GMP Audit v14.

09 Scope Outline

Audit #: _______________________________ Start Time: _______________________

Date: __________________________________ End Time: ________________________

Auditor Name: _______________________________________________________________________________

Facility Name: ______________________________________ FDA Registration #: ________________

Customer: ___________________________________________________________________________________

Location: ____________________________________________________________________________________

GPS: ________________________________________________________________________________________

Approximate Size of the Facility (ft²or m²): _______________________________________________________

Season Duration: _____________________________________________________________________________

Commodities Observed: _______________________________________________________________________

Additional Commodities: ______________________________________________________________________

Supervisor: __________________________________________________________________________________

# of Employees: ______________________________________________________________________________

Product washed or hydrovaced: ________________________________________________________________

Wet/High Humidity Storage: ___________________________________________________________________

Cooling Equipment Audited: ___________________________________________________________________

Lines Audited: _______________________________________________________________________________

Audit Scope (& any exclusion): _________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

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 PRIMUSLABS V14.09 GMP AUDIT
Checklist

GOOD MANUFACTURING PRACTICES - SECTION 1

Category # Question Total Recommendations
Points
1.1.1 There was no significant threat to the safety 15
of the product that may be considered
critical and warrants an automatic failure?
Explain. ANY DOWN SCORE IN THIS
QUESTION RESULTS IN AUTOMATIC
FAILURE OF THE AUDIT.

Storage Areas 1.2.1 Are all chemicals (pesticides, sanitizers, 15

& Packaging detergents, lubricants, etc.) stored securely,
Materials safely and are they labeled correctly?

Storage Areas 1.2.2 Are "food grade" and "non-food grade" 10

& Packaging chemicals used appropriately, according to
Materials label and stored in a controlled manner?

Storage Areas 1.2.3 Are ingredients (including ice), products, and 15

& Packaging packaging stored to prevent cross
Materials contamination (this includes iced product
pallets stored above pallets of product without
adequate protection as well any allergen cross
contamination issues)?
Storage Areas 1.2.4 Is the storage area completely enclosed? 10
& Packaging
Materials

Storage Areas 1.2.5 Is the facility's use restricted to the storage of 5

& Packaging food products?
Materials

Storage Areas 1.2.6 Are rejected or on hold materials clearly 10

& Packaging identified and separated from other materials?
Materials

Storage Areas 1.2.7 Are raw materials, work in progress, 15

& Packaging ingredients (including water and ice),
Materials finished goods and food contact packaging
within accepted tolerances for spoilage and
free from adulteration? ANY DOWN SCORE
IN THIS QUESTION RESULTS IN
AUTOMATIC FAILURE OF THE AUDIT.

Storage Areas 1.2.8 Are all storage areas clean, especially the 10
& Packaging racking structures, lights, ceilings, floor areas
Materials by the walls and other hard to reach areas?

Storage Areas 1.2.9 Are materials (commodities, packaging, 5

& Packaging ingredients, processing aids, work in progress,
Materials etc.) properly marked with rotation codes
(receipt dates, manufacture dates, etc)?

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Storage Areas 1.2.10 Are materials (commodities, packaging, 5
& Packaging ingredients, processing aids, work in progress,
Materials etc.) rotated using FIFO policy?

Storage Areas 1.2.11 Are storage areas at the appropriate 10

& Packaging temperatures for the specific products being
Materials stored?

Operational 1.3.1 Does the process flow, facility layout, employee 15

Practices control, utensil control, internal vehicle use, etc.
ensure that finished goods are not
contaminated by raw materials?

Operational 1.3.2 Are all exposed materials (product, packaging, 15

Practices etc.) protected from overhead contamination
(e.g. ladders, motors, condensation, lubricants,
walkways, loose panels, degrading insulation,
etc.)?

Operational 1.3.3 Are packing and/or processing areas 15

Practices completely enclosed?
Operational 1.3.4 Are storage areas clean and well maintained; 15
Practices especially lights, floor areas by the wall and
equipment, and other hard to reach areas?

Operational 1.3.5 Is all re-work / re-packaging handled correctly? 10

Practices
Operational 1.3.6 Are raw materials examined before use? 5
Practices
Operational 1.3.7 Are finished products coded (carton and unit 10
Practices packaging) for the day of production?
Operational 1.3.8 Does finished product coding clearly link to 10
Practices supplier(s) of incoming materials? (Auditor
performs a live traceback test to verify
documentation reviewed for 2.4.1.)
Operational 1.3.9 Are foreign material control methods (e.g. 10
Practices metal detectors, metal traps, visual inspection,
etc.) in place? Are these systems regularly
tested (where relevant) to ensure proper
operation?
Operational 1.3.10 Does the facility use the appropriate test strips, 10
Practices test kits or test probes for verifying the
concentrations of anti-microbial chemicals
(product washing water, terminal sanitizers, dip
stations, etc) being used and are they in
operational condition?

