Pfa Guide 2010

Yum! Brands Global Restaurants, Inc.
(A&W Restaurants; KFC, Long John Silver’s; Pizza Hut, and Taco Bell)
Packaging Facility Audit Guidelines

Audit and Approval Evaluation
2010 version
These guidelines are for use in Approval and Ongoing Packaging Facility evaluations of
suppliers and facilities that supply products for Yum! Brands Global Restaurants, Inc.
Passing score for USA and Global Packaging suppliers manufacturing facilities is:
• Minimum 80% and no automatic failures
• All Packaging manufacturing facilities shall be audited annually by a Yum! Brands approved
auditor and done at the cost of the supplier
• Facilities receiving a failing audit should submit corrective actions to Yum! Brands and
schedule a follow up to failure audit within 60 days
1. Points noted in parentheses (10 points) represent points earned.
2. All criteria in BOLD PRINT are Automatic Failures (Non conformances for international
markets) of the audit. Automatic Failures appear under the "No points" categories. Only the
bolded line of criteria will result in immediate failure of this audit. Observation of any actual
product contamination by a Yum! Brands auditor triggers an Automatic Failure of the
audit/evaluation; however, the audit shall be taken through to completion to identify any
further issues. Automatic failures of an Approval Audit will result in a Non-Approval rating.
3. Each question scoring an Automatic Failure is to have a corrective action inserted into the
Action Plan section of the score sheet. This information is to be completed by the auditor
with the supplier's input.
4. If a supplier's process makes it impossible to meet guidelines exactly as written, the supplier
may request alternate minimum standards from Yum! Brands QA. An alternate minimum
standards is issued only under extreme circumstances and only with the approval of the
appropriate Yum! Brands QA contact. The document shall be signed by the Yum! Brands
QA contact and forwarded to the supplier. The supplier shall request and keep on file an
updated alternate minimum standards annually.
5. Documentation faxed to the facility at the time of the audit is not acceptable.
6. When guidelines refer to product, the reference is to any product manufactured for Yum!
Brands restaurants' use.
7. All Systems/procedures must be in place prior to a plant attaining Approved Status.

AUDITOR is to ensure procedures are established even if Yum! Brands product is not yet
being produced in the facility.
8. Those elements not applicable to the type of audit or the facility being audited shall be
designated as N/A on the scoresheet.
_____________________________ DEFINITIONS __________________________
Every deviation cannot be noted in the Guidelines, therefore the following will be used when
scoring the audit:
• Full conformance means all Guideline requirements are met
• Minor non-conformances refers to single/isolated instance(s) of failure to meet
Guideline requirements
• Major non-conformances refer to numerous instances of failure to meet Guideline
requirements
• No points shall be given if there is systematic failure to meet
Guideline requirements
• No points shall be awarded if there are no records, written program
or procedures
Audit Sections:
• "Category" means the section being assessed (example: 1.0)
• "Element" the specific bulleted requirement within the audit point
(example: 1.1, 1.2, etc.)
• "Criteria" is the explanation of each audit point
For the purposes of this audit/evaluation:

• "single" occurrence one instance
• "isolated" occurrences two or three instances
• "numerous" occurrences more than three instances
• "maintained" kept up-to-date and on file at the facility being audited
• "established" written and implemented
•"documentation" established documents supplied to confirm Guideline
requirements
•"program/procedures" written program or written procedures
• "records" actual data collected and maintained, based on the criteria
outlined in the procedures. Auditor to review between 1%
and 10% of the records since the last audit, enough to get
a representative sample. If issues are found, an additional
sample of records should be reviewed to determine if the
issue is isolated or reoccurring. All record corrections shall
be single lined out (so that the correction can still be read)
and initialed. Whiteout shall not be used in correcting
records.
• GMP's Good Manufacturing Practices
•"significant" systematic failure
•"systematic" systems are not in place or obviously not fully implemented
• "analytical tests" refers to the chemical or instrumental packaging testing
used to verify compliance to Yum! Brands specification
• "packing" or packing material refers to the material used to wrap/hold/contain product
(finished goods).
Yum! Brands Global Restaurants reserves the right to audit all corrective actions noted on
audits.
In certain situations, multiple audit questions could be marked down for the same finding. In this
situation, the auditor should use his/her best judgment and record the finding under the most
appropriate audit point. Circumstances may warrant the auditor to mark down an issue in
multiple locations.
It is important to understand that local laws and practices may differ from certain audit
guidelines. In all cases, the more restrictive requirement will prevail. It is important that the
auditor realize these differences and judge the supplier accordingly.
AUDIT GUIDELINES
1.0 PEST CONTROL
(Documents faxed to the supplier at the time of audit are not acceptable.)
1.1 A documented pest control program is established.

(Program - Documentation)
Full conformance (20 points): Supplier must provide a documented pest control program. The
service shall be provided by a licensed, insured and certified Pest Control Operator, or the
service may be provided by a licensed, insured and certified pest control service. A PCO from
within the supplier's organization who is licensed, insured and certified can apply pesticides, or
a Pest Control Operator trainee can apply pesticides if authorized under local laws to apply
pesticides. A license and certificate may be one and the same in some locations, but the name
must match the name signed on service reports. If on-site employee is certified, he/she may
supervise someone else applying pesticides. Under either scenario, copies of all documents
should be maintained at the facility. License(s), insurance and certification must be current.
The program shall include:

• a designated pest control operator (PCO) or company name
• defined frequency of scheduled service intervals: shall be minimum monthly basis
• how all traps, bait stations, glueboards and insectocutors shall be labeled (include PCO
initials and date inspected
• how unit inspections will be tracked. (Example: if electronic scanning of units is done or
punch cards are used, that date and initials are on final report)
• approved list of pesticides used: where they are applied and how they are applied
• up-to-date schematic map – map shall be dated and have all traps, bait stations, glue
boards and insectocutors designated and identified in a way to allow for ease of tracking
and trending
In some areas, the application of non-restricted chemicals (example: foggers for flying pests)
does not require an applicator's license, however, all chemicals used in a facility are to be listed
in the pest control program manual on an "approved list of chemicals," whether they are applied
by licensed or non-licensed plant personnel.
Minor non-conformance (15 points): One of the following will constitute a minor non-
conformance:
• single/isolated instance(s) of unclear or incomplete documentation
• one element in above requirements is not on file or current (frequency addressed as a major
non-conformance)
• schematic map is not up-to-date/complete
Major non-conformance (6 points): The following will constitute a major non-conformance:

• two or more elements in the above list of requirements are not documented
• scheduled service intervals are less frequent than monthly
No points: No points will be awarded if the following situations is encountered:

• no program
1.2 Pesticides are approved for use in a food manufacturing facility*. Handling and mixing procedures,
Material Safety Data Sheets (MSDS) and pesticide labels are on file. All pesticides are properly
labeled and stored.
(Documentation-Observation)
Full conformance (15 points): The auditor shall verify that:
• MSDS must be provided for pesticides used
• MSDS must be readily available for employees' reference
• all pesticides must be approved for use in a food manufacturing facility
• labels and mix procedures shall be on file
* Retail Packaging facilities should use pesticides that are approved for use in a food
manufacturing facility.
If pesticides are kept on site, they:

• must be properly labeled
• stored (according to MSDS) in a locked, secured area accessible to authorized personnel
only
• glue boards are not classified as pesticides but shall be stored away from food products
• empty pesticide containers shall be labeled " for insecticide use only" or similar
Unlicensed/unapproved pest control chemicals are not acceptable for use in the packaging
facility (example: cans of Raid).
Auditor to pick 3-4 chemicals that are applied in the plant and check for MSDS sheets and
sample labels. Check to see if the PCO wrote in a new chemical in the manual that does not
normally appear on the service log. NOTE: Glueboards are not considered pesticides.
Hard copies of MSDS sheets shall be located in the plant.

