IFS HPC v2 Guideline2

HPC
IFS HPC Version 2

IFS Global Markets Food 2
Guideline
Guideline
Typical assessor questions and advice
for IFS Global Markets – Food
Version 1, December 2016

Number Requirement Example of questions to be asked Additional explanations
1
1.1 Corporate policy / Corporate principles
1.1.1 The senior management shall draw up and implement a • How and where is corporate policy documented?
corporate policy. The corporate policy shall include as a mini- • When was the last update of the corporate policy?
mum reference to: • What are the contents of the corporate policy?
• customer and consumer focus, • How was corporate policy communicated to all employees?
• environmental responsibility, <corporate policy>, <posters>, <documented evidence of
• occupational health, corporate policy communication on product safety>
• buildings, • Here the senior management unambiguously carries the
• machines and equipment, responsibility. The guidelines should be set out in writing
• product requirements (includes: product safety, quality, and available for members of staff in manuals and notices.
legality, process and specification). The issues mentioned are fundamental for corporate princi-
ples.
The corporate policy shall be communicated to all employees. • Is the corporate policy agreed by suppliers and customers?
1.1.2 The content of the corporate policy shall have been broken • What short, medium and long term quality objectives are
down into specific objectives for the relevant departments. addressed?
The responsibility and the time scale for achievement shall be • How are the objectives attained on product and process
defined for each department of the company. safety?
• What is the time frame to attain the objectives?
• Who is responsible for objectives attainment?
• What actions are taken by specific departments, e.g.
purchase, to attain the objectives?
<written review meeting minutes>, <list of attendees at
review meeting>, <quality and product safety objectives>,
e.g. evaluation based on balanced scorecard system
• It should be checked, if the aims are known by the mem-
bers of staff and if these aims are implemented.
IFS HPC VERSION 2 GUIDELINE 2 | 77

1.1.3 From the corporate policy, the quality and product safety • Are these objectives known by concerned employees?
objectives shall be communicated to the employees in the • What tools are used to measure that the objectives have
respective departments and shall be effectively implemented. been attained?
The company shall ensure that all relevant information is <list of attendees at review meeting>,
communicated effectively and in a timely manner to the <mailing list of review meeting minutes>,
relevant personnel. <posters showing the different department objectives>
• The members of staff should be regularly informed of
quality objectives and its importance for their work, e.g.
within trainings. By means of questions should be checked,
if the members of staff know their obligations and influ-
ence capability.
1.1.4 The senior management shall ensure that the achievement of • How often is this review performed?
all objectives is regularly reviewed, as a minimum the objec- • Is the extent of the review conforming to the size of the
tives shall be reviewed annually. company?
<review>, <review minutes>,<internal audit report>,
<other review data on product records>
• The achievement of objectives should be checked best by
Management reviews. The statements of the ISO 9001:2015
could be considered as assistant.
1.2 Corporate structure
1.2.1 An organization chart shall be available showing the structure • Is an organisation chart available?
of the company. • When was the last update of the organisation chart made?
• How is the organisation structured?
<Organisation chart>
• Organigrams are common and a good possibility to
describe structures and processes most realistic

1.2.2 Competences and responsibilities, including deputation of • For which positions do written job descriptions exist?
responsibility shall be clearly specified. • What is regulated in the job descriptions?
• Who, for example substitutes QA manager during her / his
absence? Is a replacement regulation available for all rele-
vant employees?
<Responsibility description for important key staff
“dedicated to a specific person”, e.g. QA Manager,
Production Manager, Shift Leader …>
• Competences and responsibilities and can also be regu-
lated in job descriptions. Regarding proxy they should be
very clear, possibly for description in organigrams.
1.2.3 KO N° 1: The senior management shall ensure that employ- • How is it ensured that employees know their responsibili-
ees are aware of their responsibilities relating to product ties?
safety and quality. Senior management shall also ensure • How does senior management ensure that employees
that mechanisms are in place to monitor the effectiveness know their responsibilities?
of the operation of the employees. Such mechanisms shall Interview Senior Management (which is not automatically the
be clearly identified and documented. Quality Manager)
The senior management is responsible for duties concerning
organisation, supervision and control. Basis for the duty of the
organisation is a clear assignment of tasks. In this regard
organigrams are a good possibility for presentation. Duties
concerning supervision and control are mostly delegated to
certain persons. They have to ensure that the assigned tasks
are realized appropriately. During the audit it should be
checked, if the responsibilities are clear for members of staff,
if they are implemented, and how they are monitored for
example: <Job description, minutes of evaluation meeting of
the members of the staff, etc.>
• Does the senior management provide sufficient training
resources, refresher training and education for relevant
employees?
• Person in charge of materiovigilance in case of medical
devices’ suppliers.

1.2.4 Employees with influence on product requirements shall be <Interview of at least: QAM, person responsible for labelling,
aware of their responsibilities, through job descriptions, and person responsible for product development, person respon-
shall be able to demonstrate understanding of their responsi- sible for production, person responsible for monitoring CP’s>
bilities.
1.2.5 The company shall have an IFS representative nominated by • Who is the IFS representative?
senior management. • What are the responsibilities of the IFS representative
<job description>, <Organigram>
The IFS representative can be the representative for quality
management. It is important that a contact person for all
interest regarding the IFS is available.
• Who is the deputy for the IFS HPC representative?
1.2.6 The senior management shall provide sufficient and relevant • How were the necessary resources defined?
resources to meet the product requirements. <budget plan>, <Investments in equipment etc>,
<personal resources>
1.2.7 The department responsible for quality and product safety • Who is the QMD manager?
management shall have a direct reporting relationship to the • Who is defined as senior management?
senior management. • How is ensured, that the senior management is up to date
about all relevant qualityand risk management related
topics?
• To whom does the QMD manager report?
<job description>, <Organigram>
1.2.8 The company shall ensure that all processes (documented • Which criteria are used to ensure process control?
and undocumented) are known by the relevant personnel • What is done to ensure that processes are known to rele-
and are applied consistently. vant personnel (incl. permanent staff and temporary work-
ers)?
Process can be understood as ISO processes.
1.3 Customer focus
1.3.1 A documented process shall be in place to identify fundamen- • How are customer needs and expectations identified?
tal needs and expectations of customers. • How often are these identified?
<questionnaire / survey regarding customers’ needs and
expectations>, <participation at relevant congresses or
working groups>, <external support by e.g. opinion
reserch centers>, <store checks>

1.3.2 The results of this process shall be evaluated and considered • What were the results of the last customer survey?
to determine quality and product safety objectives. <analysis of customer surveys>
• How these results were evaluated regarding quality objec-
tives? <quality objectives>, <bench mark tests>
• Have identified needs influenced on the production pro-
cess? <survey analyses>
1.4 Management Review
1.4.1 Senior management shall ensure that the quality and product • When is the quality management system reviewed and
safety management systems are reviewed at least annually, or evaluated? How often was the system reviewed last year?
more regularly, if changes occur. Such reviews shall contain at What was the result of the review? <review report>
least: • Does the management review take into consideration, as a
• results of audits, minimum, the assessment of the following:
• customer feedback, ·· documents from the previous management review,
• process compliance and product conformity, ·· results from internal and external audits, as well as
• status of preventive and corrective actions, inspections,
• follow up actions from previous management reviews, ·· performance indicators for customers, complaints and
• changes that could affect the product safety and quality withdras / recalls,
management system, ·· incidents, corrective actions, results out of specifications
• complaints from Authorities, and non confomring materials,
• recommendations for improvement. ·· process performance and product compliance,
·· review of risk management system and changes which
may affect quality and product safety system,
·· evolutions of scientific information related to products,
·· improvement of quality system efficiency anf production
process,
·· improvement of product, related to customer require-
ments,
·· outsourced production
·· needs in resources (including investments)
·· Product Defense (if applicable)?
• Is the extent of the Management review conforming to the
size of the company?
• Is the senior management participating at the performance
of the management review?

1.4.2 This review shall include the evaluation of measures for the • Based on the review result, have any actions for improve-
control of the quality and product safety management system ment been taken?
and for the continuous improvement process. <improvement actions>
1.4.3 The company shall identify and review regularly (e.g. by • When is infrastructure (building, machinery, transport)
internal audits or factory inspection) the infrastructure evaluated?
needed to achieve conformity to product requirements. This • What was the result of infrastructure evaluation?
shall include, for example, the following items: <audit report>
• buildings, • Who evaluated infrastructure?
• supply systems, • What were the results of the infrastructure assessment?
• machines and equipment, <corrective actions>, <investment plan>
• laboratory equipment, • Were the results used for further infrastructure planning?
• transport. <investment plan>
The results of the review shall be considered, with due con- • What risks were identified according to the results of infra-
sideration to risk, for investment planning. structure assessment? <risk analysis>
• What are infrastructure related investments for the near
future? <investment plan>
1.4.4 The company shall identify and review regularly (e.g. by • When is the work environment (staff facilities, environmen-
internal audits or factory inspection) the work environment tal conditions, safety and security at work, hygienic condi-
needed to achieve conformity to product requirements. This tions, workplace design etc.) evaluated?
shall include for example, the following criteria: • What was the result of work environment evaluation?
• staff facilities, <audit report>
• environmental conditions, • Who evaluated work environment?
• hygienic conditions, • What were the results of the work environment assess-
• workplace design, ment? <corrective actions>, <investment plan>
• external influences (e.g. noise, vibration). • Were the results used for further work environment plan-
The results of the review shall be considered, with due ning? <investment plan>
consideration to risk for investment planning. • What risks were identified according to the results of the
work environment assessment? <risk analysis>
• What are work environment related investments for the
near future? <investment plan>

2 Quality and Product Safety Management System
2.1 Quality Management
2.1.1 Documentation requirements
2.1.1.1 The quality and product safety management system shall be • Where is documentation concerning the quality system for
documented and implemented, and shall be retained in one quality assurance and product safety retained?
location (it can be an electronic documented system). <procedure for document control>
The IFS makes no requirements concerning the visual aspects
or the content of the quality management manual.
The documents have to be centrally stored and available for
every member of staff.
2.1.1.2 A documented procedure shall exist for the control of docu- • What rules exist regarding document control?
ments and their amendments. • Do the documents have an identification code?
• How is the identification code structured?
• How can a revision be identified?
• How and how long are expired documents kept in an
archieve?
• Who is responsible for changes?
<procedure for documents>
• How is the approval and release of documents guaranteed?
It should be fixed, which documents and in which way they
are drawn up in the business (standard documentation).
This also applies to labelling and documentation.
2.1.1.3 All documents shall be clearly legible, unambiguous and • Are all documents legible?
comprehensive. They shall be available to relevant personnel • Are the documents unambiguous?
at all times. • Are the documents available at the right places? Also after
office hours?
• How do relevant employees have access to documents?
• How are document changes communicated to relevant
employees?
• Are there any distribution lists for documents?
<Examples>, <procedure>, <distribution lists>

2.1.1.4 All documents which are necessary for compliance with the • How is document validity identified?
product requirements shall be available in their latest version. • How is it ensured that only valid documents are in
circulation? <for product requirements see IFS glossary>
2.1.1.5 The reason for any amendments to documents, critical for the • Are the reasons for any amendments to documents, critical
product requirements shall be recorded and approved. for the product requirements recorded? <examples>
2.1.1.6 Documents shall be removed from the job area and destroyed <procedure for documents>
if they are outdated. • Who is responsible for the exchange of expired docu-
ments?
2.1.2 Record keeping
2.1.2.1 All relevant records necessary for the product requirements • What records exist?
shall be completed, detailed and securely maintained (e.g. • Are the records complete?
with backup system) and shall be available on request. • Are the records available?
<is availability checked regularly e.g. in a traceability test?>
Record can exist as papers or electronically.
2.1.2.2 Records shall be legible and genuine. They shall be main- • Are records plausible?
tained in a way that subsequent manipulation of records is • Are records legible?
prohibited. • What kind of assurance is given that records cannot be
subsequently manipulated?
• Are the records reviewed by a supervisor?
• Records may not be taken by pencil.
2.1.2.3 All records, including records showing the effective control of • Where are records stored?
process, product safety and quality shall be kept in accor- • Who stores records?
dance with legal requirements and customer specifications • How long are records kept?
(this includes, for instance and where relevant, the cosmetic • On what basis were record storage times defined?
product information file). • For products with a short shelflife, was record storage time
These records shall be kept for a minimum of one year after definition based on risk analysis?
the end of shelf life period. For products which have no shelf <procedure documents>, <risk analysis>
life, the duration of record keeping shall be in line with cus-
tomers‘ requirements.

2.1.2.4 Any amendments to records shall only be carried out by • How are amendments to records carried out?
authorized persons. • Who is authorized to make amendments?
• In case of absence, who is the deputy authorized to make
amendments?
• How are amendments authorized?
Responsibilities have to be well defined.
2.2 Product Safety Management
2.2.1 Risk management system (Hazard analysis and Risk assessment)
2.2.1.1 Before developing a risk management system, the company • Does the company have implemented good manufactur- In cases where there is no
shall have implemented all necessary Good Manufacturing ing practices? specified GMPs in the scope of
Practices (GMP’s) which are commonly used in its scope of Companies have to use the GMPs which are commonly use activity, company can create its
activity. in their field of activity. own GMPs taken as a model
e.g. ISO 22716 or Regulation (EC) No 2023 / 2006 of any other GMPs implemented
22 December 2006, etc. in other HPC scopes.
GMP principles shall be based
on scientific literature and state
of the art for each branch. GMP
shall take into account product
and process specific quality and
risk related production steps
and shall cover all basic manu-
facturing and control activities
such as hygiene, chemical
safety, equipment etc. The
manafacturing against GMP
principles is the basis for the
implementation of the risk
management system. The
documentation of GMP and risk
management system can be
handled separately or in a
combined analysis.

