hygiene and connectivity. can be applied in any scenario in which accurate
• SOPs to be followed for the tests weighing is crucial to product quality and safety.
• Test weight verification/recalibration frequency
• Verification of tolerance, control and warning limits
0.01%
• For more information about Good Weighing • For more information about CarePacs® and their
0.1% Practice™, risk evaluation or effective scale role in establishing cost-effective, highly accurate
operation, log onto scale testing practices, visit
Weighing k
Accuracy r Ris ting www.mt.com/gwp www.mt.com/carepacs
1% he Tes
Hig ore
10% =M
Impact
Low Medium High
If a measurement mistake has no impact on the pro- • appeal to instrument functions and self-tests, or
cess (low risk) and required tolerance is wide (>10%), • use weights to perform simplified routine testing.
there is almost no need for verification. Conversely, if a
mistake would impact consumer health (high risk) Verification tests only work if an operator can obtain
and process accuracy has a narrow tolerance appropriate weights. METTLER TOLEDO has developed
(<0.1%), a verification procedure with higher frequency two-weight sets called CarePacs, which are sufficient
is necessary. More risk plus stricter tolerance equals to conduct all tests required to ensure scale accuracy
higher testing frequency. called CarePacs and can also supply high-quality ref-
erence weights for testing any capacity scale. Because
Service technician calibration is the only method to es- a larger and more expensive weight set is not required,
tablish national and international standards compli- the initial investment is reduced. Costs associated with
ance and also determines measurement uncertainty maintenance and recalibration are lowered as well. Mettler-Toledo GmbH
Industrial Division
so that it can be confirmed that process tolerances CH-8606 Nänikon, Switzerland For more information
can be achieved. However, to determine if an instru- METTLER TOLEDO can assist with the appropriate Tel. + 41 44 944 22 11
ment will satisfy process tolerance on a daily basis, combination of tests as well as the selection of test Local contact: www.mt.com/contacts
an operator can: weights themselves.
Meeting Legal Metrology 1 When are Verified Instruments Needed?
Legal Metrology
Standards
Legal metrology generally includes provisions • Weighing medical patients for the purpose of moni-
related to: toring, diagnosis and treatment
Legal Metrology
• Units of measurement, • Preparing prescriptions in a pharmacy or formulat-
• Measurement results (e.g. prepackages) ing medication in a pharmaceutical laboratory
• Measuring instruments • Calculating a price on the basis of mass for a direct
public sale or the labeling of pre-packaged com-
Weight determination related to consumer protection – whether the concern is health, as well as the legal control performed by or on behalf modities
public safety, the environment, or fair taxation/trade – is subject to tight regulation. of a government.
This strict application of weight standards is known as Legal Metrology. Global regulations – For definitions of ‘Verification‘, ‘Calibration‘ and ‘Ad-
in combination with national or local laws – create performance control and reliability Determining mass justment‘ see paragraph “6 Additional Resources”
verification requirements for weighing instruments used in these legal applications. Legally verified instruments are required for determi-
nation of mass in (variations depending on national When weight impacts cost
law): Regardless of whether the transaction is with another
For specific weighing applications as e.g. legal-for-
• A commercial transaction business or direct-to-consumer, it is wise to check
trade, it is mandatory to use a verified scale. But the
• The calculation of a toll, tariff, tax, bonus, penalty, if a verified instrument is needed in any situation
verified scale must also be used correctly. Improper
remuneration, indemnity or similar payment where money is charged for weighed amounts – or
use of a verified scale can lead to incorrect results as
• The application of law or regulations; expert opinion whenever the weight of a product directly impacts
quickly as use of an unverified scale. Re-verification
given in court proceedings a business deal.
must then be performed, increasing production costs.
Persistent inaccuracies can even result in fines. In-
creasingly demanding legal metrology requirements
worldwide are not only challenging manufacturers but
also entire industries. Within these tightening struc- 2 Oversight and Requirements for Instrument Approval
tures, questions such as the following become topics
of heated debate: Legal metrology is subject to national legislation. world’s population and 96 percent of its economy.
• Where do we need a verified scales or balance? However, these authorities or institutes are also orga- Each region of the world also has its own organizing
• Can we adjust a verified instrument and what are
Contents
nized on a global level. body – such as WELMEC or NCWM – representing
the consequences? 1 When are Verified Instruments Needed? different national legal metrology authorities. A rough
• What do we have to do in case of a scale failure 2 Oversight and Requirements Established in 1955, the International Organization of map of these regional bodies and the countries they
or equipment change? for Instrument Approval Legal Metrology (OIML) is an intergovernmental treaty serve follows.
• What legal actions can be taken by authorities organization. Their members cover 86 percent of the
3 Designing a Compliant System
in the case of non-compliance, and what conse-
quences can we expect? And, finally, 4 Planning for and Maintaining
• How costly could non-compliance be to us? a Compliant System Legal metrology organisations (worldwide)
5 Summary
COOMET (Euro-Asian Cooperation
This paper highlights various aspects of legal metrolo-
6 Additional Resources of National Metrology Institutions)
gy, as well as actions that can be taken to effectively
APLMF
#UKC2CEKƂE
implement legally compliant weighing activities – Legal Metrology Forum)
while at the same time ensuring efficient, cost-effective SADC/SADCMEL (Southern
performance control/maintenance of compliant mea- African Development Community)
suring devices. EMLMF (Euro-Mediterranean

Legal Metrology Forum)
WELMEC ((Western) European

Legal Metrology Corporation)
SIM (Sistema Interamericano

de Metrologia)
NCWM (National Conference

on Weights and Measures)
MC (Measurement Canada)

Approval process 3 Designing a Compliant System
Though these organizations are separate, each has a similar approach to approving instruments
used in legal applications. The following chart gives a basic idea of actions required. A systematic analysis helps identify whether a specific If there are questions as to whether or not a verified
weighing application requires a verified scale or not. scale is needed, an ISO 17025-certified service pro-
Legal Metrology
Legal Metrology
vider such as METTLER TOLEDO can provide guidance
The following examples illustrate different applications for the decision-making process.
or transaction conditions that require verified scales.
Correct specification
Purchasing
Incoming inspection
Mounting Quality
Installation Material Production Packaging Shipment Delivery
Adjustment, if required receiving control
Test documentation
Verification
Certificate of compliance
Direct sales of boxed Dry mass control if Weigh and price calcula-
meat to ready meal product is sold with defined tions of fresh food at the
manufacturer or hotels water content (humidity) point of sales on a cash
Notification Submission documentation register scale
& Approval Approval certificate
Net content control of Weigh Floor scales for bags of

Internal Keeping records of documentation for the finished packed goods Price grain, vehicle scales for
Documenta- Labelling selling whole flour batches
tion required period of time
Recognizing a Verified Instrument

