HACCP Audit

SGS/Cargill Animal
Nutrition Feed
Audit Verification Checklist
SGS/Cargill Animal Nutrition Global Feed Program

Good Manufacturing Practices (GMP),
Hazard Analysis Critical Control Point (HACCP) &
Cargill Feed Quality System Verification Audit Checklist
Version: 2.1 (Maintenance)

Issue Version
Version Date: September 20, 2008
Author: Victor Muliyil - Technical Specialist, North America

SGS HACCP/ISO 22000/Food Safety Services
CARGILL VIETNAM LTD.

Lot 29, Bien Hoa Industrial Zone 2,
Dong Nai, Vietnam
ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Page 1 of 57
AUTHOR: VICTOR MULIYIL
SGS/Cargill Animal
Nutrition Feed
ed Program
GMP),
HACCP) &
udit Checklist
ecialist, North America

d Safety Services

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SGS/Cargill Animal
Nutrition Feed
AUDIT REPORT SUMMARY
SGS CARGILL ANIMAL NUTRITION GLOBAL FEED SAFETY PROGRAM
PARTIAL SYSTEM MAINTENANCE AUDIT
A partial system
CARGILL maintenance
VIETNAM LTD. audit was performed at the processing facility of
Lot 29, Bien Hoa Industrial Zone 2, Dong Nai, Vietnam
hereafter referred to as "the facility"
to evaluate compliance of the facility to the SGS/Cargill Animal Nutrition Global Feed Program Standard Checklist,
version 2.1, Sept. 20, 2008, hereafter referred to as the standard. This standard incorporates key elements of the
guidelines/regulations for Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Point (HACCP)
systems set out by the Codex Alimentarius Commission, the US FDA and the Canadian Food Inspection Agency.
The facility was able to earn an adequate score to achieve a PASS rating for the audit and will
continue to operate under the current certification until the next scheduled SGS audit. If "PASS" rating was not
achieved, corrective actions must be immediately implemented to achieve a "PASS" rating or certification will be
withdrawn by SGS.
Key to Abbreviations:
SOP - Standard Operating Procedure CL - Critical Limit

WI - Work Instruction CA - Corrective Action
HA - Hazard Analysis CAR - Corrective Action Report
CCP - Critical Control Point HC - HACCP Co-ordinator
NC - Not checked (applicable to maintenance audits where minor criteria are split between 2 audits)
Company & Site Audited: Ref#

CARGILL VIETNAM LTD.
Lot 29, Bien Hoa Industrial Zone 2, Dong Nai, Vietnam CVFD 09/0841
Products/pack type produced: Aquaculture feed (Extruded and 100% bag), Poultry feed (Mash, crumble, pellet), Swine feed
forms: (Mash, pellet, complete feed, concentrate)
(NOTE: Edit as required)
Medication Used: YES Prohibited Material Used: NO
Lead Auditor Name: Dam Thi Xuan Trang Review Auditor Name: Supreeya Sansawat
Lead Auditor Signature: trangdam Review Auditor Signature:
Date(s) of Audit: 7-Dec-10 Date of Review: Jan 5'2010
Audit Start Date/Time: 07 Dec10 / 8:00 Audit End Date/Time: 07 Dec 10/ 18:00
Report Issue Date: 29-Dec-10 Date of Previous SGS Audit: 17-18 Dec 2009
Audit Score Summary & Pass/Fail Determination:
Module 1 Score: 1000 /1000

Module 2 Score: 1000 /1000

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SGS/Cargill Animal
Nutrition Feed
Module 3 Score:
980 /1000
Pass Requirements:
1. Overall score of 750/1000 or higher
2. Must achieve a score of at least 500/1000 on each module
Weighting of Modules:
Follow Up Audit Module 1 x 40% + Module 2 x 20% + Module 3 x 40% =
Overall Score Achieved This Maintenance Audit: 992 /1000
Audit Outcome: (outline) PASS or

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SGS/Cargill Animal
Nutrition Feed
Standard Checklist,
s key elements of the
Control Point (HACCP)
Inspection Agency.
S" rating was not

certification will be
rrective Action
rrective Action Report
ACCP Co-ordinator
ween 2 audits)
VFD 09/0841
mble, pellet), Swine feed
preeya Sansawat
Dec 10/ 18:00
-18 Dec 2009

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SGS/Cargill Animal
Nutrition Feed
Overall Score

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SGS/Cargill Animal
Nutrition Feed
1.1 Building Exterior
Point
Deducted
Ref. No. Criterion Value Comments
Score
Area surrounding facility is in a
The external areas are maintained in
condition that does not contaminate
1.1.1 10 good condition and clean, no pest
process & does not pose pest
harbourage
harborage or entry risk
Receiving pits & silos secured
Receiving areas are suitable for prevent
1.1.2 against pest or contaminated water 10
pest / contamination water entry.
entry
External premises inspection protocol
Specified in SOP_ House keeping audit:
1.1.3 in place, with frequency & 10
GMP/HKP/PL 001 date 20.5.05
responsibility listed in SOP
Inspection performed and verified
regularly (minimum quarterly) with Inspection performed every day and
1.1.4 10
prompt follow up on all identified non- verified each month.
conformances
Records of inspections and C.A.
Full records are kept on file. Last audit
1.1.5 retained a minimum of 1 year on 10
on 2.12.2010
hardcopy or electronically
0

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SGS/Cargill Animal
Nutrition Feed
1.2 Building Interior - Design
Deducted
Score
Building conditions, materials &
cleanliness does not pose a No contamination risk from building
1.2.1 10
significant contamination threat to condition and materials.
process
Production & ingredient/product Feed storage and bulk raw material
1.2.2 storage areas protected adequately 10 warehouse have gaps. It was inadequate
against pests to prevent pest access.
Internal premises inspection protocol
Internal inspection procedure are
1.2.3 in place, with frequency & 10
specified in SOP: GMP / HPK/PL/001
responsibility listed in SOP
Inspection performed and verified
regularly (minimum monthly) &
Inspection performed every day, weekly
corrective action taken where and
1.2.4 10 and verified monthly. Last internal
when required (all significant non-
inspection dated 01/12/2010
conformances corrected with
documentation prior to next audit)
0

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SGS/Cargill Animal
Nutrition Feed
Building Interior - Lighting &
1.3
Air Quality
Deducted
Score
Lighting is adequate to read
1.3.1 formulae, labels, tags & scales + 10 Lights are maintained in good condition.
permits effective cleaning
Lighting adequate to identify
visual/pest contamination hazards in
1.3.2 10 Adequate light for production areas.
receiving, shipping, storage &
production areas
0
1.4 Building Interior - Air Quality
Deducted
Score
Ventilation adequate to prevent
1.4.1 contaminated air or condensate 10 Adequate ventilation at production areas
contacting product
Dust collector materials segregated &
Dust collected, no risk of cross
1.4.2 handled adequately to prevent cross 10
contamination.
contamination
0

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SGS/Cargill Animal
Nutrition Feed
1.5 Building Interior - Waste
Deducted
Score
Defined in Waste disposal
SOP/WD/PL/001. Hazardous waste eg.
fluorescent lamp, empty chemical
Adequate waste storage capacity &
container are stored in the secured
1.5.1 frequency of removal to avoid 10
storage and removed every 6 months by
contamination risk
licensed service. Domestic waste are
collected and disposed twice per week
by local service.
Waste containers & tanks leak free Waste bins, waste storage are no leakage
1.5.2 10
and isolated from main flow areas and isolated from main flow areas
Waste bins are clearly identified for each

1.5.3 Waste containers clearly identified 10
kind of waste
0
Building Interior - Sanitary

1.6
Facilities
Deducted
Score
Adequate hand washing facilities
1.6.1 10 Handwashing facilities are available
available for staff
Adequate hand cleansing soap and Liquid soap and driers are available at
1.6.2 10
drying equipment present the hand washing station
0

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SGS/Cargill Animal
Nutrition Feed
1.7
Building Interior - Premises
& Equipment Cleaning
Deducted
Score
Cleaning chemicals stored
Only use chemical for fumigating silos.
adequately to prevent product
Contact with fumigation service if
1.7.1 contamination, clearly labeled with 10
cleaning is required . Not store cleaning
identity, even if stored in temporary
chemical in the factory.
containers
Cleaning program for for each equipment