2.2.1.2 The basis of the company’s product safety control system • The company’s risk asssement study is based on which The risk management system
shall be a fully implemented, systematic and comprehensive principles? <literature listed in the corresponding risk shall be implemented for each
risk management system. It shall take into account any legal management procedure> production site taking into
requirements of the production and destination countries • Has every site / plant a separate risk assessment study? account the local situation.
which may go beyond such principles. The risk management • Which specific regulations are taken care of in the risk
system shall be implemented at each production-site. assessment study? <risk assessment study>
The risk management system shall cover all raw material • Are the legal requirements of the destination country are
groups, products or product groups, as well as every process known, especially the labeling regulation?’
(included outsourced process) from goods receipt to product • How is the customer involved in the labelling process?
dispatch, including product development and product pack- <responisibilities>
aging. • Does the risk management system cover all products (e.g.
raw materials, product groups, packaging material …)?
• Are support processes such as purchasing or storage
implemented in the risk management system?
• Does the risk management system cover all processes
including outsorcing processes and product development?
• What is the categorisation principle?
<product group overview>, <flow chart>
2.2.1.3 The company shall ensure that the risk management system is • Is it based upon scientific literature or technically verified
based upon scientific literature, or technical verified specifica- specifications relating to the manufactured products and
tions relating to the manufactured products and procedures. procedures? <e.g: FME(C)A, RPN, risk matrix, ISO 14971
The risk management system shall be maintained in line with (medical devices), or HACCP etc.>
any new technical and scientific process development. • How are new technical developments taken care of?
<references of used literature, etc.>
It should be considered that the system has to be constantly
updated. It is the only way to guarantee the functioning of
the system.

2.2.1.4 Risk management system shall be reviewed and necessary • How are new standards e.g. new version of the IFS HPC
changes shall be made when any modification is made in the introduced in the modification of the risk management
product, process or any change that could affect product system?
requirements. • What reasons may have an impact on the modification of
the risk mangement system? <new products>,
<new product goups>, <changes in building and exteri-
ors>, <equipment and machines>
Changes in product can be e.g. a change in packaging mate-
rial (bottle, pot or sachet), change of ingredients (e.g.
eco-products, allergens, nano-particles etc.).
Changes of process can be caused e.g. by the implementation
of new equipment, a new process flow or the transfer of
different production steps to a contractor (e.g. co-packing).
The system should be reviewed minimum annually by the

whole risk management team and if changes occur caused by
product modifications, changes in process and steps or
changes in equipment and building.
2.2.2 Risk management team
2.2.2.1 The risk management team shall be multidisciplinary and • Who is member of the team?
include operational staff. Personnel appointed as risk manage- • Which departments / functions are included in the team?
ment team members shall have specific knowledge of hazards • How was qualification for team membership verified?
and risks associated to products and processes. <evidences for education, advanced training>,
Where competent knowledge is not available, external expert <Qualification record / evidence list>
advice shall be obtained. • What hazards are connected to the product?
• Does a contract exist with an external expert?
<service contract>
•
It should be checked if competent knowledge is given by a
member of the staff and then trained in the company (a
certificate should be available) or if an external expert advice
is obtained.

2.2.2.2 Those responsible for the development and maintenance of • What is the content of a risk management training course?
risk management system shall have received adequate train- <Risk management training proofs>
ing in the application of the risk management principles • When was the last training course held?
based on the risk management tool (Risk matrix, FMEA, <training proofs>
HACCP, RPN, etc.) which the company uses. • Who participated in this training course?
<training proofs>
• What is the education and the experience of those respon-
sible for development and maintenance of the risk man-
agement system?
2.2.2.3 The risk management team shall have senior management • Is the team well known across the company?
support and shall be well known and established within the • How was it announced?
company. <job descriptions>, <team matrix>, <blackboard notice>,
<presence of management in any risk management brief>,
<result of risk assessment rewiew included in Management
review>
• Does the senior management provide sufficient personnel
and temporary resources for the risk management team to
take care on administration, development and training of
risk management requirements?
2.2.3 Hazard analysis and risk assessment
2.2.3.1 Describe the product • Does a product description exist for each product / product
The assessment shall make reference to the full description of group?
the product including all applicable relevant information on • What is included in the product description?
product safety and regulation such as: <product description>, <product specification>,
• composition (raw materials, rework, reprocessing, etc.), <list of products and specifications>
• physical, chemical and microbiological parameters, For household and cosmetics CLP
• methods of treatment,
• packaging, labeling,
• durability (shelf life),
• conditions for storage
• method of transport.

2.2.3.2 Identify intended use • What is the intended use of the product?
The intended use of the product shall be described in relation • Is it considered as well the foreseeable use of the product?
to the expected use of the product by the consumer, taking • Is the forseeable use in all destination countries the same?
into account vulnerable groups of consumers. • The product is unsuitable for which consumer group?
• Is the product suitable for children, pregnant women,
senior persons?<product description>
Vulnerable groups of consumers: babies, children, seniors,
allergic person or pregnant woman.
2.2.3.3 Construct flow diagram • Are flow charts available for all products?
A flow diagram shall exist for each product, product groups, <flow charts for all products>
raw material groups, etc., and for all variations of the pro- • Are the flow charts dated?
cesses and sub-processes (including rework and reprocess- In the event of CCPs are identified in the flow chart, are these
ing). The flow diagram shall be dated, and clearly identify identified accordingly?
each critical control point with the number assigned to it. In • Do they have a number?
the event of any changes the flow diagram shall be revised. • Are all flow charts with CCP’s up-to date?
It may happen that companies don’t identify the CCPs within
the flow chart.
This is not mandatory, although it would be helpful for the
company.
2.2.3.4 On-site confirmation of the flow diagram • Was the flow chart checked / confirmed during a meeting?
The risk management team shall review the processes at all <meeting minutes>
operation stages against the flow diagram. Where relevant,
amendments of the diagram will be made.

2.2.3.5 Conduct a hazard analysis and risk assessment for each step
2.2.3.5.1 A hazard analysis shall be available for all physical, chemical • Does a hazard analysis exist for each step ? The hazard analysis shall cover
and biological hazards that may be reasonably expected. <hazard analysis> all products and processes. For
A hazard analysis and a risk assessment shall be conducted for • Which biological, physical and chemical hazards can be each product or product group
each step from raw materials to the finished products includ- expected? <hazard analysis>, a full description shall be avail-
ing development and packaging material validation. <if applicable: allergen-related hazards> able, which includes all relevant
The risk assessment shall take into account potential risks for information on product safety.
safety and legality. This shall take into account e.g.: As an example:
• allergen contamination • composition
• foreign bodies • physical or chemical proper-
• microbiological contamination e.g. water ties that impact product
The risk assessment shall be the basis for raw material accep- safety
tance, testing procedures and supplier approval and monitor- • legal requirements
ing. • treatment and processing
• packaging
• labelling
• storage and distribution
conditions
• outsourced processes
• instructions for use, potential
customer misuse
• R&D
2.2.3.5.2 Based on the hazard analysis, the risk assessment shall • Does a hazard analysis for all product groups including
demonstrate the actions required if a hazard is a risk, taking harm and likelihood exist?
into account the probability of harm to the consumer and the <hazard analysis>,
severity of damage (effect, potential consequences). The <methodology: risk matrix, FMEA, HACCP, RPN, etc.>
methodology for assessing risk shall be documented.

2.2.3.6 Determine critical control points In case the company has identified CCPs: This requirement can not be
Based on level of acceptability of risk, critical control points • Which CCPs are defined? rated with N / A. See Part 1 of
shall be identified and documented. • Which prerequisite measures were taken regarding CCPs? the Standard.
• Which prerequisite measures are documented?
• How are the measures documented? Depending its scope of activity
<hazard analysis>, <flow chart>, <decision tree>, and / or production process (es)
<prerequisite measures> a company may no have deter-
An example for a preventive measure is the documentation mined CCPs. In the event that
at the control of incoming goods (e.g. checking of quality, a company does not have any
labelling). CCP’s, the company shall docu-
• Based on methodology: Did the company identify any CP’s? ment a logical approach which
• Which prerequisite measures were taken regarding CP’s? needs to be assessed by the
auditor.
2.2.3.7 Establish critical limits for each critical control point • Is a critical limit defined for each CCP?
For each critical control point, the appropriate critical limits • What critical limits are defined?
shall be defined and validated in order to clearly identify • How were the critical limits determined?
when a process is out of control. <risk assessment study>
2.2.3.8 KO N° 2: Establish a monitoring system for each critical • How are CCPs monitored? Process monitoring shall be
control point • Are the CCPs under control? established and adequately
Specific monitoring procedures shall be established for • How is the monitoring of each CCP documented? controlled to ensure products
each critical control point to detect any loss of control. • Who documents? are produced within the
Records of monitoring shall be maintained for a relevant • Are date, time, responsible employee and result / reading required process specification.
period. Each defined critical control point shall be under documented? All risks that need specific
control at all times. Monitoring and control of each critical • How long will records be stored? monitoring shall based on
control point shall be demonstrated by records. The records • Where are records stored? <CCP records> methodology be identified as
shall specify the person responsible, as well as the date and • Based on methodology: How are CP’s / CCP’s monitored? Control Points (CP’s) or Critical
result of the monitoring activities. • Are CP’s / CCP’s under control? Control points (CCP’s). Clear
• How is the monitoring of each CP / CCP documented? limits shall be available.
• Who documents? For all risks identified as
• Are date, time, responsible employee and result / reading CP’s / CCP’s the company shall
documented? implement, maintain and
• How long will records be stored? document specific preventive
• Where are the records stored? <CP / CCP records> and corrective measures.
This KO requirement could be rated as N / A. See Part 1 of the
Standard.

2.2.3.9 Establish corrective actions • What corrective actions exist ?
For each critical control point, corrective actions shall be • When was a corrective action carried out?
established. In case the monitoring indicates that a particular • Where are corrective actions documented?
critical control point is not under control, adequate corrective • Who documents the taken corrective actions?
actions shall be taken and documented. <CCP records>, <corrective actions>,
Such corrective actions shall also take into account any based on methodology:
non-conforming products. <CCP records>, <corrective actions>
2.2.3.10 Establish verification procedures • How often is the system verified?
Procedures of verification shall be established to confirm that • What was the date of the last verification?
the risk management system is effective. Verification of the • What was the result of the last verification?
risk management system shall be performed at least once a • Does the system reflect the results of the verification?
year. Examples of verification activities include: • What was the last date when the system was changed?
• internal audits, <audit reports or other reports for validation>
• analyses, • Was the last verification a routine verification or based on
• sampling, relevant non conformities, recalls, rebuilding activities …?
• evaluations,
• complaints by authorities and customers.
The results of this verification shall be incorporated into the
risk management system.
3 Resource Management
3.1 Human resources management
3.1.1 All personnel performing work that affects product safety, • How is it ensured that new employees have the right
legality and quality shall have the required competence capabilities for the job?
(demonstrated by education, work experience and / or train-
ing) based on hazard analysis and assessment of associated
risk.

3.2 Personnel hygiene management
3.2.1 Personnel hygiene
3.2.1.1 There shall be documented requirements relating to person- • Did the company define different hygiene zones? Examples of topics which need
nel hygiene. These include, as a minimum the following crite- • What is the policy regarding personal hygiene? to be addressed:
ria: <hygiene rules for employees> • management of wearing and
• protective clothing, Based on risk assessment, which are the rules regarding changing of protective
• hand washing and disinfection, personnel hygiene including hand cleaning, food and bever- clothing (including dispos-
• eating and drinking, ages, smoking, handling of injuries, finger nails and jewellery, able and reusable gloves).
• smoking, and hair and beards? E.g.: • policies relating to the wear-
• actions to be taken in case of cuts or skin abrasions, • all hair shall be covered completely if headgear / hair- ing of protective clothing
• fingernails, jewelry and personal belongings, net / bonnet and / or beard snood is required to prevent away from the production
• hair and beards. product contamination environment
The requirements shall be based on hazard analysis and • are fingernails kept short, clean, and unpolished? • disposable protective cloth-
assessment of associated risk in relation to product and pro- • false fingernails are not permitted ing, if used, shall be subject
cess. • personal belongings (use of medicines, etc.) to adequate control to avoid
• Where is it allowed to smoke? product contamination.
• How should lesions be treated / covered?

3.2.1.2 The requirements for personnel hygiene shall be in place and • How is the hygiene policy communicated?
applied by all relevant personnel, contractors and visitors. <hygiene rules for employees>
Compliance with the requirements shall be checked regularly. • How is it assured that personnel and external persons
know and follow the relevant hygiene rules?
<hygiene rules for visitors>
• Are employees, visitors and contractors able to understand
the hygiene requirements (language)?
• How are employees monitored during work?
<minutes site inspection>, <list of identified failures>,
<results of hygiene monitoring> etc.
• Is employee compliance to hygiene rules checked on a
regular basis? <minutes site inspection>,
<list of identified failures>, etc.
To check if In toilets and where appropriate, signs urging staff
to wash hands are in place.
• Does the auditor recieve an adequate introduction into the
hygiene rules before entering the production?
• In case contractors come regularly (e.g. maintenance or
pest control suppliers), are they trained into the hygiene
rules in a defined frequency?
• How is the regular training for each single employee of the
contractor controlled e.g. using lists?
• How are temporary workers trained by the company or the
supplier (providing temporary workers)?
3.2.1.3 Visible jewelry (incl. piercing) and watches shall not be worn. • Is it allowed to use jewellery and watches in production
Any exceptions shall have been comprehensively evaluated areas? <personnel hygiene rules>
based on hazard analysis and assessment of associated risk. • Is allowance based on risk hazard analysis?
<risk assessment>
Explanation regarding differing rules and risk assessment

3.2.1.4 Cuts and skin abrasions shall be covered by a colored plas- • What colour is the plaster and where is it used?
ter / bandage (different from the product color). Any excep- • Does the plaster contain a metal strip?
tions shall have been comprehensively evaluated based on on • Is the metal detector abel to detect the plaster?
hazard analysis and assessment of associated risk. • What is an employee required to observe in case of hand
injury?
<personnel hygiene rules>
3.2.1.5 Based on hazard analysis and assessment of associated risk, • Hand-cleaning is performed at a suitable frequency to
there shall be a program to control effectiveness of hand maintain hygienic conditions?
hygiene. Mainly applicable for scope 1 and 4.
• In case employees wear gloves, how is hand hygiene
ensured? (see also 3.2.2.3)
3.2.2 Protective clothing for personnel, contractors and visitors
3.2.2.1 Company procedures shall exist to ensure that all personnel, • What are the rules regarding protective clothing?
contractors and visitors are aware of the rules regarding the <personnel hygiene rules>
management of wearing and changing protective clothing in • Are the protective clothing rules based on risk analysis?
specified areas in accordance with product requirements. <risk analysis>
• When must protective clothing be changed? <personnel
hygiene rules>
examples of areas: catering, changing rooms, smoking area,
toilets, high risk areas, etc.
3.2.2.2 In work areas where wearing headgear and / or beard snood • In which production areas is wearing of protective head-
(covering) is required, the hair shall be covered completely, so gear and / or beard snood mandatory?
that product contamination is prevented. • What kind of headgear is used?
• How shall headgear be used? <personnel hygiene rules>
• In case beard protection shall be worn, is there a limit until
what length a beard is allowed?
• Is it based on risk assessment?
3.2.2.3 Clearly defined usage rules shall exist for work areas / activities • In which production areas is wearing of gloves mandatory?
where it is required to wear gloves (colored differently from <personnel hygiene rules>
the product color). Compliance with these rules shall be • What kinds of gloves are used?
checked on a regular basis. • When must gloves be changed?
• How is the compliance with these rules checked?
<glove swab test results>, <on site inspections>