Specifying the right instrument
Type approved Instruments have to be marked and verified for all uses subject to legal metrology.
A selected instrument should meet the metrological
requirements defined by the process, in which it will
be used. Data that should be checked are:
Europe USA China
• Weighing range(s) defined by value(s) for minimum
CE Mark NTEP Certificate of Conformance Certificate ID: CMC
and maximum capacity indicated by Min/Max
Metrology mark
• Measuring accuracy required by the expected
Model: TS976
process. This sets requirements to the accuracy
TC7918 Langacher 44
8606 Greifensee
class of the instrument and verification scale
interval “e”
100 - 50/60HZ 0.15A www.ml.com
6000
• Environmental conditions such as temperature

range
This paper and all given examples focus on non-automatic weighing instruments. Automatic weighing
is described in the European Measuring Instrument Directive (2004/22/EC) and other national regulations.
Weighing accuracy facts: 4 Planning for and Maintaining a Compliant System
The accuracy classes for instruments including the maximum permissible error on verification/class
is given in the table below (OIML R 76-1:2006). Any installation of weighing instruments that meet the following graph summarizes the individual parties
legal requirements should be planned carefully. As an involved in setting up a compliant weighing process
example, based on current European regulations,
Legal Metrology
Legal Metrology
Maximum
permissible Load in verification scale intervals (e)
error (MPE)
Preparation of instrument Instrument in routine operation
Max. permissible Max. permissible Class I Class II Class III Class IIII
error on verifica- error in routine Notification Docu-
Evaluation Purchasing Installation Verification Periodic re-verification
tion operation Special accuracy High accuracy Medium accuracy Ordinary accuracy & approval mentation
0.5 e 1e 0…50000 0…5000 0…500 0…50

European law Non automatic WI*: European Directive 2009/23/EC
1e 2e 50000…200000 5000…20000 500…2000 50…200 Automatic WI*: European Directive 2004/22/EC

European
1.5 e 3e > 200000 20000…100000 2000…10000 200…1000
Harmonized Standards EN 45501 valid for non-automatic WI*
In case of a 3000e verified scale (class III) the mini- uncertainty profile of a scale that fulfills OIML require-
mum capacity is set at 20e (e.g. OIML). A maximum ments (initial verification). At all points, the scale’s ab- Initial verification Re-verification after 1-3 years,
permissible error of +/- 0.5e is accepted for an initial solute measurement uncertainty is comprised within depending on national law.
National law
verification and +/-1e during routine operation. In the the limits set by OIML (graph 1). Re-verification after repair/re-
following two diagrams we illustrate the measurement placement or change of relevant
parts.
Example: 3kg scale with 3000e resolution Example: 3kg scale with 3000e resolution
2.0 2.0
Relative uncer-
Measurement uncertainty
+- 1.7 % at initial verification
tainty of a 3kg Instrument Type Approval Certificate Declaration of conformity Re-verification certificates
scale in compli-
(+- 3.4 % during routine operation) Documentation (Notified Body) (Manufacturer) (National authority)
Relative Uncertainty (%)
1.5 1.5
ance with MPE
Maximum OIML
permissible
error OIML
Error (g)
User’s responsibility
1.0 1.0
Absolute uncer- 1. Proper use & maintenance
tainty of a 3kg
Scale in compli- Proper evaluation Calibration (recommenda- according to manufacturer’s
ance with MPE according to process tion: use service provider
0.5
OIML
0.5 instructions & process specifi-
specifications with ISO 17025 accredita- cations
tion) qualification and 2. Individual performance
500 1000 1500 2000 20 500 1000 1500 2000 validation documentation check with traceable weights
Load (g) Load (g) according to process (e.g. MT Good Weighing
Graph 1: MPE within tolerances for a 3 kg scale Graph 2: Relative uncertainty of a 3 kg scale specifications Practice™)
* WI = Weighing Instruments
Looking at the relative measurement uncertainty of probably be outside of the tolerance your process re-
this instrument (graph 2), we can see that at 20e quires. It is therefore strongly recommended to define
(min = minimum capacity according OIML) the mea- a second minimum weight corresponding to the effec- Ensuring traceability
surement uncertainty of the instrument is of 1.7% for tive process tolerance required and to adopt the largest Traceability of the weighing process is required for The chart above can be used for ensuring that required
initial verification (and consequently 3.4% during rou- of both minimum weights: The OIML minimum capaci- legal-use scales. Complete documentation of installa- documentation is available on every necessary step
tine operation). ty or the process related minimum weight. tion, maintenance and ongoing performance of a along the quality chain.
scale is mandatory.
In other words, a strict application of the OIML recom- Helping tools to determine if your installed instruments
mendations may lead to measurement uncertainty of meet process related standards are commonly avail-
maximal 3.4%. This is accepted from legal point of able (see “6 Additional Resources: Good Weighing
view for all legal applications listed above, but may Pratice™”).
Maintaining compliance The application of industry benchmarks or a system
such as METTLER TOLEDO’s Good Weighing Prac-
Maintaining compliance over time requires a docu-
mented control system that accounts for: tice™ (GWP®) Verification can help ensure a system
Definitions (from Dictionary of Weighing Terms, A Guide to the Terminology of Weighing, R. Nater, A. Reichmuth,
• Maintenance meets expected process parameters all the time.
R. Schwartz, M. Borys, P. Zervos, Springer, 2009)
• Calibration
Legal Metrology
Legal Metrology
• Service Re-verification Verification
• Repair Legal metrology requires re-verification after any in- Procedure which includes the examination and marking and/or issuing of a verification certificate that ascertains
• Modification strument manipulation that impacts metrological char- and confirms that the measuring instrument complies with statutory requirements.
acteristics. Any sealing break by non-authorized per-
When establishing a performance verification sched- sonnel automatically causes accreditation loss. Calibration
ule, process requirements should be considered in ad- Re-verification is mandatory. Result of the action of calibrating an instrument. To calibrate means to determine the deviation between
dition to specific regulatory requirements.
the measurement value and the true value of the measure under specific measurement conditions.
Standard re-verification (generally after 1-3 years) is
While the company operating the scales can carry out usually performed by the respective national weights Adjustment
all of the required actions, it may be advisable to con- and measures inspectors. Any use of an instrument Adjusting is the action of setting a measuring instrument or standard so that the measured value is correct,
tract with an experienced service provider to ensure le- outside of its verification period or after unauthorized or deviates as little as possible from the correct value, or the deviation remains within acceptable limits of error.
gal-use scales remain in good working order. instrument manipulation may lead to an investigation
and prosecution for operating a non-compliant scale. Principles of assurance of metrological control, CHAPTER II
THE METROLOGICAL CONTROL SYSTEM, INTERNATIONAL DOCUMENT, OIML D 16, Edition 1986
OIML
www.oiml.org/publications
National Institute of Standards and Technology (NIST)

http://ts.nist.gov
5 Summary
For more about Good Weighing Practice™, risk evaluation, or effective scale operation, log onto
Legal metrology regulations require correct handling It is up to the user to guarantee that verified instru- www.mt.com/gwp
and management of verified instruments as part of a ments are maintained well and operate within legal
company’s overall quality management system. Inter- tolerances. Systematic performance checks against Professional factory service is offered by METTLER TOLEDO
national and national law defined guidelines, as well the company’s own process parameters can offer www.mt.com/service
as process steps and requirements, for how to install, practical support to achieve product quality and safety
handle, check and service verified instruments. within legal metrology tolerances.
Weights and measures inspectors will check to see if Certified service providers offer systematic methods
instruments are being used according to the applica- that support the user along the whole process chain-
ble regulations. They will also conduct the re-verifica- starting with determining where a verified instrument is
tion process after a certain time period. needed through providing appropriate maintenance
and calibration documentation for the next audit.
Mettler-Toledo GmbH
Industrial Division
Tel. + 41 44 944 22 11