• If supplier subscribes to a faxable MSDS sheet service, the fax must be available within 10
minutes and there shall be appropriate signage and 24 hour access to phones and fax
machine.
• Multi-lingual MSDS may also be available through a faxable MSDS service. Multilingual
MSDS not required if translator on site.
**NOTE: This is the only instance in which faxed documents at the time of a Yum! Brands
audit are acceptable.
conformance:
• MSDS and labels available, but filing system or fax system are disorganized making quick
access to the information difficult
• single/isolated instance of missing MSDS and/or sample label
• single/isolated instance of pesticides secure on site, but not properly labeled
• single/isolated instance of empty pesticide container not labeled “insecticide use only” or
similar
Major non-conformance (5 point): One of the following will constitute a major non-
conformance:
• greater than three MSDS and/or labels are missing for pesticide(s) found in use
• concentration mix directions are missing for pesticide(s) found in use
• records indicate incorrect concentrations used for pesticides
• numerous instances of pesticides secured on site, but not properly labeled
• pesticides are segregated on site, but not held under lock and key
• numerous empty pesticide containers not labeled "insecticide use only" or similar
No points: No points will be awarded if the following situation is encountered:

• use of non-regulatory approved material
• pesticides not secured and/or labeled and found in common storage with food or
packaging material
• any pesticide storage or pest control equipment maintenance issue which has
contaminated product or packing
1.3 PCO (Pest Control Operator) service reports, including usage logs, are current and
available for review.
(Records)
Full conformance (10 points): Supplier must provide service reports from the pest control
organization or complete inspection records if service is performed internally. They must
include:
• individual conducting service
• services performed
• date of service
• application method used
• chemicals, quantities and concentrations used
• signs of activity
• scheduled follow-up based on pest activity, if necessary
• corrective actions documented for frequent activity or other issues noted on service report or
separate report
The service log records shall indicate the application method used for each chemical. The
auditor is to verify that the application method agrees with the standards/methods of application
noted in the service contract and by the manufacturer.
AUDITOR: Match the PCO who fills out the service logs to the PCO who signs off on the traps,
to the PCO whose certification is in the book, making sure all 3 match.
conformance:
• frequencies not matching those outlined in the pest control program
• single/isolated instances of missing or incomplete information/records
• single element missing
Major non-conformance (3 points): One of the following will constitute a major non-
conformance:
• numerous instances of missing or incomplete information/records
• two elements missing
No points: No points will be awarded if one of the following situations is encountered:

• no service reports
• the number of incomplete records indicates systematic failure
• more than two elements missing
1.4 There is a pest activity trend report with corrective action(s) identified.
(Records)
Full conformance (5 points): Documentation is available which:
• identifies and analyzes pest activity
• trend analysis for all pest control/monitoring devices (including traps, bait staitions, glue
boards, insectocutors)
• includes follow-up/corrective actions documented when a trend is identified
The auditor should look for a pictorial representation of activity by trap or station over time. All
traps shall be included in review, however, only activity is diagrammed. This could be in the
form of a Pareto chart, a frequency diagram or a checklist (Yum! brands does not specify the
type of chart to be used).
conformance:
• trend analysis is conducted, but follow up actions are not formalized
• one type of pest control/monitoring device is not trended
• single/isolated instance of missing records
Major non-conformance (1 point): One of the following will constitute a major non-conformance
• two types of pest control/monitoring devices are not trended
• numerous instances of missing records

• there are no records kept of historical pest activity
• more than two types of pest control/monitoring devices are not trended
1.5 There is no evidence of INTERNAL pest activity.

(Observation)
Full conformance (10 points): All areas should be free of reoccurring/existing "internal" pest
activity. Specifically there shall be:
• no reoccurring/existing rodent activity and/or bird nesting observed around the interior
perimeter of the facility
• no evidence of live animals observed inside the facility such as cats, dogs, deer, etc.
• no evidence of excreta/pellets
• no evidence of pests including insects, spiders/webbing, rodents, lizards, ants or birds in the
facility or on product or packing
• no evidence of gnawed bags/cases or rodents on stored stock or numerous excreta on the
floor/shelves of any storage area
• no decomposed rodent(s) or other animals (frogs, lizards, etc.) in traps. The interior traps
shall be checked often and the dead rodent(s) or other animals removed
• glueboards shall be free of significant insect build up
Note: Any live insect activity is an issue and should be graded accordingly. Insects should be at
a very minimum on glue boards. Active cobwebs with spiders are considered pest activity;
however, old dusty cobwebs are evidence of poor housekeeping and should be covered in
section 3.3.
conformance:
• single/isolated instance(s) of pest activity noted on the interior of the facility that does not
pose an immediate threat of product contamination
• freshly trapped rodent found in trap (or internal bait station - International)
conformance:
• numerous instances of pest activity noted in the interior of the facility
• insect activity which has the potential for contaminating product
• numerous instances of significant numbers of insects found on glue boards
• evidence of live animals observed inside the facility

• decomposed rodents in traps
• any observation of contaminated product
1.6 There is no evidence of EXTERNAL pest activity.

(Observation)
Full conformance (10 points): All areas shall be free of reoccurring/existing external pest
activity. Specifically there shall be:
no reoccurring/existing rodent activity (significant burrows, trails, excreta, tracks), animal spoors
and/or bird nesting observed around the exterior perimeter of the facility (within 20 ft / 6 meters)
• no decomposed rodent(s) or other animals (frogs, lizards, etc.) in bait stations or along
perimeter
The exterior bait stations shall be checked often and the dead rodent(s) removed. Decomposed
rodent(s) or other animals shall not be evident and could render the bait stations ineffective.
Gnawed rodenticide blocks (bait) and freshly trapped rodents should be noted as observations
but no points should be deducted in this section.
Minor non-conformance (7 points): Single/isolated instance of reoccurring/existing rodent

activity (burrows, trails, excreta, tracks, animal spoor) and/or bird nesting observed around the
exterior perimeter of the facility or trailers/containers
Major non-conformance (3 points): Numerous instances of reoccurring/existing activity around
the exterior perimeter of the facility

