B.

HACCP
It is the intent of this section to provide resources for The HACCP Audit , which
follows with links to electronic document resources entered in the comments
column. Each Business Unit will designate a Food Safety Coordinator who will be
trained to be an Internal Auditor. We have selected SGS to train the coordinators
and certify our plants.

Many audit questions are self explanatory. The documents are sample SOPs from
our certified plants, and other forms necessary to support our manufacturing
process. The audit point values are deducted from the total scores when the
question is a defect. It is the responsibility of the Business Units to maintain the
HACCP program certification.

Audit Title Page

Audit Summary
Section 1
Building exterior
Building interior - design
Building interior - lighting
Building interior - air quality
Building Interior - waste
Building Interior - Sanitary facilities
Building Interior - Premises & Equipment Cleaning
Water & steam
Storage & Transportation
Equipment design maintenance & calibration
Personnel training & hygiene
Equipment Cleaning/Flushing/Sequencing
Pest control
Recall program
Prerequisite program records

Section 2
HACCP Team & Preliminary Steps
Hazard Analysis
Critical Control Points
Critical Limits
Monitoring
Corrective Action
Internal Verification
Record Templates
 Section 3
Receiving, Raw Materials, Transportation & Storage
Process Inspection & Monitoring
Sampling
Corrective Actions
Verification Procedures

Non Conformities Log

Procedures and Records Reviewed

HACCP AUDIT - with resources (hyperlinks in comments column

will assist in preparing your HACCP plan)

1.1 Building Exterior

Point Deducted
Ref. No. Criterion Comments
Value Score
The following documents and forms
cover 1.1 through 1.7. There are also
references to records within the
documents.
Hkaudit.doc
Structure not in close proximity to
Housekeepingaudit.doc
1.1.1 any pollutant producing facilities 10
that could contaminate product
elev_hk_audit.doc

Sanitation.doc

housekeeping_all.xls

Grading, dust proofing of roads /

1.1.2 lots / other exterior areas do not 10
pose significant contamination risk
Grounds free of refuse or debris
1.1.3 that could present a significant risk 10
of pest harborage
pest.doc
Receiving pits & silos secured
1.1.4 against pest or contaminated water 10
PEST FREE 2000 SANITARY
entry
DESIGN CHECKLIST.doc
Building secured adequately to
1.1.5 10
deter pest entry
External premises inspection
1.1.6 protocol in place, with frequency & 10 Need SOP Security.doc
responsibility listed in SOP
Inspection performed and verified
1.1.7 10
regularly (minimum quarterly)
 Protocol in place for addressing See Pest Program write up from
1.1.8 10
inadequacies inspector and actions taken.
Corrective action taken where and SOPs must address first steps of
when required (at minimum, all corrective action. Follow CA SOP for
1.1.9
deviations corrected with 10 CA.doc
documentation prior to next audit)
FEED INDUSTRY CAR TEMPLATE
2003 Rev. 1.1.DOC
Records of inspections and C.A.
1.1.10 10
kept for time required by regulation
0
1.2 Building Interior - Design
Point Deducted
Ref. No. Criterion Comments
Value Score
F/W/C relatively clean & well
1.2.1 maintained to prevent product 10 Housekeeping audit
contamination
See construction specs in
1.2.2
Building condition & materials pose 10 Webster/Production and
no contamination threat Engineering/Specifications for
standards.

Production & ingredient/product

HACCP Master\HACCP-
1.2.3 storage areas protected adequately 10
CorporateManual\pest.doc
against pests

Internal premises inspection

1.2.4 protocol in place, with frequency & 10 Housekeeping Audit
responsibility listed in SOP
Inspection performed and verified
1.2.5 10 Monthly Housekeeping Audits
regularly (minimum monthly)
Notes of corrective action taken on
Corrective action taken where and
previous audit is one way to do this.
when required (at minimum, all
1.2.6 10 Maintenance records may also be
deviations corrected with
involved See section 1.1.9 for
documentation prior to next audit)
hyperlinks to CAR documents.
0

1.3 Building Interior - Light

Point Deducted
Ref. No. Criterion Comments
Value Score
Lighting is adequate to read
See Safety manual for recommendation
1.3.1 formulas, labels, tags & scales + 10
on lighting requirements
permits effective cleaning
Lighting adequate to identify
visual/pest contamination hazards
1.3.2 10
in receiving, shipping, storage &
production areas
0
 1.4 Building Interior - Air Quality
Point Deducted
Ref. No. Criterion Comments
Value Score
Ventilation adequate to prevent
1.4.1
contaminated air/steam contacting Intake air for finished feed processing
product 10 and air compression should not be
drawn from ingredient bulk receiving
area.

Dust collector materials segregated

SOP for Dust Collectors Cleaning and
1.4.2 & handled adequately to prevent 10
Inspection Required
cross contamination
Maintenance Safety Inspections and
Lighting/dust/air inspections and
1.4.3 10 Housekeeping Inspections,
corrective action documented
Environmental Audit
0

1.5 Building Interior - Waste

Point Deducted
Ref. No. Criterion Comments
Value Score
Adequate waste storage capacity to See CAN environment website and
1.5.1 10
avoid risk audit.

Waste containers & tanks leak free

1.5.2 10
and isolated from main flow areas
1.5.3 Waste containers clearly identified 10
Containers cleaned and maintained Suggest this be added to Housekeeping
1.5.4 10
regularly audit.
Dumpsters must be covered from rain
Waste does not pose cross and kept away from mixing and
1.5.5 10
contamination risk receiving open process areas such as
pits.
0
 1.6 Building Interior - Sanitary Facilities
Point Deducted
Ref. No. Criterion Comments
Value Score
Adequate hand washing facilities
1.6.1 10 Hygiene.doc
available
Adequate hand cleansing soap and
1.6.2 10
sanitary drying equipment present
0