Reaching Specified Food Attributes 1 The Quality Umbrella: Good Measuring Practices
Good Measuring Practices
with Compliant Analytical Instruments Guided by considerations on process safety, METTLER
TOLEDO has published a series of eight guidelines
needs and then selecting the models best suited to
comply with these requirements. Next, the program

specific to various product lines under the umbrella of provides standard procedures for equipment installa-
the Good Measuring Practices program. They were de- tion and qualification and for extensive operator train-
veloped as a tangible means of translating the well- ing, guaranteeing a smooth start – free of application
established and widely enforced, albeit rather generic errors and complications. Finally, the guidelines rec-
Increasing consumer safety and public health awareness pose some demanding challeng-
working instructions, such as good laboratory practice ommend appropriate routine operations, such as fre-
es on the food and beverage industry of today. At the same time, the pressure on margins
(GLP) or good manufacturing practice (GMP), into quent verification testing by the operator and regularly
is rising too. Hence, the food and beverage industry is walking on a narrow path between specific sets of guiding principles for its own product scheduled maintenance services with subsequent cali-
high process efficacy and low process risks. Despite the cost pressure, to compete in the portfolio, which are, however, also fully applicable for bration executed by the manufacturer’s field service
market the food industry needs to produce safe and high quality food. any other manufacturers’ instruments. technicians. These measures are recommended to en-
sure optimized operating hours, to guarantee accuracy
Analytical instruments play a key role in the bio- Recognizing the paramount importance of standard- of the measuring processes and thus to minimize the
logical, chemical and physical examination of raw ized methods, various industrial guidelines were es- risk of out-of-specification results.
materials, of finished food stuff but also of elements tablished between 2007 and 2016, covering technolo-
like the packaging material etc. By investing in the gies used for standard chemical and physical While meeting these guidelines can sometimes be
correct measuring and monitoring devices and by measurements and analysis such as weighing, titra- cumbersome, not meeting them can cause products to
maintaining them regularly companies can reach tion or pipetting, conductivity or pH measurement, de- be ineffective. The Good Measuring Practices program
compliance with internal and external standards termining density or refractive indexes, or thermal provides continuous proactive support throughout the
more easily. By training the staff professionally the analysis. entire lifecycle of laboratory equipment, giving the user
level of performance can be enhanced additionally. the confidence that he can run the instrument at any
The guidelines address all critical interactions between time within proper operational conditions and thus al-
The better the biological, chemical and physical the instrument, its location and environment and the ways fully rely on the results without any compromise
analyses the greater are the control possibilities in operator, starting by evaluating the application-specific on quality.
production, and the closer are the properties of the
finished product to the specifications. High precision
measuring devices that undergo frequent performance
verification assure the attributes that are desired. Also 2 Risk-Based Management Approach
from a cost of ownership perspective, getting it right
the first time costs considerably less than measuring Content
Ensuring that manufacturing processes critical to prod- Ensuring that the final results are always within these
and evaluating repeatedly. 1 Good Measuring Practices uct quality generate results within predefined tolerance very often rather narrow process tolerance ranges re-
2 Risk-Based Management Approach windows is fundamental. The potential risk for eco- quires an in-depth knowledge of the applications, a
3 The Eight Guidelines nomic damage related to not meeting such quality re- thorough understanding of the underlying measuring
quirements is specific to each process step and there- principles, and – most importantly – a continuous
4 The Five Steps in Each Lifecycle
fore needs to be thoroughly assessed together with the control of the operational state of the equipment in
5 How Can the Guidelines Assist? responsible manager. Appropriate quality assurance use. Anything less means leaving results to chance.
6 Optimized Test Procedures Are Key measures are then to be identified, implemented, doc-
umented and continuously monitored.
7 Summary

All Good Measuring Practices guidelines involve a Implementing a systematic and scientific evaluation Keeping an eye on risk and security equilibrates pro- • Instrument Installation / Operator Training – ensuring
scientific process-specific risk check. The assessment approach for optimal equipment selection, installation cess hazards with testing efforts and operational effi- professional installation and setup of the instrument
of the risk associated with each measuring process and maintenance is the only way to safeguard consis- cacy in every one of the following five basic steps of followed by an in-depth user familiarization on oper-
provides the instrument operator with detailed recom- tent adherence of critical manufacturing standards to an instrument’s lifecycle: ational fundamentals by the manufacturer’s experts;
mendations on frequency and method for regular per- process requirements across various production loca- • Initial Qualification / Regular Calibration – testing

formance verifications, and proposes intervals for pre- tions – and even throughout the industry. This ensures • Evaluation of application, environment and instru- and releasing the instrument for dedicated routine
ventive maintenance visits. Only such a holistic view not only manufacturing accuracy but consistent prod- ment requirements – gaining a detailed understand- operations, ensuring full compliance with internal
of the entire measuring process allows proper instru- uct quality for enhanced safety industry-wide. ing of all criteria to be taken into account for setting quality standards as well as global and local indus-
ment performance day-in, day-out, all year around. up an efficient workflow while achieving secure pro- trial regulations and norms;
cesses and high-quality results, and, last but not • Routine Operation – providing explicit guidance on
least, guaranteeing safe data handling; optimal frequency and methods of process verifica-
• Selection of the instrument – identifying the best tion by the operator, and recommendations for
suited package of equipment plus service that meets scheduling preventive maintenance and re-calibra-
3 The Eight Guidelines the financial budget and best complies with process tion visits by the manufacturer’s service team.
requirements over a long period of time;
METTLER TOLEDO’S Good Measuring Practices pro- • GDRP™ – Good Density and Refractometry
gram currently hosts eight different guidelines, each Practice™
specific for a group of instruments, all of them provid- for density meters and refractometers;
ing application-driven, risk-based management advice • GEP™ – Good Electrochemistry Practice™
for laboratory equipment. This includes for pH, redox, conductivity, ion and dissolved 5
oxygen meters; Routine 1
• GWP® – Good Weighing Practice™ • GTAP™ – Good Thermal Analysis Practice™ Operation Evaluation
for laboratory balances, scales and moisture ana- for thermal analysis instruments;
lyzers; • GMDP™ – Good Melting and Dropping Point
• GTP® – Good Titration Practice™ Practice™
for titrators; for melting and dropping point instruments; Good
• GPP™ – Good Pipetting Practice™ • GUVP™ – Good UV/VIS Spectroscopy Practice™ Measuring
for pipettes; for ultraviolet and visible light spectrophotometers. 4
Calibration / Practices 2
3WCNKƂECVKQP Selection
4 The Five Steps in Each Lifecycle 3

Installation /
Each of the Good Measuring Practices guidelines in- For all these stages in an instrument’s life, Good Mea- Training
troduced above and described in more detail in later suring Practices consultants provide a process frame-
chapters of this paper is structured in five steps that work to maximize operational security. Each guideline
represent key moments in the lifecycle of an instru- can therefore be considered as an easy-to-follow se-
ment. The guidelines present advisory support begin- quence to identify appropriate quality assurance mea-
ning already with pre-purchase considerations, going sures for handling laboratory instrumentation in any
all the way to recommendations for testing, calibrating given quality management system. All Good Measuring Practices guidelines follow this guidelines in order to give more emphasis to topics
and maintenance interventions during the many years lifecycle consultancy in five steps; however, depending of superior importance to the instrument’s risk-based
of daily operation. on the very nature of the various instrument groups, lifecycle management.
the focus of steps 3 and 4 differs slightly between
5 How Can the Guidelines Assist? 7 Summary
Each step of the lifecycle of the Good Measuring • Service optimization: Each guideline issues recom- Precision measurements and chemical analysis apply- entific, risk-based management guidelines for various
Practices guidelines contains business-relevant de- mendations for testing and service schemes that are ing technologies, such as weighing, titration, or pipet- technologies relevant in most research, production and