Operational 1.3.11 Are hand washing stations adequate in 15

Practices number, appropriate in location, in working
order, have warm water, adequately stocked
(e.g. disposable towels, soap, etc.) and
restricted to hand washing purposes only?

Operational 1.3.12 Are toilet facilities adequate in number and 15

Practices location and are they adequately stocked (e.g.
toilet paper, disposable towels, soap, etc.)?

Operational 1.3.13 Are secondary hand sanitation stations (e.g., 5

Practices touch-free dispensers) adequate in number and
location? Are the stations maintained properly?

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 Operational 1.3.14 Are foot dip stations adequate in number and 3
Practices location? Are the stations maintained properly?

Operational 1.3.15 Are single service containers used for their 5

Practices intended purpose only so that potential cross
contamination is prevented?

Operational 1.3.16 Are re-usable containers clean and clearly 10

Practices designated for the specific purpose (raw
product, finished product, re-work, ice, trash,
etc.) such that cross contamination is
prevented?
Operational 1.3.17 Are food safety measuring devices working 3
Practices properly and calibrated (where applicable)?

Employee 1.4.1 Are employees washing and sanitizing their 15

Practices hands before starting work each day, after
using the restroom, after breaks and whenever
hands may be contaminated?

Employee 1.4.2 Are employees’ fingernails clean, short and 5

Practices free of nail polish?
Employee 1.4.3 Is there no sign of any employees with boils, 10
Practices sores, open wounds or exhibiting signs of
foodborne illness working in indirect or direct
contact with food?
Employee 1.4.4 Are first aid kits adequately stocked and readily 5
Practices available? Are blue metal detectable
waterproof band aids used?
Employee 1.4.5 Are employees wearing effective hair 10
Practices restraints?
Employee 1.4.6 Is jewelry confined to a plain wedding band and 3
Practices watches are not worn?
Employee 1.4.7 Are all employees wearing outer garments 10
Practices suitable for the operation (e.g. smocks, aprons,
sleeves and non-latex gloves)?

Employee 1.4.8 Do employees remove protective outer 5

Practices garments e.g. smocks, aprons, sleeves and
gloves when on break, before using the toilets
and when going home at the end of their shift?

Employee 1.4.9 Is there a designated area for employees to 5

Practices leave protective outer garments e.g. smocks,
aprons, sleeves and gloves when on break and
before using the toilets?

Employee 1.4.10 Employees personal items are not being stored 5

Practices in the production or material storage areas?

Employee 1.4.11 Is smoking, eating, chewing and drinking 10

Practices confined to designated areas; spitting is
prohibited in all areas?
Employee 1.4.12 Are all items removed from garment (smock, 3
Practices shirt, blouse, etc) top pockets?

Equipment 1.5.1 Are food contact equipment surfaces free of 15

flaking paint, corrosion, rust and other
unhygienic materials (e.g. tape, string,
cardboard, etc.)?

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 Equipment 1.5.2 Are non-food contact equipment surfaces free 10
of flaking paint, corrosion, rust and other
unhygienic materials (e.g. tape, string,
cardboard, etc.)?
Equipment 1.5.3 Does equipment design and condition (e.g. 15
smooth surfaces, smooth weld seams, non-
toxic materials, no wood, or other absorbant
materials) facilitate effective cleaning and
maintenance?
Equipment 1.5.4 Are thermometers (independent of thermostat 5
probes) present in all coolers and freezers?

Equipment 1.5.5 Are all thermometers non-glass and non- 10

mercury?

Equipment 1.6.1 Are food contact equipment surfaces clean? 15

Cleaning
Equipment 1.6.2 Are non-food contact equipment surfaces 10
Cleaning clean?
Equipment 1.6.3 During cleaning are foods and packaging 15
Cleaning protected from contamination?
Equipment 1.6.4 Are cooling units including coils in coolers and 5
Cleaning freezers clean and free of aged, dirty ice?

Equipment 1.6.5 Are all fan guards dust-free and the ceiling in 5
Cleaning front of the fans free of excessive black
deposits?
Equipment 1.6.6 Is stored equipment that is not used on a daily 10
Cleaning basis stored in a clean condition with food-
contact surfaces protected and/or are they
retained on cleaning schedules in some
manner, even though they are not in use?