3.2.2.4 Suitable protective clothing and devices to ensure personnel • Are protective clothing and devices given to the person-
safety shall be available in sufficient quantity for each nel? If so, how many?
employee, when required. <examples of devices: plugs, otoplastic, filter masks …>
• How many protective suits / uniforms are at the disposal of
each employee?
• How often is an employee supposed to change her / his
protective suit / uniform?
• Are there outside pockets in the uniform above the hip?
• Are temporary workers included in those rules?
• In case the contract company providing temporary workers
provides the protective clothing, are the hygiene require-
ments the same?
Any exceptions shall be explained based on risk assessment.
For suitable is understood as kept in good conditions, no
impact on product safety.
3.2.2.5 When required, all protective clothing shall be thoroughly and Mainly applicable for scopes 1, 3 and 4 In cases where items of per-
regularly laundered. Based on hazard analysis and assessment • How is protective clothing laundered? sonal protective clothing are
of associated risk, taking into consideration the processes and <personnel hygiene rules> not suitable for laundering
products, the company shall determine if clothing shall be • Are there any employees who launder their protective (such as chain mail, gloves and
washed by a contract laundry, on-site laundry or by the clothing at home? If yes, how are they transported to the aprons), these shall be cleaned
employee. audited site? and sanitized at a frequency
• Is there a cleaning instruction for employees cleaning at based on risk assessment.
home? If necessary, there shall be
• Is protective clothes laundering based on a risk assess- cleaning devices for boots,
ment? <risk assessment> shoes and other protective
• Cleaning of protective clothing, choice of a contracted clothing in place and used
laundry etc. based on risk assessment.
3.2.2.6 Guidelines shall exist for laundering of protective clothing • How is the laundering procedure checked for effective-
and a procedure shall be in place for checking its cleanliness, ness? <protective clothes swab test results>
when required. • What guidelines exist regarding protective clothes launder-
ing? <personnel hygiene rules>

3.2.2.7 The company shall review that implemented preventive • Does an inspection plan exist? <report of inspection>
measures to ensure personnel safety related to hazardous security tests (simulations in case of fire), automatic stop
working conditions are effective. systems, specific training on working conditions, etc.
• Are protective glasses, ear plug or gloves in place?
• Is the protective equipment suitable to guarantee person-
nel safety e.g. type of gloves, facial masks, safety shoes …?
3.2.3 Procedures applicable to infectious diseases
3.2.3.1 There shall be written and communicated measures for per- • How shall personnel and visitors behave in case or suspi-
sonnel, contractors and visitors in case of any infectious cion of an infectious disease?
disease which may have an impact on product safety. In case • How is it ensured that personnel and visitors know the
of declaration of infectious disease, actions shall be taken in guidelines?
order to minimize risk of contamination of products. <personnel hygiene rules>, <visitors hygiene rules>
Special consideration shall be given to areas where product
safety could be compromised.
Where there may be risk to product safety, and where legally
allowable, visitors and contractors shall be required to com-
plete a health questionnaire prior to entering the raw-mate-
rial, preparation, processing, packing, and storage areas.
This requirement may not be applicable in certain countries
taking into account national legislation.

3.3 Training and instruction
3.3.1 The company shall implement documented training and / or • Who is responsible for training? <training proof>
instruction programs with respect to the product require- • What are the evidences for the trainer’s qualification?
ments and the training needs of the employees based on • What was the content of the last training session?
their job which shall include: <training program>
• training contents, • How are foreign employees trained / instructed?
• training frequency, • Who participates in the training sessions?
• employee’s task, • How are the instruction necessities for each employee
• languages, determined?
• qualified trainer / tutor, • How often are training sessions held? <training schedule>
• evaluation methodology. Examples of training content: CP and CCP, personnel hygiene
(infectious diseases, vomiting, diarrhea, “Infection Protection
Act”), facility hygiene, cleaning and disinfection, GMP‘s for
cosmetics, crisis managements, management of chemicals,
etc.)
Programs shall take into consideration company‘s specific
issues, product safety, product related legal requirements and
product / process modifications.
3.3.2 The documented training and / or instruction programs shall • Are prospective employees (including temporary workers)
apply to all personnel, including temporary workers and trained / instructed upon employment?
employees from external companies, employed in the respec- • Which employees are trained / instructed upon employ-
tive work area. Upon employment, and before commencing ment?
work, they shall be trained in accordance with the docu- • What is the content of these instructions?
mented training / instruction programs. <training proofs>
• Is an introductional training plan implemented for all
relevant employees?
E-learning and webinars could also fit with the requirement,
as long as this can be checked / assessed by the auditor.

3.3.3 Records shall be available of all training / instruction events, • Which training courses are undertaken?
stating: • Are there any special training courses?
• list of participants (this shall include their signature), • Are training courses documented?
• date, • What has been documented?
• duration, • Have participants signed the training proofs?
• contents of training, • How often are hygiene training sessions held?
• name of trainer / tutor. • What was the content of the last hygiene training session?
There shall be a procedure or program in place to prove the • How the result of the training is evaluated?
effectiveness of the training and / or instruction programs. <training proofs>
3.3.4 The contents of training and / or instruction shall be reviewed • Who is responsible for updating the training?
and updated regularly and take into account company’s • In case of mandatory training e.g. fork lift driving, first aid
specific issues, product safety, product related legal require- etc., how is it traced?
ments and product / process modifications. • What is the frequency of training?
• How are training contents reviewed? <review test>
• When are training contents reviewed?
• When was the latest training content update done?
3.4 Staff facilities, sanitary facilities and equipment for personnel hygiene
3.4.1 The company shall provide staff facilities, which shall be • How many employees are there?
proportional in size, equipped for the number of personnel • Do they have access to a cafeteria?
and designed and operated so as to minimize product safety • Are there locker-rooms?
risk. Such facilities shall be kept clean and in good condition. • Where are the restrooms?
• Are there bathing facilities? <plant lay-out>
• Are they mantained in a good conditions?
Staff facilities is for instance changing room, smoking area,
dining room, etc.
3.4.2 There shall be in place rules and facilities to ensure the correct • How are based on risk assessment food or other personal
management for personnel belongings and food and other belongings transferred or stored throught designated areas
materials brought to work by personnel and shall include, of a hygiene zone? <any restrictions?>
food from dining room and from vending machines. The food
and other materials shall only be stored and / or consumed in
designated areas.

3.4.3 The company shall provide suitable changing rooms for • Are there locker-rooms for employees and visitors with Where an operation includes a
personnel, contractors and visitors. Where necessary, outdoor separation for outdoor and protective clothing? special hygiene zone, with e.g.
clothing and protective clothing shall be stored separately. • And for clean and dirty workwear? clean room technology, person-
nel shall enter via a specially
designated changing facility at
the entrance.
The changing facilities shall
include the following require-
ments:
• clear instructions for the
order of changing into
dedicated protective clothes
to prevent the contamina-
tion of clean clothing
• adequate footwear shall be
provided to be worn in the
high-risk area
• an effective system shall be
provided to segregate areas
for wearing hygiene and
other footwear, e.g. a barrier
or bench system
• protective clothing shall be
visually distinctive from that
worn in other areas and shall
not be worn outside of the
hygiene zone
• hand-washing during the
changing procedure shall be
incorporated to prevent
contamination of the clean
protective clothing
• on entry to hygiene zone
and close to work ,
hand-washing and disinfec-
tion shall be provided.

3.4.4 Changing rooms shall be separated from production area and • Do locker-rooms give direct access to processing areas?
shall be sited so that they allow direct access to the areas • How is protective clothing handled during breaks / inter-
where products are handled. vals? <Personnel hygiene rules>
Based on hazard analysis and assessment of associated risk, • Does a hazard analysis exist for locker-rooms with no direct
exceptions shall be justified and managed. access to processing areas? <Hazard analysis>
There should not be any long ways or additional rooms
between the changing room and the production room to
minimize hazards on the way to the production. The changing
room shall be separated from the production area (door).
3.4.5 Toilets shall not have direct access to an area where products • Do toilets open directly into production areas?
are handled. The sanitary facilities shall be equipped with
adequate hand washing facilities. Sanitary facilities shall have
adequate natural or mechanical ventilation. Mechanical
airflow from a contaminated area to a clean area shall be
avoided.
3.4.6 Adequate hand hygiene facilities shall be provided near • Are there enough hand washing facilities available at the
points of entry to and within production areas, as well as at entrance to processing areas and in social areas?
staff facilities. Based on hazard analysis and assessment of • Are enough hand cleaning facilities available in the pro-
associated risk, further areas shall be similarly equipped. duction area itself, in case water is not available at each
work station are adequate alternative facilies available?
In case of hand hygiene facilities within production process
check if the safety of the products is not comprised.
3.4.7 Hand washing facilities shall provide as a minimum: This requirement is the minimun expected for companies
• water, under scope 2.
• liquid soap, • Are all hand washing facilities provided with appropriate
• appropriate equipment for hand drying. equipment for hand drying, liquid soap and disinfectant?
• In an appropiate amount?
• Are all hand washing facilities provided with running
potable water at an appropriate temperature for a suitable
hand washing?
• Are sufficient cleaning and / or disinfectant dispensers
available at the entrance of the production area?

3.4.8 If necessary, following additional requirements regarding Mainly applicable for companies under scope 1, 3 and 4.
hand hygiene shall also be provided: <hand disinfection devices and signs or pictograms>
• hand contact-free fittings, <signs / pictograms>
• hand disinfection,
• adequate hygiene equipment,
• signage highlighting hand hygiene requirements,
• waste container with hand contact free opening.
4 Planning and production process
4.1 Contract agreement
4.1.1 The requirements which are defined in the contract with the • What assurances are given that customer requirements and
customer shall be established, agreed upon and reviewed own specifications are in accordance with each other?
concerning their acceptability before a supply agreement is • Do written supply agreements with customers exist?
concluded. All clauses related to quality and product safety • Do specific customer requirements for purchased products
shall be known and communicated to each relevant depart- exist?
ment. • Who checks and approves specifications?
• Who ensures that the proper raw materials are available
whenever needed?
• Who is responsible for the transfer of updated specifica-
tions?
• How is ensured that all relevant departments are informed
about changes in specification?
4.1.2 Changes of existing contractual agreements shall be docu- • How is it ensured that customers are informed about
mented, communicated and updated between the contract product changes?
partners. • Who checks and approves specifications?
• How is ensured that all relevant departments are informed
about changes in contracts?

4.2 Specifications and formulas
4.2.1 Raw Materials (including packaging materials), semi-finished products and rework specifications
4.2.1.1 Specifications shall be available and in place for all raw • Are specifications available for all raw materials, ingredi- Check if raw material accep-
materials (raw materials / ingredients, additives, packaging ents, additives, packaging materials and rework? and are tance and its release for use is
materials, rework) and where relevant, for semi-finished relevant also for semi-finished products? based on one or a combination
product. The specifications shall be up to date, unambiguous, • What is the procedure regarding changing of any raw of (including outsourced prod-
available and always in conformance with legal requirements. material? ucts e.g. raw material, inter-
• Is the supplier of the raw material dedicated by the cus- meditae products / material,
tomer? etc.):
• Is the degree of purity e.g. Ph.Eur. dedicated by the cus- • visual inspection on receipt
tomer? (e.g. inspection on presence
• What assurance is given that specifications are followed? of pests)
<proof of specification compliance, e.g. lab results> • certificates of conformance
• What assurance is given that specifications are in confor- — specific to each consign-
mance with legal requirements? ment
• Who approves the specifications? • certificates of analysis
• Are all specifications approved? • product sampling and test-
• Is there a system in place which assures that any client is ing
informed when there is a change of a raw material which • free from declaration
could have an impact on any client specification and / or on
the final products?
In the IFS audit is checked by a relevant random sample, if the
current specifications are available and valid.
4.2.1.2 Identification of raw materials including packaging materials • In case of brokers of raw materials is the name and the
shall contain the following information: production site of the raw material known?
• name of the product, • In case of different production sites of one supplier,
• unique identification code, are all sites released for the designated raw material?
• date or number of receipt (if relevant) <e.g. production hygiene and production equipment of the
• supplier’s name, site might have an impact on the quality of the raw mate-
• expiry date, if existing rial or packaging material>
• batch reference given by the supplier and the one given at • Does the COA of alternative suppliers of the same raw
receipt, if different. material contain the same information?
<check of batch labels>, <COA’s if applicable>

4.2.1.3 A reevaluation of the suitability of raw materials shall be in • How the best before date is followed?
place, in cases where raw materials are close to the best • In case the expiry date of the raw material falls into the life
before date, or when they are returned to storage or other cycle of the finished product, is the efficacy of the finished
relevant parameters given by the supplier. product (e,g, sun protection, disinfection etc.) still guran-
teed?
4.2.1.4 When raw materials including packaging materials are • How are raw materials identified after repacking ?
repacked, the new label shall contain the relevant information
as on the original label.
4.2.1.5 Where relevant, raw material specifications identifying aller- Mainly applicable for scopes 1 and 2
gens requiring declaration shall be available. The company • Are allergens identified in specifications?
shall maintain a continuously up to date listing of all raw E.g: some fragrances
materials containing allergens used at its premises, which also • Does a list exist that covers allergens in use?
identifies all blends and formulas to which such raw materials <allergen list>
containing allergens are added. In case of perfumes or essential oils, it must be guaranteed by
tests of the finish product that no allergens are developing by
so called precursor substances.
This is relevant for household chemicals as well as for cos-
metic!
4.2.2 Finished product specifications
4.2.2.1 Specifications shall be available for all final products and shall • How are specifications compiled, checked and approved?
be agreed upon in writing with customers. The specifications • Are there specifications for all final products?
shall be up to date, traceable, unambiguous, available to • How are up to date specifications recognizable?
relevant personnel and always in conformance with legal and <specifications>
customer requirements.