liverables for the responsible managers in various costoptimized while providing safe margins with re- ting, are common methods of various departments, quality control laboratories.
departments of any company such as the quality gard to process tolerances, following the paradigm such as R&D, quality control or production.
assurance manager, the department head, or the “Test as much as needed but as little as possible”. Applying the holistic approach embedded in all of
procurement officer, who typically focus on both • Audit-worthy documentation: The guidelines further In order to guarantee adherence to internal and exter- METTLER TOLEDO’s Good Measuring Practices
product quality and process profitability. However, provide information on METTLER TOLEDO’s equip- nal norms and regulations, to enhance data and prod- guidelines is the only way to secure long-term process
the guidelines also contribute significantly to trouble- ment qualification packages and calibration certifi- uct quality, and last but not least to minimize consum- consistency, performance reliability and overall data
free applications and are thus of interest to instrument cates, obtainable in audit-proof formats, fully com- er risks, it is crucial to ensure that the instrumentation quality day-in, day-out. This approach addresses the
operators, providing fundamental knowledge and pliant with industrial standards and norms under is selected according to a risk-based evaluation of the basic quality needs for a food manufacturer at all
practical tips and tricks for smooth and uninterrupted any regulatory regime, professionally documenting application process, professionally commissioned, in- workbenches of research, production and quality
workflows. The guidelines may assist regarding the the measuring performance of instruments and its stalled, maintained and calibrated, as well as to make control departments.
following topics: interpretation linked to pass/fail criteria. sure that the operators are adequately trained.
• Stability and sustainability: Last but not least, fol- Good Measuring Practices
• Quality assurance: The guidelines provide the sci- lowing the guidelines leads you to increased pro- Under the umbrella of its Good Measuring Practices www.mt.com/gp
entific fundament for top quality, highly accurate cess stability and lean workflows, thus contributing program, METTLER TOLEDO has developed eight sci-
measuring results, combining the operator’s appli- to ecological sustainability, supporting reduction of
cation expertise with the manufacturer’s technologi- process waste due to excessive testing and/or poor
cal proficiency and the built-in test and reminder product quality.
functionalities of the instruments.
• Minimized risk: The guidelines were established to Each of these guidelines ensures high process quality,
assist with active management of process risks by particularly when coupled with professional consulta-
defining and implementing operational methods that tion, and thus helps prevent the kind of poor results Guides and white papers
ensure procedural consistency while fulfilling quality that causes economic damage due to production de- Scientific literature on current topics in the field of laboratory weighing,
assurance and regulatory requirements taking into lays, rework or recall, or monetary losses in terms of analytical instruments and liquid handling can be found here:
account environmental influences. fines and even litigation. www.mt.com/lab-library
Webinars
METTLER TOLEDO provide web-based seminars (webinars) on different topics.
6 Optimized Test Procedures Are Key Check out Good Weighing Practice™ - The Global Weighing Guideline, at:
www.mt.com/webinars
The systematic approach taken in the Good Measuring If operators must continually test their equipment and
Practices program seeks to ensure that sufficient ac- take it offline, the impact to already thin profit margins
tion is taken to guarantee accurate and reproducible in the fast-paced industry may become business criti-
results without onerous or burdensome over-testing. cal if not business threatening. The guidance given in
This helps achieve operational continuity while taking the various Good Measuring Practices frameworks for
into account process requirements and a potentially balancing process risks and testing efforts seeks to
negative impact on product quality, and hence con- ensure optimal uptime while providing greater confi-
sumer satisfaction and environment. dence for smooth internal quality reviews and worry-
free external audits.
Mettler-Toledo GmbH
Tel. +41-44-944 22 11 For more information


Moisture Analyzer 1 Influences on Accuracy
Moisture Analysis
Routine Performance Testing The accuracy of moisture analyzer results may be
influenced by several factors. The most important are
Safety factor
Reproducibility of the moisture content as determined
Moisture Analysis
variability of the heating temperature, of the weighing from a limited number of measurements will vary,
results and of the sample characteristics. In this white even if the setup is left unaltered. Besides these sta-
paper we elaborate on how these influences on the tistical variations, environmental conditions, sample
Moisture affects the processibility, shelf life, usability and quality of many food products. accuracy affect the final drying result and how these handling and different operators influence the perfor-
Errors when conducting moisture analysis may negatively impact quality results and influences can be controlled by performing appropriate mance of the moisture analyzer. It is therefore recom-
routine testing. It is important to know that there are mended to apply a safety factor to stay within the de-
influence product prices. This white paper offers guidance on how to optimize moisture
two types of influences that can limit the performance fined acceptance criteria. It is good practice to define
content determination and instrument performance. of an instrument - permanent and temporary influ- two different acceptance criteria, the warning and the
ences. control limit. The control limit represents the limit value
which has to be adhered to in order to satisfy the
Most products and ingredients have optimum moisture Permanent influences occur and persist. They limit the required accuracy. The warning limit is defined as the
content for obtaining the best possible processing re- accuracy of the moisture analyzer and will be detected control limit divided by the safety factor and provides
sults and therefore attaining maximum quality. Further- when the next performance test is carried out. They do an early warning to indicate that the accuracy of the
more, moisture content impacts on price and there are not disappear until a corrective action has been taken. moisture determination might deteriorate. It is recom-
statutory rules for some products governing the maxi- Temporary influences limit the accuracy of a moisture mended to apply a safety factor of minimum 2 by de-
mum permissible moisture content (e.g. as defined by analyzer only for the duration of the influence. The fault to compensate for the variations. The safety factor
national food regulations). This means that trade and limitation on the accuracy will disappear without any should be increased in accordance with the strength
industry need to determine moisture content levels. intervention or corrective action as soon as the influ- of the expected influences. I.e. in rough environments
ence has stopped. a higher safety factor should be applied.
To run measurement equipment and analytical instru-
ments in a quality system, industry specific regulatory
requirements often have to be followed. But regulatory
Routine test Temporary Routine test
guidance is commonly not very specific. They do not inƃWences
offer specific statements as to how the guidelines
should be achieved in everyday practices. Questions Control limit
such as “How often should I test my instrument?” are
not answered.
Contents
Warning limit
This white paper describes the influences and sources 1 Influences on Accuracy
of error which may be present when conducting mois- 2 Accuracy of Moisture Analyzer Results
ture analyses. It discusses the routine tests which are Accuracy of
3 Routine Testing of Moisture Analyzers
necessary to ensure reliable determination of the mois- moisture determination
ture content and correct functioning of the instrument. 4 Summary
Figure 1: Temporary influences may affect the accuracy of a moisture analyzer without being detected by a routine test. The safety factor
The recommended tests and their frequencies are pre- 5 Additional Resources builds a margin between the warning and control limits to lower the probability that measurements exceed the control limit even if tempo-
sented in the framework of a risk-based approach. rary external influences reduce the accuracy.