Equipment 1.6.7 Are all utensils, hoses, and other items not 10
Cleaning being used stored clean and in a manner to
prevent contamination?
Equipment 1.6.8 Are maintenance tools that are used in the 3
Cleaning production and storage areas of the facility
clean, sanitary and corrosion free?

Equipment 1.6.9 Are excess lubricants removed from the 5

Cleaning equipment and are lubricant catch pans fitted
where needed?

General 1.7.1 Are spills cleaned up immediately? 10

Cleaning
General 1.7.2 Are waste and garbage frequently removed 5
Cleaning from packing and storage areas?

General 1.7.3 Do floor drains appear clean, free from odors 5

Cleaning and well maintained?
General 1.7.4 Do high level areas including overhead pipes, 10
Cleaning ducts, fans, etc. appear clean?
General 1.7.5 Are plastic strip curtains maintained in a good 5
Cleaning condition, kept clean and mounted so that the
tips are not touching the floor?

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 General 1.7.6 Does personal protection equipment (PPE) for 3
Cleaning the sanitation crew meet label requirements of
chemicals used; is it in good condition and
stored to prevent cross contamination to raw
materials, work in progress, ingredients,
finished goods and packaging?

General 1.7.7 Is cleaning equipment maintained clean and 10

Cleaning stored properly?
General 1.7.8 Is cleaning equipment identified in order to 10
Cleaning prevent potential cross contamination issues
e.g. production, maintenance, outside,
restroom equipment?
General 1.7.9 Are all items used for sanitation appropriate for 5
Cleaning their designated purpose? (no steel wool, metal
bristles, etc.)
General 1.7.10 Are toilet facilities and hand-wash stations 15
Cleaning clean?
General 1.7.11 Are employee break facilities clean, including 5
Cleaning microwaves and refrigerators? No rotting or out
of date foodstuffs?
General 1.7.12 Is the maintenance shop organized - i.e. 5
Cleaning equipment and spares stored in a neat and tidy
fashion?
General 1.7.13 Are internal transport vehicles (e.g. forklifts, 5
Cleaning bobcats, pallet jacks, trolleys, floor cleaners,
etc.), clean, do not emit toxic fumes and being
used in a sanitary manner?

General 1.7.14 Are shipping trucks clean and in good 5

Cleaning condition?

Pest Control 1.8.1 Are products or ingredients free of 15

insects/rodents/birds/reptiles/mammals or
any evidence of them? ANY DOWN SCORE
IN THIS QUESTION RESULTS IN
AUTOMATIC FAILURE OF THE AUDIT.

Pest Control 1.8.2 Are packaging supplies free of 15

insects/rodents/birds/reptiles/mammals or
any evidence of them? ANY DOWN SCORE
IN THIS QUESTION RESULTS IN
AUTOMATIC FAILURE OF THE AUDIT.

Pest Control 1.8.3 Are plant and storage areas free of 15

insects/rodents/birds/reptiles/mammals or any
evidence of them?
Pest Control 1.8.4 Is the area outside the facility free of evidence 10
of pest activity?
Pest Control 1.8.5 Does the operation have a pest control 15
program? ANY DOWN SCORE IN THIS
QUESTION RESULTS IN AUTOMATIC
FAILURE OF THE AUDIT.
Pest Control 1.8.6 Are pest control devices (inc. rodent traps and 10
insect light traps) located away from all
exposed raw materials, work in progress,
finished goods and packaging? Poisonous
rodent bait traps are not used within the
facility?

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 Pest Control 1.8.7 Are pest control devices maintained in a clean 5
and intact condition and marked as monitored
(or bar code scanned) on a regular basis?

Pest Control 1.8.8 Are interior and exterior building perimeter pest 5
control devices adequate in number and
location?
Pest Control 1.8.9 Are all pest control devices identified by a 5
number or other code (e.g. barcode) ?
Pest Control 1.8.10 Are all pest control devices properly installed 5
and secured?

Buildings and 1.9.1 Are signs supporting GMPs posted 10

Grounds appropriately?
Buildings and 1.9.2 Are all lights in the facility that could potentially 15
Grounds contaminate raw materials, work in progress,
ingredients (including ice), finished goods,
equipment or packaging shielded, coated or
otherwise shatter resistant to protect product
from contamination in the event of breakage?