Adequately detailed procedures in including frequency, responsibility,
place for each cleaning task on methodsare specified in
1.7.2 premises/equipment, including 10 SOP/SC/PL/001 - SOP/SC/PL/008.
frequency, responsibility & Sanitation program for premises are
documentation requirements defined in GMP/HS/PL/001. Rev
03/11/2010
Cleaning chemicals for feed contact Aluminium Phosphide for fumigation

surfaces are approved for feed use & silos comply with Dicision 23/2007/QD-
1.7.3 10
used according to BNN date 28.3/07 for feed use. Contract
package/procedure instructions with licesed service for fumigation.
Inspection & cleaning for each

Equipment, including bins and silos
equipment including bins and silos are
are inspected at least annually or
1.7.4 10 defined in SOP/SC/PL/001-
whenever emptied and are cleaned if
SOP/SC/PL/008. Last cleaning date
cleaning is required
28/10/2010.
Cleaning tasks scheduled on all

equipment as part of housekeeping Cleaning records for all equipment as
1.7.5 10
or preventative maintenance defined in the schedule kept in file
program - followed and documented
Floors, pits, walls, & equipment

1.7.6 10 Plant is kept in good hygiene condition
adequately clean
No excessive build up of debris, No excessive build up of debris, residue
1.7.7 residue or webbing in receiving, 10 or webbing in receiving, process or
process or storage areas storage areas
0
Building Interior - Water &

1.8
Steam

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SGS/Cargill Animal
Nutrition Feed
Deducted
Score
Water quality meet standard for drinking
Water in direct contact with product is
water following QCVN 01:2009 BYT of
from municipal drinking water supply
1.8.1 10 Minishtry of Health. Test result KT3-
OR is verified or tested annually to
08172/MT10 date 15/9/2010 issued by
meet domestic potability standards
QUATEST3
Steam & boiler checks performed Boiler water treatment SOP/PRO/PL/008

1.8.2 regularly to minimize product 10 . Test result verifed, showing no risk of
contamination risk product contamination

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SGS/Cargill Animal
Nutrition Feed
Purchasing, Receiving,
1.9
Storage & Transportation
Deducted
Score
All items purchased are from

approved suppliers. Supplier
specifications must include relevant
hazard control specifications or Suppliers are selected and approved
conditions. If corporate entity does following Ingredient supplier selection
the purchasing, the facility is aware procedure SOP/PUR/TD/002.
1.9.1 of the procedure used at corporate 10 "Ingredient supplier Category"
level to verify supplier hazard control. Specifications are available, including
Controls must include prohibited safety parameters eg. Samonella,
material & medications. Ideally, mycotoxin, pesticide, heavy metal.
hazards may also include mycotoxin
levels, heavy metals & Salmonella
(the latter for monitoring purposes).
Facility has documented complaint

procedures in place, which include Defined in the Complaint hadling
1.9.2 10
method to identify status of the procedure GMP/COM/CS/001.
complaint. (Open/pending or closed)
Complaints - Those complaints

dealing with incidents related to drug
safety/efficacy shall be kept in a Customer complaints year 2010 kept on
1.9.3 10
separate file. (NOTE: Quality issues file.
related to medicated feed do NOT
need a separate file)
All complaints shall include date of Complaints in last 6 months verified. All
complaint, name and address of in formation eg. date of complaint, name
customer, name and lot number/ID of and address of customer, name and lot
feed involved (where available), number/ID of feed involved, details of
1.9.4 10
details of complaint, investigation complaint, investigation results,
results, disposition of complaint, date disposition of complaint, date and
and endorsement of responsible endorsement of responsible person are
person. defined in the records
Procedure Ingredient Analysis

Facility follows a written ingredient
SOP/QA/TD/003. Facility follows
1.9.5 assay schedule/program or requires 10
requires daily entry of samples in
daily entry of samples in StarLIMS.
StarLIMS.

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Nutrition Feed
If the facility handles prohibited
material, written approval from the
President of CAN is required to be
on file. In addition, procedures
must require flushing of common
1.9.6 100 NA Not use prohibited materials
equipment immediately following
prohibited material with an amount
of material equal to the verified
drug flush or a minimum of 300 lbs
(150kgs), whichever is greater
Receiving SOP lists certificates

Certificates are required to inspect prior
receiver must inspect prior to
1.9.7 10 receiving as defined in Ingredient
accepting raw materials if certificates
receiving procedure SOP/REC/PL/01.
are required for each shipment
Procedure states that: a) returned,

rework or rerun material must be
identified with respect to prohibited
material and/or medication content
Specified in Return Feed acceptance
prior to being received; b) facility will
SOP/FRN/CS/001 & Rework
not receive unidentified material; c)
1.9.8 10 SOP/FRN/TD/002. Rerun records
once received, such material must be
verified, following procedure
isolated & labeled to prevent cross
SOP/FRN/CS/001
contamination of raw materials or
finished products; d) all re-mixing
must be done in accordance with
schedule in PIM
Defined in Ingredient shelf-life

monitoring procedure SOP/ QA/PL/011
Stock rotation protocol present and
& Finished feed shelf-life monitoring
monitored. (FIFO/FEFO). No expired
1.9.9 10 procedure SOP/QA/PL/012. Shelf-life of
drugs in inventory except those
drugs printed monthly to check expiry
clearly identified for disposal
date. No expired drugs found in
inventory.
Medicated raw material adequately

Defined in Ingredient storage
segregated in separate storage area
SOP/IST/PL/001 and observed at the
1.9.10 with containers closed or bag tops 10
onsite inspection and from the
folded down to prevent cross
interviewed employees.
contamination
Medicated flush material adequately
labeled with medication flushed & Sequencing and Flushing procedure
1.9.11 10
segregated from regular product or SOP/QA/PL/013 are strictly followed.
raw materials

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SGS/Cargill Animal
Nutrition Feed
Following Procedure: Finished Feed
Finished product stored to prevent storage SOP/FFS/PL/001. Finished
1.9.12 10
hazard creation products are stored in good condition,
stored off the floors, walls and ceillings
Finished product & raw material

storage/stacking maintains adequate
perimeter to prevent pest harborage. Ingredient and finished product are
1.9.13 NOTE: If cleaning can be 10 placed an adequate distance from walls,
demonstrated without perimeter floors, ceilings to prevent pest harborage.
present (e.g. removal of skids for
cleaning), this is adequate
Work and storage areas for feed

materials and products are physically No fertilizers, herbicides, toxic chemicals
1.9.14 10
separated from fertilizers, herbicides present in the facility
and other potential contaminants.
Loading procedures must require

Defined in Finished feed truck cleaning
1.9.15 inspection for clean, empty 10
procedure SOP/ FFL/ PL/ 001
compartments prior to loading
Free prohibited material, medication

residue or other contamination risk,
Trucking contractors for inbound cleaning frequency are defined in the
and outbound trucks are reviewed contract with ingredient suppliers/
to have procedures in place or to vehicle contractors. In addition,
1.9.16 certify that trucks are free from 100 outbound trucks/ inbound trucks are
prohibited material, medication inspected before loading/ unloading.
residue or other contamination Procedures: Inbound ingredient
risk transportation SOP/PUR/TD/002-F1 &
Finished feed truck cleaning procedure
SOP/ FFL/ PL/ 001
Facility owned portable augers, Defined in the Inbound ingredient

loaders or bulk trucks are cleaned transportation SOP/PUR/TD/004.
1.9.17 10
using adequate procedures to Specified in the contract with ingredient
minimize cross-contamination supplier/ commitment
Facility staff loads / unloads /
Defined in the Hygiene & sanitation
1.9.18 sequences carriers in manner to 10
GMP/HS/PL/001
prevent feed contamination
The facility's Toll Manufacturers are
identified and meet CAN
1.9.19 10 NA No Toll Manufacturers.
requirements for Approving Toll
Manufacturers.
0

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SGS/Cargill Animal
Nutrition Feed
Equipment Design,
1.10
Maintenance & Calibration
Deducted
Score
Design / installation permits proper Equipment arrangement is adequate