1.7 Building Interior - Premises & Equipment Cleaning

Point Deducted
Ref. No. Criterion Comments
Value Score
Cleaning chemicals clearly labeled
1.7.1 with identity, even if stored in 10 See safety audit
temporary containers
Written SOPs for each cleaning eqcleaning.doc
1.7.2 10
task on premises/equipment housekeeping_all.xls
sanitation.doc
SOP includes goal, person cleaning
1.7.3 10
and reviewer sign offs HACCP Master\HACCP-
CorporateManual\housekeeping_all.xls
Cleaning chemicals are safe &
1.7.4 10
used appropriately
Equipment, including bins and silos Binclean.doc
1.7.5 are cleaned and inspected at least 10
annually and before use bininspection.doc
Cleaning programs kept on master Housekeepingaudit.doc
1.7.6 schedule - followed and 10
documented housekeeping_all.xls
Schedules / methods / C. A.
1.7.7 10
validated records kept
Must score 9 of 10 points to be
Floors, pits, walls, & equipment
1.7.8 10 adequate in each area on housekeeping
adequately clean
audit.
No build up of debris, residue or
See audits if evidence is there for
1.7.9 webbing in receiving, process or 10
corrective actions.
storage areas
Routine monitoring is performed to
1.7.10 10 housekeeping_all.xls
verify cleaning
Cleaning performed in a manner
1.7.11 that minimizes risk of cross 10 sanitation.doc
contamination
0

1.8 Building Interior - Water & Steam

 Point Deducted
Ref. No. Criterion Comments
Value Score
Water meets local drinking water
standards for basic bacterial count
and Cd, As, Pb, Hg (confirmed waterqc.doc
1.8.1 through review or performance of 10
credible tests at least annually or as see test records/annual
required to maintain feed safety
control)
Steam & boiler checks performed See boiler log
1.8.2 regularly to minimize product 10
contamination risk boilerchem.doc
0

1.9 Purchasing, Receiving, Storage & Transportation

Point Deducted
Ref. No. Criterion Comments
Value Score
QA Supplier Checklist.doc

Tradico New Ingredient Assessment

Profile.doc

All items purchased are from Purchasing.doc

approved suppliers with adequate
1.9.1 written assurance of compliance to
hazard control specifications or
conditions
10 HACCP-Forms-Letter Requesting
Adequate Cleanout of Conveyance.doc
HACCP-Forms-
PorcineProteinCertificate.doc

INGREDIENT SUPPLIER
CERTIFICATION.doc
Suppliers have been provided with
product specifications basis
1.9.2 ingredient manual or 10
districts/countrys established
specifications
Ingredient claims are filed within the
time allotted basis trading rules or
1.9.3
according to terms of purchase 10
contracts in international countires.
Procedures are in place to insure
that 100% of potential ingredient
1.9.4
claims are filed 10

There are no outstanding ingredient

claims more than 60 days old, or
1.9.5
outside time limits set by trading 10
rules. (USA only)
 For complaints, Policy Adjustments-
Feed dollars (70 RPT) have been
reduced since last year and claim
1.9.6 10
dollars are within budgeted limits
set for the district/country.

Complaints (Medicated) Those

complaints dealing with
experiences of product defects
1.9.7 10
relative to the drugs efficiency or
safety shall be kept in a separate
file.
All complaints shall include date of
complaint, name and address of
customer, name and lot number of
1.9.8 feed involved, details of complaint, 10
investigation results, disposition of
complaint, date and endorsement
of responsible person.
Laboratory Ingredient Analysis
results are used to evaluate
suppliers; and suppliers with lower
1.9.9 10
quality ingredients are eliminated or
paid discounted prices for their
products.
If the facility handles prohibited
material, receiving SOP clearly
states requirement to flush flushing.doc
receiving line into prohibited
materialstorage vessel or silo bulkreceive.doc
1.9.10 with minimum 150 kg (ideally 200 100
kg) flush medium immediately Do not receive restricted materials
after prohibited material is without approval from the Division
received in common line OR President.
alternate, validated procedure is
in place
 bulkreceive.doc

aflatoxin_test.doc

binsetup.doc

bulkrecsam.doc

bulkrectest.doc

dailyreceiving.doc

dailymed.doc

drugrecon.doc

elevreceive.doc

hold.doc
Receiving SOP lists certificates
receiver must inspect prior to
1.9.11 10 liquidrec.doc
accepting products requiring such
shipment certification
purchasing.doc

QA Ingredient Test.doc

railcars.doc

rt.doc

rtndsample.doc

Returnrecord.doc

salt.doc

starlink.doc

starlinkform.doc

wbagreceive.doc
Only returned or rework material
identified with respect to prohibited
Returnrecord.doc
material and/or medication content
can be accepted. If accepted, such
1.9.12 10 preturns.doc
material must be isolated and
labeled to prevent cross
contamination of raw materials or
finished products.
Stock rotation timing and protocol
1.9.13 present and monitored + no expired 10 inventory.doc
drugs are found in inventory.
 Medicated raw material adequately
segregated in separate storage
1.9.14 area with containers closed or bag 10 wbagreceive.doc
tops folded down to prevent cross
contamination
Flush material adequately labeled flushing.doc
with medication flushed &
1.9.15 segregated from regular product or 10 Guidelines on Choosing Scheduling
raw materials Versus Flushing.doc
Sequence.doc

Warehouse Plan should address

Finished product stored to prevent separation of raw and finished products
1.9.16 10
hazard creation and provide room for effective stock
rotation and housekeeping

Finished product & raw material

storage/stacking maintains
1.9.17 adequate perimeter to prevent pest 10
harborage & prevents product or
packaging damage
Work and storage areas for feed
materials and products are
1.9.18 physically separated from fertilizers, 10
herbicides and other potential
contaminants.
Empty trucks to be inspected to
bulkloadout.doc
1.9.19 have clean, empty compartments 10
wbagloadout.doc
prior to loading - documented
See contractors file

Customer Certification Training

Program

DELIVERY VEHICLES
Trucking contractors are
standards.doc
reviewed to have procedures in
Guidelines on Choosing Scheduling
1.9.20 place or to certify that trucks are 100
Versus Flushing.doc
free from prohibited material or
other contamination risk
HACCP-Forms-Letter Requesting
Adequate Cleanout of Conveyance.doc

Truck Flushing changes 04.doc

trainSOP_carrier.doc
On site trucks cleaned per proper eqcleaning.doc
1.9.21 10
protocol - protocol present sanitation.doc
bulkreceive.doc
Facility staff loads / unloads / dailyreceiving.doc
1.9.22 sequences carriers in manner to 10 unitrec.xls
prevent feed contamination unitlo.xls

0
 The following items were listed in the Camrose binder for Equipment Performance and
Maintenance- These documents may vary depending upon your plant: Maintenance SOP,
(training Signoff for all SOPs) Grease Spec from supplier, Maintenance Monthly Inspection, PM
inspection printout from Maintenance program internal inspections, oil and lube schedule,
maintenance register, PM audit, Packaging Scales SOP, Daily Packaging Scale Calibration ,
External Calibration record, Bulk Scale SOP, external calibration record, Mixing Scale SOP,
External calibration record, Shortmix Scale SOP, external calibration records, Daily internal
records, Calibration SOP, Calibration Worksheet, Flow Rate Guide Checklist , Plant Change
SOP, Government Scale Check results.