Buildings and 1.9.3 Has the facility eliminated or controlled any 15

Grounds potential metal, glass or plastic contamination
issues?
Buildings and 1.9.4 Has the facility eliminated the use of wooden 5
Grounds items or surfaces?
Buildings and 1.9.5 Is there adequate lighting in the packing and 5
Grounds storage areas?
Buildings and 1.9.6 Are ventilation systems properly designed and 10
Grounds functioning to prevent product contamination
from condensation, mold, dust, odors and
vapors?
Buildings and 1.9.7 Are floor surfaces in good condition, with no 10
Grounds standing water, no debris trapping cracks and
are they easy to clean?
Buildings and 1.9.8 Are the floor drains where they are needed for 5
Grounds drainage and cleanup?
Buildings and 1.9.9 Are doors to the outside pest proof? 5
Grounds
Buildings and 1.9.10 Are dock doors fitted with buffers to seal 5
Grounds against trucks?
Buildings and 1.9.11 Are dock load levelers and shelters maintained 3
Grounds in a good condition, pest proof and debris free?

Buildings and 1.9.12 Are exterior walls free of holes to exclude 5

Grounds pests? Are pipes, vents, air ducts designed
and protected in order to prevent pest entry
e.g. by using fine mesh?

Buildings and 1.9.13 Are interior walls and ceilings free of cracks 5
Grounds and crevices to prevent pest harborage and
allow proper sanitation?
Buildings and 1.9.14 Where used in production, storage or 5
Grounds supporting areas do false ceiling areas have
adequate access to allow for inspection and
cleaning?
Buildings and 1.9.15 Is an 18" (46 cm) internal wall perimeter being 5
Grounds maintained within the facility, with adequate
access to these wall perimeters thereby
allowing inspection and cleaning?

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 Buildings and 1.9.16 Is the exterior area immediately outside the 5
Grounds facility free of litter, weeds and standing water?

Buildings and 1.9.17 Are control measures being implemented for 5

Grounds the storage of pallets, equipment, tires, etc.
(e.g. out of the mud, pipe ends capped,
stacked to prevent pest harborage, away from
building perimeter)?

Buildings and 1.9.18 Are pallets inspected to separate and replace 5

Grounds dirty or broken pallets?
Buildings and 1.9.19 Is the area around the dumpster/cull truck/trash 3
Grounds area clean?
Buildings and 1.9.20 Are outside garbage receptacles and 5
Grounds dumpsters kept covered or closed?
Buildings and 1.9.21 Are all water lines protected against back 5
Grounds siphonage?
Buildings and 1.9.22 Is the on-site laboratory (where applicable) 5
Grounds completely enclosed and separated from
production and/or storage areas?

FOOD SAFETY FILE REQUIREMENTS - SECTION 2

Category # Question Total Recommendations
Points
Management 2.1.1 Is the operation registered as a food handling 10
Systems establishment?
Management 2.1.2 Is there a documented food safety policy 5
Systems reflecting the organization's ongoing
commitment to providing a safe product?
Management 2.1.3 Is there an organizational chart showing who 3
Systems has food safety responsibilities and to whom
they report?
Management 2.1.4 Is there a designated person responsible for 10
Systems the food safety program?
Management 2.1.5 Is there a food safety committee and are there 5
Systems logs of food safety meetings with topics
covered and attendees?

Control of 2.2.1 Is there a written document control procedure 3

Documents and describing how documents will be maintained,
Records updated and replaced?
Control of 2.2.2 Are all records stored for a minimum period of 5
Documents and 24 months?
Records
Control of 2.2.3 Are food safety related documents and records 10
Documents and stored and handled in a secured manner?
Records Records recorded in permanent ink, not pencil;
errors single-lined through and initialed?

General File 2.3.1 Are there written Standard Operating 5

Requirements Procedures (SOPs) that detail work instructions
for activities ensuring food safety and Good
Manufacturing Practices?

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General File 2.3.2 Are there specific Standard Operating 10
Requirements Procedures (SOPs) for the changing and
testing of water and ice systems e.g. wash
systems, hydrovacuums, hydrocoolers, ice
making machines, ice injectors, etc?

General File 2.3.3 Is there a documented glass and brittle plastic 5

Requirements management policy and procedure (including
company glass and brittle plastic policy, glass
breakage procedure and where necessary a
glass register)?
General File 2.3.4 Are the SOPs available to relevant users and is 5
Requirements a master copy maintained in a central file (SOP
Manual)?

Traceability 2.4.1 Is there is a documented account that indicates 10

how the company product tracking system
works, thereby enabling trace back and trace
forward to occur in the event of a potential
recall issue?
Traceability 2.4.2 Does the facility have a documented recall 15
program including: procedures, recall team
roles, their contact details, external contact
listings and (in the USA) an explanation of
different recall classes?