2 Accuracy of Moisture Analyzer Results Weighing unit A nonlinearity error has no considerable influence on
the moisture content result as the weight loss due to
There are several properties which limit the perfor- the drying process is generally small compared to the
The following chapters focus on the main permanent • How strong are the influences with regard to the mance of the weighing unit. The most important are balance capacity.
influences that affect the determination of moisture accuracy of the moisture determination? repeatability, eccentricity, nonlinearity and sensitivity.
Moisture Analysis
Moisture Analysis
content. To find out what the main influences are and • What measures can be taken to control these Consequently, routine nonlinearity tests by the user
what measures are meaningful in terms of quantifying influences? Sensitivity are not recommended.
the accuracy of a moisture analyzer, the questions Sensitivity is the ratio between the weighing value (in-
below need to be answered. Variability in moisture analyzer results is mainly influ- dicated on the balance) and the actual mass of the Repeatability
• What causes variations of moisture content results enced by three elements: the heating unit, the weigh- reference weight. A sensitivity of 1 (one) means that Repeatability is the ability of a weighing instrument
[%MC] in a moisture analyzer? ing unit and the sample itself. the displayed mass value equals the mass of the ref- to provide identical results when the same load is
• Where do these influences come from? erence weight. The evaluation of the moisture content placed several times and in a practically identical
[%MC] is based on the difference between the wet way on the weighing pan under reasonably constant
sample weight and the dry sample weight. Determin- test conditions. Repeatability is the dominant error
Heating unit ing the moisture content is based on relative weight for small sample weights. It influences both readings
measurements. Hence sensitivity has no impact on (wet weight and dry weight). However, repeatability
If the heating temperature is too high: the moisture result. has a very small influence on the accuracy as com-
• Components may oxidize, burn or combust. pared to a possible temperature deviation between
• Properties of the substance change and not all Eccentricity the programmed target temperature and the actual
moisture can evaporate (e.g. paint or glue forms Eccentricity is the deviation in the measurement value temperature.
a skin when the drying temperature is too high). caused by eccentric loading, in other words, asym-
metrical placement of the load on the weighing pan.
Temperature elasticity of the sample Generally, the eccentricity error has no considerable Relevance of deviations of
It is important to know how susceptible the sample is influence on the moisture content result: Firstly, the heating unit and weighing unit
to the variations in heating temperature. For some weight loss due to the drying process is usually small
substances, the result of the moisture determination compared to the balance capacity, and secondly, the In general, measurement errors due to deviations
Heating temperature variability (%MC) barely changes even when the heating temper- sample is not moved during drying. between the programmed target temperature and the
Possible reasons for variability of the heating ature changes considerably. Other substances show actual temperature are more likely and have a higher
temperature are: large differences in moisture content when the heating Consequently, eccentricity is not a dominant contribu- impact on the accuracy of the %MC results than mea-
• The heating unit is not adjusted correctly or has not temperature varies only slightly. The degree to which tor to the measurement uncertainty and routine eccen- surement errors due to the influence of repeatability
been adjusted on site, under working conditions. the %MC result of a sample is affected by a tempera- tricity tests by the user are not recommended. of the weighing unit. Also the impact of a change in
• The instrument location has changed since the last ture change in °C is called “temperature elasticity”. heating temperature is larger for samples with higher
adjustment/calibration. Therefore, the amount of influence from an erroneous Nonlinearity temperature elasticity.
• The protective glass or reflector is contaminated. temperature change depends on the temperature elas- The ideal characteristic weighing curve of a balance is
• The temperature sensor is defective or contaminated. ticity of the sample. a straight line through the measurement points of no- Hence, tests that detect temperature deviations
• The temperature calibration kit is defective. • High temperature elasticity load and full load (nominal weighing capacity). Non- (SmartCal, temperature calibration) are more often
• The correction values of the temperature calibration Substances with high temperature elasticity exhibit a linearity is the deviation of the indicated weighing val- required than weighing performance tests.
kit were not applied correctly during temperature big change in the moisture content result with just a ue from this straight line.
adjustment. small change in heating temperature (typically or-
ganic substances).
Impact of temperature variability • Low temperature elasticity
on the moisture result Substances with low temperature elasticity need a 3 Routine Testing of Moisture Analyzers
If the heating temperature is too low: big change in the heating temperature until an influ-
• Not all moisture is able to evaporate since lower ence on the moisture content result is visible (typi-
layers of the sample are not heated enough. cally inorganic substances). Maintaining the accuracy of an instrument and reduc- User
• Only a certain part of the moisture evaporates ing the risk of being out of specification requires test- In between maintenance and calibration by the service
(e.g. ethanol but not water). ing by the service provider and the user. provider, the user should perform routine tests to mon-
• Only the surface water but not the crystal water itor the most important parameters influencing mea-
evaporates. Service surement accuracy.
By calibrating all measurement components of the in-
strument using traceable standards and manufacturer Instrument
SOPs, the service provider provides a comprehensive Many state-of-the-art instruments include built-in test
statement of the instrument’s condition. and adjustment functionalities, as well as software
and hardware features (e.g. LevelControl) that help to
avoid measurement errors.
maintenance where all parts are cleaned and the func-
tions of all components are tested before calibration.
4 Summary
Hierarchy of tests – temperature The calibration of the weighing unit comprises the Deviations of a moisture analyzer are mainly influ- By service engineer
versus weighing comprehensive tests of the weighing parameters. If de- enced by the heating unit, the weighing unit and the • Calibration & adjustment
Moisture Analysis
Moisture Analysis
As described above, measurement errors due to devia- viations from manufacturer tolerances are detected, an sample.
tions between the programmed target temperature and adjustment is carried out. The calibration of the heat- By instrument
the actual temperature are more likely and have a ing unit using the temperature calibration kit is per- Temperature deviations are more likely than weighing • Test with built-in reference weight
higher impact on the accuracy of the %MC results formed against manufacturer tolerances. If deviations deviations and have a bigger impact on the moisture (FACT, by instrument)
than measurement errors due to the influence of re- occur, an adjustment is performed. All calibration re- result.
peatability of the weighing unit. Weighing is a more sults are documented and handed out to the user. The frequency of each routine test depends on the risk
stable and controlled process than heating. Hence, the The following tests are recommended for performance that is associated with the measurement process.
risk stemming from the weighing unit is rather low, as SmartCal test (by user) monitoring of a moisture analyzer:
long as no defect occurs. The SmartCal test substance is highly temperature For more detailed information, read the full white paper
elastic and contains a specific amount of moisture By the user ‘Routine Testing Moisture Analyzer’:
Therefore, the main reason to test the weighing unit is which makes it an ideal test substance for verifying • SmartCal test
to check its proper functioning and/or detect defects. the performance of moisture analyzers. Specific con- • Sensitivity test (SmartCal test can be done instead) www.mt.com/moisture-routine-testing
This can be done by performing periodic sensitivity trol limits for the SmartCal test are recommended by • Temperature calibration (SmartCal test can be done
tests. Periodic testing of eccentricity, nonlinearity and METTLER TOLEDO. instead)
repeatability is not as important and can be done by
the service technician within the framework of periodic A defect or substantial inaccuracy will be detected with
maintenance when performing a calibration. Tempera- SmartCal by showing a result outside the SmartCal
ture deviations are more likely and have a bigger im- control limits.
pact on the moisture result than variability in weighing.
The impact depends on the temperature elasticity of Sensitivity test (by user)
the sample. Performing the sensitivity test delivers an indication of • Moisture analyzers, METTLER TOLEDO • White Paper: Drying Oven vs. Halogen Moisture An-
incorrect adjustment of the weighing unit as well as www.mt.com/moisture alyzer – A Practical Guide to Compare Methods,
defects of the weighing cell that require more in depth METTLER TOLEDO
Conclusion
diagnosis before further use of the moisture analyzer • Method Collection: Find Your Moisture Method for www.mt.com/moisture-or-oven
The frequency of tests that focus on temperature
(e.g. defect due to improper transportation). Food, METTLER TOLEDO
should be higher than tests that focus on the weighing
www.mt.com/moisture-food-methods
accuracy. Moisture analyzers that are used to measure
Temperature calibration (by user)
the moisture content of samples with higher tempera-
Temperature calibration is performed by using a tem-
ture elasticity require more frequent testing than those
perature calibration kit as a reference. Performing a
used for samples with lower temperature elasticity.
temperature calibration indicates the condition of the
heating unit. Temperature deviations due to changes
Recommended tests
in the environment, will be detected.
During the routine operation of a moisture analyzer
only those tests are recommended which deliver a
Test or adjustment with built-in reference weight
meaningful statement with regards to controlling the
(by instrument)
quality of the measurement result.
Testing and adjustment mechanisms built into instru-
ments consist of one or more reference weights, and a
Calibration and adjustment of weighing loading mechanism that is activated either manually
and heating unit (by service engineer) or automatically. Such a mechanism allows conve-
Calibration by a service engineer is an extensive test nient testing and/or adjustment of the sensitivity of the
of all important parameters of a moisture analyzer. weighing instrument.
Preferably, a calibration is combined with preventative
Mettler-Toledo GmbH
Tel. +41 44 944 22 11 For more information
Fax +41 44 944 30 60