4.2.2.2 KO N° 3: Current and approved finished product • What assurance is given that specified recipe is followed?
specifications shall be the basis for the composition of • How is recipe compliance checked?
products. They shall also be the basis for the control of • What assurance is given that specifications are followed?
the production process and to monitor the finished <proof of specification compliance, e.g. lab results>
products’ compliance. • What assurance is given that specifications are in confor-
mance with legal requirements?
Here the abidance can be tested. Therefore a comparison of
recipe and specification of the end product and the end
product respectively is important. This should be tested
regularly in internal audits.
4.2.2.3 Where customers specifically require that products are “free • Do customers demand that certain substances are not
from” certain substances or ingredients, or that certain included in the product?
methods of treatment or production are excluded, verifiable • If so, how is it managed by QA?
procedures shall be in place. • In case the customer requires an agreed product specifica-
tion, is it signed from both sides?
4.2.2.4 There shall be a procedure for the creation, the modification • Who writes, amends, checks and approves specifications?
and approval of specifications for all parts of the process, • How are updated specifications communicated to all
which shall include the preliminary acceptance of the cus- relevant departments? <adaption of analytical methods>,
tomer, if specifications have been agreed with customers. <limits, tolerances>, <claims>, <stability, challenge tests>

4.2.2.5 The specification control procedure shall include the update • Check if correct packaging
of finished product specification in case of any modification and labels are used and how
requested by the customer and / or defined by the company, it is documented and
related to: approved. This shall be
• raw material, regularly checked, at least
• formula / recipe, before a new label is issued
• process with influence on the final product, for use and checks shall be
• packaging with influence on the final product. documented.
• Check if a modification of
raw materials causes
changes in safety, legality,
performance, labelling or
stability of the finished
product
formula causes changes in
safety, legality, performance,
labelling or stability of the
finished product
processs causes changes
performance or stability of
the finished product
the packaging causes
changes in safety, legality,
performance, labelling or
stability of the finished
product

4.3 Legislative framework and R&D process
4.3.1 Legislative framework
4.3.1.1 The company shall comply with the current applicable legisla- • How is the legislation followed?
tion and shall be able to demonstrate its own role in the • How is the legislation followed for each destination coun-
supply chain. try?
• How are the updates of the legislative texts or other man-
aged?
• Who is responsible? <procedure>, <text>
The target is to check that the company knows and applies
the legislation applicable to the products which are manufac-
tured / conditioned on-site.
Examples of EU relevant legislation: liability for defective
products, general product safety, cosmetics, aerosol, danger-
ous chemicals, biocides, medical device directive, REACH,
Cosmetic GMP, Classification Labelling and Packaging, deter-
gents, food contact materials, etc.
4.3.1.2 The company shall have a system in place to ensure that it is • How does management ensure that all relevant legislation
kept informed of all relevant legislation on product safety and in place and known?
quality issues, scientific and technical developments and • How does management ensure that purchased products
industry codes of practice. Legislation shall be understood comply with all relevant legislation?
and applied. • How does management ensure that manufactured prod-
ucts comply with all relevant legislation?
<laws subscription>, <training>
• How does management ensure that manufactured prod-
ucts comply with all relevant legislation?
• Does the company use additional external support?
4.3.1.3 For all relevant raw materials, safety data sheets shall be Mainly applicable for scopes 1 and 2 (mandatory for scope 2)
available in the format required by the destination country <AR>, <new GHS labelling>
and kept up to date.

4.3.1.4 Where relevant, the safety data sheet and / or composition for <CPNP notification for cosmetics>,
final products shall be provided and communicated to the <CE-labelling for medical devices>, <REACH>,
appropriate organizations (e.g. national safety centers, public <ChemBiozidMeldeV notification of biocidal products>
website, etc.), taking into consideration the current legislation
of the destination country.
4.3.1.5 In accordance with the current legislation, the company shall Mainly applicable for scope 1
mandate a qualified safety assessor to consider the general <check qualification of the safety assessor>,
toxicological profile of the ingredients, their chemical struc- <check if the report includes all necessary information
ture and exposure level, and finally provide the company with e.g. toxicological, microbiological, allergen, packaging
a safety assessment of the finished product regarding human material etc.>
health.
4.3.1.6 A process shall be in place to ensure that labelling complies • How is the company informed about the country of deliv-
with current legislation of destination country and customer eries?
requirements. • Does the country know which are the countries of deliver-
ies?
• Who is responsible of the label’s validation?
• How are integrated all legislatives requirements?
4.3.1.7 The conformity of the product with its labeling shall be • Export goes to which countries?
reviewed each time before a new label is issued for use. Such • Which countries have special requirements?
review shall take into account the product requirements and • Who issues the labels?
particular relevant legislation in the destination countries. • Who approves labels?
• How is conformity of the product and label reviewed?
• There should be a procedure for control of conformity.
• Are valid legal texts available?
4.3.2 R & D process
4.3.2.1 The company shall have an implemented procedure for R & D • How new development is validated?
that takes into account risks and patents and that demon- • Who is responsible?
strates that all existing and new products are designed to • Is there a legal department for validation?
meet legal requirements. <procedure>
In case external support is necessary:
• Is the supplier qualified?
• Is a contract available?

4.3.2.2 The progress and the results of R & D shall be properly • Are all steps and test results for product development
recorded. properly recorded?
<product development documentation>
• Is the R & D plan considered in the risk management sys-
tem?
4.3.2.3 Without the authorization from the patent holder, the com- • How the validation of absence of patent is made for a new
pany shall not use raw materials, or composition and shall not development?
process finished products that are already patented. How to check the patent free aspect: the company shall
provide written evidence that the products are free of any
patent or agreement of licensing processes.
<Name of patent lawyer>
4.3.2.4 Product formulation, manufacturing processes and the fulfil- • What do product development procedures look like?
ment of product requirements shall have been ensured by <product development procedures>
factory trials, performance tests, stability tests, organoleptic • What tests are made while a product is developed?
assessments where relevant and product testing. <test results>
• Is developed product submitted to trial runs?
<trial run documentation>
• Does the company use external support? <qualification>
4.3.2.5 Where relevant, shelf life tests shall be carried out taking into Mainly applicable for scopes 1, 2 and 4
account product formulation, packaging, manufacturing and • How are shelf lives determined?
storage conditions. The shelf life (e.g. best before date) of the • How are PAO’s (relevant for cosmetics) determined?
labeled goods shall be calculated accordingly, from the origi- <microbiological tests>, <state of aggregation>
nal production date. • Are products submitted to shelf-life tests?
Where relevant, for products with shelf lives, tests shall be <shelf-life test results>
done at the end of the product shelf life on retained samples.
4.3.2.6 Where specific R & D tests are needed, equipment shall be • Are there all necessary equipments to validate a new
available and pertinent (such as dosages for regulated ingre- product? <records>
dients, preservatives, biocides etc.). In case tests are not per- • Is the technical equipment state of the art?
formed on-site, results of these external tests shall be
available.

4.3.2.7 Claims shall be supported by scientific evidence (e.g. sun • How the validation of claims is made?
screen formulations, detergents, etc.) in order to ensure that For scope 1: Is the legislation taken into account to declare
the product meet the stated claim. claims on the products? E.g. Regulation (EU) No 655 / 2013 on
claims used in cosmetic products
Any efficacy and especially safety related claims about a
product, e.g., a weight limit for a trampoline or sun protection
factor (Cosmetovigilance) on a cream, shall be fully validated
to ensure that products meet the stated claim.
4.3.2.8 Where relevant, pilot equipment(s) shall be available and used Mainly applicable for scopes 1 and 2
in order to warranty good formulation’s industrialization. • Are there pilot equipments?
4.3.2.9 The consumer packaging shall be designed and labelled to • How the consumer packaging is validated for the safety
prevent non intended use in order to protect the safety of the aspect?
potential user. The risk assessment shall address this topic. • Is any change in consumer packaging (material, size, type)
considered in the safety report (relevant for cosmetics)?
• Who is responsible for labelling? <procedure>
4.3.2.10 If required by law and based on hazard analysis and Mainly applicable for scopes 1 and 2
assessment of associated risk, the company shall verify the • How is it ensured that packaging materials have no nega-
capability of the packaging material for each relevant tive effects on the product?
product (e.g. organoleptic tests, storage tests, chemical • Did the company consider migration tests (mandatory for
analysis). cosmetics)?
• Has a risk assessment been performed in relation to suit-
ability of packaging material? <risk assessment>
Packaging material should be tested concerning negative
influences on the product. The results should be documented.
• Which frecuency?
• Are all components of the packaging material considered?

4.4 Purchasing
4.4.1 The company shall control purchasing processes to ensure that • How is it ensured that purchased products and services
all externally sourced materials (raw materials, including pack- conform to specifications?
aging materials) and services, which have an impact on product
safety and quality, comply with requirements. Where a com-
pany chooses to outsource any process that may have an
impact on product safety and quality, the company shall ensure
control over such processes and fulfill requirements ref. 4.4.8
4.4.2 Purchased products and services shall conform to current • How is it ensured that purchased products and services
specifications and contractual agreements. conform to specifications?
Regarding purchased products relevant control of incoming
goods should be realized. Additionally the services should be
checked regularly within internal audits.
4.4.3 The schedule of these checks shall take into account the • How are purchased products and their specifications
product requirements, supplier status and the impact of raw reviewed? <incoming product check-list>, <lab tests>
materials on the finished product. • Does a test schedule exist? <test schedule>
4.4.4 There shall be a procedure for approval and monitoring of • Which suppliers are monitored? <raw material suppliers, Make sure that if the produc-
suppliers (internal and external), outsourced production and packaging material suppliers, service suppliers>, tion site changes raw materials
sub-processes. In case of any kind of outsourced production, <list of service suppliers: external labs, maintenance, but not supplier, the company
the customer shall always be informed. placement officer, cleaning personnel, pest control etc.> has to ensure that new material
• How are wholesalers monitored? is also assessed.
• Does an approval procedure exist for new suppliers and
co-packers? <supplier procedures>
• How are supplies monitored?
• Are suppliers graded? <supplier grading systems>
• Have suppliers been barred?
• How is a barred supplier identified?
• How is the qualification of suppliers ensured?
<product entry monitoring>, <supplier audits>, <lab tests>
• Are there any co-packers? <co-packers list>
• How are co-packers monitored?
• Are co-packers IFS certified? <certificate>
An assessment of suppliers with consistent, defined criteria is
a practical possibility.

4.4.5 The approval and monitoring procedure shall contain clear • How often are external audits made? <external audit plan>
assessment criteria such as: audits, certificates of analysis, • Which criteria are consulted for supplier assessment?
supplier reliability and complaints, as well as required perfor- • Which supplier has analysis certificates?
mance standards based on hazard analysis and assessment of <analysis certificates>
associated risk. • How was the risk analysis for supplier approval performed?
<risk analysis>
4.4.6 The results of supplier’s assessment shall be reviewed regu- • Who reviews the results of supplier assessments?
larly. There shall be records of the reviews and of the actions • How often are the results of supplier assessments
taken as a consequence of assessment. reviewed?
• What actions are taken after review of the results for sup-
plier assessments? <audit results>
4.4.7 There shall be records to identify which raw material including • What products come from which supplier?
packaging and semi-finished products are sourced from each <in case of multi-site suppliers, which site>
supplier. • Is there a list available with all current suppliers?
<supplier list>
4.4.8 Outsourced production (if applicable)
4.4.8.1 Control of outsourced processes shall be identified, risk <quality management system>, <risk management system>,
assessed and documented within the product safety and <GMP>
quality management system.

4.4.8.2 A contract shall exist between the company and its subcon- <contract>
tractor. e.g. information that the contract could contain:
a) Concerning the product :
• Product description
• Product composition (including technical file and SDS of
the raw material)
• Product use (intended and foreseeable)
• Product specifications (physical, …)
• Product information (on the packaging)
• Packaging specifications (including composition, para
meters, …)
• Product legislation including generic product safety
regulation, general legislation (REACh, waste, …),
specific legislation (plastic materials, GMP, …)
• Product conformity test report, coming from an accredited
laboratory (microbiology, etc.)
b) Concerning the subcontractor itself :

• Description of subcontracted operation (production of …)
• Description of quality control operations (type & frequency)
• Description of traceability from raw material to delivery
• Description of requested documents for delivery
(certificate of conformity, certificate of analysis, etc.)
• Obligation to have a legislation update

4.4.8.3 Based on hazard analysis and assessment of associated risk, <current IFS HPC checklist> “the company shall regularly
the company shall regularly audit the subcontractor, by using In the event that the subcontractor is already IFS HPC audit the subcontractor…”
an audit checklist covering IFS HPC requirements (including certified or under any other product safety scheme should As this is a risk based process, it
e.g. relevant documented risk management system, control be taken into account in order to decrease the frequency is responsibility of company A
plan, traceability system, crisis management, etc.). Documents of the audits / checks to the subcontractor. (being IFS HPC certified) to
of such checks shall be available. establish the frequency of the
visits to its subcontractor (com-
pany B).
The following factors shall be
taken into consideration for
that purpose (by no means
exhaustive):
• A first visit to company B is
highly recommendable in
order to ensure the product
safety of the goods provided.
• If company B is or not IFS
HPC certified or certified
under any other product
safety scheme. This could be
used as an evidence to
decrease or increase the
frequency of the visits.
• Every time there is a change
in company’s B process (es),
or change of raw materials,
equipment etc. that could
affect the safety / compliant
of the product(s) delivered
to company A.
• In the event of complaints
from customers and / or
authorities.