Traceability 2.4.3 Is testing of recall procedures (including trace 10

back) performed and documented at least once
every six months? Can the company identify
where affected product was sent?

Traceability 2.4.4 Is there a written procedure for handling on 10

hold and rejected materials?
Traceability 2.4.5 Is there a documented system for dealing with 5
food safety complaints/feedback from
consumers and buyers along with records and
company responses, including corrective
actions?

Supplier 2.5.1 Are there written specifications for own grown 3

Control raw materials, purchased edible raw
materials/ingredients, packaging materials,
processing and sanitation chemicals?

Supplier 2.5.2 Are there written specifications for finished 3

Control goods?
Supplier 2.5.3 Is there a list of approved suppliers of 5
Control purchased raw materials/ingredients,
packaging materials and processing and
sanitation chemicals?
Supplier 2.5.4 Is there a written procedure for approval and 3
Control continued monitoring of suppliers of purchased
raw materials/ingredients, packaging materials
processing and sanitation chemicals?

Supplier 2.5.5 Does the facility have relevant third party audit 15
Control reports, supplier third party audit certifications
and/or supplier letters of guarantee for
purchased edible raw materials/ingredients,
packaging materials and processing
chemicals?

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 Supplier 2.5.6 Does the facility have relevant third party audit 10
Control reports, supplier third party audit certifications
and/or supplier letters of guarantee for
packaging items?

Chemicals 2.6.1 Are copies of all Materials Safety Data Sheets 5

(detergents, sanitizers, pesticides, etc.) on file
and fully accessible at all times with clear
indexes?

Chemicals 2.6.2 Are there copies of specimen labels for 5

chemicals used, where the full label is not
immediately accessible e.g. rodent chemicals,
product sanitizers?
Chemicals 2.6.3 Is there a chemical inventory and/or usage log? 3

Pest Control 2.7.1 Is there a documented pest control program, 15

including a copy of the contract with the
extermination company (if used), Pest Control
Operator license(s) (if baits are used) and
insurance documents?
Pest Control 2.7.2 Is there a schematic drawing of the plant 10
showing numbered locations of all traps and
bait stations, both inside and outside the plant?

Pest Control 2.7.3 Are service reports created for pest control 10
checks detailing inspection records, application
records, and corrective actions of issues noted
(in-house and/or contract)?

Internal and 2.8.1 Are there written procedures for handling 3

External regulatory inspections?
Inspections
Internal and 2.8.2 Are there records of regulatory inspections 5
External and/or contracted third party inspections,
Inspections company responses and corrective actions, if
any?
Internal and 2.8.3 Is there a program for periodic facility/GMP 10
External internal (self) inspections and are records
Inspections maintained detailing corrective actions?

Internal and 2.8.4 Is there a program for periodic inspections of 5

External food safety system records e.g. pest control
Inspections records, temperature control records, sanitation
records, maintenance records, etc.?

Internal and 2.8.5 Is there a daily pre-operation inspection log? 5

External
Inspections
Internal and 2.8.6 Does the facility have incoming goods (raw 5
External materials, ingredients and packaging materials)
Inspections inspection data?
Internal and 2.8.7 Are there inspection logs on incoming trailers 10
External for rodents and insects, cleanliness, holes and
Inspections temperature control?

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 Internal and 2.8.8 Is there an incidents report (sometimes called 5
External a Notice(s) of Unusual Occurrence and
Inspections Corrective Actions Log (NUOCA)) used for
recording infrequent and/or unusual events?

Internal and 2.8.9 Is there a current certificate of inspection for 3

External backflow prevention assemblies on water lines
Inspections entering the facility?

Process Control 2.9.1 Are there records for the necessary process 10
monitoring activities (e.g. pH, water
temperature, heating processes, etc.) showing
the monitoring frequencies, results and where
necessary the corrective actions?

Process Control 2.9.2 Are there records (with corrective actions) that 10
show anti-microbial (e.g. free chlorine, ORP,
peracetic acid) strength testing of wash water
and ice solutions prior to start up and
throughout the production runs?

Process Control 2.9.3 Are there records (with corrective actions) that 3
show anti-microbial strength testing of
hand/foot/tool dip stations? Are there stock
check and replenishment records for gel and
spray stations?
Process Control 2.9.4 Is there a tool accountability program for knives 3
and similar cutting hand tools used in the
production process?
Process Control 2.9.5 Are there written procedures for the set-up, 10
calibration, maintenance and verification of
foreign material control systems e.g. metal
detectors?
Process Control 2.9.6 Are there equipment calibration procedures 10
and records for pH meters, ORP meters,
thermometers and other measuring equipment
related to the food safety of the product?