Intrinsic Safety Intrinsically Safe Solutions 1 Hazardous Areas and their Classifications
Accurate Weighing in Hazardous Areas An explosion is the sudden exothermic chemical reac- tion energy below the minimum ignition energy. The
Intrinsic Safety
tion of a flammable material with oxygen and the si- minimum ignition energy is the smallest amount of en-
multaneous release of high energy. To eliminate the ergy required to ignite a combustible vapor, gas or
risk of explosion, one of the three elements of the “Tri- dust cloud. The minimum ignition energy is measured
Accidents in hazardous areas can have dramatic consequences for businesses in terms angle of Fire” must be removed. in joules.
of both human life and profit. Intrinsically safe equipment is designed to ensure process
safety and to comply with hazardous area standards and regulations. For example, the explosive “hydrogen-air” mixture can
ignite with very low energy input; its minimum ignition
energy at atmospheric pressure is about 10-5 joules.
Oxygen (O2) The minimum ignition energy of dusts is in the range
of several milijoules up to 100 milijoules.
Two primary considerations must be taken into ac-
count when choosing the right weighing equipment Businesses conducting collection, transformation and
for hazardous areas. They must be approved for the production processes with inflammable substances
defined hazardous area classification and they must are obliged to conduct hazardous risk analysis to
Ignition Flammable
feature an appropriate method of ignition protection. source Substance
identify the potentially hazardous areas where danger-
When it comes to weighing applications in hazardous concentrations of explosive mixtures of flammable
ous areas, the two most common ignition protection Triangle of Fire or explosive materials can occur. Such areas are
types available are intrinsic safety and flameproof Picture 1. Triangle of Fire called “hazardous areas.”
(or explosionproof).
Flammable substances may be present in the form of When electrical equipment is used in a location classi-
Intrinsic safety is one of the safest ignition protection gases, vapors, mists or dusts. Together with oxygen fied as hazardous, it must be appropriately certified
types. It provides a range of benefits which sets it these substances can form an explosive atmosphere. and provide the required level of protection. The selec-
apart from other protection types. This white paper de- It can be ignited by an ignition source such as flames, tion of an appropriate protection method is based on
scribes the principles of intrinsic safety and compares sparks, hot surfaces or electromagnetic fields. the classification of the hazardous area. That is why it
it to other protection methods, specifically flameproof/ is important to understand area classifications and
explosionproof. In addition, the white paper examines One approach to prevent an explosion is to eliminate their differences. Picture 2 shows a weighing tank and
different weighing configurations in hazardous areas. the ignition source by keeping the system’s active igni- the distribution and classification of hazardous areas.
Contents
1 Hazardous Areas and their Classifications
2 Ignition Protection Methods
3 Intrinsic Safety – Basic Principles Zone 1 / Division 1
4 Intrinsic Safety – Benefits

5 Summary Zone 0 /
Division 1
6 Additional References
Flammable or Ex-
plosive
Substance
Zone 2 / Zone 2 /
Division 2 Division 2
Picture 2. Hazardous Area Definitions

Classification varies throughout the world, but general-
ly, there are two types of classification. Europe has
According to the ATEX Directive, hazardous areas are
divided into three zones for gases and three zones for
2 Ignition Protection Methods
adopted the International Electro Technical Commis- dust substances. The classification is defined accord-
sion (IEC) philosophy referred to as “Zoning.” ing to the probability of the presence of an explosive The basic safety concept is to eliminate the simultane- as well as the applicable standard and the classified
atmosphere. Each zone is corresponding to the partic- ous existence of the possible ignition sources. area.
Intrinsic Safety
Intrinsic Safety
Information and specifications for zone classification ular equipment category. The method of protection will likely depend on the de-
are defined in the norm IEC EN60079-10 and in na- gree of safety needed for the defined hazardous area While the protection methods are standardized, those
tional standards. Furthermore, the installation and op- In North America, areas are classified into classes. classification. In addition, other considerations must standards may vary in different countries. However,
eration of electrical systems in hazardous locations Classes are further categorized into Division 1 and Di- be made, such as the size of the equipment, its nor- the principles of protection are the same regardless of
and the zone classification within the European Com- vision 2, according to the probability of materials mal function, power requirements, installation costs the country. When it comes to designing and develop-
munity are defined in the ATEX 2014/34/EU Directive. present in a potentially hazardous quantity. Class I and flexibility of the protection method for mainte- ing weighing equipment for hazardous areas, the two
(Gases) and Class II (Dust) hazardous areas are di- nance. methods, intrinsic safety and flameproof, are mainly
Table 1 shows an overview of the zones, divisions and vided into subgroups based on the type of flammable applied. Intrinsic safety provides numerous technical
the allocation of equipment for the relevant hazardous gas, vapor or particles present. Class III (Fibers) is not Tables 2 and 3 show an overview of the standardized and economical advantages, which makes it the pre-
area classification. divided into subgroups. types of protection for Zones and Class/Division. It de- ferred protection method for weighing equipment.
scribes the basic principle of each protection method
Protection types: zones