1.10.1 10
operation, cleaning & maintenance for operating, cleaning, maintenance
No evidence of equipment No maintenance deficiencies and

1.10.2 maintenance deficiencies that could 10 temporary repairs observed at the
generate feed contamination hazards audit time.
Each liquid and pneumatic
unloading system and tank is
adequately identified and locked to Each liquid and pneumatic unloading
1.10.3 prevent unauthorized receipt, 10 system and tank are identified and
unloading errors, and contamination. locked with cap covered.
Fat and soap stock systems are free

of copper and brass piping, fittings,
etc. (these materials are catalysts in Tank, piping, fittings of Tra fish Fat
1.10.4 the rancidity process). Check internal 10 stock system are made by stainless-
audit or maintenance records for steel
evidence
Maintenance frequencies specified Maintenance program is established

1.10.5 are followed as prescribed in 10 monthly and implemented. Lubricant
procedures oil used is food grade (H1 grade)
External calibration (or internal

calibration to traceable reference Defined in the Scale calibration
standard) of all critical equipment schedule SOP/ CME/ PL001. Mixer
(including mixer & medication Scale and medication scale are
scales) is performed at least once
1.10.6
within each 12 month period using
100 calibrated at least once per year by
written, valid calibration methods Quatest of Dong Nai Province. Scale
or qualified contractor. calibration certificate No B. 1293 .10
Recalibration must be performed dated 12/11/2010
after scale repair
Maintenance records include

equipment ID, date and person ID & Maintenance records include
1.10.7 signature/initials (on line records are 10 equipment ID, date and signature of
permitted provided they are operator and supervisor.
password protected)

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Nutrition Feed
Calibration record on medication Medication scales for hand-adds are
scales for hand-adds or calibrated every day. Calibration file
medication micro bins is current
1.10.8
(within last 12 months) & shows
1000 for last 12 months are checked &
equipment is operating within shows equipment is operating within
acceptable limits acceptable limits.
Calibration record complete has

1.10.9 equipment / person ID & signature 100 Calibration record are available
& date & results
Medication scales can effectively

weigh target amounts. Scale check
1.10.10
tolerance is a maximum of +/- 2
100 Tolerance is max. of +/-2 graduation
graduations
Mixer validations are scheduled at Defined in the Mixer efficiency test

least annually or after ribbon procedure SOP/QA/PL/008. Mixer
replacement on each mixer & CV efficiency are tested every 6 months.
1.10.11 100
limit must be < or = 10%. If local Test result dated 22/9/2010 CV=
regulatory requirements mandate 7.066 % for Feed code
lower CV limits, these must be met 7595NB/54646.
Tolerances have been established in

the batch controller for weighing bulk Defined in the Tolerances of batch
1.10.12 ingredients; tolerances are checked 10 controller is checked twice per year.
and documented at least twice per Last check dated 10/9/2010
year.
Alarm logs are maintained with Alarm logs are defined in batching
1.10.13 batching records and actions taken 10 report. Ex: Batch No 5 dated
on alarms are documented 30/10/2010.
Liquid meters are checked every six Liquid meters (oil, water, fat,
months, corrected if necessary, and
1.10.14
documented in files? (Quarterly on
10 soybean oil) are checked every 6
lysine & methionine liquid meters.) months. Records are kept on file.
Defective equipment is ID'd or Defined in maintenance program. No

1.10.15 tagged adequately to prevent 10 defective equipment observed at the
accidental use audit time.
No defective equipment with
critical impact on feed safety is
1.10.16 permitted to be used until verified 100 Defined in SOP
to be operating within acceptable
limits
0

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SGS/Cargill Animal
Nutrition Feed
1.11 Training & Procedures
Deducted
Score
Procedures are in place covering

key prerequisite programs that Training program drefined in
impact on control of feed safety GMP/TRG/PL/001. Training plan
1.11.1 (including training, calibration, 1000 established covering HACCP, CCP
medication handling/weighing, monotoring, calibration, drug
drug reconciliation & truck ceconciliation
inspections)
Location has conducted a food safety

awareness training session, including
1.11.2 the CAN HACCP video, within the 10 Last training CAN HACCP on 06.12.10
last 12 months. List Last Training
Date _________________
Requirements for each critical

GMP task are set out in adequately
SOP verified covering objective,
detailed SOPs which include at
1.11.3 100 procedure, responsibility, related records,
minimum the purpose (objective),
verification and corrective action
procedure, responsibility for task
& related records
SOPs also include responsibility &

SOP verified covering objective,
frequency for routine & system
1.11.4 10 procedure, responsibility, related records,
verification of task + first steps of
verification and corrective action
corrective action
SOP is in place stating that no
product requiring veterinarian
prescription is produced without No product requiring veterinarian
1.11.5 100
the prescription on file. (Only if prescription.
veterinarian prescriptions are
used)
Procedures in place to ensure

formulas are developed, modified,
issued and implemented into Defined in Formulation issue &
production by adequately withdrawal SOP/FOR/TD/001. Formulas
1.11.6 trained/qualified personnel. All 100 are developed, modified, issued and
formulas must be approved as per implemented into production by Tradico
PIM (2 initials). Plant has name & Bien Hoa (Head Office)
initial list of approved formula
reviewers

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Nutrition Feed
Procedures in place to ensure
labels/tags are developed,
modified and issued by adequately
trained, qualified personnel to
All tags/ labels issued by Tradico Bien
minimize risk of mislabeled
hoa (head office) and reviewed, approved
1.11.7 product. All tags used on product 100
to comply with VN regulation before
conform to local requirements. All
printing.
labels/tags must be approved as
per PIM (initial/dated). Plant has
name & initial list of approved
label reviewers
All custom mix feeds must be labeled

properly: customer name and
address, date of shipment,
1.11.8 appropriate label information and 10 No produce custom mix feed
assigned number. NOTE: This
information can also be listed on
shipping documents or/and TLOs
Staff trained in critical SOPs with

Evaluation staff in critical SOP
regular evaluation (annually at
1.11.9 100 conducted at least once per year by
minimum for the critical SOP's
HACCP training checklist for new staff.
with direct impact on feed safety)
Training & evaluation records are

Training & evaluation records are kept
1.11.10 in place, current & verified by 100
on file & verified 6/12/2010.
qualified personnel
Visitor access is controlled
Defined in Personal hygiene procedure
1.11.11 adequately to prevent 100
GMP/HS/PL/001
contamination
0

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SGS/Cargill Animal
Nutrition Feed
1.12 Flushing/ Sequencing
Deducted
Score
Adequately detailed SOPs for Flushing & sequencing defined in
1.12.1 10
flushing & sequencing are available SOP/QA/PL/013
Where available, (auditor must ask

facility management if available),
automated sequencing and flushing
protection software is active and set
up accurately in plants which have
automated computer controls. Automated sequencing and flushing
1.12.2 Procedures for using this software 10 software is available. SOP for flusing and
are written into the SOPs for Sequencing: SOP/QA/PL/013
Flushing and Sequencing within such
plants OR competence is
demonstrated adequately to the
auditor in the absence of a written
SOP for software use.
Sequencing & flushing protocol

adequate to prevent product
cross-contamination. The quantity Flush material used is 150kg. Test
of flush material used must be result on 26.11.10 for Tylosin
validated through residue testing Phosphate, Flofenicol and 25/11/2010
1.12.3 100 for Chlotetracycline by Pacific Lab
to demonstrate that the amount is
effective. NOTE: Sequencing must service (Singapore) show that residue
be followed through all equipment of drug was not detected.
in the process where cross
contamination could occur

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Nutrition Feed
1.13 Pest Control Program
Deducted
Score
Pest control program GMP/ PCL/ Pl/

Written pest control program present,
001. Contract with Pest Master for Pest
1.13.1 with operator & applicator licenses 10
service. (Ltd Company Xuan Thu, Go
current & on file
Vap Dist. HCM City, Oct 2010.)
Chemcial use are detailed on the contract