• evidence of significant rodent activity (burrows, trails, excreta, tracks, animal spoor)
• decomposed rodent(s) or other animals (frogs, lizards, etc.) in bait stations.
1.7 All pest control devices are located in such a manner as not to contaminate
product, packing, or equipment.
(Observation)
Full conformance (10 points): Care is taken to locate pest control devices in such a manner
that they do not pose a threat to contaminating product, packing, or equipment. This includes
the following restrictions:
• bait stations and other pesticides shall be used outside the facility. (In countries where bait
inside a dry goods storage area is common practice, the bait station must be secured. The
bait must not be granular and must be contained and secured inside a bait station)
• if used, insectocutors shall be regularly cleaned out (kept free from a build-up of insects and
debris that has the potential for "spilling over")
• if used, insectocutors must be at least 10 feet (3 meters) from covered/protected product or
packing material and at least 30 feet (10 meters) from exposed product, equipment, or
packing material. Insectocutors shall not be located above dock doors. Hallways where
product passes through are exempt from these distances, as long as product does not stop
or is not stored in hallway
• if used, electronic pulse units (such as Vector Fly Systems) or units that solely captured by a
glue board type paper shall not be located over dock doors and must be at least 5 feet (1.5
meters) from protected or exposed product or packing material
• no fly swatters shall be evident in production or storage areas
In general, traps, glue boards and all pest control devices, including insectocutors, must be
positioned and maintained in a manner to prevent contamination.
Minor non-conformance: (7 points): One of the following will constitute a minor non-
conformance:
• one instance of improperly positioning or maintaining an insectocutor or electronic pulse unit
in a storage or loading area (covered/protected product)
• single/isolated instance of a fly swatter found in production or storage area
conformance:
• more than one instance of improperly positioning or maintaining an insectocutor or
electronic pulse unit in a storage or loading area (covered/protected product)
• numerous instances of fly swatters found in production or storage area

• one instance of bait/poison inside the facility (in U.S.), or an instance of bait/poison
inside processing area or any area with the potential for direct product contamination
• pest control device which is positioned/maintained in such a manner that has the
potential for product, packing, or equipment contamination
• any observation of contamination of product or packing material
1.8 The number and placement of pest control devices are effective (Interior of facility).
(Observation)
Full conformance (10 points): As a guide to number and placement of traps and bait stations:
• traps shall be positioned at a maximum of 25-foot (8-meter) intervals around the interior
perimeter of the building area and around interior perimeter of all walled in product and
packing storage areas. Office areas are exempt. If a wall is less than 25 feet (8 meters)
long, it shall have at least one device.
• inside the facility, only traps (no glue boards) shall be placed within 6 feet (2 meters) of both
sides of all outside exit/entry doors. This includes both sides of the pedestrian doors. Effort
shall be made to avoid placing traps on curbing.
• traps should be positioned so that openings are parallel with and closest to the wall
• glue boards must be maintained and in proper positions if used as alternatives to trap
stations (elsewhere than either side of entry doors)
• if mechanical wind-up traps are used, they must be wound. Winding is checked by
triggering the spring device to operate the trap. The trap must be rewound after testing.
• approximately 10% of all pest control units shall be checked by the auditor
• traps are encouraged in all practical areas of the plant, including production areas. High
trafficked areas and areas that are constantly wet may be excused from trap requirements
(ex. frequent wash down areas) where maintenance and consistent performance is
prohibitive. No exemptions will be granted for trap placement by exterior doors.
• interior of traps, bottom of glue boards shall have service labels dated and initialed after
each treatment by the recorded PCO. (Electronic scan method or punch cards are
acceptable as long as PCO initials/signature are on final report, and the cards/scan codes
are inside the device requiring the PCO to open the station.)
Local regulations may require exceptions/differences to above guidelines. At all times, local
regulations must be met.
conformance:
• single/isolated instance(s) of traps and glue boards not working properly or inadequately
maintained
• single instance of missing trap or glue board
conformance:
• isolated instances of a missing trap or glue board
• numerous combined instances of traps or glue boards not working properly or inadequately
maintained
• traps or glue board not positioned at proper intervals
• traps or glue boards found without service label or date

• numerous instances of traps or glue boards not used where GMPs would allow use
• systematic failure to maintain traps and glueboards
1.9 The number and placement of traps and bait stations are effective. Bait stations are
secured and tamper resistant. (Exterior of facility)
(Observation)
Full conformance (10 points): As a guide to number and placement of traps and bait stations:
• bait stations shall be positioned at maximum of 50 foot (15 meters) intervals around the
exterior of the building perimeter, except where there is public access. (Public access is
defined as access easily gained by the general public such as parking lots or sidewalks,
school areas or area of environmental concern.)
• bait stations shall be secured to minimize movement of the device and be tamper resistant.
Bait stations shall be secured with either a ground rod or a chain, or glued to the
wall/ground, or secured with patio blocks. Bait stations must be tamper resistant through
the use of screws, latches, locks or by other effective means
• bait in bait stations shall be secured inside the bait station on a rod (horizontal or vertical)
above the floor of the station, or the bait station is designed so bait cannot be removed by a
rodent or "float away" in a heavy rain. No loose granular rodenticide to be used
• no bait stations shall be missing entire bait
• no bait shall be found outside bait station
• no old or moldy bait observed
• exterior stations should be within 20 feet (6 meters) of outside dumpster areas
• approximately 10% of the pest control units shall be checked by the auditor (auditor does
not have to check bait station/traps beyond the immediate exterior junction of structure and
ground)
• interior of traps, bottom of glue boards shall have service labels dated and initialed after
each treatment by the recorded PCO. (Electronic scan method or punch cards are
acceptable as long as PCO initials/signature are on final report, and the cards/scan codes
are inside the device requiring the PCO to open the station.)
conformance:
• single/isolated instance(s) of traps or bait stations not working properly or inadequately
maintained (all are present)
• single instance of missing trap or bait station
• single/isolated instance(s) of improperly securing and/or making a bait station tamper
resistant
• single/isolated instance(s) of unsecured bait inside bait stations
• single/isolated instance(s) of bait stations missing bait or having moldy bait
conformance:
• isolated instance(s) of a missing trap or bait station
• numerous combined instances of traps or glue boards not working properly or inadequately
maintained
• numerous instances of improperly securing and/or making a bait station tamper resistant
• numerous instances of unsecured bait inside bait station
• numerous instances of bait stations missing bait or having moldy bait
• traps or bait stations not positioned at proper intervals

• numerous incidences of traps or bait stations not used where GMPs would allow use
• systematic failure to maintain traps or bait stations
• systematic failure to secure bait or bait stations or to make bait stations tamper resistant
• one instance of bait found outside a bait station
2.0 SANITATION
2.1 A master sanitation program is established.