“by using an audit checklist
covering IFS HPC require-
ments …”
It means to cover specific
chapters of the IFS HPC related
to product(s) / process (es)
safety.
4.4.8.4 The checks performed at the subcontractor shall be per- • Who is / are the auditor(s)? <auditors list>
formed by a qualified auditor / inspector. • How are auditors qualified for this job?
<continued education evidence>
4.4.8.5 If relevant, the company shall check the products on receipt <COA’s>, <testing plan for incoming goods>,
from its subcontractor. <external tests in preferable ISO 17025 accredited labs>
4.5 Factory location
4.5.1 Site security
4.5.1.1 Senior management shall ensure that hazards related to site Suitable equipment and installation shall be in place to
security (fire, explosions, electrical devices, flooding) are ensure site security (e.g. fire extinguishers).
identified and preventive measures are managed. • Which equipments or installations are in place to ensure
site security?
• Does the emergency plan include business continuity
aspects?

4.5.1.2 The production and storage areas of the site shall be secured • How is it ensured that unauthorized persons have no
effectively by controlled access in order to prevent unautho- access to production and storage areas?
rized entry. • What control measures are in place in order to control the
entrance to those areas?
• Do entry controls exist?
• How are external activities under responsibility of the
company monitored like transport or storage?
• Based on the hazard analysis and assessment of associated
risks, what areas have been identified as critical?
• What control measures are in place in order to control the
entrance to those areas?
• How does the company maintain control over who enters
to the premises and critical areas?
• What are the access controls applicable to the following
people?
·· Temporary employees
·· Contractors
·· Visitors
·· Employees
·· Carrier drivers
See Product Defense guideline (requirement 6,2,1)

4.5.2 Factory exterior
4.5.2.1 The company shall investigate to what extent the factory • Does a location investigation exist?
environment (e.g. ground, air) may have an adverse impact on • Can a location have a negative influence on product qual-
product safety and product quality. ity?
In each case, appropriate measures shall be established. <location analysis>, <neighbouring companies>
The effectiveness of the established measures shall be • What protective measures have been established if poten-
periodically reviewed (examples: extremely dusty air, strong tially damaging materials / substances are nearby?
smells). <protective measures>, <corrective actions>
• Is efficiency of protective measures regularly reviewed?
• Who reviews the efficiency of the established protective
measures?
• How is efficiency of established protective measures
reviewed?
Check if the factory environment (e.g. ground, air, toilets,
cleaning facilities, handling of waste, chemical canisters and
catering facilities) has no adverse / negative impact on product
safety and product quality (examples: extremely dusty air,
strong smells, tape management, non-separated toilets with
direct access to hygiene areas like production, flaking paint,
drum-nippel, chains of conveyor belts).
Waste collection rooms and containers (incl. presses) shall be
designed to be kept clean and minimize animal and pest
attraction.
4.5.2.2 The factory exterior shall be sustainable maintained, clean • Are factory exteriors tidy?
and tidy. The external condition of the premises shall be • Are factory exteriors reviewed through internal audits?
considered within the internal audit process. <audit results>
4.5.2.3 All grounds within the site shall be in good condition. Where • Are grounds within the factory premises in good condi- Check if piping is self-draining
natural drainage is inadequate, a suitable drainage equipment tion? and arranged that process
shall be installed. • Is natural drainage sufficient? waste water goes directly to
• If natural drainage is insufficient, has a suitable drainage drain. Where significant
system been installed? amounts of water are used,
floors have adequate draining
to avoid ponding.

4.5.3 Plant layout and process flow
4.5.3.1 Plans clearly describing internal flows of finished products, • How is it ensured that cross-contamination is avoided?
raw materials including packaging materials, waste, person- <waste elimination plan>, <personnel flow plan>,
nel, water, etc. shall be in place. A site map covering all build- <materials flow plan>, <process flow plan>,
ings of the facility shall be available. <hydraulic plan>
4.5.3.2 The process flow, from receipt of goods to dispatch, shall be • How is cross-contamination avoided within factory
organized so that a contamination of raw materials including premises?
packaging materials, semi-processed, rework and finished <process flow-diagram>, <in case of co-packers /
products is avoided. The risk of cross-contamination shall be subcontractors, transport- / storage-suppliers: additional
minimized through effective measures. flow diagram>
Documented procedures shall be established to ensure the
effective management of e.g. allergenic materials to prevent
cross-contamination into products not containing the aller-
gen.
4.5.3.3 Where relevant, products shall not be produced, stored and Mainly applicable for scope 1 and 2
filled on the same equipment as products with another • How is it ensured that cross-contamination is avoided?
intended use, unless evidence is available that there is no <waste elimination plan>, <personnel flow plan>,
negative effect on the products. <materials flow plan>, <process flow plan>,
<hydraulic plan>, <process validation>,
<cleaning validation>
4.5.3.4 If production areas are identified as microbiologically sensi- Mainly applicable for scopes 1, 3 (food contact materials)
tive (e.g. clean room technology), a positive air pressure and 4
equipment shall be installed. Assessment of the level of the • Are there high care areas?
microorganisms shall be performed at risk based intervals. • (How) Are high care areas ventilated?
• How often are air borne micro-organism counts made?
<micro-organism count results>
• Who carries out the micro-organism measurements?

4.5.4 Buildings and facilities
4.5.4.1 Building and internal structures
4.5.4.1.1 All buildings used in the manufacture or storage of products Visit and inspection of buildings
shall be designed and constructed in order to allow unob-
structed installation, ease of maintenance, efficient pest
control and easy cleaning of the equipment, as well as com-
pliance with all relevant legislation.
4.5.4.1.2 Rooms where the products are prepared, treated, processed Visit and inspection of rooms
and stored shall be designed and constructed, so that product
compliance and product safety is ensured.
4.5.4.1.3 Walls shall be constructed to prevent the accumulation • Are walls mouldy?
of dirt, to reduce condensation and mold growth, and to Check if the accumulation of dirt, condensation and mould
facilitate cleaning. growth is minimised, and adequate cleaning is possible.
4.5.4.1.4 Floors shall be in good condition and shall be designed to • Are floors cleanable?
meet production requirements (e.g. mechanical loads, clean- • How often are floors cleaned?
ing materials, etc.) and to facilitate cleaning and disinfection, <cleaning schedule>, <cleaning evidence>
where required.
4.5.4.1.5 Ceilings (or, where no ceilings are fitted, the undersides of • How often are ceilings cleaned?
roofs) and overhead fixtures (incl. piping, cables, lamps) shall <cleaning schedule>, <cleaning evidence>
be suitable for the process and shall be designed and con- If ceilings and overhead fixtures are present, check if there is
structed to minimize the accumulation of dirt, the detach- adequate access to the cavity in order to facilitate the control
ment of paints or other coating materials, condensation and of pest activity, unless the cavity is completely sealed.
mold growth. Ceilings and overheads shall be designed to
facilitate cleaning and prevent product contamination.
4.5.4.1.6 Windows and other openings shall be designed and con- • Can dirt accumulate on window sills?
structed to avoid the accumulation of dirt and shall be main- Check if the accumulation of dirt, condensation and mould
tained in good condition. growth is minimised, and adequate cleaning is possible.
4.5.4.1.7 Doors and gates shall be in good condition and easy to clean. • Are doors damaged? Are doors sealing completely ?
In general check if walls, floors, drainage, windows, ceilings
and overhead fixtures are in good condition, constructed
and maintained to prevent the risk of product contamination
(e.g. no splittering parts, liveries or corrosion).

4.5.4.1.8 Drainage equipment shall be designed to facilitate cleaning • How is waste water disposal ensured?
and to minimize the risk of product contamination (e.g. • How often are gullies cleaned?
adverse impact, ingress of pests, environment impact etc.). <cleaning evidence>, <drainage schedule>
The hygienic disposal of waste water shall be ensured.
4.5.4.1.9 Where relevant, for laboratories: Mainly applicable for scope 1
• location of laboratories at the factory shall not affect prod- (microbiology: mainly applicable for scopes 1 and 4)
uct safety • Visit of lab
• microbiological laboratory shall be physically separated • Who have access to the laboratories and especially to the
from chemical laboratory microbiological laboratory?
• suitable equipment and environment shall be available for • If there is no own microbiological laboratory, but microbio-
all tests performed. logical analysis necessary, who performs the microbiologi-
cal analysis and how often?
4.5.4.2 Lighting, air conditioning / ventilation
4.5.4.2.1 All working areas shall have adequate lighting. • What is the assurance that all working areas are adequately
illuminated?
4.5.4.2.2 Based on hazard analysis and assessment of associated risk, all • Where are fly killing units mandatory? <fly trap plan>
lightning equipment and electric fly killer units shall be pro- • Are all fly killing units and lamps protected by splinter
tected. shields? <lighting protectors>
The factory areas where this clause shall apply:
• handling of unpackaged products,
• storage of raw materials, including packaging materials,
• handling of raw materials,
• changing rooms.
This does not preclude that other areas cannot have pro-
tected lighting equipment or electric fly killer units.
4.5.4.2.3 Adequate natural and / or artificial ventilation shall exist in all • How is ventilation reviewed?
areas. • How are air filters maintained and cleaned?
<maintenance schedule>,
4.5.4.2.4 If ventilation equipment is installed, filters and other compo-
<maintenance documentation>,
nents which require cleaning or replacement shall be easily
<cleaning protocols>
accessible.
• Check the risk of contamination by using air in the produc-
tion within a risk assessment

4.5.4.2.5 The use of air in the production (e.g. compressed air supply) • Is the use of air during production based on risk assess-
shall avoid contamination and be based on hazard analysis ment? <risk assessment>
and assessment of associated risk. • Are there production areas with underor over-pressuriza-
tion?
Compressed air, which is used in direct contact with the
product must be filtered.
4.5.4.2.6 Dust extraction equipment shall be installed in areas where Mainly applicable for scope 3, 4, also for scope 2 (e.g. washing
considerable amounts of dust are generated. powders)
• Are there areas where large amounts of dust are formed?
• How are cross contaminations avoided? <weighting areas>
• Do dust extraction devices exist in these areas?
4.5.4.3 Water quality
4.5.4.3.1 All process waters (including water used as an ingredient) Mainly applicable for scopes 1 and 2
shall be tested regularly for compliance with chemical, physi- <control plan of the water>
cal and microbiological specifications. Special attention shall
be paid after periods of no water consumption (e.g. after a
weekend or holiday period). The risk assessment shall address
this topic.
The company shall demonstrate the effectiveness of its water
treatment and usage.
4.5.4.3.2 A water monitoring program (especially in the case of cold Mainly applicable for scopes 1 and 2
mixing operations) shall verify that the water treatment is • Is water treated on site (water hardness correction,
adequate and effective on a risk based plan. chlorination, sterilization, filtration …)?
• Is water analysed according to legal requirements (own
water supply, outside supply).
• Do results comply with standards?
<control plan of the water>, <several analysis results>

4.5.4.3.3 Recycled water which is used in the process shall not pose a • What for is water used in the company (social facilities,
contamination risk. The water shall comply with applicable cleaning procedures, product ingredient, etc)?
legal requirements for potable water; records of compliance • Is water treated on site (water hardness correction, chlori-
testing shall be available. nation, sterilization, filtration …)?
• Are local legal requirements on hand?
• Is water analysed according to legal requirements (own
water supply, outside supply).
• Do results comply with standards?
<several analyses results>
4.6 Cleaning and disinfection
4.6.1 Based on hazard analysis and assessment of associated risk, • Who is in charge of cleaning and disinfection? Documented cleaning proce-
cleaning and disinfection schedules shall be available and <cleaning schedule> dures shall be in place and
implemented. These shall specify: • What kind cleaning products and disinfectants are used? maintained for the building,
• objectives, <up to date cleaning products and disinfectant list> plant and all equipment. These
• responsibilities, • What must be observed when using different cleaning include special cleaning work
• the products used and their instructions for use, products and disinfectants? such as cooling unit, fans and
• the areas to be cleaned and / or disinfected, <product instructions> intermediate disinfection etc.
• cleaning frequency, • What areas are cleaned and disinfected? Cleaning procedures shall as a
• documentation requirements, <cleaning schedule> minimum include the:
• hazard symbols (if necessary). • How often are areas cleaned and disinfected? • functionality
These schedules shall be documented. • Where are cleaning and disinfection procedures docu- • responsibility for cleaning
mented? <cleaning procedures documentation> • item / area to be cleaned
• Do hazard symbols exist? • frequency of cleaning
• Does a contract exist for external service provider? • method of cleaning, includ-
<external services contract> ing dismantling equipment
• How is it ensured that disinfectant will not be in contact for cleaning purposes where
with processed products? required
• cleaning chemicals and
4.6.2 Where relevant, only qualified personnel shall be allowed to Mainly applicable for scopes 1, 2 and 4
concentrations
undertake cleaning and disinfection. The personnel shall be • Are cleaning personnel qualified? <training proof>
• cleaning materials to be
trained and retrained to carry out the cleaning schedules. • How often are they trained?
used
• Who trains them?
• cleaning records and respon-
• Are these trainings documented?
sibility for verification
• Are there any checks on topics learnt after training?
• hazard symbols

4.6.3 Based on hazard analysis and assessment of associated risk, • How are cleaning and disinfection controls performed? The frequency and methods of
the effectiveness and safety of the cleaning and disinfection <cleaning controls> cleaning shall be based on risk.
measures shall be verified, validated for equipment and • Who performs these controls? <cleaning controls> Cleaning activities take place in
documented according to a sampling schedule by using • How often are cleaning and disinfection controls per- periods without production, or
appropriate procedures. formed? <cleaning controls> they do not affect product
Resultant corrective actions shall be documented. • Where are cleaning and disinfection controls documented? quality. The procedures shall be
• When are corrective actions executed? <corrective actions> implemented to ensure appro-
• Who executes corrective actions? priate standards of cleaning are
• Who reviews effectiveness of corrective actions? achieved.
• Where are corrective actions documented?
• How are cleaning methods validated?
• Does the company consider all relevant product groups?
• Is the validation performed for all relevant process steps
e.g. mixing and filling?
• In case of personal care and household care products on
the same production lines: Is the cleaning validation per-
formed based on risk assessment?
Limits of acceptable and unacceptable cleaning and disinfec-

tion performance (also for intermediate disinfection) shall be
defined, based on the potential hazards (e.g. microbiological,
allergen or foreign body contamination). Acceptable levels
of cleaning may be defined by visual appearance, ATP bio
luminescence techniques, microbiological testing or chemical
testing (e.g. CIP-equipment, resiued of liquids in food
boxes / containers, etc.) as appropriate. The cleaning and
disinfection procedures and frequency shall be validated and
records maintained. Derived corrective actions will be docu-
mented and tracked.