All chemical use detailed, with safe
and pest control logs. List of chemical
concentrations & validated methods
used verified comply with List of
to minimize product contamination
1.13.2 10 Agriculture Dept. Eg. bait station of
risk. NOTE: A technician log of
Biorat applied for rodent control which
chemical use on visit dates is to be
placed outside the premises. Permethrine
considered adequate
used for fly insect control.
All pest control devices appear to be

functioning adequately to control pest
hazards. Poison bait stations are
adequately mapped OR tagged at
Rodent control by bait stations screening.
locations & anchored to prevent
1.13.3 10 Bait station are identified, fixed. Insect
product contamination in areas
control by spraying
where they are in close proximity to
open product, ports or pits
ContractwithPestMasterforpest
control.Rodentinspectionconducted
Records of inspection, sighting logs weeklyandinsectcontrolbyspraying
& defective findings are complete
1.13.4 10 conductedmonthly.Birdscontrolledby
and signed by contractor & internal
staff member scaringdevices.RecordsofPestcontrol
verifiedincludesignatureofcontractor
andstaffmember
Corrective actions are written (on file)
1.13.5 by internal staff and signed off when 10 Correctiveactionrecordsarekeptonfile
complete
0

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SGS/Cargill Animal
Nutrition Feed
1.14 Recall Program
Deducted
Score
Recall product procedure GMP/ PRC/
1.14.1 Written recall procedure is on file 100
CS/ 001
Recall team & responsibilities for recall
Team responsible for recall is listed
defined in recall procedure GMP/ PRC/
1.14.2 with current contact information. 10
CS/ 001. List of contact information
(Local/District/Regional/Corporate)
covered in the procedure
Methods of product ID, contacting

regulatory agencies and information
broadcast detailed OR the corporate
1.14.3 10 Clearly defined in Recall procedure
regulatory affairs contact at CAN is
notified and further actions deferred
to this department
Competent mock recall performed

& documented at least annually to
assess effectiveness with
adequate follow up. Recall
procedure must be adequate to Mock recall performed and documented
1.14.4 determine quantities of target 100 at least once per year. Last mock recall
FINISHED product still at the performed on 4.12.10
facility plus quantities shipped to
each customer within 2 hours of
initiation (list date of last mock recall
in comments section)
Frequency of mock recall listed in

SOP - at least once per 12 month
period for at least 1 bagged product
Mock recall performed and documented
& 1 bulk product. (Mock recall should
1.14.5 10 at least once per year. Last mock recall
also include a recall based on a
performed on 4/12/2010
defective lot of a raw material or
ingredient - comment but do not
deduct score if this is not done)
Lot numbers/tag stamps are legible &

Lot number of ingredient defined on tags
distribution records show adequate
1.14.6 10 and documented on production records to
product tracking to make recalls
ensure traceability
effective
All food safety recalls/retrievals are
1.14.7 submitted to CAN QA Mgr (Sue 10 Defined in Recall procedure
Carlson)
0

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Nutrition Feed
1.15 Records
Deducted
Score
1.15.1 Records are legible 10 Records are legible
Written record review procedures
Records review procedure is available
1.15.2 available (separate or contained in 10
SOP/DOC/AD/001
SOP's)
Prompt review required for critical Drug inventories are taken and compared
records of prerequisite programs. to book inventory by 9:00 a.m. the next
1.15.3 100
(Scale calibration, residue testing, working day. Drug trax for year 2010
mock recall, mixer validations) verified
Drug inventories are taken and

compared to book inventory by
9:00 a.m. the next working day. All
discrepancies identified by the
Drug Trax program are
investigated with the results of the
investigation documented and
signed by plant manager or
Drug Trax performed daily. Form QA 82
adequately trained designate.
1.15.4 100 & QA 83 are to be used. Drug Trax last 6
Forms QC82 and QC83 are to be
months verified during audit
used.
REQUIREMENTS:
Maximum 0.1kg on <=20
kg weights / 0.5% on >20 kg
weights OR
"Max 0.2 lb difference
on <= 40 lb. drug usage / 0.5%
difference on >40 lb. drug usage"
Vitamin and selenium premixes are

taken and compared to book value
by 10:00 a.m. daily. All discrepancies Vitamin inventories performed by 10:00
1.15.5 10
greater than 0.5% are investigated daily
and initialed by plant manager or
adequately trained designate
Drug Trax expiration date report for Expiration date report for all drugs &
1.15.6 all drugs is printed monthly and 10 other ingredients is printed monthly and
reviewed to ensure all are current reviewed
Bulk medication in line scale
checked every working day at
1.15.7 100 NA Bulk medication is not application
minimum, with records reviewed
within 1 week

Page 23 of 57
SGS/Cargill Animal
Nutrition Feed
Fill/Empty reconciliationAudit Verification Checklist
completed on each bulk
1.15.8 medication micro bin according to 100 NA Bulk medication is not application
procedure/frequency approved by
DGM
0

Page 24 of 57
SGS/Cargill Animal
Nutrition Feed
HACCP Prerequisite
Programs
Deducted
Ref. No. Criterion Comments
Score
1.1 Building exterior 0
1.2 Building interior - design 0
1.3 Building interior - lighting 0
1.4 Building interior - air quality 0
1.5 Building Interior - waste 0
1.6 Building Interior - Sanitary facilities 0
Building Interior - Premises &
1.7 0
Equipment Cleaning
1.8 Water & steam 0
1.9 Storage & Transportation 0
Equipment design maintenance &
1.10 0
calibration
1.11 Personnel training & hygiene 0
Equipment
1.12 0
Cleaning/Flushing/Sequencing
1.13 Pest control 0
1.14 Recall program 0
1.15 Prerequisite program records 0
Total deducted - Module 0
1

Page 25 of 57
SGS/Cargill Animal
Nutrition Feed
HACCP Team & Preliminary
2.1
Steps
Deducted
Score
HACCP team in place with multiple HACCPteamwithmultipledepartments,
2.1.1 departments represented- names & 10
ex:production,Lab.,trade,
titles documented.
There is a written commitment from Commitmentonproducefeedsafety

senior management to adhere to fromCargillGeneralDirector.Decision
2.1.2 HACCP principles. (Note: Can be 10
ofestablishingHACCPteamsignedby
facility's manager or higher company
official PlantManager
HACCP Coordinator can

2.1.3 100 HACCPteamtrainedHACCPbySGS
effectively perform required tasks
Product described adequately for all Productdescriptionsaredocumentedin

2.1.4 10
intended uses HACCPplan
All ingredients itemized with all
2.1.5 sources listed (hard copy or on line 10 Allingredientsarelisted
listing)
Product and process flows
2.1.6 adequately described with 100 ClearlydefinedinHACCPplan
schematics or illustrations
0

Page 26 of 57
SGS/Cargill Animal
Nutrition Feed
2.2 Hazard Analysis
Deducted
Score
Listing of significant process steps is
2.2.1 10 Defind in HACCP hazard analysis sheet.
adequate in hazard analysis
Raw material hazards eg. Salmonella,
E.coli in fishmeal, Mycotoxin in grain,
Raw material hazards considered heavy metal in crude fish oil, antibiotic
2.2.2 10
adequately in Tra fish fat, pesticide in broken rice
and rice branare clealy defined in the
hazard analysis -raw
Critical biological hazards Critical biological hazards considered as
2.2.3 1000
considered adequately Salmonella, E. coli, in fish meal
Minor biological hazards considered Minor biological hazards as Yeast &
2.2.4 10
adequately mould, pathogen
Critical Chemical hazards as drug over
Critical chemical hazards
2.2.5 1000 dosage, drug cross contamination, Beta-
considered adequately
Agonist in Chinese micro
Minor chemical / biochemical Minor chemical hazards eg. Mycotoxin,

2.2.6 10
hazards considered adequately heavy metal, BSE, antibiotic
Physical hazards considered

2.2.7 adequately if applicable for market 10 Physical hazards eg. foreign matter
country
Process chemical, cross Cross contamination hazard is

2.2.8 contamination or equipment 10 considered in hazard analysis step of
generated hazards considered HACCP plans
Adequate methods of reduction /

2.2.9 prevention / elimination are listed 1000 Specified on Hazard analysis
for each critical hazard sheet
Methods of reduction / prevention /
Specified on Hazard analysis
2.2.10 elimination are listed for each minor 10
sheet
hazard