1.10 Equipment Design, Maintenance & Calibration

Point Deducted
Ref. No. Criterion Comments
Value Score
See standard equipment and
Design / installation permits proper
1.10.1 10 construction specifications for
operation, cleaning & maintenance
equipment in P&E website.
maintenance.doc
Equipment maintained in adequate
maint_safety.doc
1.10.2 condition so as not to contaminate 10
See Maintenance Program Audit and
ingredients or products
Records.
Feed contact surfaces non-toxic
and non-absorbent, free from
1.10.3 10
deterioration that could contaminate
product
Equipment will withstand repeated
1.10.4 10
cleaning as required
All chemicals / lubricants / paints on
1.10.5 feed contact surfaces do not create 10
hazards
Each liquid and pnematic unloading
system and tank is adequately
1.10.6 identified and locked to prevent 10
unauthorized receipt, unloaing
errors, and contamination
Fat and soap stock systems are
free ofcopper and brass piping,
1.10.7 10
fittings, etc. (these materials are
catalysts in the rancidity process)
Maintenance frequencies specified
are followed & are adequate to See Maintenance Equipment Electronic
1.10.8 10
minimize risk of product files.
contamination
Written, validated calibration calibration.doc
methods or qualified contractor bulkscale.doc
1.10.9 used, frequency of external 100 scalemix.doc
calibration of all critical scaletestpkg.doc
equipment is at least annual Scaletestsm.doc
Maintenance and calibration done
1.10.10 10 See calibration records on file.
by trained personnel
 Maintenance record complete and
1.10.11 includes equipment ID, date and 10 See Maintenance Program Files
person ID & signature

Calibration record on medication

scales for hand-adds or
medication micro bins is current See Calibration Records
1.10.12 1000
(within last 12 months) & shows Equipment Maintenance Binder
equipment is operating within
acceptable limits

Calibration record complete has

1.10.13 equipment / person ID & 100 same
signature & date & results

New medication scales must

have a scale check tolerance of
0.1% of the capacity of the scale
(0.2% for scales which have been
in operation >3 months) or +/- 1
1.10.14 100 Scaletestsm.doc
graduation, whichever is greater.
However, scale check tolerance
cannot exceed 10% of lowest
medication amount weighed on
the scale

Mixer validations are scheduled

at least annually or after ribbon
1.10.15 replacement on each mixer &
100
have maximum CV limit of 5% for
dilute drug premixes;10% on all
other items.
Cargill Standard is CV of 10 or less
for complete feed. See Integrity
Manual Appendix for test
procedures.

Tolerances have been established

in the batch controller for weighting
1.10.16 bulk ingredients; tolerances are 10
checked and documented at leat
twice per year.
Alarm lots are maintained with
1.10.17 batching records and actions taken 10
on alarms are documented
Liquid meters are checked every
six months, corrected if necessary,
1.10.18 and documented in files?
(Quarterly on lysine & methionine
liquid meters.)
Defective equipment is ID'd
Tagged and Power locked out with all
1.10.19 adequately to prevent accidental 10
operators having documented notice.
use
 No defective equipment with
impact on feed safety is
1.10.20 permitted to be used until 100 See Corrective Action records.
verified to be operating within
acceptable limits
0

1.11 Training & Procedures

Point Deducted
Ref. No. Criterion Comments
Value Score
All staff trained in critical hygiene (if
hygiene.doc
1.11.1 this could affect product) prior to 10
trainingplan_new.doc
beginning work
training.doc
Adequate, written GMP training traintasklist_name.doc
program available for staff trainSOPlist_byjob.doc
1.11.2 covering all key prerequisite 1000 Employee Training records - Employee Files
Confidential - Management
programs required by the Cargill Maintenance Exam PS Office
standard Task Procedure Binder PS Office

Location has conducted a food

safety awareness training session,
including the CAN fd safety video,
1.11.3 10
within the last 12 months. List last
training date ___________

Staff for each task seem to Timely SOP and HACCP training
1.11.4 10
understand requirements signoffs are essential.
Requirements for each critical
GMP task are set out in
adequately detailed SOPs which
CRITERIA FOR STANDARD
1.11.5 include at minimum the purpose 100
OPERATING PROCEDURES.doc
(objective), procedure,
responsibility for task & related
records
SOPs also include responsibility &
frequency for routine & system
1.11.6 10
verification of task + first steps of
corrective action

SOP in place stating that no

product requiring veterinarian
prescription is shipped without
the prescription on file. In the
See VFD section in Integrity Manual
case of prescription renewals
1.11.7 100 for procedures per FDA. These will
(e.g. verbal renewals by
vary according to country.
veterinarian) the prescription
must be on file and verified
within 48 hours of renewal
(procedure documented).
 Procedures in place to ensure
formulations are developed, formulation.doc
modified and issued by formulaguide.doc
1.11.8 100
adequately trained, qualified See this Product Integrity Manual
personnel if medications and/or
prohibited material is used
Procedures in place to ensure
labels/tags are controlled and Labeling- USA.doc
issued by adequately trained,
qualified personnel to minimize Integrity Manual has more specific
risk of mislabeled product if instructions by Species.
1.11.9 100
medications and/or prohibited
material is used. All tags Laws are different for each country
conform to local requirements and the countrys law must be
and tags for medicated feed followed.
include withdrawal instructions.
All custom mix shipping documents
contain: customer name and
address, date of shipment, base
1.11.10 feed label, and drug level with 10
purpose statement and withdrawal
instructions (if medicated), and
assigned number. (USA only)