4.6.4 Cleaning and disinfection measures shall be validated accord- Mainly applicable for scopes 1 and 2
ing to any changing circumstances (e.g. construction work, • When are cleaning and disinfection procedures validated?
new products, new machines, changes of climate etc.). Where • Who adapts cleaning and disinfection procedures?
necessary, the cleaning and disinfection schedules shall be • How often are cleaning and disinfection schedules
adapted. changed?
It has to be assured that the measures of cleaning and disin-
fection are effective. It is possible to ensure it by hygiene
monitoring.
• In case of personal care and household care products on
the same production lines: Is the cleaning validation per-
formed based on risk assessment?
4.6.5 Current safety data sheets (SDS) and instructions for use shall • Are material safety data sheets available for all cleaning
be always available on-site for chemicals and cleaning agents. agents?
Personnel responsible for cleaning shall be able to demon- • Are material safety data sheets available for chemicals?
strate their knowledge of such instructions. <Example of chemicals: e.g lubricants, etc.>
• Are these no older than two years?
• Are cleaning chemicals instructions up to date?
• How are instructions transmitted to personnel in charge of
cleaning procedures?
• Where and when can the instructions be inspected?
4.6.6 Cleaning utensils and chemicals shall be clearly identified, • How are cleaning utensils and chemicals recognizable?
used and stored appropriately, to avoid contamination or <chemicals list>
unintended use. • Where are cleaning utensils and chemicals stored?
<chemicals storage list>
Check, if chemical canisters, purge lines, etc. in production
and storage areas do not affect product safety.
4.6.7 The cleaning of production tools shall, if relevant, be carried • Where are containers cleaned?
out at specific locations or specific time periods separated • When and where are tools cleaned?
from the production process. If this is not possible, these • Where are containers and tools dried?
operations shall be controlled as to not affect the product • How do the company avoid, if applicable, crosscontamina-
safety and quality. tions from the cleaning chamber to the production area?
<cleaning evidence>

4.6.8 Where a company hires a third-party service provider for • How is the external cleaning personnel trained
cleaning and disinfection activities, all requirements specified
within section 4.6 shall be clearly defined in the respective
contract.
4.7 Waste Disposal
4.7.1 A waste management procedure shall exist and shall be <plan>
implemented to avoid cross contamination.
4.7.2 All current legal requirements for waste disposal shall be met. • How is it ensured that current legal waste disposal require-
ments are met? <certificates, contracts and delivery notes
of external suppliers>
• How is waste material disposed of?
Where licensing is required for the disposal of categorised
waste, it shall be removed by licensed contractors and records
of disposal shall be maintained and available for audit.
4.7.3 Waste collection containers and, where existing, compactors • What kind of waste exists? Waste collection rooms and
shall be clearly marked, suitably designed, in good state of • What wastes are collected in separate containers? containers (incl. presses) shall
repair, easy to clean, and disinfected where necessary. • How are waste containers marked? be designed to be kept clean
• Can waste containers easily be cleaned? and minimise animal and pest
• How often are the containers discharged, for each kind of attraction.
waste? <cleaning protocol>
4.7.4 Waste shall be collected in separate containers in accordance • What kinds of waste disposal records exist? Who is respon-
with the intended means of disposal. Such waste shall be sible for waste disposal?
disposed by authorized third parties only. Records of waste <waste disposal registry>,
disposal shall be kept by the company. <is dangerous waste handled and stored correctly>
Whenever possible, destruction of waste shall be intended to unfit product = not intended to be re-used or recycled.
avoid re-use of unfit products.

4.8 Risk of foreign materials
4.8.1 Based on hazard analysis and assessment of associated risk, • What kinds of foreign bodies may be found?
procedures shall be in place to avoid contamination with • Where foreign body sources identified through risk assess-
foreign material. ment? <risk assessment>
• Are staples or needles used?
• How are contaminated products handled?
<segregation records>
• What is done in case of glass breakage?
<glass breakage prevention procedures>
• What shall be considered when glass fixtures are replaced?
<glass handling procedures>
4.8.2 In all areas, i.e. handling of raw materials including packaging • Under what circumstances is the use of wood allowed?
materials, processing and storage, where risk assessment has <risk analysis>
identified the potential for product contamination, the use of • Is the wooden tool in use in good and clean conditions?
wood shall be excluded. Where the use of wood cannot be Who inspects and how often is the wooden tool condition
avoided, the risk shall be controlled. inspected? <plant inspections>
If there are wooden items used, check the condition of wood.
This items have to be in good condition and free from
damage or splinters which could contaminate products.
Continually monitored to ensure the conditions.

4.8.3 Where metal and / or other foreign material detectors are Mainly applicable for scopes 1 and 4 Check if the detection is sub-
required, they shall be installed to ensure efficiency of detec- • Where are the metal / foreign body detector installed? jected to interference factors
tion, in order to avoid subsequent contamination. <equipment lay-out> (e.g. X-Ray, metal etc.), the
detection is placed at an appro-
priate step of the process flow,
and if possible, after the prod-
uct has been packed.
Retained or removed material is
examined and recorded to
identify contamination risks.
Checks of proper function of
detectors are carried out regu-
larly by qualified personnel.
In case of malfunction or failure
of a metal and / or foreign
material detector, corrective
actions shall be defined, imple-
mented and documented.
4.8.4 The accuracy of detectors shall be specified. Checks of proper Mainly applicable for scopes 1 and 4
function of detectors shall be carried out regularly. In case of • Is the detection limit based on risk assessment?
malfunction or failure of foreign material detector, corrective <are all test pieces smaller than the potential hazarduous
actions shall be defined, implemented and documented. foreign body?>
• How often are detector accuracies checked?
• Who checks detector accuracy?
<metal detector check-list>
• What corrective actions exist when a detector is defective?
• Are corrective actions verified?
• Are operational defects documented?
<defect / failure protocols>

4.8.5 Potentially contaminated products shall be isolated. Access • Are potentially contaminated products automatically
and actions for further handling or checking for these isolated isolated?
products shall be carried out only by authorized personnel • Who may handle / has access to isolated products?
according to defined procedures. If product’s contamination • How are isolated products handled?
is confirmed, those shall be treated as non-conforming <non-conforming products list>, <isolation protocol>
products.
4.8.6 A glass and brittle material management shall be imple- • Is every glass breakage documented? Documented procedures detail-
mented, taking into account preventive and corrective <glass breakage registry> ing the action to be taken in
measures; the system shall include reference to procedures in • In case of glass breakage: Is the potential risk for product case of breakage of glass or
the event of glass or brittle material breakage. contamination evaluated? (link to 4.8.5) other brittle items shall be
Where a risk assessment has identified a potential for product • Where is glass breakage documented? <glass register> implemented and include the
contamination, the presence of brittle material (including • Are there exceptions to documentation? following:
glass) shall be excluded or, if this is not possible, the risk shall • Are exceptions based on risk assessment? • quarantining the products
be managed. <risk assessment> and production area that
All stationary objects made of or incorporating glass or brittle were potentially affected
material, which are present in areas of handling of raw materi- • cleaning the production area
als, processing, packing and storage, should be listed in a • inspecting the production
specific register including details of their exact location, area and authorising to
number, type and condition (except when used as part of the continue production
product). • changing of workwear and
inspection of footwear
• breakages of glass and
brittle material shall be
recorded. Exceptions shall be
justified and documented in
the risk assessment
• specifying those staff autho-
rised to carry out the above
mentioned / listed points
4.9 Pest Monitoring / Pest Control

4.9.1 The company shall have a pest control system in place which • How is pest control organized? <pest control procedures>
is in compliance with local legal requirements, and as a mini- • Which pests are controlled?
mum shall cover the following criteria: • Which kinds of baits are used?
• the factory environment (potential pests), • Are safety data sheets for the used agents available,
• site plan with area for application (bait map), are the safety data sheets up to date?
• identification of the baits on-site, <pest control chemicals list>
• responsibilities (in-house / external), • Is product contamination through baits being prevented?
• used products / agents and their instructions for use and <bait map>
safety, • Who is responsible for pest control?
• the frequency of inspections. • What is inspection scheduled?
The pest control system shall be based on hazard analysis and
assessment of associated risk.
4.9.2 The company shall have qualified and trained in-house staff • Is pest control executed by own staff members?
and / or employ the services of a qualified external provider. • Who is responsible for pest control?
Where an external provider is used, the activities required • What kind of training has the responsible person? <training
on-site shall be specified in a written contract. evidence>
• Is pest control executed by external services provider?
• Does a written contract exist between services provider
and company? <written contract>
• What is the content of the contract?
• What kind of training has the external services provider?
<training evidence>
4.9.3 Pest control inspections and resulting actions shall be docu- • Where are inspections and resulting corrective actions
mented. Implementation of actions shall be monitored and documented? <inspection results>
recorded. • Are documents signed and dated by both parties?
• Which corrective actions were executed lately?

4.9.4 Baits, traps and insect exterminators shall be functioning, in • Where are electrical fly killers installed?
sufficient number and placed in an appropriate position. They • How the correct position of the killing units was defined?
shall be constructed and positioned as not to cause any <fly killer map>
contamination. • Are all fly killers correctly working and connected?
• Is the number of insects and the type evaluated?
Baits, traps and insect killers (electric fly killers, etc.) are fitted
correctly in sufficient number available and at a suitable
location. Bait stations, fly-killing devices and / or pheromone
traps shall be robustly constructed, operational, and effective
in eliminating the target pests, and be positioned to avoid
potential contamination of materials and products.
4.9.5 Incoming deliveries shall be checked on receipt for the pres- • Are incoming goods where applicable inspected for pest
ence of pests. Any infestation shall be documented and con- contamination?
trol measures taken. • Where is this documented? <incoming goods inspection>
• Is pest presence documented?
<incoming goods inspection>
• What control measures are taken when pests are found?
<corrective actions>
• Where are these control measures documented?
<corrective actions>
4.9.6 If windows pose a risk of a source of contamination such as • Are windows sealed with insect gratings?
the ingress of pests, windows and roof glazing shall remain <pest control schedule>
closed and sealed during production. • Is integrity of gratings regularly reviewed?
If they are designed to be opened for ventilation purposes, <monitoring schedule>
they shall be sealed by easy removable pest screens or other
measures in order to avoid any contamination.
4.9.7 Based on hazard analysis and assessment of associated risk, • Do outer doors prevent pest entrance into production
external doors and gates shall be designed to prevent the areas?
ingress of pests; if possible, they shall be self-closing. • Do outer doors directly lead to the production area where
open products are handled?

4.10 Receipt of goods and storage
4.10.1 All incoming goods, including packaging materials, shall be • What goods are inspected when received?
identified and checked for conformity against specifica- <receipt checks>
tions / other legally required documentation and to a deter- • What is checked when received?
mined control plan. The control plan shall be risk based. Test • Is receipt documented?
results shall be documented. • Who checks?
4.10.2 The storage conditions and locations of raw materials includ- • Where are raw materials, semi-finished products and
ing packaging materials, semi-processed and finished prod- packaging materials stored? <storage plan>
ucts as well as working materials shall in each case • How is cross-contamination avoided?
correspond to product requirements, shall not be detrimental <product flow plan>
to other products and shall minimize cross contamination. This also applies to supplies, auxiliaries and additives
High outside temperatures shall be taken into consideration
when storing outside products.
4.10.3 Where relevant, for semi-finished products, maximum dura- <take into account that the expiry date of the finished
tion for storage shall be defined. product might be influenced by the expiry date of the semi-
When this duration is reached, the semi-finished product shall finished product>
be re-evaluated before use. Check if somewhere it‘s addressed that semi finished products
are checked against best before date
4.10.4 Outdoor storage shall be kept to a minimum. Where goods • Are goods stored outdoors?
are stored outside, hazard analysis and assessment of associ- • What is stored outdoors?
ated risk shall be undertaken in order to ensure that there is • Are temperature and hygiene conditions adequate? <silos>
no risk of contamination or adverse effect on quality and • What rules exist for outdoor storage?
product safety. • Is outdoor storage based on risk assessment?
<risk assessment>
4.10.5 When relevant, sampling of raw materials and of bulk product Mainly applicable for scopes 1, 2 and 4
shall be performed in an appropriate manner and by autho- • Where are raw materials sampling performed?
rized personnel. • Is for microbiologically sensitive materials an adequate
sampling cabin available?
• Who is responsible of this performance?
<procedure>, <job instruction>

4.10.6 Products shall be clearly identified on receipt and when • How is “FIFO” ensured?
stored. Use of products shall be undertaken in accordance Use of products is undertaken in accordance with the princi-
with the principles of First In / First Out and / or First ples of First In / First Out and / or First Expired / First Out.
Expired / First Out, in accordance with relevant industry best
practices.
4.10.7 Periodic inventory shall be performed to ensure stock reliabil- • How is made the periodic inventory?
ity. Any significant discrepancy shall be investigated and All products shall be clearly identified.
corrective action taken.
4.10.8 Where a company hires a third-party storage service provider, • Is storage leased to storage service provider?
the service provider shall be subject to IFS Logistics require- • Does a contract exist? <service provider contract>
ments. If the third party service provider is not certified to IFS • What is specified in the contract?
Logistics, all relevant requirements equivalent to the compa- • Has storage service provider an IFS Logistics certification?
ny’s own warehousing practices shall be fulfilled and this shall <certificate copy>
be clearly defined in the respective contract.
4.11 Transport
4.11.1 Before loading transport vehicles, their condition (e.g. • What is checked before loading?
absence of strange smells, high dust load, adverse humidity, <expedition inspection>
absence of contamination, pests, mold) shall be checked and • Where is inspection documented?
actions taken, if necessary. At the raw materials and packag- • What corrective actions are taken?
ing materials receipt, checks shall be made in order to assess
that transportation has taken place under in good conditions.
4.11.2 In case of transport of dangerous goods, the company shall • How do they ensure that legislation is consistenly applied?
ensure that all the relevant legislative requirements are ful- • Who verifies this?
filled. <CLP regulation>, <dangerous goods safety advisor>
4.11.3 Adequate hygienic requirements for all transport vehicles and • Are transport vehicles cleaned?
equipment used for loading / unloading (e.g. hoses of silo • Where are cleaning procedures documented?
installations) shall exist. There shall be records of the actions <cleaning protocol>
taken.
4.11.4 Where relevant, loading and unloading areas shall have • How is goods reception organized?
equipment in place to protect transported products from • How is loading organized?
external influences.