Page 27 of 57
SGS/Cargill Animal
Nutrition Feed
Review & written approval is in place
for each revision of process flow
diagrams, hazard analysis forms,
CCP determination and HACCP plan
forms (all components) by HACCP
Coordinator or designated, HACCP plans are reviewed and signed
2.2.11 10
adequately trained alternate other by HACCP team leader
than author (author should also sign
the plan forms). NOTE: Signatures
on current revision logs are
acceptable in place of signing off
each SOP or HACCP document

Page 28 of 57
SGS/Cargill Animal
Nutrition Feed
Establishment of Critical
2.3
Control Points
Deducted
Score
Each point selected as a CCP
2.3.1 justified by a competent decision 100 CCPs selected by decision tree
process
No CCP's missed without
2.3.2 1000 Adequate justification for all CCPs
adequate justification
All CCPs listed on hazard analysis
2.3.3 10 There are 4 CCPs
worksheet
Critical limits & proactive

2.3.4 100 Critical limits are available
monitoring possible for all CCPs
Validation of all CCPs has been

2.3.5 performed through testing or 10 Validation records are maintainted
research
0

Page 29 of 57
SGS/Cargill Animal
Nutrition Feed
2.4
Establishment of Critical
Limits and Operating Limits
Deducted
Score
CL listed for each control measure
2.4.1 1000 Critical limits available
at a CCP
Reliable sources or qualified CLs are established by qualified
2.4.2 10
personnel used to establish CLs personnel.
CL's are accurately described and
specific to task being performed in
2.4.3 real operation time (not verification 10 CLs are performed in real operation time
analytical results or theoretical
outcomes)
Critical limits can be readily
2.4.4 100 Critical limits are measurable
measured
Medication reconciliation CL must
be < or = 5% of daily use for hand
2.4.5 100 Medication reconciliation CL <= 5%
adds; < or = 10% for fill/empty for
bulk medications
0

Page 30 of 57
SGS/Cargill Animal
Nutrition Feed
Critical Control Point
2.5
Monitoring
Deducted
Score
All parameters to be monitored listed
2.5.1 10 All parameters are listed
adequately at CCPs
Adequate monitoring procedures are

documented. Eg. CCP1: Salmonella in
Fishmeal (Commitment from supplier
and testing every lot at receiving). CCP2:
drug level (shortmixing, formula hand
All monitoring listed on HACCP plan add, drug tracking) Scale calibration,
2.5.2 10
or plan refers to adequate SOP house keeping. CCP3: Sequencing or
flushing procedure SOP/QA/PL/013;
shortmixing dumping SOP/PRO/PL/009;
mixing and batching rework
SOP/PRO/PL/004. CCP4: Test Beta
agonist in Micro Chinese at every lot
Monitoring procedure adequate to

2.5.3 control critical hazards or identify 1000 Specified in HACCP plans
deviations adequately
Equipment to be used is described
2.5.4 10 Equipment is suitable for activities
adequately & is suitable for activity
Title of person monitoring & verifying
Person assigned for monitoring &
2.5.5 is listed on plan or in accompanying 10
verified defined on HACCP plan & SOP
SOP
Monitoring method and frequency
Adequale monitoring method and
2.5.6 adjusted in response to negative 10
frequency are implemented.
findings (if any)
Monitoring SOPs eg. Microbiological
Monitoring SOP's present & test SOP/QA/TD/007. Drug tracking
2.5.7 adequately detailed (all SOP 100 SOP/QA/PL/005. Sequencing &
components included) Flushing SOP/QA/PL/013. Beta-Agonist
analysis SOP/QA/PL/016
Corrective action required to be
Corrective action procedure are available
2.5.8 taken if monitoring was 100
and defined in the HACCP plan
inadequate or if CL exceeded
Review (routine verification) required
2.5.9 to be done promptly after monitoring 10 Monitoring records are reviewed daily.
interval end
0

Page 31 of 57
SGS/Cargill Animal
Nutrition Feed
2.6 Corrective Actions
Deducted
Score
Written corrective action (CA)
procedures available (at least Corrective action procedures defined in
2.6.1 1000
general steps) for critical CL HACCP plan & SOP
deviations
Procedures are adequate &
2.6.2 100 Specified in SOP
contain all SOP criteria
If used, predetermined CA CA procedures are listed in HACCP

2.6.3 10
procedures are listed in HACCP plan plans
Personnel to be involved + extent of

2.6.4 authority defined in plan or related 10 Specified in HACCP plan & SOPs
SOP's for CA's
Determination &
identification/isolation procedures
2.6.5 100 Specified in HACCP plan & SOPs
for affected product are included
in plan or SOP's
Product disposition options (at

2.6.6 least general steps) are adequate 100 Specified in HACCP plan & SOPs
& listed in plan or related SOP's

Page 32 of 57
SGS/Cargill Animal
Nutrition Feed
Internal Verification of the
2.7
HACCP Program
Deducted
Score
HACCP plan or plant procedures
require internal GMP/HACCP
GMP/ HACCP system audit performed
2.7.1 system audit to be performed once 1000
once per quarter
within each 12 month period at
minimum
Procedures for internal audit

require on site observations, staff
interviews & random record review Defined in SOP internal audit
2.7.2 100
to verify GMP/HACCP procedures SOP/CME/PL/001-F01
& implementation/documentation
during verification audit
Adequate testing of equipment with

critical impact on feed safety is listed
2.7.3 10 Verification procedure available
in operational procedures or in
HACCP plan
Review of validation data is included
2.7.4 in the verification procedures or 10 Validation datas have been reviewed
HACCP plan
Procedure requires documentation

of non-conformances and timely
follow up to inadequacies found
through internal audit. For critical
non-conformances, any affected
product was put on hold &
identified immediately to prevent it
from being shipped, then Internal audit procedure is in place and
corrective actions were taken & cover all elements that meet this
2.7.5 100
closed out (with satisfactory requirement. Last audit performed by
review) within 30 days. Major non- Plant Manager of Cargill Hung Yen
conformances were corrected
within 60 days, minors prior to
next scheduled internal audit.
NOTE: If non-conformance has an
impact on feed safety, the auditor will
elevate "Comment" findings to
"Minor" at next audit if not corrected

Page 33 of 57
SGS/Cargill Animal
Nutrition Feed
Corrective actions taken in response
Internal audit verified during audit show
2.7.6 to internal audit findings are reviewed 10
that CA taken & reviewed
for effectiveness

Page 34 of 57
SGS/Cargill Animal
Nutrition Feed
2.8 Record Templates
Deducted
Score
All the following record templates are
structured with adequate information
requirements, spaces for Full records are maintained
operator/author & reviewer sign
off/date:
HACCP team records (highlights of
2.8.1 meetings documented in a consistent 10 Full records are maintained
format are acceptable)
2.8.2 Plant schematics 10 Plan diagram is kept on file
All flow diagrams are documented and
2.8.3 All process flow diagrams 10
kept on file
Product descriptions &

ingredients listed adequately
2.8.4 (ideally source companies listed), 100 Clearly defined in HACCP plan
including special market
regulations or requirements
Supplier review record templates or

2.8.5 10 Supplier assessment records are available
equivalent are available
2.8.6 Hazard analysis worksheet 100 Clearly defined in HACCP plan
HACCP plan & support documents HACCP plan and support documentseg.
2.8.7 10
(i.e. supporting SOP's) GMP, SOP is available
2.8.8 CCP monitoring records 100 Full monitoring records are kept on file
2.8.9 CL records or data listing 10 Defined in HACCP plan
records of process deviation are kept on
2.8.10 Process deviation / CAR 100
file
HACCP team meeting minus are
2.8.11 Records of HACCP team meetings 10
maintained
2.8.12 Hold / release memos 10 Full records are maintained
2.8.13 Validation data 10 Full records are maintained
2.8.14 Verification audit records 10 Verification records are maintained
0

Page 35 of 57
SGS/Cargill Animal
Nutrition Feed
HACCP Plan
Deducted
Score
2.1 HACCP Team & Preliminary Steps 0
2.2 Hazard Analysis 0
2.3 Critical Control Points 0
2.4 Critical Limits 0
2.5 Monitoring 0
2.6 Corrective Action 0
2.7 Internal Verification 0
2.8 Record Templates 0
2