Equipment
Hazardous area classification Protection type Protection principle Standard Zone
marking
Equipment
Substance Hazardous area characteristics USA USA NEC505 ATEX IEC/EN: 60079-0 EU: Ex
category General regulation Basis for protection type ANSI/ISA: 60079-0 USA: AEx Gas/dust
NEC500 / NEC506 2014/34/EU
CSA: C22.2 No. 60079-0 Canada: Ex
Explosive atmosphere is present IEC/EN: 60079-11 ia 0/20
Zone 0 1G Limit energy; no sparks or hot surfaces
continuously Intrinsic safety 'I'
that can cause an ignition
ANSI/ISA: 60079-11 ib 1/21
Division 1 CSA: C22.2 No. 60079-11 ic 2/22
Gases / Explosive atmosphere is likely to Enclosure can withstand an IEC/EN: 60079-1
Class I Zone 1 2G (1G) Flameproof db 1
vapors occur occasionally internal explosion without igniting ANSI/ISA: 60079-1
(NEC505) enclosures 'd' db 2
external atmosphere CSA: 22.2 No. 60079-1
Explosive atmosphere is likely to
3G IEC/EN: 60079-31 ta 20
occur infrequently or for short Division 2 Zone 2 Protection by Special enclosure design (dust)
(1G and 2G) ANSI/ISA: 60079-31 tb 21
periods of time enclosure 't' to exclude explosive atmospheres
CSA: 22.2 No. 60079-31 tc 22
Explosive atmosphere is present Dust and water tight enclosure.
IEC/EN: 60079 -7
eb
1
Zone 20 1D Increased safety 'e' ANSI/ISA: 60079-7 2
continuously Prevent sparks or hot surfaces ec
Division 1 CSA: 22.2 No. 60079-7
Explosive atmosphere is likely to Non-sparking equipment IEC/EN: 60079-15 nA 2
Class II Zone 21 2D (1D)
Dusts occur occasionally Non-sparking 'n' ANSI/ISA: 60079-15
(NEC506) Sparking with protection CSA: 22.2 No. 60079-15 nC 2
Explosive atmosphere is likely to
3D IEC/EN: 60079-18 ma 0/20
occur infrequently or for short Division 2 Zone 22 Encapsulation 'm'
Keep explosive atmosphere away
ANSI/ISA: 60079-18 mb 1/21
(1D and 2D) from ignition source
periods of time CSA: 22.2 No. 60079-18 mc 2/22
Table 1 - Hazardous Area Classification according to EU and USA Standards. Prevent ingress of explosive pxb/pyb 1
gas atmosphere IEC/EN: 60079-2 pzc 2
Pressurized
ANSI/ISA: 60079-2
enclosures 'p' Prevent ingress of explosive pb 21
CSA: 22.2 No. 60079-2
dust atmosphere pc 22
IEC/EN: 60079-6
Keep explosive atmosphere away from ob 1
Oil immersion 'o' ANSI/ISA: 60079-6
ignition source ob 2
CSA: 22.2 No. 60079-6
IEC/EN: 60079-5
Prevents ignition from spreading qb 1
Powder filled 'q' ANSI/ISA: 60079-5
by snuffing in an inert powder qc 2
CSA: 22.2 No. 60079-5
Table 2. Protection Methods and Related Electrical Standards for Zones
Protection types: class/division
Hazardous area Safe area
Protection type Protection principle Standard Class Division
General Basis for protection type FM3600 I,II,III 1 and 2
Limit energy; no sparks or hot surfaces that can FM3600 R Isc

Intrinsic Safety
Intrinsic Safety
Intrinsic safety I, II, III 1 and 2
cause an ignition UL913
Enclosure can withstand an internal explosion V Voc

Explosionproof FM3615
without damage and without igniting external I 1 and 2
enclosure UL1203
atmosphere
Equipment with circuits where any arc / heat I 2
Non-incendive ISA 12.12.01
released is incapable of igniting a flammable II 2
equipment FM3611
atmosphere III 1 and 2
Purged and Purge enclosure with protective gas, prevent
NFPA 496 I, II, III 1 and 2 Picture 3 Intrinsically Safe Circuit.
pressurized entrance of flammable compounds
Enclosure does not allow entrance of dust, pre- FM3616
Dust ignition-proof II, III 1 and 2
vents ignition of exterior atmosphere UL1203
Dust-tight enclosure Enclosure prevents entrance of dust

NEMA 250 II 2 Intrinsically safe system terminals, is possible through a special barrier. This is
UL50E III 1 and 2
An intrinsically safe system may combine intrinsically achieved via a communication interface ACM 500,
I 2
Equipment which is completely sealed by fusion safe elements, associated elements and special ap- which encompasses both intrinsically safe and non-
Hermetically sealed — II 2
to prevent contact with the external atmosphere intrinsically safe electrical circuits.
III 1 and 2 proved wiring with standard equipment, which is in-
Keep the explosive atmosphere away from the stalled in the safe area. All elements of the system
Oil immersion — I 2
ignition source must be compatible to form an intrinsically safe system. In an intrinsically safe system, physical barriers are
Power to system is shut off when presence of ANSI/ISA 12.13.03 used between the hazardous and safe areas to limit
Gas detection system I 1 and 2
combustible gas is detected FM6320 the energy that enters the hazardous area. Intrinsically
Let’s consider an example with an intrinsically safe
Table 3. Protection Methods and Related Electrical Standards for Class/Division weighing system (picture 4). In our example, the in- safe barriers maintain approved levels of voltage and
trinsically safe apparatus consists of an analog weigh- current via power limiting components. They ensure
ing platform and the intrinsically safe weighing termi- that even under fault conditions, no more than the ap-
nal IND560x. The intrinsically safe power supply proved voltage or current enters the hazardous area.
3 Intrinsic Safety – Basic Principles APS768x serves as the power source for the weighing This allows standard electrical devices installed in the
terminal and is defined as a simple apparatus. Com- safe area, such as printers, computers and PLC sys-
munication to the standard peripherial instruments, tems, to be directly linked into a hazardous area.
Since it was introduced in non-mining applications, Intrinsically safe technology prevents explosions by
such as PC, barcode reader or even remote control
intrinsic safety has evolved to become one of the most ensuring that the energy transferred to a hazardous
commonly used protection methods in process indus- area is well below the energy required to initiate an ex-
tries. Today, intrinsic safety is one of safest and most plosion. As such, it is restricted to electrical apparatus- Hazardous area Safe area
advanced methods of ignition protection. It has be- es and circuits in which the output or consumption of
come the method of choice because, independent energy is limited. Intrinsically safe systems enable Communication
Weighing module
from the application, it keeps the entire system safe. equipment to be used without risk of igniting any flam- terminal
mable gas, dust or fibers that may present in hazard-
RS232 Ethernet cable
ous areas.
RS232
Intrinsically safe circuit PC