(Program - Records)
Full conformance (15 points): There is a documented master sanitation program to include a
cleaning schedule of the physical structure, equipment and all other areas of the facility.
Records shall be maintained. The program shall include:
• frequency of cleaning
• identify responsible position for task
• all defined methods and procedures for each task (SOP's)
• the cleaning products and concentrations used
• individual accountability and sign-off for each task completed (a position or a name; typically
the sanitation supervisor.)
• cleaning procedures are designed and ordered to prevent potential contamination of product
and re-contamination of cleaned areas
conformance:
• single/isolated instances of incomplete records
• one element above is missing in program
conformance:
• numerous instances of incomplete records
• two or more elements are missing in program

• no records
• no written program
• order, procedures and use of equipment do not conform to good sanitation practices
• no consideration given to the possibility of re-contaminating clean areas
2.2 A training program for the sanitation crew has been established.
(Program - Records)
Full conformance (10 points): Supplier must have a documented training program for the
sanitation personnel that includes job skills, job safety and product safety. Records must be
kept for each individual assigned to the sanitation crew which verifies he/she has been
appropriately trained. If an outside company is utilized, supplier must maintain copies of training
records of crew members. If members are trained as a team, the team member training must
be reflected in records. The auditor shall verify that:
• training program includes a summary of how training will occur and the exit criteria used to
verify skill requirements
• training program includes job skills, job safety and product safety
• training is ongoing (at minimum annual basis)
• training records are kept current with date of training and name of employees attending
training
• training records document on-the-job training, when applicable
• cleaning assignments are based on skill
Training programs must address job basics and any specialized training. Video recordings or
computer-based training may be used as the documented training program as long as records
confirm attendees.
conformance:
• single/isolated instance(s) of incomplete training records
• one element is missing.
conformance:
• two elements are missing
• the training records are outdated
• ongoing training frequency is more than annually but less than every 3 years

• no written program
• more than two elements are missing
• systematic failure to provide training
• no training records
• ongoing training exceeds 3 years
2.3 Cleaning and sanitizing chemicals are approved for use in the facility. MSDS and
labels are available.
(Documentation – Records - Observation)
Full conformance (15 points): Auditor shall verify that:
• all cleaning and sanitizing chemicals utilized in the facility must be approved for application
in the facility and/or meet regulatory guidelines
• labels and Material Safety Data Sheets (MSDS) must be available for all cleaning and
sanitizing chemicals; both industrial and commercially purchased products
In the U.S.
If supplier subscribes to a faxable MSDS sheet service, the fax must be available within 10
minutes and there shall be appropriate signage and 24 hour access to phones and fax
machine.
Multi-lingual MSDS may also be available through a faxable MSDS service. Multilingual
MSDS not required if translator on site.
**NOTE: This is the only instance in which faxed documents at the time of a Yum! Brands audit
is acceptable.
Auditor shall randomly select at minimum four (4) chemicals to check and verify documentation.
conformance:
• all materials approved for application, but MSDS and/or sample labels (chemical, hazard
data sheets) are not readily available and easy to locate
• single/isolated instance of a missing MSDS and/or sample label

• greater than three missing MSDS and or sample labels

• one instance of "approved" cleaning chemical or sanitizer being used in an
unapproved application
• unapproved chemicals being used
2.4 Cleaning equipment and chemicals are properly stored.

(Observation)
Full conformance (10 points): Cleaning equipment and chemical storage areas shall be:
• organized
• properly cleaned prior to storage
• segregated from product and packing materials
• secured to prevent unauthorized use of cleaning equipment and/or chemicals. Typically this
would be a locked closet or "cage" located in a general storage room. Acceptable
alternatives to a lock and key would be in an area which cannot be accessed by the general
work force -- such as in a closet in the plant manager's office
Any office cleaning chemicals which are not approved for use in manufacturing areas, shall be
stored in a secured area outside of manufacturing areas and stored apart from chemicals
approved for use in a manufacturing area (example: chemicals stored under a sink in the office
restroom area).
Cleaning chemicals/sanitizers may be in a production area if they are secured and do not pose
a risk of product contamination (example: sanitizer bottles on wall racks).
conformance:
• single/isolated instance(s) of equipment not properly stored (left in hallways around
production areas when not in use)
• isolated instances where cleaning equipment does not appear to be properly cleaned prior
to storage
conformance:
• cleaning chemical storage is segregated, but not secured
• numerous instances of improperly cleaned and stored equipment
No points: Cleaning chemicals are stored with product, in the same room or above, and
run the risk of contaminating the product
2.5 Cleaner and sanitizer concentrations and applications comply with the Sanitation
Program.
(Observation - Records)
• sanitizer and cleaning chemical concentrations and applications must match the
requirements of the cleaning program and the manufacturer's recommendation for the
application
• records indicate that sanitizer concentrations are checked and noted per the program
outline. A "no rinse" sanitizer out of an automatic mix system shall have periodic
verification - minimum quarterly. Test strips may be used for verification.
The auditor may take steps to verify concentrations of hand sanitizers and/or sanitizing
solution(s) by having the appropriate person mix the solution and test it with test strips or a test
kit. If supplier does not have test strips or testing kit for auditor's concentration verification, it will
be interpreted that there is "systematic failure to use correct concentrations," as they cannot be
verified. Auditor may choose to only review records of same. Cleaner concentrations shall be
recorded on a log list that is signed and dated each time a mixture is made.
conformance:
• records are unclear or contain isolated omissions, but chemicals appear to be used within
established concentrations
• single/isolated instance(s) of a chemical found being used at the incorrect concentration
conformance:
• records contain numerous omissions
• numerous instances of chemicals found to be used at incorrect concentration levels
• record of automatic system being calibrated, but less than quarterly

• systematic failure to maintain records
• systematic failure to use correct concentration of chemicals
• sanitizer concentrations are not checked (verified) or recorded
• cleaning chemical concentrations are not recorded
2.6 Adequate machinery maintenance and effective cleaning practices are evident.
• cleaning effectiveness and overall facility sanitation is monitored through documented
inspections
• pre-operative inspection records and visual impression of the auditor indicate the program is
effective
• records indicate follow-up is assigned and corrective action takes place
conformance:
• single/isolated omission(s) in inspection records
• single/isolated instance of follow-up action not documented
• observation of a single/isolated minor cleaning issue
conformance:
• numerous incomplete inspection records
• numerous instances of follow up action not documented
• observation of numerous minor cleaning issues

• no pre-operative inspection conducted
2.7 Water quality testing and monitoring

(Records)
Full conformance (15 points): Supplier maintains records of water quality checks and the plant
meets local regulatory requirements and standards for potable drinking water. The sample for
testing must be drawn from the plant. Dry plants ARE required to test water (example: for hand
washing purposes).
Specifically, dry plants (corrugated and paperboard facilities, even though water is used to mix
starch/adhesive can qualify as dry) shall test for:
• Total Plate Count
• Coliforms
• E. coli (not necessary if Coliform count is zero)
Facilites using water in processing shall also include the following tests on water:
• heavy metals -- lead and mercury
• off flavors and odors
Facility has established a water filtration procedure to prevent foreign material contamination
(i.e. rust, gravel, sand) from water when water is used in processing (chilled water for
forming/reprocessing polymer structures). All facility water does not have to be filtered, but it
must be potable.
• requirements are for a 10 micron filter or smaller to be used at the point specific to which
water becomes a part of the process
• backflow devices shall be installed where necessary, especially where process water is
recycled
All filtration devices should have a maintenance record indicating: date of last check, condition
of the equipment, corrective action where filters have needed repairing or replacing, and the
individual who performed the maintenance.
conformance:
• it has been more than 12 months but less than 18 months since a water quality check has
been performed, and the facility has not had a water quality problem in the past
• sample was not drawn at plant
• single/isolated instance(s) of missing or incomplete records, but filtration is used
• inadequate filter size
conformance:
• it has been more than 18 months since a water quality check was performed
• testing did not include all required elements
• numerous instances of missing or incomplete filtration records
• water used in processing is not filtered

• no record of water quality testing exists
• water is not potable
2.8 Equipment design and condition allow for proper cleaning.