Page 36 of 57
SGS/Cargill Animal
Nutrition Feed
3.1
Receiving, Raw Materials,
Transportation & Storage
Deducted
Score
Receiving records show that
validated SOP is followed after
3.1.1 prohibited material is received if 100 NA Not use prohibited materials
received in common line (if
applicable at this facility)
Receiver is aware of incoming raw Ingredient specification are provided to
3.1.2 material hazards that are under 10 relevant staff. Receiver interviewed
his/her control aware of material hazards
Defined in inbound ingredient
Receivers check visually for visible transportation SOP/PUR/TD/004.
3.1.3 hazards on trucks or raw materials 10 Receiving records verified show that
before accepting into facility sanitation of truck is inspected &
recorded.
Reference samples are readily
Defined in Ingredient receiving
3.1.4 available to the receiver to do raw 10
SOP/REC/PL/001
material visual comparisons
Receiver inspects certificates of
analysis as required prior to Defined in Ingredient receiving
3.1.5 10
accepting products requiring such SOP/REC/PL/001
shipment certification
Carrier company records in place for
safe transport & control of cross
Defined in contract of carrier: cleaning
contamination OR declaration of
3.1.6 10 truck and no transport any hazardous
previous load (indicating no
subtances eg. Pesticide, fertilizer...
contamination risk) or adequate
cleaning is on file
Truck inspection report completed
Truck inspection report completed on
3.1.7 diligently on each outgoing 100
each outgoing shipment
shipment
Pre-unloading approval for incoming
ingredients was received if required Defined in Ingredient receiving
3.1.8 by HACCP plan or SOP (Example: 10 SOP/REC/PL/001 & specification of
acceptable mycotoxin tests, drug ingredients
expiry <60days, etc.)

Page 37 of 57
SGS/Cargill Animal
Nutrition Feed
All drug (Category I and II) receiving
records MUST contain the following
Drug receiving records verified did not
information: drug identity,
3.1.9 10 10 contain manufacturer of drug as defined
(inc.potency), manufacturer, lot
in Procedure SOP/REC/PL/002.
number, expiration date, condition),
date, initialed by receiver
Lot number (or equivalent method

to uniquely identify lot) is
recorded for every batch of raw
material received. NOTE: Plant
Lot numbers recorded for all materials
3.1.10 must satisfactorily 100
and ingredients coming
demonstrate/explain adequate
traceability capability (one level
forward - one level back in the
supply chain)
10

Page 38 of 57
SGS/Cargill Animal
Nutrition Feed
Process Inspection &
3.2
Monitoring
Deducted
Score
Critical equipment, especially

Equipment are kept in good repair &
medication weighing scales, are
3.2.1 100 weighing scale is operating within
operating within acceptable limits;
acceptable limits
usage follows HACCP plan or SOP
Equipment set-up adequate

3.2.2 according to plan or SOP 10 Adequate equipment set-up
requirements
Equipment & personnel meet Equipment and pesonnel are meet
3.2.3 10
requirements of plan or SOP's requirements of plan
Process steps follow formulation

3.2.4 100 Good operating
procedures in all critical respects.
Process steps follow label/tag

procedures in all critical respects.
Specifically: There are no obsolete
tags, they are stored and organized
Following tag procedure, no obsolete
3.2.5 to prevent mix-ups, tag storage area 10
tags found
is clean and well lit, plant has
approved master tag showing proper
approvals (initials/date on each),
bags/tags are coded legibly
The semi-annual tag code listing is

3.2.6 on file and has changes noted (USA 10 NA Factory located in Vietnam
only)
Each medicated ingredient has its
own clean, labeled scoop for the
weighing operation. Common scoops Defined in SOP/IST/PL/001. Onsite
3.2.7 used for other micro ingredients are 10 inspection observe and staff interviewed
kept clean with no visible build up or follow SOP
residue.
Each prepared micro addition is

clearly labeled with individual tags
identifying the formula and batch
3.2.8 they belong to (e.g. product 4053; 1 10 Individual tags are available
of 4). NOTE: Bar codes or equivalent
identifiers may also be used

Page 39 of 57
SGS/Cargill Animal
Nutrition Feed
Personnel can do critical tasks
3.2.9 adequately (evaluated through 100 Adequate training for staff
observations + questioning)
Personnel adequately aware of
3.2.10 100 Staff interviewed aware of CL & CA
CL's & first steps of CA
Monitoring & recording adequate
3.2.11 100 Monitoring records verified
and as plan
Staff delegation listed in plan for
3.2.12 10 Defined in HACCP plan & SOPs
significant feed safety tasks
Critical records for prerequisite

programs (training, calibration,
mock recall, mixer validations) are
completed & reviewed adequately,
Records for prerequisite programs are
3.2.13 showing proper completion times, 100 completed & reviewed
data & signatures/dates of
operator & reviewer or verifier.
Note: List any critical records
determined to be non-conformant
Records required by the HACCP

plan, (including CCP monitoring,
CA, internal audit), are completed
adequately, showing proper
3.2.14 100 Completely records kept maintain
completion times, data &
signatures/dates. Note: List any
critical records determined to be non-
conformant
Records required by the HACCP

plan, (including CCP monitoring,
CA, internal audit), are reviewed
adequately & within frequency All records have reviewed adequately,
3.2.15 100
stated in SOP/Plan, with verifier signed and dated
signatures/dates listed. Note: List
any critical records determined to be
non-conformant
Production formula book/batch

controller agrees with master formula
book. Procedure Formulation issue and
3.2.16 Formulas have proper approval 10
withdrawal SOP/FOR/TD/001
(initials) - prior to production use
Discontinued formulas (including

custom mixes and tags) are kept for
3.2.17 12 months at minimum. (must also 10 All records are kept for 3 years
meet local regulatory requirements if
these are more stringent)

Page 40 of 57
SGS/Cargill Animal
Nutrition Feed
Plant formulas (including customAudit
mix) Verification Checklist
contain the following information:
product identification, typewritten
only (NO handwritten formula
3.2.18 changes), 10 Formulas contain the items mentioned
date into production, date
discontinued and initials of
responsible person.
Standardized Process Improvement

Sheets are being used and are being SPI sheet used and being filled out
3.2.19
filled out completely & accurately. 10
completely & accurately
Critical aspects of daily production

records are reviewed the next Drugs & Vitamin inventories reviewed
3.2.20
business day and signed off/initialed 10
the next day and signed by Plant manager
by a qualified reviewer.
All run lengths, bag and bulk are
reconciled to 3% (maximum of 2,200
lbs/1000 kg) prior to shipment and Defined in Packing procedure
endorsed. Any discrepancies are SOP/PRO/OL/007. Packing reports
3.2.21 10
investigated and documented. verified, showing bag reconciliation
(Check 5 day record.) <3%.
A copy of the current annual

registration of drug establishment
3.2.22 (FDA Form 2656E) and federal Feed 10 NA Factory located in Vietnam
Mill License are displayed at the
U.S. facility (USA only)
Magnets are inventoried and a Following magnet cleaning procedure
cleaning frequency is established SOP/SC/PL/001. Magnets inspected,
3.2.23
and cleaning documented 10
cleaning & inventoried every run.
Records kept on file
Other process records related to the

prerequisite or feed safety programs
are completed & reviewed All records are reviewed, signed and
3.2.24 10
adequately (live & archived records) dated
showing proper completion times,
data & signatures/dates