Maintenance & 2.10.1 Does the facility have a preventative 10

Sanitation maintenance program and with a documented
schedule?
Maintenance & 2.10.2 Is there a log of maintenance work or repairs 10
Sanitation ordered and is it signed off on work completed?

Maintenance & 2.10.3 Are there logs showing that equipment is 5

Sanitation cleaned and sanitized after maintenance work
has been completed?
Maintenance & 2.10.4 Is there a written cleaning schedule (Master 10
Sanitation Sanitation Schedule) that shows what and
where is to be cleaned and how often?

Maintenance & 2.10.5 Are there written cleaning and sanitation 10

Sanitation procedures (Sanitation Standard Operating
Procedures) for the facility and all equipment?

Maintenance & 2.10.6 Are sanitation logs on file that show what 5
Sanitation cleaning was done, when and who carried out
the cleaning?
Maintenance & 2.10.7 Are there records showing verification of 5
Sanitation cleaning chemical concentrations?

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Maintenance & 2.10.8 Are there documented procedures and 5
Sanitation completion records for clean-in-place (CIP)
activities, where applicable (e.g. cleaning re-
circulating water systems such as washing
flumes, ice injectors, hydrocoolers, ice makers,
etc.)?
Maintenance & 2.10.9 Is there a log indicating that floor drains are 5
Sanitation cleaned on a regular basis (minimum daily in
wet and fresh-cut production areas)?

Maintenance & 2.10.10 Are there records showing cooling units are 10
Sanitation serviced and cleaned at least every 12 months
or more frequently as required?

Maintenance & 2.10.11 Is there a routine program and written 5

Sanitation procedure to validate sanitation effectiveness
on food contact surfaces using ATP
bioluminescence testing?

Personnel 2.11.1 Are there records of new employee food safety 10

(GMP) orientation training (with topics covered
and attendees) and are new employees
required to sign the company’s food safety
hygiene and health policy?

Personnel 2.11.2 Are there logs of ongoing employee food safety 10

education training with topics covered and
attendees?
Personnel 2.11.3 Are there written procedures in place that 3
require food handlers to report any cuts or
grazes and/or if they are suffering any illnesses
that might be a contamination risk to the
products being produced? (Verbal confirmation
accepted.)

Personnel 2.11.4 Is there a documented training program with 5

training logs for the sanitation employees
including best practices and chemical use
details?
Personnel 2.11.5 Are visitors and contractors required to sign a 3
log stating that they will comply with the
operations’ personal hygiene and health
policies?
Personnel 2.11.6 Is there an employee non- 3
conformance/disciplinary action procedure?
(Verbal confirmation accepted.)

Testing 2.12.1 Are there records of routine equipment 10

microbiological testing?
Testing 2.12.2 Are there records of routine environmental 10
microbiological testing?
Testing 2.12.3 Are there routine microbiological tests on water 10
used in the facility (sampled from within the
facility)?
Testing 2.12.4 Are there routine microbiological tests on ice 5
used in the facility (either produced in-house or
purchased)?
Testing 2.12.5 Do laboratory test results indicate test 5
procedures meet accepted standards?

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 Testing 2.12.6 Where testing has been performed for any 5
reason, (e.g. buyer requirements) does the
testing meet all the specification requirements
(e.g. type of test, test frequency, test
methodology, thresholds, corrective actions,
etc.) and are proper records of tests with formal
corrective actions being maintained?

Temperature 2.13.1 Are there records of final product temperature 10

Controlled checks for temperature sensitive product?
Storage &
Distribution
Temperature 2.13.2 Are there temperature logs for the 5
Controlled packing/processing room (if refrigerated)?
Storage &
Distribution
Temperature 2.13.3 Are there temperature logs for storage rooms? 5
Controlled
Storage &
Distribution
Temperature 2.13.4 Are there records of shipping truck temperature 5
Controlled checks, indicating that the truck was pre-cooled
Storage & prior to loading?
Distribution
Temperature 2.13.5 Are there sanitary condition logs for shipping 10
Controlled trucks (cleanliness, trailer condition, odor,
Storage & etc.)?
Distribution

HACCP PROGRAM AUDIT - SECTION 3

Category # Question Total Recommendations
Points
HACCP Team 3.1.1 Is there a team responsible for HACCP 15
development, implementation and on-going
maintenance?
HACCP Team 3.1.2 Is there documented HACCP specific training 10
for the HACCP team, management and
operating personnel?