(Observation)
• processing and packing equipment is well maintained and designed to allow thorough
cleaning without dead spots and other areas which could conceal debris
• product contact surfaces and cleaning equipment must be made of materials that are easily
cleaned
Note: Wooden handled cleaning equipment is acceptable in a Packaging facility.
conformance:
• cleaning is generally effective, but single/isolated areas pose a problem without
modifications being made
• single/isolated instance(s) of inappropriate equipment used
conformance:
• cleaning is generally effective, but numerous areas pose a problem without modifications
being made
• numerous instances of inappropriate equipment used
No Points: No points will be awarded if one of the following situations is encountered:

• condition of equipment will not allow for proper cleaning under normal operating conditions
• more than five areas pose a problem without modifications
3.0 OPERATIONS AND FACILITY:
3.1 A maintenance related product safety program is established. Records are

maintained.
(Program – Records -Observation)
Full conformance (10 points): Supplier must have a written maintenance-related product safety
program that defines:
• a procedure for ensuring that proper cleaning and sanitation procedures occur before
equipment is placed back into service following maintenance
• a procedure for the notification of production and sanitation personnel when maintenance
work is complete (records of notification of sanitation personnel may be contained in
sanitation reports)
• a procedure for reconciling parts and tools after maintenance is performed. All parts and
tools must be accounted for by initial/signature on work order records indicating all parts and
tools are reconciled. (Any missing tools, parts or pieces of equipment shall be documented
and immediately brought to the attention of management.)
• initialed/signed work order records show that parts and tools are reconciled, and product
contact zones have been cleaned and sanitized before release to production
• No loose or unaccounted for parts or tools are found in the processing areas from
observations
Minor non-conformance (7 points):

• single/isolated instance(s) of incomplete records
• Single incidence of loose or unaccounted for parts or tools in processing area.
conformance:
• program only targets certain pieces of equipment
• program only addresses start-ups
• one of the above requirements is missing
• tools and parts reconciliation not included

• systematic failure of the program, indicated by systematic missing or incomplete
records
• numerous observations of loose or unaccounted for parts or tools in the processing
area.
• no program
3.2 Procedures for monthly facility inspections (including production areas, non-production
areas and surrounding grounds) are established. Records are maintained.
(Program - Records)
Full conformance (5 points): Procedures for periodic inspections have been established.
Procedures shall include:
• inspection frequency, including review (at minimum, conducted monthly)
• who is responsible for conducting inspections (may be individual or group)
• check list of areas inspected (must include production areas, non-production areas, and
surrounding grounds)
• documentation of findings with follow-up corrective actions
Grounds include to property line or 100 feet (30.5m) from the plant, which ever is less and all
dumpster (waste disposal) areas.
conformance:
• one of the above elements missing
• single/isolated instance(s) of follow up actions not documented for issues noted
• single/isolated instance(s) of incomplete or missing records
conformance:
• two or more above elements are missing
• numerous instances of follow up actions not in place for issues noted
• numerous instances of incomplete or missing records
• frequency of inspection is more than quarterly but less than monthly

• no procedures for inspection
• inspection is less frequent than quarterly
3.3 Housekeeping is acceptable for INTERIOR of the facility.

(Observation)
Full conformance (10 points): Interior housekeeping is clean with no obvious cleanliness
issues. Physical inspection of the facility shows all areas to be properly maintained to prevent
possible product contamination and to protect product integrity.
• trash receptacles are emptied frequently to prevent overflow
• there are an adequate number of trash receptacles and they are in good condition/repair
with no offensive odor evident
• trash and product spills are promptly cleaned up (no aged spills)
• walls and ceilings in storage and production areas are clean and free of debris and/or dust
accumulation (practices to maintain acceptable levels shall be evaluated for effectiveness)
conformance:
• single/isolated instance(s) of minor housekeeping issues which do not pose a risk to
product/packing
• single/isolated instance(s) of improperly maintained trash receptacles or trash/product build
up, inadequate number or odor evident
conformance:
• numerous instances of housekeeping issues
• a single condition that may pose the potential risk of product/packing contamination is
observed
• numerous instances of failure to maintain trash receptacles, remove trash build up

• multiple potential product contamination threats
• any observation of direct product contamination
3.4 Housekeeping is acceptable for EXTERIOR grounds of facility.

(Observation)
Full conformance (10 points): Grounds are:
• clean and litter free
• no weeds or tall grass within the immediate vicinity (20 feet / 6 meters) of the building
• no standing water (consider recent rains) / any drainage issues or issues with down spouts
are addressed here
• all trash dumpsters to have and use lids and remain covered with no odor or trash build up
around the dumpsters
Auditor shall look no further than 100 feet (30 meters) from structure. There shall be no other
business conducted within this 100 foot perimeter (30 meters) of building that may risk the
contamination of product or packing materials.
(Equipment storage outside is addressed in Element 3.13.)
conformance:
• single/isolated instance(s) of inadequately maintained grounds that do not pose a risk of
pest attraction or harborage
• single/isolated instance(s) of trash/dumpster build up, odor evident or uncovered
• single/isolated instance(s) of standing water (not including recent rains)
conformance:
• numerous instances of inadequately maintained grounds that do not pose a risk of pest
attraction or harborage
• single/isolated instance(s) of inadequately maintained grounds that may pose a risk of pest
attraction or harborage
• numerous instances of trash/dumpster build up, odor evident or uncovered
• numerous instances of standing water (not including recent rains)

• systematic failure to properly maintain grounds, remove litter and weeds
• systematic failure to remove trash/dumpster build up
• excessive areas of standing water
• a business that poses a potential or actual risk of contamination to product or packing is
located within 100 feet (30 meters) of the plant
3.5 Facility repairs are complete for equipment, physical structure, walls, floors and
ceilings with no temporary repair materials used.
(Observation)
Full conformance (5 points): Physical inspection of the facility shows:
• general maintenance and appearance are properly maintained
• exterior walls are of sound construction, with no cracks or openings
• interior ceiling, walls and floors are in good repair with no leaks or cracks
• all repairs and equipment modifications are professionally completed without the use of
string, tape, wire or other improvised materials
• at times temporary repairs may be necessary to complete the shift's production run and shall
not pose a risk to product safety. Repairs of this nature are acceptable as long as the
repairs are labeled with date and time.
Note: Duct tape may be used on ducts.
conformance:
• inspection shows single/isolated improvised repair used longer than one shift that does not
pose a threat to product or packing contamination
• single/isolated instance(s) of improperly maintained walls, floor or ceiling
conformance:
• inspection shows numerous improvised repairs used longer than one shift which do not
pose a threat to product or packing contamination
• inspection shows improvised repair in production area which may pose a risk of product or
packing contamination
• numerous instances of improperly maintained walls, floors or ceilings

• numerous areas of potential contamination
• any observation of product contamination
3.6 A minimum 18" (46 cm) inspection perimeter is maintained throughout the storage areas.
Full conformance (5 points): An inspection perimeter is maintained to allow for the proper
inspection of storage areas and to deter harborage of pests.
Note: This area shall be measured from the wall at the floor - if an interior column exists which
imposes on the 18 inch (46 cm) distance, there must be access around column for maintenance
and pest control management. If an inspection perimeter is physically impossible, it is
permissible that the bottom rack be 18 inches (46 cm) off the floor. Inspection perimeters are
not required in product staging areas.
If a room is too small to effectively maintain an 18 inch (46 cm) perimeter or if the bottom rack is
not 18 inches (46 cm) off the floor, the area must be cleaned and inspected at a minimum of
monthly and documentation of these activities must be available for each specific area.
Minor non-conformance (3 points): The following will constitute a minor non-conformance:

• isolated instances of the inspection perimeter not being maintained
• single/isolated instance of missing cleaning records for areas too small to maintain
perimeters activities
Major non-conformance (1 point): The following will constitute a major non-conformance:

• numerous instances of the inspection perimeter not being maintained
• numerous instances of missing cleaning records for areas too small to maintain perimeters

• facility does not maintain inspection perimeters
• no documentation of cleaning activities if area is too small to maintain perimeters
3.7 Doors and openings are pest resistant.