Page 41 of 57
SGS/Cargill Animal
Nutrition Feed
3.3 Sampling & Testing
Deducted
Score
Medication residue tests on

finished product/flush material Flush material used is 150kg of
3.3.1 tested at least annually. Testing 100 ingredient. Validation records show that
must include at least confirmation residue of drug was not detected.
of flush effectiveness
Salmonella and E.coli in fishmeal tested

for every lot. Aflatoxin in corn tested
Ingredient/product samples drawn & twice per month, in rice, wheat, soy once
tested in accordance with SOP/PIM. per month; heavy metal in MCP, Procine,
3.3.2 Plant has identified critical bagged 10 tapioca, broken rice 2times/ year.
ingredients and one sample of each Pesticide in rice bran, broken rice from
is taken yearly (minimum) COA supplier taken every 3 quarter.
Antibiotic in meat & bone meal, Catfish
fat taken 1time/ quarter.
Pellet durability is tested against

standards identified by facility for
specified feeds (check past month). If PDI tested every day. PDI test results in
3.3.3 a PDI falls outside standard, the 10 last 6 months verified, showing PDI does
facility consistently follows their not fall outside standard
written procedure that details action
to be taken
Verify ground grain particle score is Grain particle score tested twice per
measured as per location schedule month as defined in SOP/ QA/ PL/001.
3.3.4 and the data is made available to 10 The test result are logged . Particle size
regional formulation dept. <900 ground corn & 900-1000 ground
broken rice
Steam Rolled Grain moisture is
tested against standards identified by
facility (check past month). If % falls
outside standard, the facility Following Finished feed analysis
3.3.5 10
consistently follows their written SOP/QA/PL/004
procedure that details action to be
taken
A drug assay schedule has been

developed and is being used. Drug assay schedule performed every 3
3.3.6
(All Category II drugs must be 10 months. Test result of drug assay
included in US facilities) verified.

Page 42 of 57
SGS/Cargill Animal
Nutrition Feed
Audit
Each Category II drug has three "in Verification Checklist
tolerance" assays over the previous
12 months which are dispersed
throughout the year or within the time
the drug is used if only seasonal
(USA only). NOTE: If 3 assays were
3.3.7
not possible due to business change 10 NA Factory located in Vietnam
or other reasons the plant must
document why the outstanding
assays were not completed
If drug assay is out of tolerance then

the investigation should consider the
efficacy/safety of the batch/feed in
question. Retained sample or Defined in Finished feed analysis
3.3.8 10
subsequent like-medicated feed SOP/QA/PL/004
samples should be submitted as per
the PIM
All Category II out of tolerance

assays plus Category I out of Test result of CTC (supplier Thanh
tolerance assays reported by state Nhon) in feed code 1202 manufactured
3.3.9 regulator - have been investigated 10 10 on 14.9.10 = 12.5%, not comply with
using the QA-80, reviewed company specification. However, no
(initial/date) by Plant Manager or investigation taken as using QA 80
designated alternate
Protein Pre-Control program is up-to- Protein Pre-Control program is up-to-

date. A completed CA Checklist is on date. Protein testing records verified,
3.3.10 file if 2 consecutive assays fall in the 10 showing Protein does not fall in the red
yellow range, or if any assay falls in range or 2 consecutive assays fall in the
the red range yellow range
Following Mixer efficiency test

SOP/QA/PL/008 & flushing &
sequencing SOP/QA/PL/013. Test result
Validation testing performed
on 26.11.10 for Tylosin Phosphate,
adequately and at minimum annually
Flofenicol and 25/11/2010 for
3.3.11 to justify any mixing, flush or 10
Chlotetracycline by Pacific Lab service
sequencing procedures where there
(Singapore) show that residue of drug
is a risk of cross contamination
was not detected. Test result dated
22/9/2010 CV= 7.066 % for Feed code
7595NB/54646.
Test results reviewed internally with

sign offs/dates + adequate corrective
3.3.12 10 Test result reviewed by Lab manager
action taken/documented if tests or
data were not within acceptable limits
10
3.4 Corrective Actions

Page 43 of 57
SGS/Cargill Animal
Nutrition Feed
Deducted
Score
All prerequisite program corrective

actions completed as per SOP or
promptly enough to maintain control
over feed safety, with adequate
3.4.1 10 CA procdure is available
documentation & verification (sign off
for initiation pf CAR & final sign off
once all defective material is
disposed of safely)
All critical prerequisite program or

HACCP program corrective
actions are completed within time
frames specified by this standard
HACCP program and procedure have
3.4.2 (section 2.7.5) at minimum. If 1000
been implemented
deviations occurred prior to
certification, new procedures have
been implemented, documented &
trained to prevent recurrence
Missing information or non-

compliant signatures on CAR's or
other critical records led to
3.4.3 100 CARs have closed and signed on time
initiation of CA & CAR &
documented retraining of staff
involved
Missing or inadequate signatures on
Defined in Corrective action
other records within the feed safety
3.4.4 10 SOP/CA/PL/001. All records verified
program led to corrective actions &
have signatures
retraining (documented)
Adequate description of deviation

(date/product ID/quantity), nature
of corrective action, (including
3.4.5 action to prevent recurrence), 100 Adequate detail on CARs
listed on all CAR's to allow
reviewers to understand deviation
and corrective action
Names & signature of personnel

initiating CAR's and CA listed on HACCP and SOPs have signed by
3.4.6 100
CAR and meet requirements of authority person
HACCP plan or related SOP's
Affected product disposed
correctly + disposition is detailed CA mentioned in SOP implemented
3.4.7 100
in records so as to be tracked
accurately at later date

Page 44 of 57
SGS/Cargill Animal
Nutrition Feed
Corrective action verified to be
effective & complete before final Defined in Corrective action
3.4.8 10
approval closure signature placed on SOP/CA/PL/001& detailed on CAR
CAR
Feed safety related CAs triggered
3.4.9 10 HACCP plan has been reviewed.
review of HACCP plan
HACCP team decision not
HACCP team decision as per codex
3.4.10 overruled without documented, 1000
guideline
objective justification
0

Page 45 of 57
SGS/Cargill Animal
Nutrition Feed
3.5 Verification Procedures
Deducted
Score
Hazard analysis & HACCP plan

have been verified during internal
audit (included on report). Note:
All criteria including module 2 were
Use of SGS/Cargill Checklist
3.5.1 100 audited. Last audit performed by Plant
Current Version in performing
Manager of Cargill Hung Yen
internal audits is adequate if all
checklist criteria for module 2
were audited
Validation data reviewed during Validation data reviewed on internal

3.5.2 10
internal audit audit
Targeted sampling performed as
Sampling performed as requirement of
3.5.3 required by regulatory agencies or 10
SOP
SOP/plan
Calibration verified on all devices
related to feed safety control (can
3.5.4 10 Calibration records are kept on file
involve a check of valid calibration
records)
Check of critical limits during audit to
ensure feasible & compliant with Mentioned in HACCP verification
requirements of local regulatory procedure, CLs verified & updated to
3.5.5 10
agency, USFDA, Codex Alimentarius compliant with requirement of Vietnam,
or CFIA as applicable to production & US FDA, Codex stan
market region(s)
Evaluation of previous verification
3.5.6 audits performed to ensure CA's 10 Following Verification procedure
were complete
Verification performed in
compliance with HACCP plan or
audit SOP, including critical SOP
review, random record review,
label and formulation review, staff
Verification performed and documented
3.5.7 interviews & site walk through (all 100
on Internal audit records
documented). Note: Use of
SGS/Cargill Checklist Current
Version in performing internal
audits is adequate if all checklist
criteria were audited

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Inadequate CA's or CAR's, (asAudit
well Verification Checklist
as those that should have been
initiated in response to errors
3.5.8 10 CARs are completely maintained
revealed by records), triggered
documented retraining of operators &
reviewers
Documentation of deviations found

during audit was adequate, with non-
3.5.9 10 Deviations documented on the CA Log
conformance and CA log generated
(can be combined in one log)
Internal audit report completed

adequately, reviewed promptly
Internal audit report completed and
3.5.10 (within 1 month of audit at latest) 100
reviewed within one month
& signed/dated by auditor &
reviewer
Verification on relevant points

repeated within a reasonably short
time frame when changes occurred
3.5.11 or new info received that could 10 Defined in Verification procedure
significantly affect the feed safety
system (e.g. system transferred to
new line or facility)
Record retention meets the

Corporate Retention Schedule (as
minimum). Facility must also meet Records retained at least for 3 years,
3.5.12 100
local regulatory requirements and comly with VN regulation
any customer agreements if
greater
0
Feed Safety Program