Review of the 3.2.1 Does a product description exist for each 10

Written HACCP product produced? Do they contain the
Plan products intended use, materials and raw
ingredients, and who the intended consumer
is?
Review of the 3.2.2 Has the process been flow charted? Is the flow 15
Written HACCP chart in sufficient detail to completely describe
Plan the process or product manufacturing steps?

Review of the 3.2.3 Has a documented hazard analysis for each 15

Written HACCP process flow been conducted, showing the
Plan various types of hazard and their associated
severity?
Review of the 3.2.4 Does the documented hazard analysis show 15
Written HACCP the controls for each identified potential food
Plan safety hazard?
Review of the 3.2.5 Have CCP decisions been made, have CCPs 15
Written HACCP been identified and where CCPs are noted,
Plan have they been developed to control the
hazards identified in the hazard analysis step?

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Review of the 3.2.6 Have monitoring requirements and frequencies 15
Written HACCP been determined for the CCPs?
Plan
Review of the 3.2.7 Are identified CCP critical control limits 5
Written HACCP supported by validation documentation?
Plan
Review of the 3.2.8 Is there a clear, detailed action plan for 15
Written HACCP operators to follow if the CCP critical control
Plan limits are exceeded? Does it describe plans to
adjust the process back into control and
withhold out of compliance products if
necessary?
Review of the 3.2.9 Have recording templates (recording forms) 10
Written HACCP been developed for monitoring the CCPs?
Plan
Review of the 3.2.10 Have specific responsibilities been assigned for 10
Written HACCP the monitoring, recording and corrective action
Plan management of each CCP?
Review of the 3.2.11 Have verification plans and schedules been 10
Written HACCP developed for each CCP?
Plan

Execution of 3.3.1 Are all of the documents noted in the HACCP 15

the HACCP plan in place for real time monitoring of the
Plan CCPs?
Execution of 3.3.2 Are the CCP monitoring activities and 15
the HACCP frequencies in conformance with the plan?
Plan
Execution of 3.3.3 Do CCP operators understand basic HACCP 15
the HACCP principles and their role in monitoring CCPs?
Plan (Interview operators to verify.)

Execution of 3.3.4 Are CCP monitoring records signed off (or 10

the HACCP initialed) by the operator(s) who are carrying
Plan out and recording the CCP check?

Execution of 3.3.5 Are corrective actions detailed in writing when 15

the HACCP the failure of a CCP occurs?
Plan
Execution of 3.3.6 Are the CCP records reviewed and signed off 10
the HACCP daily by the quality control supervisor and/or
Plan management as part of the verification plan?

Execution of 3.3.7 Is any other CCP verification performed (apart 10

the HACCP from daily record verification) according to the
Plan HACCP Plan?

Management 3.4.1 Are changes in the process, equipment, 10

Support of ingredients etc., causing timely reviews of
HACCP HACCP systems, including hazard analysis,
CCP decisions, CCP records and staff
training?
Management 3.4.2 Is the plant conducting self-audits of the 10
Support of HACCP program?
HACCP
Management 3.4.3 Have standard operating procedures (SOPs) 10
Support of been created for the CCP monitoring
HACCP processes that include how to carry out the
monitoring?

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 Management 3.4.4 Are monitoring and verification information 10
Support of reviewed and discussed at management level
HACCP meetings?
Management 3.4.5 Are there independent audits e.g. third party 10
Support of audits, of the plant's HACCP program (at least
HACCP every 12 months)?

FOOD DEFENSE - SECTION 4

Category # Question Total Recommendations
Points
Physical 4.1.1 Are the facility external areas and vulnerable 5
Security entry points (i.e. those that are not permanently
locked) surrounded by security fencing?

Physical 4.1.2 Is access to the facility controlled by locks, 10

Security swipe cards, alarms or other devices?

Physical 4.1.3 Are inbound food product storage areas (fruits, 5

Security vegetables, etc.) secure i.e. within the secure
compound?
Physical 4.1.4 Are chemicals such as chlorine, citric acid, 5
Security fungicides and sanitation chemicals stored
within secured areas with controlled access?

Physical 4.1.5 Are packaging material (cartons, wrap film, fruit 5

Security cups, etc.) storage areas secure, i.e. within the
secure compound?

Employee 4.2.1 Are background checks conducted on all 5

Security personnel with special attention to employees
who have access to sensitive areas and/or
control of sensitive processes (verbal
confirmation accepted)?