4.11.5 Security of transport vehicles shall be appropriately main- How are transport vehicles checked?
tained.
4.11.6 Where a company hires a third-party transport service pro- • Are there internal or external transportation regulations?
vider all the requirements specified within section 4.11 shall • Does a contract exist with a transportation services
be clearly defined in the respective contract or the service provider? <service provider contract>
provider shall be subject to IFS Logistics requirements.
4.12 Maintenance and repair
4.12.1 An adequate system of maintenance shall be in place. This • How is maintenance organized?
system shall be maintained and documented, covering all <maintenance plan>
critical equipment (incl. transport) for compliance with prod- • Where are maintenance procedures documented?
uct requirements. This applies both for internal and external • Which equipments are subject to external maintenance?
maintenance activities.
4.12.2 Product requirements and prevention of contamination shall • How is it ensured that maintenance and repair works do Check if, the company ensures
be ensured during and after maintenance and repair work. not affect product safety? that safety and / or legality of
Records of maintenance and repair work and of corrective • How are lighting fixtures repaired? product is not jeopardised
actions taken shall be kept. • Where are repair works documented? during maintenance and subse-
• Are corrective actions necessary after repair works? quent cleaning operations.
• What rules are in place for re-activating equipment when Maintenance work and result-
maintenance is completed? ing cleaning operations are
<examples for repair works and maintenance> documented on production
protocols.
Tape engineering is minimized
to an unavoidable level.
4.12.3 All materials used for maintenance and repair shall be fit for • How is it ensured that materials used in maintenance or
the intended use. repair work are fit for intended use?
• What kinds of greases are used? <grease list>
(e.g. food-grade oils, non-toxic solvents, etc.).
Check if maintenance tools like oil and grease / lubricant used
in production are food approved. Tool box is clean and no
equipment is missing.

4.12.4 Failures of plant and equipment (incl. transport) covered by • Are processing interruptions documented?
the maintenance system shall be documented and reviewed <processing interruptions>
so as to adapt the maintenance system accordingly. • Are processing interruptions considered in maintenance
planning?
4.12.5 Temporary repairs shall be carried out so that product require- • Are temporary repairs allowed?
ments are not affected. Such work shall be documented and a • Where are these documented?
short-term deadline set for eliminating the fault. • How fast must temporary repairs be definitely mended?
• Who verifies this?
4.12.6 Where a company hires a third-party maintenance and repair • Does a contract exist with a maintenance and repair
service provider, all the company specified requirements services provider? <service provider contract>,
regarding material and equipment shall be clearly defined, <training of subcontractor>
documented and maintained.
4.13 Equipment
4.13.1 Equipment shall be suitably designed and specified for the • Are equipments and consumables suitably designed and
intended use. Before commissioning, it shall be verified that were they checked before start up?
the product requirements are complied with. <start up protocol>
Consumables used for equipment should not affect the qual-
ity of the product.
4.13.2 Equipment shall be designed and locationed so that cleaning • Are equipments suitably designed and were they checked
and maintenance operations can be effectively performed. before start up? <start up protocol>
• What rules exist for start up of new equipments?
• Were new equipments immediately considered in mainte-
nance plan?
• Does an equipment installation plan exist?
<machinery installation plan>

4.14 Traceability
4.14.1 KO N° 4: A traceability system shall be in place which • How is traceability ensured? <traceability procedures> The company shall test the
enables the identification of product lots and their relation • What products come from which supplier? traceability system across the
to batches of raw materials, packaging in direct contact • Is there a list available with all current suppliers? range of product groups to
with product and packaging intended or expected to be in <supplier list> ensure traceability can be
direct contact with product. The traceability system shall • Are test results, specifications, amounts, delivery notes and determined from raw material
incorporate all relevant processing and distribution records. dates or retain samples traceable? to finished product and vice
Traceability shall be assured and documented until delivery versa, including quantity
to the customer. check / mass balance. Where
rework or any reworking opera-
tion is performed, traceability
shall be maintained. This shall
occur at a predetermined
frequency and results shall be
retained for inspection.
It‘s expected that the company

is able to identify if a batch of
raw materials is used for the
production of several batches
of products.
4.14.2 Downstream and upstream traceability records (from produc- <traceability test records>
tion-sites to the customers) shall be available. The timeframe
for producing these records for review shall be compliant with
customer’s requirements.
4.14.3 Traceability shall be in place to identify the relationship <check of labels>
between batches of final products and their labels.

4.14.4 The traceability system shall be tested on a periodic basis at • When was the last traceability test in both directions done?
least annually, and each time the traceability system changes. <traceability test results>
The test shall verify downstream and upstream traceability • What percentage of total amount was traced?
(from raw materials to delivered products and vice versa), • How big is a lot?
including quantity checking. Test results shall be recorded. • Does the test also consider test results, retain samples and
delivery notes?
• Who is participating at the test?
• How long does the test need?
4.14.5 Based on hazard analysis and assessment of associated risk, • Can rework be completely traced? Traceability shall include rework
on legal requirements and on customer specifications, trace- <results from rework traceability test> in all cases.
ability shall be ensured at all stages, including work in prog- • How is rework documented ? Although in some situations
ress, post treatment and rework. • Can packing be completely traced? (e.g. paper), this is not risky and
traceability is not a must.
Example: cutting scrap from the
paper production can be used
as raw material in the paper
mill and it is not always possi-
ble to trace it to each lot of
finished product. It may be
possible for the company to
treat this paper-rework as a
known raw material.
4.14.6 Where relevant, it shall be possible to identify at all times all Mainly applicable for scopes 1, 2 and 4
major equipment used for the production of finished product • Where have you registered equipments used for the
(containers of raw materials and of semi-finished products, production?
mixers, filling lines, etc.).
4.14.7 Identified samples representative of the manufacturing batch • How many samples do you keep and during how much
shall be stored appropriately and kept until expiration date of time?
the finished product and, if necessary, for a determined • How these samples are identified?
period beyond this date (“sample bank”). • Do you visit the storage of this samples and check the
respect of the requirements customers?
• Do the samples take into account potential interaction
between packaging material and product?

5 Measurements, analyses, corrective actions and management of incidents
5.1 Internal audits
5.1.1 Effective internal audits shall be conducted according to a • Does an up to date internal audit plan exist? <audit plan>
defined agreed audit program and shall cover at least all • Is audit plan based on risk assessment? <risk assessment>
requirements of the IFS HPC Standard. Scope and frequency • Is a checklist available?
of internal audits shall be determined by risk assessment. <is the checkliset based on IFS HPC requirements>
This is also applicable for off-site storage locations owned or
rented by the company. The auditors shall be competent and independent from the
audited department.
The results of these reviews influence a risk-based investment
planning.
5.1.2 Internal audits shall be carried out at least once a year in all • How often are internal audits performed? <audit plan>
departments. The following issues can be taken into consideration for
internal audits: all production steps (packaging area, labeling,
GMP’s, CCP’s) traceability, control plan (analysis, calibration)
documentation management (updates) management of
non-conformities (complaints, internal non-conformities,
withdrawal, recall)
5.1.3 The auditors shall be competent and independent from the • Who are the auditors? <auditors list>
audited department. • Who is auditing the QM- / RM-responsible?
• How are auditors qualified for this job?
<continued education evidence>
• Have auditors any connection with audit area?
• Gets the company external support, external auditors for
internal audits, at multinational companies special auditor
teams?

5.1.4 Audit results shall be communicated to the senior manage- • How are audit results communicated to the persons in
ment and to responsible persons of concerned department. charge? <audit report distribution>
Necessary corrective actions and a schedule for implementa- • Are corrective actions documented? <audit report>
tion shall be determined, documented and communicated to • Is a time schedule in place for corrective actions?
every relevant person. <audit report>
• From which audits were corrective actions derived?
<audit report containing corrective actions>
• How are audit results forwarded to senior management?
<audit report distribution>
• How are audit results evaluated?
5.1.5 It shall be documented, how and when the corrective actions • How is the corrective action verification regulated?
resulting from the internal audits shall be verified. <verification evidence>
• Who verifies and when?
5.2 Factory inspections
5.2.1 Regular factory inspections shall be planned and carried out • How often and who makes site inspections? <site inspec-
to assess criteria such as product control, hygiene, foreign tions protocol>
material hazards, personal hygiene, and housekeeping. • What is reviewed during site inspections?
Any deviation and the associated corrective actions shall be • For which areas do site inspections exist?
documented. Topics to be included within the factory inspection could be
for instance: hygiene, building, foreign bodies, safety, etc.
5.3 Manufacturing process validation and control
5.3.1 The criteria for process validation and control shall be clearly • How the start up of production is validated?
defined. All processes critical to product safety and product <production records>
compliance shall be validated. • How are new products / processes validated?

5.3.2 Processing operations shall be carried out in accordance with • How are following the processing operation?
processing control documentation, and shall include: • Where are present informations for the production?
·· suitable equipment, • What kinds of monitoring exist?
·· composition of the product, <fabrication order>, <job instruction>,
·· list of all raw materials identified according to relevant <nomenclature produit>
documents indicating batch numbers and quantities,
·· detailed processing operations for each stage, such as
addition of raw materials, temperatures, mixing times,
sampling and semi-finished product transfer.
Where applicable, a batch number shall be assigned.
5.3.3 In circumstances where the control of process and working <printed measurement data>
environment parameters (temperature, time, pressure, chemi-
cal properties etc.) is essential to ensure the product require-
ments are met, such parameters shall be monitored and
recorded continuously and / or at appropriate intervals.
5.3.4 The company shall ensure that in the event of changes to • What happens when a failure occurs?
processing methods, equipment and product formulation • What happens when cold chain is interrupted?
(including rework and packaging material), process character- <machinery stand still protocol>
istics are reviewed in order to assure that product require-
ments are complied with. If relevant, customers shall be
informed accordingly.
5.3.5 Where relevant, all rework operations shall be validated, Mainly applicable for scopes 1, 2 and 4
monitored and documented. These operations shall not affect • How is it assured that reworks comply to specifications?
the product requirements. • Where is rework documented?
<model documentation for rework>
• Who reviews rework results?
• Who decides rework liberation?
• What kinds of rework are used in practice?
<use of product in a following lot>,
<adaption of chemical parameters: pH, viscosity …>,
<relabelling of the consumer-packaging / outer box>,
<re-packing of finished products>
• Is all rework performed internally?
• Is the traceability of rework tested regularly?

5.3.6 There shall be appropriate procedures for prompt notification, <printed measurement data>
recording and monitoring of equipment malfunction and
process deviations.
5.3.7 Process validation shall be performed using the collected How is process validation mathematically firmed?
data that is relevant for product safety and the processes.
If substantial modifications occur, a revalidation shall be
carried out.
5.4 Calibration, adjustment and checking of measuring and monitoring devices
5.4.1 The company shall identify the measuring and monitoring • What kinds of monitoring devices exist? Check if measuring equipment
devices required to ensure compliance with product require- <monitoring devices list> used to ensure and monitor
ments. These devices shall be listed and clearly identified. • What is demanded of monitoring devices? product safety and legality are:
• What monitoring device is adequate for which kind of • documented –> list of equip-
measurement? ment and location
• How are monitoring devices identified? • an identification code and
<identification stickers on monitoring devices> calibration due date
• Do calibrated devices exist? • prevention from adjustment
<monitoring devices list> by unauthorised staff
• protection from damage,
deterioration or misuse.
• at a predetermined fre-
quency, based on risk assess-
ment Results shall be
documented.

5.4.2 All measuring devices shall be checked, adjusted and cali- • How is measuring devices check organized?
brated, under a monitoring system, at specified intervals and <calibration procedures>
in accordance with defined recognized standard / methods. • Are measuring devices regularly calibrated?
The results of these checks, adjustments and calibrations shall <calibration protocol>
be documented. Where necessary, corrective actions on • Who is responsible for calibration?
devices and on processes and products shall be carried out. • How is calibration done?
• Where is it documented? <calibration records>
• What corrective actions are taken when a tolerance
deviation is found?
<corrective actions>, <calibration protocol>
• Is calibration up to date? <calibration certificate>
• Do the company perform additional internal checks of
measuring devices on a risk based frequency?
5.4.3 All measuring devices shall be used exclusively for their • What actions are taken when measurement results are
defined purpose. uncertain?
• How are embargoed measuring devices identified?
<identification stickers>
5.4.4 The calibration status of the measuring devices shall be • How is calibration status of measuring device identified?
clearly identified (labelling on the device or on a list of tested <measuring devices list>, <software solution>
devices).
5.5 Quantity checking (quantity control / filling quantities)
5.5.1 The frequency and methodology of quantity checking shall • How is it ensured that legal requirements for amount
be determined so that the legal requirements and customer control are met?
specifications, or if relevant, guidelines for nominal quantity • How is it ensured that customer requirements for amount
are met. control are met?
Check if the frequency and methodology of quantity checking
meet the requirements of appropriate legislation governing
quantity verification.
Records of checks shall be kept. The scales are used for
weight-labelling to identify labelling of the consumer packag-
ing, shall be adjusted / calibrated / officially certified.
Furthermore, the adjustment of the scales (bubble level)
should be taken into consideration.

5.5.2 A procedure shall exist to define compliance criteria for lot <procedure for quantity checking (frequency)>,
quantity checking. <comliance criteria>
5.5.3 Checks shall be implemented and recorded, according to a <sampling plan based on scientific literature>
sampling plan which ensures a proper representation of the
manufacturing lot.
5.5.4 Results of these checks shall be compliant with defined crite- <compliance criteria>, <tolerances>
ria for all products ready to be delivered.
5.5.5 If relevant, all equipment used for final checking shall be • Are measuring devices in use regularly calibrated?
legally approved. • Where is calibration recorded? <calibration protocol>
• Are there calibrated measuring devices?
<calibration certificate>
Or close to the date to be approved (transition period).
5.6 Product analysis (including quality checks)
5.6.1 There shall be procedures ensuring that all specified product • Which physical, chemical or microbiological analyses are Check if the quality of the
requirements are met, including legal requirements, perfor- made or subcontracted? finished product / s is reviewed
mance and specifications. Results of microbiological, physical <analyses results>, regularly by carrying out inter-
and chemical analysis required for that purpose shall be <Analytical methods and parameters shall be agreed with nal tests according to the
available. the customer, if applicable external analytics shall be per- specification.
formed in desgnated laboratories.> • tests shall be in accordance
Performance tests. with specifications and
related to the impact on
respective parameters of
product characteristic
• Durability studies including
sensory tests
• Consideration of the product
formulation
• Microbiological, chemical
criteria
• packaging, production and
storage conditions
• migration tests if needed.