Compliance
Deducted
Score
Receiving, Raw Materials,
3.1 10
Transportation & Storage
3.2 Process Inspection & Monitoring 0
3.3 Sampling & Testing 10
3.4 Corrective Actions 0
3.5 Verification Procedures 0
3

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SGS/Cargill Animal
Nutrition Feed
Audit+Verification
LIST OF NON-CONFORMITIES CORRECTIVE Checklist
ACTION SCHEDULE:
NOTE: Commented (C) items may result in points deducted if not addressed by the next audit.
Criticals must be closed out within 30 days (affected product stopped immediately), Majors within 60
days, minors before next audit.
Deducted
Ref. No. Criterion Value
Score
Production & ingredient/product
1.2.2 storage areas protected adequately 10 10
against pests
All drug (Category I and II) receiving

records MUST contain the following
information: drug identity,
3.1.9 10 10
(inc.potency), manufacturer, lot
number, expiration date, condition),
date, initialed by receiver
All Category II out of tolerance

assays plus Category I out of
tolerance assays reported by state
3.3.9 regulator - have been investigated 10 10
using the QA-80, reviewed
(initial/date) by Plant Manager or
designated alternate

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SGS/Cargill Animal
Nutrition Feed

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SGS/Cargill Animal
Nutrition Feed
TIVE ACTION SCHEDULE: Audit Verification Checklist
ducted if not addressed by the next audit.

duct stopped immediately), Majors within 60
next audit.
Comments Corrective Action
Feed storage and bulk raw material

warehouse have gaps. It was inadequate
to prevent pest access.
Drug receiving records did not contain

manufacturer of drug as defined in
Procedure SOP/REC/PL/002.
Test result of CTC (supplier Thanh

Nhon) in feed code 1202 manufactured
on 14.9.10 = 12.5%, not comply with
company specification. However, no
investigation taken as using QA 80

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Nutrition Feed

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Nutrition Feed
CA Completion Date CA Verified By

Page 53 of 57
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Nutrition Feed

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SGS/Cargill Animal
Nutrition Feed
Audit Verification
Records to be sampled at each audit Checklist
Daily: Choose at least 6-8 dates for initial audit, 8-10 dates for maintenance/recertification audits
Note: CAN cannot instruct auditors which time frame to sample, the criteria is in the audit procedure
PACKING PCS PIS = PROCESS IMPROVEMENT SHEET
MIXING PCS PCS = PROCESS CONTROL SHEET
PELLETING PCS
BULK SHIPPING CONTROL SHEET
BAG SHIPPING CTL SHEET
DRUG RECEIVING SHEET
DRUG USAGE PIS
DAILY HOUSEKEEPING SIGNOFF
RECEIVING TICKET
DAILY DRUG/PREMIX INVENTORY SHEET
DRUG TRAX (QA 82, QA 83, QA 84) (1.15.3)
BULK RECEIVING CONTROL SHEET (TRUCK & RAIL)
BAG RECEIVING CONTROL SHEET
DAILY SHORTMIX SCALE CALIBRATION
Months of: Choose 6 months at random

HOUSEKEEPING AUDIT / INSPECTION (internal & external)
REGISTER INSPECTION-LUBE-OIL SCHEDULE
MAINTENANCE PROGRAM (ELECTRONIC)
DRUG TRAX MONTHLY INVENTORY CTL REPORT (1.15.5)
GRAIN PARTICLE SCORE
Annual records:
WATER TEST RECORDS
HACCP TEAM MEETING MINUTES
EXTERNAL SCALE CALIBRATION RECORDS
FLUSH MATERIAL/RESIDUE TEST DATA
BIN INSPECTION & CLEAN-OUT
FEED (CUSTOMER) COMPLAINTS
PEST CONTROL BINDER
MIXER VALIDATIONS (CV)
INTERNAL QA / HACCP AUDIT
TRAINING (personnel training binder, SOP ongoing training, employee training records) & EVALUATION RECORDS
for Panel Control Technician, Bulk receiver & shipper, Bag receiver & shipper, Pellet tech
MOCK RECALL (INGREDIENT, FP BULK AND FP BAGGED)
CORRECTIVE ACTIONS
NOTE: For Supplier Approval & Carrier Company Declarations not done at facility, check procedure for corpor
INGREDIENT SPECIFICATION FILE & SUPPLIER APPROVAL FILE(S) (Supplier Approval Files only if supplier appr
CARRIER CERTIFICATION OF NON-CONTAMINANT BY RUMINANT MEAT MEAL OR FEED (If done internally)
REGULATORY AGENCY REPORT (most recent)
HACCP PLAN
ALARM LOGS
METER CALIBRATION SHEETS (WATER/FAT/SOYOIL/MOLASSES/ALIMET)

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Nutrition Feed
DETAILED RETURN FORMS FORAudit
FEED Verification
RETURNED FORChecklist
FEED SAFETY REASONS
DRUG WARNINGS
BOILER TEST RESULTS
PDI RESULTS
PRE-CONTROL CORRECTIVE ACTION CHECKLIST
PRE-CONTROL SAMPLE LOG SPREADSHEET (RESULTS)
INGREDIENT CLAIMS (1.9.3 - 1.9.4 - 1.9.5)

COMPLAINTS MEDICATED (1.9.7 - 1.9.8)
LAB INGREDIENT RESULTS - SUPPLIER EVALUATION (1.9.9)
SEMI-ANNUAL TAG CODE LISTING (3.2.4)
DISCONTINUED FORMULAS & TAGS (12 MONTHS) (3.2.20)
PELLET COOLER MOISTURE CHECKS - LAST 12 MONTHS (3.3.3)
STEAM ROLLED GRAIN MOISTURE & TESTS (3.3.5)
DRUG TOLERANCE ASSAYS (3.3.6 - 3.3.7 - 3.3.8 - 3.3.9) USA only
FDA FORM 2656E & FEDERAL MILL LICENSE (3.2.25)
MAGNET CLEANING (3.2.26). NOTE: this is often included on the appropriate pcs (rec'g, pelleting, etc.)
MINIMUM DRUG INCLUSION

Page 56 of 57
SGS/Cargill Animal
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dit procedure
PROVEMENT SHEET
ONTROL SHEET
ALUATION RECORDS
& shipper, Pellet tech
ck procedure for corporate approval

Files only if supplier approval is done on site)
D (If done internally)

Page 57 of 57

HACCP Audit

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SGS/Cargill Animal

SGS/Cargill Animal Nutrition Global Feed Program

Version: 2.1 (Maintenance)

Version Date: September 20, 2008

Author: Victor Muliyil - Technical Specialist, North America

CARGILL VIETNAM LTD.

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

ecialist, North America

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

SOP - Standard Operating Procedure CL - Critical Limit

Company & Site Audited: Ref#

Medication Used: YES Prohibited Material Used: NO

Lead Auditor Signature: trangdam Review Auditor Signature:

Date(s) of Audit: 7-Dec-10 Date of Review: Jan 5'2010

Audit Score Summary & Pass/Fail Determination:

Module 1 Score: 1000 /1000

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Follow Up Audit Module 1 x 40% + Module 2 x 20% + Module 3 x 40% =

Overall Score Achieved This Maintenance Audit: 992 /1000

Audit Outcome: (outline) PASS or

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

S" rating was not

mble, pellet), Swine feed

Dec 10/ 18:00

-18 Dec 2009

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

1.4 Building Interior - Air Quality

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Waste bins are clearly identified for each

Building Interior - Sanitary

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Cleaning program for for each equipment

Cleaning chemicals for feed contact Aluminium Phosphide for fumigation

Inspection & cleaning for each

Cleaning tasks scheduled on all

Floors, pits, walls, & equipment

Building Interior - Water &

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Steam & boiler checks performed Boiler water treatment SOP/PRO/PL/008

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

All items purchased are from

Facility has documented complaint

Complaints - Those complaints

Procedure Ingredient Analysis

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Receiving SOP lists certificates

Procedure states that: a) returned,

Defined in Ingredient shelf-life

Medicated raw material adequately

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008

Finished product & raw material

Work and storage areas for feed

Loading procedures must require

Free prohibited material, medication

Facility owned portable augers, Defined in the Inbound ingredient

ISSUE VERSION Issue Version 2.1; Sept. 20, 2008