Staff performing important feed
safety related tasks are trained to
1.11.11
recognize hazards and related
protocol
Staff trained in critical SOPs
with regular evaluation (annually
1.11.12
at minimum for the critical SOP's
with direct impact on feed safety)
Training & evaluation records are
1.11.13 in place, current & verified by
qualified personnel
All training is performed by
1.11.14
competent trainers
Personal clothing kept separate
1.11.15
from work areas
Visitor access is controlled
1.11.16 adequately to prevent
contamination
See HACCP team training Records.
And employee records
Western Canada Training Records
binder includes:
Hygiene SOP, Access to Plant SOP,
training signoff, visitor log, traffic
flow, training SOP,SOP training and
SOP verification schedule, document
list, task procedure list, SOP training
100 list by name,drugwarning,
feedwarnings,ionophore
training,feedorders SOP, Driver
checklists, Food Training,dailyload,
New employee training,consultant
production training schedule, Dairy
Focus-Learning about the feedmill,
training for carriers, any changes
and retraining, panel techs certified
list, pelleting technician certification
list, training presentations
SOPs have to be reviewed and a
signoff by the reviewed with
100 signature and date. Training signoff
on each SOP is documented per the
yearly training schedule.
100 See Training Binder
Show documented HACCP train the
10
trainer sessions.
Lockers are to be made available for
10
each plant employee.
100 Access to Plant SOP
0
 1.12 Flushing/ Sequencing
Point Deducted
Ref. No. Criterion Comments
Value Score
flushing.doc
Written SOPs for flushing &
1.12.1 10 Guidelines on Choosing Scheduling
sequencing of production
Versus Flushing.doc
SOP includes staff responsible for
1.12.2 sequencing & flushing, as well as 10
review

Sequencing & flushing protocol

adequate to prevent product
contamination by prohibited
material or excess/wrong
1.12.3 medication. The quantity of flush
Residue testing procedure described
100
in the integrity manual.
material must be validated to
demonstrate that the quantity is
effective. A minimum of 150-200
kg is recommended.

0
1.13 Pest Control Program
Point Deducted
Ref. No. Criterion Comments
Value Score
Written pest control program
1.13.1 10 pest.doc
present
Person on staff responsible or
1.13.2 outside contractor named, licenses 10 See Pest Companys book.
valid & on file
All chemical use detailed, with safe
concentrations & validated methods
1.13.3 10 same
to minimize product contamination
risk
All pest control devices are properly
1.13.4 anchored, tagged & are functioning 10
adequately to control pest hazards.
Frequency of procedures is
1.13.5 10
adequate & followed diligently
Records of inspection, sighting logs
& defective findings are complete
1.13.6 10
and signed by contractor & internal
staff member
Corrective actions are written (on
1.13.7 file) by internal staff and signed off 10
when complete
0
 1.14 Recall Program
Ref. No. Criterion
1.14.1 Written recall procedure is on file
Person or team responsible for
1.14.2
recall is detailed on protocol
Methods of product ID and
1.14.3
information broadcast detailed
Methods of identifying products
1.14.4
adequately are listed
Procedure must include informing
1.14.5 regulatory body if public health is at
risk
Competent mock recall
performed & documented at least
annually to assess effectiveness
with adequate follow up. Recall
procedure must be adequate to
determine quantities of target
1.14.6
product still at the facility and
quantities shipped to each
customer within 2 hours of
initiation (list date of last mock
recall in comments section)
Point Deducted
Comments
Value Score
Binder for Recalls includes the
following records:
Retrieval Team
Returns SOP, ReturnRecord.doc,
Product Retrieval Policy,Customer
complaint form, investigation.doc,
Feed Complaint Plant
Checklist,Recall SOP, Product
Retrieval Exercise checklist,
100
Mock Recall Medication list,Mock
Recall records to show document
trail, SOP Hold Procedure, Daily
Retrieval Status, TLO, QA manual
forms, mixing records, Corporate
Food Safety Policy and Contacts list,
Product Integrity Manual Policy,
Lab assay results, Drug Control
Record,
10 Retrieval Team
10
10
10 FDA Product Retrieval Policy.doc
All recall procedures are detailed in
100
the Product Integrity Manual.

Frequency of mock recall listed in

SOP - at least 1/ year/product or
risk group (products with different
1.14.7 10
distribution methods, e.g. bag vs.
bulk, must be separately tested for
recall)
Lot breakdown, lot numbers & tag Traceability Program requirements are
1.14.8 stamps are legible & allow proper 10 integrated into the Product Integrity
separation of dates Manual.
 Lot number tracking & distribution
1.14.9 records adequate to allow effective 10
recall
0
1.15 Records
Point Deducted
Ref. No. Criterion Comments
Value Score
Records legible
1.15.1 10
Written record review procedures
1.15.2 10
available
Record review performed
promptly for critical records.
Drug inventories are taken and
compated to book inventory by
9:00 a.m. daily. All discrepancies
identified by the Drug Trax
program are investigated with
the results of the investigation
1.15.3 documented and signed by a 100 drugrecon.doc
responsible person. Forms
QC82 and QC83 are to be used.
REQURIEMENTS: <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
1.15.4 discrepancies greater than 0.5 lbs. 10
are investigated and initialed by a
responsible person.

Drug Trax expiration date report for

1.15.5 all drugs is printed monthly and 10
reviewed to ensure all are current.

Bulk medication in line scale
checked every working day at
1.15.6
minimum, with records reviewed
within 1 week
It is not the norm for CAN to use
Bulk Medication scales and should
100
have approval from the Area
Supervisor.

Fill/Empty reconciliation
completed on each bulk
1.15.7 medication bin every 10-15 days 100
with record reviewed within 1
working day of reconciliation
 Records allow events to be traced
1.15.8 10
accurately
Record retention meet regulatory
1.15.9 10
criteria
0

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 Cleaning/
1.12 0
Flushing/Sequencing
1.13 Pest control 0
1.14 Recall program 0
1.15 Prerequisite program records 0
Total deducted - 0
Module 1
The HACCP plan binder typically includes HACCP implementation log, HACCP training log and
minutes , SOP Training and SOP verification schedule, meeting minutes and attendance sheets,
Product return records, basic training for non-production support HACCP plan introduction,
Document List, Cargill records policy, HACCP Forms 1,2,3,4, HACCP Forms 5,6,7,8, HACCP
forms 9,10, Memos on changes and documentation of training, Policy and documented training,
Mixer Validation, Employee Signoff, Mixer CV results, HACCP System Verification, Certification
form issued by SGS, Internal HACCP Audit SOP, Internal Audit, Corrective Action SOP, (all need
training signoff sheet), Management Commitment Letter- See Product Integrity Manual, Whole
HACCP audit, HACCP training certification for FSC from SGS.

2.1 HACCP Team & Preliminary Steps

Point Deducted
Ref. No. Criterion Comments
Value Score
HACCP team in place - names, Describe the team In HACCP plan
2.1.1 10
titles and skills documented introduction
Skill sets are adequately distributed
2.1.2 10 Job classes should be well represented
amongst the team
Is there a written commitment from See Product Integrity Manual and place
2.1.3 10
senior management a copy of the management commitment
 in the HACCP plan binder.