(Observation)
Full conformance (5 points): Facilities shall seal openings to deter pest infestation. This
includes:
• screened openings and/or fly fan devices
• weather stripping around doors
• sealed loading dock doors
• well maintained dock levelers
• outer doors kept closed when not in use
Minor non-conformance (3 points): Single instance of non-conformance to above requirements
Major non-conformance (1 point): Isolated instances of non-conformance to above

requirements
No points: Numerous instances of non-conformance to above requirements
3.8 Walkways, permanent ladders and conveyors are shielded to protect product and
packing materials from possible contamination.
(Observation)
Full conformance (5 points): All walkways, permanent ladders and conveyors have shielding to
prevent product contamination.
• walkways and ladders over product are shielded with at least 3” (7 cm) kick plates (the intent
is to prevent dirt or foreign objects from falling onto product or packing materials
• electric motors which are located directly over exposed product are shielded
• hand held hoists or other mechanical lifting devices shall have appropriate product
protection, as the situation warrants (no observed product contamination visible)
Minor non-conformance (3 points): Single/isolated instance of unshielded ladders, walkways or

conveyors
Major non-conformance (1 point): Numerous instances of unshielded ladders, walkways or

conveyors
No points: Any observation of direct contamination of product or packing materials
3.9 Lights and other breakable materials are shielded to prevent potential
contamination. Facility shall have a glass policy.
(Procedure - Observation)
Full conformance (10 points): All lights and glass are shielded to prevent product or packing
contamination in the event a bulb or glass pane breaks. This procedure shall include:
• all lights and glass in areas of production, warehousing and storage (example: emergency
lights, insectocutors, clock faces, fork lift truck, loading lights, etc.)
• computer or video monitors shall be covered with a plastic film to prevent shattering during
breakage (touch screens are exempt)
• office glass that is not tempered. Tempered glass does not require a film.
Glass Policy shall include:

• the control glass that is located on site (example: laboratory glassware, breakrooms,
maintenance, etc.)
• glass control, guidelines for broken glass incidents
• glass disposal instructions.
The only exception to this glass policy is a fire extinguisher housing.
Note: If overhead lights in facility are not shielded, check the inventory of bulbs to make sure
they are Teflon safety coated or have a plastic sheath and are acknowledged as shatterproof.
Minor non-conformance: (7 points): Single/isolated instance of unshielded glass corrected

during the audit that would not pose a product safety risk
• no glass policy in place to manage glassware on-site, or policy does not include all elements
• inspection shows single/isolated unshielded/breakable material that may pose a product
safety risk to finished product, materials, or packing and is corrected during the audit
• inspection shows single/isolated unshielded/breakable material that would not pose a
product safety risk to finished product, materials, or packing and is not corrected during the
audit.

• systematic failure to shield or make all glass shatterproof
• any observation of direct contamination of product or packing materials
• inspection shows single/isolated unshielded/breakable material which would pose a
product safety risk to finished product, materials, or packing and is not corrected
during the audit
3.10 Break areas, locker rooms, restrooms and wash stations are maintained in a clean and
orderly manner.
(Observation)
Full conformance (5 points): Break areas, locker rooms, restrooms and wash stations (if
applicable) shall be kept free of loose trash/rubbish, mold and spillage residue. For full points:
• drains must function properly (no standing water)
• rest room supplies must be adequate and accessible (toilet paper, hot warm water, paper
towels/air dryers and anti-microbial/bacterial soap)
• rest room fixtures are in good operating condition and clean
• no offensive odor shall be evident
• trash cans must be in all break areas and rest rooms, and women's rest rooms shall have
covered sanitary receptacles in stalls
("Usage" of hand wash facilities is addressed in Element 4.6. Hand wash "signage" addressed
in 4.7).
Minor non-conformance (3 points): Single/isolated instance(s) of non-conformance to above

requirements
Major non-conformance (1 point): Numerous instances of non-conformance to above

requirements
No points: Systematic failure to properly maintain areas
3.11 Air ventilation through the facility is adequate with no odors or airborne
contaminants which could carry over to product.
(Observation)
Full conformance (5 points): Auditor will verify that:
• no condition exists which could deposit airborne contaminants or condensate onto product
or packing materials
• no condition exists that could allow a carry over of odors to the product or packing materials
• auditor observes adequate ventilation in all production areas
The regrinding of plastic or the shredding, packing, or bailing of paper trim shall be conducted in
rooms separate from the fabricating room, in order to control dust. Compressed air used in the
facility for cleaning purposes should be filtered. Filtered is defined as air particles 50 microns or
smaller that shall not contain dirt, oil or water.
conformance:
• single instance of dust, airborne particulate, condensate or offensive odor noted in non-
production areas and the condition poses no threat to finished goods or packing materials
• compressed air is not filtered
Major non-conformance (1 point): Isolated instances of dust, airborne particulate, condensate

or offensive odor in a production/storage area that poses a potential threat to product
contamination

• multiple potential product contamination threats
3.12 Forklifts and batteries are well maintained and properly stored.
(Observation)
Full conformance (5 points): Forklifts and batteries are well maintained and batteries are
properly stored. Auditor will verify that:
• no leaking batteries or other fluids are found
• storage and charging area is clean and away from product storage/processing areas
• access must be available behind battery storage areas where pest control devices may be
in place (or under batteries if battery storage is wall mounted)
• batteries shall be stored a minimum of 6 feet (2 m) away from any finished goods or packing
materials. In areas where product/packing passes through or is transported but does not
stop, the 6 foot (2m) minimum is not applicable. Office records may be stored near batteries
• battery storage shall be clean underneath (any liquid or unknown spill from a forklift shall be
addressed here)
Note: Propane/gasoline powered forklifts are acceptable for use in a Packaging facility.
Minor non-conformance (3 points): Single/isolated instance of not meeting the above criteria
conformance:
• numerous instances of not meeting the above criteria
• leaking batteries found in fork lifts in production area(s) but forklifts are not conveying
product or packing materials

• forklifts conveying product are leaking any fluids
• batteries are found stored above or below product or packing materials
• leaking batteries are used in forklifts that are conveying product or packing
• significant evidence of leaking batteries
3.13 Idle equipment and spare parts are properly cleaned and stored.
(Observation)
• all surplus/unused equipment is stored in non-production areas in a clean condition and
manner so as not to cause rodent harborage (includes storage inside and outside the plant)
• piping shall be stored on racks
• piping stored outside the facility must have the ends sealed to prevent harboring rodents
• if supplier is storing equipment around the exterior of building, it should be kept outside of a
20' (6 m) perimeter area
• even equipment stored outside the 20' (6 m) area (but within 100’ inspection perimeter),
should be a minimum of 6" (15 cm) off the ground
Minor non-conformance (3 points): Single/isolated instance(s) of improperly stored equipment

or parts, but it does not appear it will encourage rodent activity
Major non-conformance (1 point): Numerous instances of improperly stored parts and/or

equipment, but does not appear it will encourage rodent activity
No points : No points will be awarded if one of the following situations is encountered:

• equipment not cleaned prior to storage, equipment stored in a production area
• interior/exterior equipment stored in a manner that may provide a place for rodent harborage
3.14 All containers are properly labeled.