Employee 4.2.2 Employees personal items are not being 5

Security stored in the production and material storage
areas?
Employee 4.2.3 Are employees issued non-reproducible 5
Security identification e.g. badges, company ID cards,
etc.?
Employee 4.2.4 Are visitors (including contractors) also 5
Security required to be issued with identification e.g.
badges, high visibility visitor apparel, etc?

Employee 4.2.5 Are visitors (including contractors) required to 5

Security "sign in" and “sign out" in a visitors logbook?

Transport 4.3.1 Does the company make use of sealed and/or 3

Security locked trailers on inbound loads (excluding
open flatbed trucks)?
Transport 4.3.2 Does the company make use of sealed and/or 3
Security locked trailers on outbound loads?

Water Supply 4.4.1 Are potable and non-potable water supplies 3

Security clearly identified?
Water Supply 4.4.2 Are tamper evident/tamper resistant systems 3
Security (e.g. tamper tags) in place where appropriate?

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 Water Supply 4.4.3 Is there restricted access to sensitive water 3
Security systems, e.g. anti-microbial addition systems
(like chlorine injection pumps), that helps
ensure that only authorized personnel are able
to adjust these systems?

Food Defense 4.5.1 Does the company have a documented food 10

Systems defense policy based on the risks associated
with the operation?
Food Defense 4.5.2 Is there a current list of emergency contact 3
Systems phone numbers for management, law
enforcement and appropriate regulatory
agencies?
Food Defense 4.5.3 Are all personnel required to undergo training 5
Systems on food defense issues and are training
records kept?
Food Defense 4.5.4 Is there is a log of who has access to sensitive 3
Systems areas e.g. a listing of key holders for access to
areas like chemical storage?

MISCELLANEOUS SURVEY QUESTIONS - SECTION 5

Category # Question Total Recommendations
Points
Allergens 5.1.1 Are there allergen risks handled or stored 0
within production and storage areas?
Allergens 5.1.2 Has a documented allergen management plan 5
been developed?
Allergens 5.1.3 Are there adequate storage controls 5
(separation, identification, etc.) that ensure that
allergens are not contaminating other raw
materials?
Allergens 5.1.4 Is there a dedicated production line or 5
adequate clean down and production
procedures that prevent allergen cross
contamination?
Allergens 5.1.5 Are utensils and work in progress storage 5
containers identified in order to prevent
allergen cross contamination?
Allergens 5.1.6 Does re-work handling take into account the 5
issues associated with allergen containing
products?
Allergens 5.1.7 Are employees trained with respect to allergen 5
risks and the facility allergen cross
contamination controls (including hand
washing between production runs) and are
there records of this allergen training?

Allergens 5.1.8 Are all products manufactured on site, labeled 5

correctly with respect to allergens?

Country of 5.2.1 Is the company labeling retail packaging with 3

Origin Labeling the correct country(ies) of origin? N/A for food
service.
Country of 5.2.2 Is the company labeling the finished goods 3
Origin Labeling carton with the correct country(ies) of origin?
N/A for food service.

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 Country of 5.2.3 Are there records that support the country(ies) 3
Origin Labeling of origin labeling e.g. bill of lading, production
records, etc.?
Country of 5.2.4 Are steps taken in the storage and production 3
Origin Labeling process to ensure that there is no commingling
of materials from different countries (unless
product will be labeled as such)?

NEW QUESTIONS (NOT PART OF OVERALL FOOD SAFETY PERCENTAGE) -

SECTION 6
Category # Question Total Recommendations
Points
Buildings and 6.1.1 Does the waste flow, from creation through to 10
Grounds leaving the operation including vehicle use and
flow, employee control, etc., ensure that facility
and products are not contaminated?

Temperature 6.1.2 Is there a written procedure requiring 5

Controlled transportation vehicles be dedicated to
Storage & produce, and that animals, animal products or
Distribution other materials that may be a source of
contamination are not allowed to be
transported?
Management 6.1.3 Is there a documented food safety plan 10
Systems covering site and facility?
Management 6.1.4 Is there a documented business continuity and 5
Systems disaster recovery plan?
Buildings and 6.1.5 Does the facility have documented evidence to 10
Grounds ensure that any food safety hazards relevant to
waste water treatments (e.g. settling ponds,
land applications, etc.) are controlled?

Review of the 6.1.6 Has the operation listed the HACCP pre- 10
Written HACCP requisite programs that are in effect at the
Plan facility?
Review of the 6.1.7 Where operating limits and frequencies been 10
Written HACCP established for the CCPs are they being
Plan monitored?

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