HACCP co-coordinator can

2.1.4 effectively perform required 100 See SGS training record.
tasks
HACCP team responsibility
2.1.5 10 Detail this in Intro to HACCP plan
delegated
Product described adequately for
2.1.6 10 See Form 1
all intended uses
All ingredients itemized with all
2.1.7 10 See Form 2
sources listed
Product and process flows
2.1.8 adequately described with 100 See form 3
schematics or illustrations
0

2.2 Hazard Analysis

Point Deducted
Ref. No. Criterion Comments
Value Score
Listing of process steps is adequate
2.2.1 10
(no significant steps missed)
Raw material hazards considered
2.2.2 10 Commodity Listing, and Forms 5,6,7,8
adequately
Critical biological hazards Same forms
2.2.3 1000
considered adequately
Minor biological hazards
2.2.4 10 Same forms
considered adequately
Critical chemical hazards
2.2.5 1000 Same forms
considered adequately
Minor chemical / biochemical Same forms
2.2.6 10
hazards considered adequately
Physical hazards considered
2.2.7 adequately if applicable for market 10 Same forms
country
Secondary ingredients / process
2.2.8 10 Same forms
chemicals considered adequately
Cross contamination hazards
2.2.9 10 Same forms
considered adequately
Equipment hazards considered
2.2.10 10 Same forms
adequately
Adequate methods of reduction /
2.2.11 prevention / elimination are listed 1000 Same forms
for each critical hazard
Methods of reduction / prevention /
2.2.12 elimination are listed for each minor 10 Same forms
hazard
Achievable controls listed for each
2.2.13 10 Same forms
hazard
 Review & written approval of
preliminary step forms, hazard
analysis forms, CCP determination
and HACCP plan forms (all
2.2.14 10
components) by HACCP Co-
coordinator or superior other than
author of plan (plan author should
also sign the plan forms)
0
2.3 Establishment of Critical Control Points
Point Deducted
Ref. No. Criterion Comments
Value Score
Each point selected as a CCP
2.3.1 100 Form 10
justified by tree
CCP justified through validation or
2.3.2 10 Form 10
adequate study
No CCP's missed without
2.3.3 1000 Form 10 and Forms 5 to 8
adequate justification
All CCPs listed on hazard analysis
2.3.4 10 Forms 5 to 8
worksheet
Critical limits possible for all
2.3.5 100 Form 10
CCPs
All CCPs can be monitored
2.3.6 100 Form 10
accurately and consistently
Validation of all CCPs has been Product Integrity Manual provides
2.3.7 performed through testing or 10 much of the required resource
research backgrounding for validation.
0
 2.4 Establishment of Critical Limits and Operating Limits
Point Deducted
Ref. No. Criterion Comments
Value Score
Adequate CL present for each
2.4.1
control measure at a CCP 1000
Reliable sources or qualified
2.4.2
personnel used to establish CLs 10

CL's are accurately described and

specific to task being performed in
2.4.3 real operation time (not verification 10
analytical results or theoretical
outcomes)
Critical limits can be readily
2.4.4 100
measured consistently
Medication reconciliation CL
must be < or = 5% of daily use for
2.4.5 100
hand adds; < or = 10% for
fill/empty for bulk medications
0

2.5 Critical Control Point Monitoring

Point Deducted
Ref. No. Criterion Comments
Value Score
All parameters to be monitored
2.5.1 10 See Form 10
listed adequately at CCPs
All monitoring listed on HACCP
2.5.2 plan or plan refers to adequate 10 See Form 10
SOP
Monitoring procedure adequate
2.5.3 to control critical hazards or 1000 See Form 10
identify deviations adequately
Equipment to be used is described
2.5.4 10 See Form 10
adequately & is suitable for activity
Title of person monitoring &
2.5.5 verifying is listed on plan or in 10 See Form 10
accompanying SOP
If non-continuous, is monitoring
2.5.6 100 See Form 10
frequency adequate for CCPs
Monitoring method and frequency
2.5.7 adjusted in response to negative 10 See Form 10
findings (if any)
Monitoring SOP's present &
2.5.8 adequately detailed (all SOP 100 See Form 10
components included)
Corrective action required to be
2.5.9 taken if monitoring was 100 See Form 10
inadequate or if CL exceeded
 Review (routine verification)
2.5.10 required to be done promptly after 10 See Form 10
monitoring interval end
0

Maintain a Corrective Action Binder with documentation of Corrective Actions

2.6 Corrective Actions
Point Deducted
Ref. No. Criterion Comments
Value Score
Written corrective action (CA)
procedures available (at least
2.6.1 1000 See Form 10
general steps) for critical CL
deviations
Procedures are adequate &
2.6.2 100 See Form 10
contain all SOP criteria
If used, predetermined CA
2.6.3 procedures are listed in HACCP 10 See Form 10
plan
Personnel to be involved + extent of
2.6.4 authority defined in plan or related 10 See Form 10
SOP's for CA's
Determination &
identification/isolation
2.6.5 100 See Form 10
procedures for affected product
are included in plan or SOP's

Product disposition options (at

2.6.6 least general steps) are adequate 100 See Form 10
& listed in plan or related SOP's

2.7 Internal Verification of the HACCP Program

Deducted
Ref. No. Criterion Value Comments
Score
HACCP plan or plant procedures
require internal GMP/HACCP
2.7.1 system audit to be performed 1000 See internal audit
once within each 12 month
period at minimum