(Observation - Documentation)
Full conformance (5 points): All containers, including trash receptacles and spray bottles are
properly labeled and the labels are legible. Color-coding is an acceptable method of
identification if there is evidence of training and understanding by the staff. Signage shall be
posted in production area as well as other appropriate areas of the facility indicating the code
usage.
conformance:
• single/isolated instance(s) of improperly or unlabeled containers in non-production areas
• color coding signage posted but not in production area (if color coding used)
Major non-conformance (1 point): Numerous instances of improperly or unlabeled containers in

non-production areas

• any instance of improperly labeled or unlabeled containers in production areas
• systematic failure to properly label containers in non-production areas
• no color coding signage in facility (if color coding used)
• no evidence of training on color coding (if color coding used)
3.15 All potentially hazardous materials and non-food grade lubricants that may
contaminate product or packing materials are potential food contact risks.
(Observation)
• hazardous materials are securely stored to prevent unauthorized use. Typically this would
be a locked closet or cage located in a storage room
• hazardous materials shall be stored away from product, packing materials and production
areas
• only food grade lubricants are used in all product/packing contact areas
• food grade verbiage should be visible on the label of lubricants and grease guns
• food grade lubricants shall be stored apart from non-food grade items so as to eliminate any
user confusion between the two
• inkjet ink and cleaners may be stored in the production area as long as contained in a
closed, labeled container
A hazardous material is "any material that due to its chemical, physical or biological nature
causes safety, public health, or environmental concerns".
Minor non-conformance (7 points): One of the following constitutes a minor non-conformance:

• auditor observes single/isolated hazardous or unapproved materials stored with product or
packing materials and there is no risk of product or packing material contamination
• auditor observes non-food grade lubricants stored with food grade materials
• auditor observes unapproved materials found in production area
• grease guns are not labeled/color coded for food and non-food grade grease
Major non-conformance (3 points): One of the following constitutes a major non-conformance:

• auditor observes numerous hazardous or unapproved materials stored with product or
packing materials and there is no risk of product or packing material contamination

• auditor observes hazardous, unknown, unlabeled or potentially hazardous or
unapproved materials that potentially could adulterate product or packing materials
• non-food grade lubricants have been used in areas that pose a risk of contaminating
product or packing materials
4.0 GOOD MANUFACTURING PRACTICES
4.1 GMP Program is established. Signs supporting GMPs are posted appropriately.
(Program - Documentation)
Full conformance (15 points): A GMP policy is established. The GMP program is written to
include:
• an effective GMP program for employees, visitors and contractors is available - shall include
how maintenance workers enter plant - appropriate dress and personal hygiene
• GMPs must be posted for all employees, contractors and visitors as appropriate
• employees are trained on GMPs on an ongoing basis (at least annually)
• an established and effective self-audit program (self audit records reviewed in 4.2)
All areas found in questions 4.3, 4.4, 4.5, 4.6, 4.7, and 4.8 shall be covered. GMPs shall be
based on the local code of regulations. (Code of Federal Regulations [21 CFR, part 110] in the
US).
conformance:
• Good Manufacturing Procedures have been developed, but guidelines are not posted
• no signage supporting GMPs, but policy is posted
conformance:
• program does not address all GMPs or does not have a visitor/contractor/maintenance
worker section
• no self audit program established
• ongoing training occurs but has been 12 to 18 months

• procedures for GMPs are not defined
• no training for GMPs
4.2 Self audits on GMP points are conducted at a minimum monthly and include corrective
action.
(Records)
Full conformance (15 points): Self-audits on GMP points must be conducted every month.
Results of the audits and the corrective action taken must be recorded.
conformance:
• self audits are conducted, but there are single/isolated omissions in the records
• self audits are conducted less frequently than monthly, but at least quarterly
conformance:
• GMP self-audits do not address follow up/corrective actions
• numerous omissions in record keeping
• self audits are conducted less frequently than quarterly, but at least once annually

• self audits are not conducted or less frequently than once each year
• records do not exist
4.3 Employees are complying with GMPs.

(Observation)
Full conformance (20 points): Employees compliance to GMP policy must be assessed.
Visitors, contractors and maintenance staff are also required to comply. The local Code of
Federal Regulations shall be used as a basis for requirements. Some of the more common
compliance criteria are:
• use of hair restraints (furnished by employer and to remain on-site)
• use of beard restraints. Uncovered mustaches are allowed in production areas, but are
limited to i) trimmed to edge of mouth and ii) trimmed close to face
• no gum chewing, eating or use of tobacco products in any area other than a designated
area
• no exposed jewelry or watches (plain wedding bands and medical alert bracelets are
acceptable) worn in the facility
• no false eyelashes, false nails, strong perfumes, body glitter or jewels, or exposed nail
polish worn in the facility
• outer pockets, above the waist, are sewn shut and/or empty
• clean company issued caps may serve as hair restraints in some facilities/areas
• ear plugs should be tethered (preferred method) or brightly colored
The above applies to production, storage and shipping dock areas where EXPOSED product is
being handled.
Minor non-conformance (15 points): Single/isolated instance(s) of failure to comply with GMPs.
Major non-conformance (6 points): Numerous instances of failure to comply with GMPs.
No Points: Systematic failure to comply with GMPs.
4.4 Personal items are stored away from processing areas.

(Observation)
Full conformance (10 points): All production, packing and storage areas must be free of
personal items; example: fans, radios, caps, coats, etc. Items supplied or approved by supplier
and remain in the facility are not defined as personal items (example: radios on desks).
Employees must be provided with personal storage areas or lockers.
Minor non-conformance (7 points): The auditor observes one instance of non-compliance to

the above requirements that does not pose a threat of contaminating product or packing
material.
conformance:
• one instance of non-compliance to the above requirements in an area where materials are
being processed or where finished goods are being packed or stored
• multiple instances that do not pose a threat of contaminating product or packing materials

• more than one instance of non-compliance in an area where materials are being processed
or where finished goods are being packed or stored
• employees are not provided with an area to store personal affects or personal items
4.5 Medical problems are not a source of contamination.

(Observation)
Full conformance (10 points): Any person who appears to have an illness, an open lesion, or
wound or any other abnormal source of microbial contamination shall be excluded from any
operation which may result in contamination until the condition is corrected. All bandages must
be covered with a non-porous covering such as latex or plastic gloves. The intent of this audit
question is to address obvious contamination caused by medical issues. It is in no way
attempting to ascertain the medical condition of the facility's employees.
Minor non-conformance: No minor non-conformance category for this audit point.
Major non-conformance: No major non-conformance to this audit point.