An electrical circuit is intrinsically safe when it produc- It also must be done in such a way that sparks pro- connection
P
Power l
supply
es energy below the minimum ignition energy (MIE), duced when opening, closing or earthing the circuit or Printer Remote
Weighing platform terminal
which is defined by the appropriate standards. In Eu- produced by any other hot part of the circuit itself
rope, IEC EN60079-11 specifies the construction and would not cause ignition. Intrinsically safe electrical
testing of intrinsically safe equipment; in the USA, equipment and wiring can be used in hazardous areas All apparatuses require equi-
potential bonding. All earthing
FM3610 does this. Intrinsically safe electrical equip- classified as Zone 1/21 and Division 1 as long as they points to the same location.
ment is designed to limit the open circuit voltage (Voc) are approved for the location.
Picture 4. Intrinsically Safe Weighing System
and the short circuit current (Isc) to keep the produced
energy at the lowest possible level.
Levels of classification and protection The classifications ensure that the equipment is suitable
for an appropriate hazardous application. For example,
5 Summary
Intrinsic safety offers three classification levels, “ia,”
“ib” or “ic,” which are based on the safety level and having equipment classified as “Ex ib” means that the
number of faults possible. Each classification attempts equipment is designed containing an intrinsically safe Weighing is an important component of many manu- A wide range of weighing platforms weigh modules
to balance the probability of an explosive atmosphere circuit and can be installed in the certified hazardous facturing processes, and it requires special attention and control terminals are available to implement haz-
Intrinsic Safety
Intrinsic Safety
being present against the probability of an ignition oc- areas Zone 1/21 and Division 1. Moreover, the “ib” clas- when conducted in potentially explosive environments. ardous area weighing applications from simple manu-
curring. The level of protection “ia” is a prerequisite for sification indicates that one fault is possible. The two most common methods for the implementa- al to highly automated weighing processes such as
Category 1 equipment and is suitable for use in tion of hazardous area approved weighing solutions filling, dosing or checkweighing. Flexible data interfac-
Zone 0/20. The level of protection “ib” for Category 2 Table 4 presents different protection levels, the numbers are intrinsic safety and flameproof/explosionproof. es ensure seamless integration into the production
equipment is suitable for use in Zone 1/21 and Divi- of faults possible and the appropriate hazardous area. However, intrinsically safe weighing technology is see- data management systems.
sion 1. The level of protection “ic” for Category 3 is ing significant growth as it combines several benefits
suitable for use in Zone 2/22 and Division 2. that help manufacturers ensure process safety while Most importantly, intrinsic safety can be considered
improving productivity. the safest and most advanced method of ignition pro-
Protection level ai ib ic tection. Intrinsically safe systems enable equipment to
Hazardous area Zone 0, 1, 2 / Division 1 Zone 1, 2 / Division 1 Zone 2 / Division 2 Intrinsically safe weighing systems are less expensive be used without risk of igniting any flammable gas,
Faults possible 2 1 Normal operation and can be installed faster. The systems are less dust or fibers providing an extra level of confidence in
Table 4. Intrinsically safe protection levels
heavy and bulky and can be easily integrated into ex- the safety of the process.
isting infrastructure. They provide the same weighing
functionality as in the safe area which ensures accu-
rate, reliable and efficient weighing processes.
4 Intrinsic Safety Benefits
In Europe, intrinsically safe systems have become the Maintenance of intrinsically safe equipment is easier
standard solution for weighing in hazardous areas. In and requires less time than with explosion proof en- 6 Additional References
other regions such as Asia or North America intrinsi- closures. The reason is that opening and closing the
cally safe weighing systems are quickly gaining ac- heavy, bolted explosion proof enclosures is labor in-
ceptance over the traditional flameproof or explosion- tensive. In addition, great care needs to be taken to • IEC EN 60079-0: Explosive Atmospheres – Part 0: • METTLER TOLEDO Hazardous On-Demand Webinar
proof protection methods. This development can be ensure the integrity of the enclosure before restarting Equipment – General Requirements Standards and Regulations –
attributed to the significant benefits intrinsic safety of- the system. However, also with intrinsically safe • IEC EN 60079-10-1: Explosive Atmospheres – Part www.mt.com/ind-hazweb-standards
fers compared to other protection methods. weighing systems it is important to make the area safe 10-1: Classification of Areas – Explosive Gas Atmo- • METTLER TOLEDO Hazardous On-Demand Webinar
when conducting maintenance activities. sphere Protection Methods –
With intrinsically safe equipment, the ignition of an ex- • IEC EN 60079-11: Explosive Atmospheres – Part 11: www.mt.com/ind-hazweb-protection
plosive atmosphere is not possible because the ener- Explosion proof housings include safety provisions to Equipment protection by intrinsic safety “i”, 5th Edition • METTLER TOLEDO Hazardous Catalog –
gy in the equipment is limited below the level required contain and vent a possible explosion which makes • ATEX Directive 2014/34/EU: Guidlines on Applica- www.mt.com/ind-hazcat
to generate sparks or hot surfaces that could cause an them larger and heavier and which also leads to me- tion, European Comission, First Edition, 2016. • METTLER TOLEDO IND560x Product Brochure –
ignition. It is very unusual that errors will occur in an chanical and structural complications. Intrinsic safety • National Electrical Code®, Article 500, NFPA 70, www.mt.com/ind560x
intrinsically safe device and in the rare occasion that enables the design of compact and modular solutions 2011, Delmar: Nacional Electric Code
an error occurs it will not cause an explosion. that can be better tailored to the process requirements • National Electrical Code, Article 505, NFPA 70, 2011,
and easily integrated into existing structures. Delmar: Nacional Electric Code
Intrinsically safe equipment and components such as
cables and cable glands are relatively inexpensive and International and local certification bodies such as
installation is less complex than with flameproof/ex- IECEx, ATEX, NEC, NEPSI, TR-CU, KTL, and others ac-
plosionproof equipment. An explosion proof system re- cept the intrinsic safety protection method. Explosion
quires a sophisticated enclosure which is able to con- proof (NEC) and Flameproof (IECEx/ATEX) protection
tain and vent an internal explosion without igniting the methods on the other hand are subject to different
surrounding atmosphere. This also leads to higher ef- standards, while other protection methods are only ac-
forts because heavy conduits and bolted enclosures cepted by individual certification bodies. However,
Mettler-Toledo GmbH
Industrial Division
need to be installed. there are some differences within the national stan- CH-8606 Nänikon, Switzerland For more information
Tel. + 41 44 944 22 11
dards on how intrinsic safety is defined.

For more information
Mettler-Toledo GmbH
Industrial Division
CH-8606 Nänikon, Switzerland

MTSI 44098208

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Food Regulatory Guide

Food Safety & Compliance with

Chapter 2 Traceability for Standard Compliance and Process Improvement 14

Chapfer 3 Improved Production Yield Through Process Oriented Recipe Management 20

Chapter 4 Food Safety – Fresh Products in Grocery Retail 26

Chapter 5 Package Quality Control – Net Content Control 34

Chapter 6 In-line Checkweighing – Aspects of a Key Technology 40

Chapter 7 Vision Inspection – Driving Quality and Process Security 46

Chapter 8 Foreign Body Detection – Metal 52

Chapter 9 Foreign Body Detection – X-ray Inspection 58

Chapter 10 Hygienic Designed Food Scales – Less Contamination, Enhanced Profits 64

Chapter 11 7 Considerations for Cleaning Production Equipment 70

Chapter 12 Efficient Quality Management in a Regulated Environment 76

Chapter 13 Meeting Legal Metrology Standards 84

Chapter 14 Reaching Specified Food Attributes with Compliant Analytical Instruments 92

Chapter 15 Moisture Analyzer Routine Performance Testing 98

Chapter 16 Intrinsically Safe Solutions – Accurate Weighing in Hazardous Areas 104

2 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 3

Quality Control Assured

Safety Safety in Explosive ATEX Directive / OSHA Law & Regulations

Consumers, retailers and food manufacturers today are increasingly focused on

6 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 7

3 GFSI-Accepted Standards 4 Comparing the Standards

importance in the coming years: Online shopping

While all certifications deal with similar food safety re-

Local contact: www.mt.com/contacts

Subject to technical changes

MES / ERP System

14 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 15

Local contact: www.mt.com/contacts

Subject to technical changes

A computer-guided and networked, rather than paper-

20 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 21

Weighing & Mixing

Barcodes guarantee simple, fast verification with the connected reader

A newly printed weighing label helps

Printers connected to weighing workstations can print

• Stock labels. These ensure stock is known upon ar-

Local contact: www.mt.com/contacts

Subject to technical changes

stipulate extensive declarations, seamless traceability and effective measures for

avoiding product recalls.

Existing traceability frameworks form a basis for fur- Supermarket Checkout

26 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 27

It is mandatory to indicate substances which can

List of ingredients in the case of more than one ingredient

Alcohol content – if more than 1.2 percent by volume

* Not required by regulation 1169/2011: please check other regulations

General guidelines for

4 Hygiene: Reducing Health Risks

Subject to technical changes

Thorough product inspection includes ensuring pack-

34 METTLER TOLEDO © 06/2017 – Food Regulatory Guide 35

Cost effectivness in the filling plant Monitoring Sample/data

Average fill quantity

Step 1: Product specification

SQC spot-checks determine batch acceptability Step 3: Product selection

Step 4: Sampling / data acquisition

Step 5: Monitoring and reporting

Package quality Product quality • Quality data management solution FreeWeigh.Net ®