On site observations on HACCP

2.7.2 100 See SGS audit.
required during verification audit

Internal staff interviews &

performance appraisals required
by verification procedures to
2.7.3 100
demonstrate staff can perform all
feed safety related tasks
adequately to control hazards
 Random, adequate record review
required by verification
procedures to demonstrate staff
2.7.4 100
can perform all feed safety
related tasks adequately to
control hazards
Adequate testing of equipment
2.7.5 listed in verification procedures or 10 See Form 10
HACCP plan
Rotational random sampling &
testing scheduled in writing as part
of annual verification (e.g. See Product Integrity Manual
2.7.6 10
medication levels/residues, requirements
Salmonella, mycotoxins, heavy
metal testing)
Review of validation data included
2.7.7 in the verification procedures or 10
HACCP plan
Procedure in place to document
2.7.8 inadequacies found through 100 Corrective Action log for audits.
internal audit
Procedure present to discuss
2.7.9 inadequacies found through internal 10 CA SOP
audit
Audit records templates adequately
2.7.10 detailed & contain all required 10 See HACCP plan binder required info.
information
Repeat of verification stipulated to
verify corrective actions on
2.7.11 10
deviations found through internal
audit
0
 2.8 Record Templates
Point Deducted
Ref. No. Criterion Comments
Value Score
All the following record
templates are structured with
adequate information Use standard forms in Hyperlinks
2.8.1
requirements, spaces for and should be no problem with 2.8
operation & reviewer sign
off/date:
2.8.2 Records of preliminary steps 10
2.8.3 HACCP team records 10
2.8.4 Plant schematics 10
2.8.5 All flow diagrams 10
Product descriptions &
ingredients listed adequately
2.8.6 (ideally source companies 100
listed), including special market
regulations or requirements
2.8.7 Supplier review 10
2.8.8 Hazard analysis worksheet 100
2.8.9 HACCP plan & support documents 10
2.8.10 CCP monitoring records 100
2.8.11 CL records or data listing 100
2.8.12 Process deviation / CAR 100
2.8.13 Records of HACCP team meetings 10
2.8.14 Hold / release memos 10
2.8.15 Validation data 10
2.8.16 Verification audit records 100
0
HACCP Plan
Point Deducted
Ref. No. Criterion Comments
Value 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
Total deducted -
Module 2 0

The following items are included in the Binder for this section at Camrose-As with each section
this is only an example. Your records may be different and your requirements different. :
Purchasing SOP, Examples of Vendor Records in NIS, Grease Specification for Food Grade in
Pellet Mills or where food or feed contact is significant., Freight Vendors, Ingredient Suppliers
listing, Restricted Use Protein Product compliance from suppliers,
 CAN Specification Manual for equipment, MRO listing of equipment suppliers,HACCP-Forms-
Letter Requesting Adequate Cleanout of Conveyance.doc, Terms and conditions of purchases,
Receiving Ticket Procedure, Receiving Ticket example, Scaling Procedures, Driver Safety Rules
and signoff sheet, Bulk Receiving and Storage SOP, Bulk Receiving PIS form, Arrival Recap from
NIS, distributor control form if used, Housekeeping Plant, Daily Receiving Record, Grain transfer,
Rail Car SOP, Bulk Receiving Tests, Energy Package Testing Schedule, Liquids SOP, Bag
Receiving and Storage SOP, Returned Feed Policy, Bagged Check Weight Schedule, Branch
Month-End Accounting checklist, Bag Receive PIS, Packaging SOPs, examples of formulas and
labels, Inventory Rotation SOP,
Bag loadout SOP, bag warehouse shipping control sheet, Signoff by customer on TLO, Bulk
Loadout SOP, Daily Loadout Sheet, Schedule B trucking contracts, Finished Feed Quality SOP,
PDI test Procedure-Product Integrity Manual, Retained Samples SOP, Bulk Receiving Sampling,
Receiving Ticket showing Red Box, Black Box, Textured Loadout SOP
Elevator Receiving and Storage SOP, Elevator Check Sheet, Daily Receiving Record, Mill Check
Sheet for BSE questions-same as elevator check sheet, Aflatoxin Testing SOP, Salt SOP

3.1 Receiving, Raw Materials, Transportation & Storage

Point Deducted
Ref. No. Criterion Comments
Value Score
Receiving process observations
3.1.1 10
adequate
Receiving personnel performing
3.1.2 critical activities as listed in plan 100
or SOP's
Receiving records show that
validated SOP is followed after
3.1.3 100
prohibited material is received if
received in common line
Receiver is aware of incoming raw
3.1.4 material hazards that are under 10
his/her control
Receivers check for visual hazards
3.1.5 on trucks or raw materials before 10
accepting into facility

Reference samples are readily

3.1.6 available to the receiver to do raw 10
material visual comparisons

Receiver inspects certificates of

analysis as required prior to
3.1.7 10
accepting products requiring such
shipment certification
Carrier company records in place &
3.1.8 for safe transport & control of cross 10
contamination
Truck inspection report
3.1.9 completed diligently on each 100
shipment & verified
Raw materials checked as required
3.1.10 10
by HACCP plan or SOP
 Approval to use from QC or
3.1.11 purchasing prior to acceptance if 10
required by SOP
Raw material lot numbers
recorded on every batch of raw
materials received, at least on
every item potentially impacting
feed safety. NOTE: All drug
(Category I and II) receiving
record MUST contain the
3.1.12 100
following information: drug
identity, (including potency),
manufacturer, lot number,
expiration date, condition (note
received in good condition or list
discrepancies), date, initialed by
receiver
0
Camrose Manufacturing Controls and Documentation Binder includes the following
documentation as an example of required documents: Formulation SOP, Veterinary Prescriptions,
Sample Formula with approvals, Formulation requests, Shortmix SOP, Mixing Sheets, Drug
Addition SOP, Daily Medication List, Division Sulfamethiazine Policy, Drug and Premix Usage ,
Drug Reconciliation SOP, Month end Cutoff, QC82 example from drug trax, QC83 example from
Drug Trax, QC84 example from Drug Trax, Stranded Kegs SOP (not applicable in all locations
unless multiple shortmixes prepared in advance), Mixing Procedures SOP, Mixing Distributor
checklist, Residue Test Request, Drug Warning Listing, Repete Procedures, Mixing Steps
Procedures, Formula Guidelines for Product Quality, Mixing Process Improvement Form, Drug
Assay form example, Rework(rerun) SOP, Return Record form, Return record mixing sheet
investigation, formulas using commodity code (x) example, Packaging SOP, Packing Process
Improvement Form, Pelleting SOP, Pelleting Distributor Checklist, Die Change critical task, Roll
Adjust critical task, Pellet Mill Disconnect Procedure, Pellet Mill Plug Critical Task, PDI test
procedure, Grinding SOP, Grinding Process Improvement Form, Grinder Inspection SOP, QA
Ingredient Testing SOP, QA Medicated Feed Testing SOP, QA Finished Feed Testing SOP,
Record Retention Policy,
 3.2 Process Inspection & Monitoring
Deducted
Ref. No. Criterion Value Comments
Score
Critical equipment, especially
medication weighing scales, are
3.2.1 operating within acceptable 100
limits; usage follows HACCP
plan or SOP
Equipment set-up adequate
3.2.2 according to plan or SOP 10
requirements
Equipment & personnel meet
3.2.3 10
requirements of plan or SOP's
Process steps follow procedures,
including formulation and
label/tag procedures, in all
critical respects. Specifically: the
semi-annual tag code listing is used
and has changes noted & there are
no obsolete tags, including sales
3.2.4 coordinators bulk supply for bulk 100
feed (USA only), tags are stored
and organized to prevent mix-ups,
tag storage area is clean and well
lighted, plant has an approved tag
file showing proper approvals
(signatures and date on each tag),
bags/tags are coded legibly.
Formulation properly considered
quality/strength of ingredients as
3.2.5 10
judged from a random check of 10
ingredients
Each medicated ingredient hasits
own clean, labeled scoop for the
weighing operation. Common
3.2.6
scoops used for other micro
ingredients are kept clean with no
visible build up or residue.
Each prepared micro addition is
clearly labeled with individual tags
3.2.7 identifying the formula and batch
they belong t0 (e.g. product 4053; 1
of 4).
Other activities performed as per
3.2.8 10
SOP's or plan
Personnel can do critical tasks
3.2.9 adequately (observations + 100
questioning)
Personnel adequately aware of
3.2.10 100
CL's & first steps of CA
 Monitoring & recording adequate
3.2.11 100
and as plan
Staff duty delegation/qualifications
3.2.12 10
listed in plan
Monitoring performed at
3.2.13 100
prescribed time and frequency
Operator knows location of
3.2.14 10
instrument
Monitoring reflects real situation
3.2.15 (appropriate description of data, 10
operator & devices)
Critical records for prerequisite
programs (training, calibration,
mock recall, mixer validations)
are completed & reviewed
3.2.16 100
adequately, showing proper
completion times, data &
signatures/dates of operator &
reviewer or verifier