The results of these tests shall
be documented, evaluated and
possible optimizing should be
derivated. If necessary the
results are communicated to
the customer.
The testing programs shall

cover based on risk assessment,
on product requirements and
customer requirements e.g. for
cosmetics pH, viscosity, total
viable count (microbiology),
density or refraction index etc.,
for diapers e.g. absorption,
retention time, content of super
absorber etc.,
kitchen towels e.g. weight per
squaremeter, size, perforation,
wet and dry strength cross and
machine direction etc.
5.6.2 Analyses, which are relevant for product safety and legality, • Is there an analytical laboratory on site?
shall preferably be performed by laboratories having appro- • Is it accredited under ISO 17025? <accreditation evidence>
priate accredited programs / methods (ISO 17025). If the analy- • Are internal lab results verified by an accredited lab?
ses are performed by a factory internal or a laboratory not • Which external laboratories are used?
having appropriate accredited programs / methods, the com- • Are these accredited under ISO 17025?
pany shall be able to demonstrate that the results are reliable. • For non accredited test methods, how the reliability of the
results could be demonstrated?
<accreditation evidence>
5.6.3 Documented evidence shall exist, which ensure the reliability • How are the analysis methods validated?
of the internal analysis results, on the basis of official and • Are analytical methods state of the art?
non-official recognized analytical methods. • Does the company perform ring tests or other tests to
show the reliability of methods?

5.6.4 A control plan shall be drawn up for internal and external • Does an inspection plan exist? <inspection plan>
analysis, based on hazard analysis and assessment of associ- • Who organizes inspection plan?
ated risk and based on additional information regarding • Which products are encompassed by inspection plan?
product quality (e.g. complaints). This plan shall cover raw (raw materials, half-finished and finished products,
materials, semi-processed and finished products and shall packaging materials, environmental tests?)
include the types of tests, their frequency and critical limits, <inspection plan>
which are linked to the specification limits. The test results • Is inspection plan based on risk assessment?
shall be documented. <risk assessment>
• Where are test results documented? <test results>
5.6.5 The analytical results shall be reviewed regularly and trends • Who reviews analytical results?
identified. Appropriate measures shall be introduced • How are analytical results verified?
promptly for any unsatisfactory results, or where such trends • Are trends investigated?
indicate unsatisfactory results. • Are corrective actions introduced when results are unsatis-
factory? <corrective actions>
5.6.6 Where internal analysis is undertaken, qualified and trained • Which tests are performed internally?
personnel shall be in place, as well as appropriate equipment • What qualifications have lab technicians?
and premises. <qualification evidence>
• Is an internal lab available?
• Is an incubator, sterilization equipment available?
• How is product contamination by internal lab prevented?
5.6.7 Results of checks on finished products including rework • Which tests are performed internally?
material shall be reviewed by authorized personnel in order to • What qualifications have lab technicians?
verify the conformity of the finished and semi-finished prod- <qualification evidence>
ucts with the acceptance criteria. • Is an internal lab available?
• Is an incubator, sterylization equipment available?
• How is product contamination prevented by internal lab?
5.6.8 Where relevant, for verification of finished product quality, • When and how are organoleptic tests performed?
organoleptic tests shall be carried out regularly. These tests <inspection plan>,
shall be in accordance with specifications and related to the <documentation of organoleptic test results>
impact on respective parameters of product characteristic.
The results of these tests shall be documented.

5.6.9 Based on any internal or external information on product risk For example, if an Alert System informs that a raw material
which may have an impact on product safety and / or quality, sourced from a specific country regularly has specific rate of
the company shall update its control plan and / or take any dangerous substance, and if the company is used to buying
appropriate measure to control the compliance of the finished this specific raw material, the company shall increase the
products. frequency of analysis of this raw material, to improve monitor-
ing.
On the other hand, if results of analysis always show good
results, and if the raw material is considered as a low risk the
company can decide to decrease the frequency of analysis.
5.7 Product quarantine (blocking / hold) and product release
5.7.1 A procedure shall be in place for the quarantine and release • Who quarantines or releases products?
of all raw materials including packaging materials, semi- <job description>, <procedure>
processed and finished products, and processing equipment. • How are quarantined products identified and stored?
The procedure shall ensure that only products and materials • How are quarantined product marked and blocked?
conforming to product requirements are processed and
dispatched.
5.8 Management of complaints from authorities and customers
5.8.1 A system shall be in place for the management of product • How are complaints handled? All objection / complaints relat-
complaints and, when relevant, shall take into account spe- <complaint handling procedure> ing to product safety, legality,
cific procedures (e.g. undesirable effects). For scope 1 and 4 (where applicable), presence of cosmetovig- and unusual or critical quality
ilance and materiovigilance . defects shall be documented,
investigated and assessed by
the appropriated competent
staff. Where it is justified,
appropriate actions (to serious-
ness and frequence of the
problems identified) shall be
taken by trained staff, if neces-
sary, immediately and tracked
and preventive actions should
be initiated to avoid recurrence.

5.8.2 All complaints shall be assessed by competent staff. Where it • Who ponders about complaint significance?
is justified, appropriate actions shall be taken immediately. • Are R & D and quality control involved?
• Who defines the actions to be taken?
• Within what time frame must actions be taken?
<complaints registration>
5.8.3 Complaints shall be analyzed with a view to implementing • Who manages complaint statistics?
preventive and corrective actions which avoid the recurrence <complaint statistics>
of the non-conformity. • How often are complaint statistics compiled?
• What actions are taken to avoid recurrence?
<corrective action form>
• A systematic evaluation of complaints shall be done.
5.8.4 The results of complaint data analysis shall be made available • To whom are complaint statistics data presented?
to the relevant responsible persons and to the senior man- <retailer complaint statistics data>
agement.
5.9 Management of incidents, product withdrawal and product recall
5.9.1 A documented procedure shall be defined for management of • What kind of crisis management is implemented? Depending on contracts, pri-
incidents and of potential emergency situations that impact • Who belongs to incident management staff? <phone list> vate labels’producers don’t
product safety, legality and quality. This procedure shall be • Who is informed when an incident occurs? have to address requirements
implemented and maintained. This includes as a minimum: • How are incidents managed? about information to consum-
the nomination and training of a crisis team, an alert contact <crisis management procedures> ers. It’s not expected that the
list, sources of legal advice (if necessary), contacts availability, • What is an incident? <incident management procedures> company (in case of private
customer information, and a communication plan, including label products) informs to
information to consumers. customers, but they should
address in their procedure how
the customers are finally
informed.
If the health and safety of the
consumer is seriously compro-
mised an immediate informa-
tion to the consumer shall be
guaranteed.

5.9.2 Updated emergency contact details (such as names and • Is a list of important telephone numbers available?
phone numbers of suppliers, customers and competent <phone list>, <emergency plan>
authorities) shall be available. A person of the company, • How often this list is checked / updated?
who has the authority to initiate the incident management • Who is informed when a crisis occurs? <alarm plan>,
process, shall be permanently available. <phone list>
• When are media involved?
<incident management procedures>
5.9.3 The company shall assign the responsibility (ies) for the exter- • Who is responsible for communication with customers, Within an organigram the
nal communication (crisis management, authorities and press / media and authorities? responsibilities can be easily
communication with media) to specific personnel. • Is a list of important telephone numbers available? shown. The communication in
<phone list>, <emergency plan> small businesses could also be
done by one person.
5.9.4 KO N° 5: There shall be an effective procedure for the • How much is distribution involved with crisis manage-
withdrawal and recall of all products, which ensures that ment?
involved customers are informed, as soon as possible. • When and who informs customer?
This procedure shall include a clear assignment of <alarm plan>, <phone list>
responsibilities. A withdrawal / recall management procedure is not enough to
define an incident management procedure.
5.9.5 The feasibility, effectiveness and timeliness of implementation • How is effectiveness of withdrawal tested? Results of the test shall be
of the withdrawal procedure shall be subject to regular inter- • How often is effectiveness of withdrawal tested? retained and shall include
nal testing, based on hazard analysis and assessment of <withdrawal test results> timings of key activities. The
associated risk, but carried out at least once a year. This shall • Is the whole recall- / withdrawal team participating at the results of the test and of any
be carried out in a manner to ensure the effective implemen- test? <test protocol>, actual recall shall be used to
tation and operation of the procedure. <if applicable: Is the security company part of the test>, review the procedure and
<if applicable: are external partners such as logistic implement improvements as
companies, warehouse partners tested> necessary. The corrective
• How long does a test need? actions after a recall / a with-
• Is the test performed in accordance to the standard opera- drawal will be tracked and
tion procedure for recall / withdrawal. processed.

5.10 Management of non-conformities and non-conforming products
5.10.1 A procedure shall exist for the management of all non- • What procedures exist for non-conforming products man- Concerning the procedure of
conforming raw materials including packaging materials, agement? non-conforming products
semi-finished and finished products and processing • How are non-conforming products identified? (quarantine zone), it should be
equipment. This procedure shall include always the following • What rules exist for product quarantine procedures? explained that this not only
criteria, but may include other requirements: • Where are stored the non-conforming products? applies to finished products but
• isolation / quarantine procedures, <quarantine tickets>, <template corrective of registration also to raw materials and
• risk assessment, form>, <procedure> semi-finished products).
• identification (e.g. labeling),
• decision about the further use (e.g. release, destruction,
rework / post-treatment, blocking, customer information,
rejection / disposal).
5.10.2 The responsibilities for the management of non-conforming • Who is responsible for putting non-conforming products
products shall be clearly identified. The procedure for the into quarantine?
management of non-conforming products shall be under- • Who may release quarantined products?
stood by all relevant employees. • How is it ensured that only authorized persons release
quarantined products?
<quarantine tickets>, <procedure>
5.10.3 Where non-conformities are present, immediate corrections • What procedures are implemented with non-conforming
shall be taken to ensure that product requirements are com- products?
plied with. • Who decides about non-conforming products?
<quarantine tickets>, <procedure>
5.10.4 Out of specification finished goods or finished goods that do For example, evidences can be provided to show that prod-
not meet other legal and / or customer requirements are not ucts have not been placed on the market (e.g.contracts with
allowed to be placed on the market. In case of private labels, external waste destroying service providers). Exceptions can
exceptions shall be agreed in writing with the contract part- be checked with examples (situations which already occured),
ners. by checking the content of the contract.
Check if these products (out of specification, etc.) are clearly
marked and separated.

5.11 Corrective actions
5.11.1 A procedure shall be in place for the recording and analysis of • What are corrective actions procedures?
the non-conformities with the objective to avoid recurrences <corrective actions procedures>
by the provision of preventive actions and / or corrective
actions.
5.11.2 KO N° 6: Corrective actions shall be clearly formulated, • Which corrective actions were implemented? Corrective actions shall be
documented and undertaken, as soon as possible to avoid <model corrective action procedures> clearly formulated, docu-
further occurrence of non-conformity. The responsibilities • Where are corrective actions documented? mented and undertaken, as
and the timescales for corrective actions shall be clearly <model corrective action procedures> soon as possible to avoid fur-
defined. The documentation shall be securely stored and • Who is responsible for corrective actions? ther occurrence of non-confor-
easily accessible. <model corrective action procedures> mity. The documentation shall
• How long may it take to implement corrective actions? be securely stored, and easily
<model corrective action procedures> accessible. The company shall
The documentation shall be adapted to the company that have a documented procedure
means it can also be documentation in hand writing. for handling non-conformances
But it has to be unambiguous. identified within the scope of
this Standard. This shall contain
at least:
• clear documentation of the
non-conformity
• assessment of consequences
by a suitably competent and
authorised person
• identification of the correc-
tive action to address the
immediate issue
• identification of an appropri-
ate timescale for correction
• identification of personnel
with appropriate authority
responsible for corrective
action

• verification that the correc-
tive action has been imple-
mented and is effective
• identification of the root
cause of the non-conformity
and implementation of any
necessary corrective action
to be checked specifically for:
• complaints by retailer
• corrective actions.
5.11.3 The effectiveness of the implemented corrective actions shall • Where are corrective actions documented?
be documented and shall be validated. <model corrective action procedures>
• How are corrective actions verified?
<model with verified corrective action procedures>
• The documentation and effectiveness shall be checked
within the internal audits
6 Product Defense (optional) See Product Defense guideline
6.1 Senior Management Responsibility
6.1.1 The company shall have a documented product defense
procedure in place to address product defense risk from
products and establish, implement and maintain a system to
reduce or eliminate the identified risk.
6.1.2 A product defense assessment shall be conducted annually or
upon changes that affect product integrity.
6.1.3 Responsibilities for product defense shall be clearly defined.
Those responsible shall be key staff or shall have access to the
senior management team.
6.1.4 Senior management shall have an internal communication
system to inform and update staff about relevant security
issues.

6.2 Site security
6.2.1 Based on the product defense procedure and legal require-
ments, the senior management should define and communi-
cate the areas in which authorized personnel are allowed to
access.
6.3 Visitor and Personnel Security
6.3.1 Visitor policy shall contain requirements relating to product
defense.
6.3.2 Employee hiring and employment termination practices shall
consider security aspects as permitted by law.
6.3.3 The company shall incorporate product security awareness,
including information on how to prevent, detect and respond
to tampering or other malicious, criminal, or terrorist actions
or threats, into training programs for staff, including tempo-
rary, contract, and volunteer staff.
The training shall regularly take place and shall be docu-
mented.
6.4 Documentation requested by legislation
6.4.1 If legislation makes registration or on-site inspections neces-
sary, these shall be carried out and evidence shall be pro-
vided.
6.4.2 A documented procedure shall be in place for managing
external inspections and regulatory visits (if applicable).
Relevant personnel shall be trained to execute the procedure.

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IFS HPC Version 2

Version 1, December 2016

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The system should be reviewed minimum annually by the

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b) Concerning the subcontractor itself :

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Limits of acceptable and unacceptable cleaning and disinfec-

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