Critical process records for both

prerequisite programs & HACCP
plan are completed adequately at
3.2.17 100
CCPs (live & archived records)
showing proper completion
times, data & signatures/dates
Critical HACCP records reviewed
adequately & at adequate
3.2.18 100
frequency, with verifier
signatures/dates listed
Production formula book/batch
controller agrees with master
formula book. All formulas are
initialed by both the Admin and
3.2.19 Plant Manager or approved 10
alternates before input to
production. A written policy is in
place covering formula approval
and implementation.

Discontinued formulas (including

3.2.20 custom mixes and tags) are kept for 10
12 months after being discontinued.

Standardized Process Improvement

Sheets are being used and are
3.2.21 10
being filled out completely &
accurately.
Daily production records are
3.2.22 reviewed daily and endorsed by a 10
responsible person.
 Plant formulas (including custom
mix) contain the following
information: product identification,
3.2.23 10
typewritten only, date into
production, date discontinued and
initials of responsible person.
All run lengths, bag and bulk are
reconciled to 3% (maximum of
3.2.24 2,000 lbs) and endorsed. Any 10
discrepancies are investigated and
document. (Check 5 day record)

A copy of the current annual

registration of drug establishment
3.2.25 (FDA Form 2656E) and federal 10
Feed Mill License are displayed at
the U.S. facility (USA only)

Magnets are inventoried and a

3.2.26 cleaning frequency is established 10
and cleaning documented.
Other process records related to
the prerequisite or feed safety
programs are completed &
3.2.27 reviewed adequately (live & 10
archived records) showing proper
completion times, data &
signatures/dates
0
 3.3 Sampling Sampling Procedures.doc
Deducted
Ref. No. Criterion Value Comments
Score
Random samples taken for
testing in compliance with
prescribed schedule, including
random medication/contaminant
Product Integrity Manual describes
residue tests on finished product
3.3.1 100 our Testing and Sampling procedure
& flush material + samples tested
and requirements in detail.
at least annually to verify flush
procedure is effective. At least
one sample of each critical
bagged ingredient is taken.
Durability standards have been
established for critical feeds. Must
be documented (Check past
3.3.2 month). Location has a 10
documented procedure detailing
action to be taken when a PDI falls
outside the standard.
The plant should have at least a 12
consecutive month record on
3.3.3 pellet cooler moisture checks. 10
Deviations are investigated and
documented.
Ground grain particle score is
measured and meets location
standards. Where formulation is
tied to particle score, (e.g. ground
corn NEV) the test results are
3.3.4 logged and match formulation 10
system specifications. The testing
frequency is included in the plants
analytical schedule and
documentation verifies tests are run
per schedule.
Specific standards are set for
steam rolled grain moistures and
3.3.5 10
tests document results meet
standard.
A drug assay schedule (in QA
manual) has been developed and is
3.3.6 being used (schedule attached). All 10
Category II drugs must be included
in U. S. plants.
Each Category II drug has three in
tolerance assays over the revious
3.3.7 10
12 months which are dispersed
throughout the year. (USA only)
 If an assay is not in tolerance,
subsequent batches must be
3.3.8 10
assayed to verify the plants ability
to correctly manufacture the feed.
All out of tolerance drugs (Category
I and II, including state assays)
have been investigated, dated and
3.3.9 10
initialed by the Plant/Branch
Manager on the Drug Control
Record (QA-80)
Validation testing performed
adequately and at minimum
3.3.10 10 same
annually to support mixing, flush or
sequencing procedures
Test results reviewed internally with
sign offs/dates + adequate
3.3.11 corrective action taken/documented 10 same
if tests or data were not within
acceptable limits
0

Corrective Action Binder for Camrose includes the following: explanation of reason for binder.
Keep a record of all CAs and manage follow-up. Keep for 2 years, concentrate on Food Safety
related CAs or Quality related that could lead to Food Safety issues, You could also keep a CA
log. Show actual CA. GMP/HACCP Audit-Corrective Actions Example, Updated Procedures
associated with Corrective Actions, Corrective Action Form, Food Safety Near Miss Report,

3.4 Corrective Actions

Deducted
Ref. No. Criterion Value Comments
Score
All prerequisite program corrective
actions completed as per SOP or
promptly enough to maintain control CRITERIA FOR STANDARD
3.4.1 10
over feed safety, with adequate OPERATING PROCEDURES.doc
documentation & verification (sign
offs for all stages)

All critical prerequisite program

or HACCP program corrective
actions completed within time
frames specified by SOP or
HACCP plan or promptly enough
3.4.2 to maintain control over feed 1000
safety. If deviations occurred
prior to certification, new
procedures have been
implemented, documented &
trained to prevent recurrence.
 Missing information or non-
HACCP audit deficiencies have
compliant signatures on CAR's
Corrective action records. Internal
or other critical records led to
3.4.3 100 audits should record deficiencies and
initiation of CA & CAR &
show corrective action
documented retraining of staff
documentation.
involved
Corrective action is documented if 2
3.4.4
consecutive protein assays fall in
the yellow range, or if any assay
falls in the red range.
Missing or inadequate signatures
on other records within the feed
3.4.5 10
safety program led to corrective
actions & retraining (documented)
Deviant data & description of
3.4.6 10
problem documented adequately
Date and time of incident listed Best to use the CAR form listed
3.4.7 100
on all CAR's above
Name & signature of monitor listed
3.4.8 10
on all CAR's
Name & signature of personnel
notified & making decisions meet
3.4.9 100
requirements of HACCP plan or
related SOP's
All affected product & lot
3.4.10 description listed adequately on 10
records
Description of hazard is adequate
3.4.11 10
in records
Nature of action taken to fix
3.4.12 problem described adequately in 10
records
All mandatory information listed
on records as required by
3.4.13 100
regulations or by Cargill Animal
Nutrition.
Separate file maintained for
3.4.14 corrective actions (internal & 10
customer complaint related)
Affected product disposed
3.4.15 correctly + disposition is 100
adequately detailed in records
Missing CA's or CAR's triggered
3.4.16 retraining of operators & reviewers 10
(documented)
Corrective action verified to be
effective & complete before final
3.4.17 10
approval closure signature placed
on CAR
 CAs triggered review of HACCP
3.4.18 10
plan
3.4.19 CAs listed for future reference 10
HACCP team decision not
3.420 overruled without objective 1000
justification
0

3.5 Verification Procedures

Deducted
Ref. No. Criterion Value Comments
Score
Hazard analysis & HACCP plan
3.5.1 verified with adequate 100
documentation
3.5.2 Validation data verified at audit 10
Targeted sampling performed as
3.5.3 required by regulatory agencies or 10
SOP/plan
Calibration verified on all devices
3.5.4 10
related to feed safety control
Check of critical limits during audit
3.5.5 to ensure feasible & compliant with 10
requirements of FDA/Codex/CFIA
Random record sampling
3.5.6 performed at audit to ensure 10
completion & review was adequate

3.5.7 Missing corrective actions recorded 10

Verification documented when CA

3.5.8 10
was not done
3.5.9 All inadequate CA documented 10
3.5.10 All late CA documented 10
Documented if problems not lead to
3.5.11 10
review?
Evaluation of previous verification
3.5.12 audits performed to ensure CA's 10
were complete
Verification performed in
compliance with HACCP plan or
audit SOP, including critical SOP
3.5.13 review, random record review, 100
label and formulation review,
staff interviews & site walk
through (all documented)
Appropriate methods used for
3.5.14 10
verification
Qualified personnel used for
3.5.15 10
validation
 Validation data adequate for
3.5.16 10
HACCP plan
Documentation of deviations found
3.5.17 during audit was adequate, with CA 10
log generated
Verification audit report
completed adequately, reviewed
3.5.18 100
promptly & signed/dated by
auditor & reviewer

Verification repeated when changes

3.5.19 10
occurred or new info received
All feed safety program related
3.5.20 records retained for period 100
required by REGULATORY
0

Feed Safety Program Compliance

Point Deducted
Ref. No. Criterion Comments
Value Score
Receiving, Raw Materials,
3.1 0
Transportation & Storage
3.2 Process Inspection & Monitoring 0
3.3 Sampling 0
3.4 Corrective Actions 0
3.5 Verification Procedures 0
Total deducted - 0
Module 3

Procedures and Records Reviewed with this Audit

Procedures and Records reviewed during this audit will be selected from the list below:
Note: If the date listed is not applicable, please provide records for the nearest date to that listed

Dates Sampled (List Specific Descriptions or Titles of Records Sampled

Dates Sampled for randomly
selected records or state which,
if any, of the listed documents
were NOT sampled on this audit
prior to submission to auditor)
Current GMP Manual or Prerequisite Program Manual with all SOP's & work
instructions for all key prerequisite programs: Premises
(exterior/interior), lighting/waste/water, equipment maintenance &
calibration, training & hygiene, receiving/transportation/storage,
cleaning, flushing/sequencing, packaging/tagging, general processing,
recall program & record keeping procedures

Current HACCP Plan Forms including:

Product description, labeling, storage & use - Form 1
Ingredients Used - Form 2
Product & process flow diagrams - Form 3
Plant schematics & utility/waste/personnel flow - Form 4
Hazard Analysis/CCP Determination - Forms 5-8
Hazards not under facility control - Form 9
HACCP Plans (including critical limits, monitoring, corrective
actions/deviation procedures, verification & record keeping - Form
10
Current Pest control program including:
Schematic of trap and bait station locations
Insurance certificate and licenses (company and technician)
Pesticide labels and MSDS sheets
Inspection Reports, Sighting Logs & Corrective Actions
Licenses - Company and technician
Current Security/Plant Access/Emergency procedures
6-8 days randomly spaced over the GMP Records: Premises exterior/interior/lighting/waste/water
last 12 months or since last SGS inspections, equipment maintenance & calibration checks (scales),
audit personnel training & hygiene, receiving/transportation/storage, cleaning,
flushing/sequencing, prerequisite program corrective actions
6-8 days randomly spaced over the Incoming goods/truck inspection records. Carrier declarations certifying
last 12 months or since last SGS non-contamination, (especially with respect to prohibited material), and
audit + current carrier certification cleaning
file.
Last 12 months Mixer validation reports & follow up on each mixer used in processing
feeds containing prohibited material or medications
Last 12 months Scale calibrations for all medication hand add or bulk medication scales
(external certified or traceable competent calibration personnel used).
Calibration records for any other equipment important to maintaining
feed safety at CCP's or critical prerequisite steps
Last 12 months Documented results of mock recalls conducted within the past 12
months
Last 12 months Training records for GMP and HACCP. At minimum, records for HACCP
Co-coordinator, lead hands and all CCP or critical prerequisite program
related operators
6-8 days randomly spaced over the HACCP program documentation and applicable records, including CCP
last 12 months or since last SGS monitoring records and corrective action file/records
audit
Current year's file Corrective action records & follow up action records for HACCP plan &
prerequisite program deviations
Current year's file Customer complaint file with corrective or follow up action records
Last 12 months Internal Audit Reports & Reverification Reports
Last 12 months Last regulatory/3rd party inspection report
Last 2 months Raw Material, Medication Residue/Prohibited Material/Flush Tests &
Finished product-testing results
Current Ingredient Specification File