• one or more individuals observed with a medical condition that likely poses the risk
of product contamination
4.6 Hand washing facilities are adequate and are used.
(Observation)
Full conformance (10 points): Hand washing facilities shall:
• be made available in the restrooms
• have hands free operation (knee, foot pedals or automated rather than handles)
• have suitable drying devices
• be stocked with warm water and soap. The use of antibacterial soap is strongly
recommended. Warm water is defined as water that reaches 100 degrees F (38°C) within
30 seconds (or as defined by local code).
Cloth towels of any sort are not acceptable to Yum! Brands. Paper towel dispensers should not
require hands to touch dispenser to expose towel for retrieval. Hand sinks need not be within
the production area if they are nearby and have appropriate signage posted.
conformance:
• single instance of a hand wash station that does not meet the above requirements
• sinks, regardless of number, do not have hands free operation
conformance:
• isolated instances of hand wash stations not meeting the above standards
-- no soap, drying facility or use of cloth towels
• isolated instances of employees not using the hand wash stations
No points: Stocked hand wash stations are not readily available or are not used.
4.7 Signs supporting hand washing are posted appropriately.

(Observation)
Full conformance (5 points): Hand wash signs must be posted in all applicable languages or as
pictorials. "Wash Hands" sign(s) must be posted and observed in all rest rooms (office and
production areas), break rooms and locker rooms. Signs shall be located in the production
areas that direct employees to wash their hands before work, after each break and when their
hands become soiled or contaminated.
Minor non-conformance (3 points): Single/isolated instance(s) of signage non-conformance
Major non-conformance (1 point): Numerous instances of signage non-conformance

• no signage posted
• systematic signage non-conformance
• signage not posted in restrooms
4.8 Work areas are orderly with tools and processing supplies properly stored.
(Observation)
Full conformance (10 points): Work areas (including maintenance shops/areas) must be kept
orderly. This includes:
• cleaning and storing equipment between uses
• keeping areas free of clutter to enable workers to perform their function
• storing tools properly when not in use
Minor non-conformance (7 points): Single/isolated instance of clutter in a work area where

there is not the potential for product contamination
Major non-conformance (3 points): Numerous areas of clutter that potentially will not
contaminate product, but hinders worker performance
No points: Product and/or packing is exposed to contamination from spare parts, improperly
stored supplies or cluttered work areas
4.9 Facility and personnel adhere to Good Laboratory practices which are understood by all
personnel responsible for laboratory testing.
(Observation)
• laboratory has sufficient work and storage space and overall facilities to handle the work
load
• the laboratory is well organized, clean and free of clutter
• no food, beverages or personal items are stored in the laboratory
• no eating, drinking or smoking allowed
• the facility is designed so there is a separation that will prevent laboratory practices from
having a detrimental effect on manufacturing
• testing equipment is clean and well-maintained
If facility doesn't have an on-site laboratory, the auditor shall select N/A for this audit point.
conformance:
• limited workspace that inhibits employees' ability to properly perform their jobs
• a single/isolated observation of clutter
• a single/isolated observation of unclean equipment, tables, floors, cabinets or wash areas is
observed
Major non-conformance (1 point): One of the following will constitute a major non-conformance:
• numerous observations of clutter
• numerous observations of unclean equipment, tables, floors, cabinets or wash areas is
observed
• facility does not provide workers with lab coats or other protective outer clothing
• lab is not well maintained
• testing equipment is in disrepair
No points: No points will be awarded if any of the following in encountered:

• eating, drinking or smoking is observed in the laboratory (or there is evidence of)
• storage of food or beverage items in the laboratory is observed
• there is no separation between the laboratory and production areas
5.0 PRODUCT PROTECTION

5.1 There are no actual or potential instances of product adulteration/contamination
observed.
(Observation)
Full conformance (30 points): Auditor does not observe any instance(s) of actual or potential
product adulteration or contamination. This section includes catch pans under motors directly
over product, as well as any other potential/actual areas for contamination that were not
captured in another section of the audit.
Auditor’s Note: This section is used to capture any potential or actual contamination not
captured elsewhere in the audit. Award full points here if observations were captured elsewhere
in the audit. Score here if problems are systematic and not fully captured in another area of
audit.
Minor non-conformance: there is not a minor non-conformance category for this audit point
Major non-conformance: there is not a minor non-conformance category for this audit point
No points: Auditor observes a condition of imminent potential product contamination or

the auditor observes actual product contamination
5.2 Foreign material/QA control devices/methods are used and evaluated to ensure
proper operation.
Full conformance (30 points): For all Yum! Brands products, appropriate foreign material/QA
controls must be in place and working properly.
• traps, screens, filters, metal detectors, magnets, imaging and reject systems, if applicable,
must be monitored and tested for calibration in accordance with Yum! Brands product
specification requirements with results and corrective actions recorded and available for
review
• foreign material / QA controls must be checked at a frequency and method that complies
with the Yum! Brands specifications/requirements and/or QA Program
• if device/method fails test, "appropriate action" is for supplier to place all product between
acceptable checks on hold and repair device or recalibrate control. Product must be then
run through a properly functioning device before release
• auditor shall observe a test and verify that foreign material and QA controls on Yum! Brands
product lines are functioning properly. Auditor shall confirm the appropriate methods are
being used, and they conform to product specification and QA program. If Yum! Brands
product is not being produced on the day of the audit, auditor will still verify functionality with
the timing required by the product being run.
• foreign material/QA control devices and imaging systems must have a product rejection
device, if physically possible, not just an alarm or belt shut off mechanism
Note: Packaging facilities are NOT required to have metal detectors.
conformance:
• records contain isolated instances of incomplete or missing information
• foreign material/QA control fails auditor's check and plant takes appropriate corrective action
(all product between acceptable checks was placed on HOLD)
conformance:
• records contain numerous instances of incomplete or missing information
• frequency of foreign material control system inspections do not meet Yum! Brands product
requirements
• foreign material/QA control devices do not have positive rejection device if physically
possible but there is another rejection method such as a line stop and alarm or warning light

• foreign material/QA control fails auditor's check and plant does not take appropriate
corrective action
• no records of inspection/calibration of foreign material/QA controls
• no follow up corrective action on non-conformances
• no foreign material QA control devices or program
5.3 Adequate product/case tracking systems are in place.

(Program - Records)
Full conformance (15 points): Facility has the capability and is coding product/cases in a
manner that allows tracking to a supplier, production facility and production date. Procedure for
identification of product is in place and documented. Product shipping/tracking logs are up to
date and accurate.
conformance:
• product/cases are coded, but a single information element is missing
• product tracking logs are kept, but are not up to date
conformance:
• product/case coding is not identifiable
• product tracking logs are not being kept
No points: No product/case tracking system or product identification system if in place.

• no documented program
• product/cases are not being coded
5.4 Supplier has an approved supplier program established for all raw material suppliers.
(Procedures – Documentation -Records)
All points (25 points): To be awarded all points a supplier shall have a program which:
• clearly defines process by which their suppliers become approved as a raw material
supplier and at a minimum shall include the following:
• product quality and food safety as approval criteria.
• an evaluation of raw material suppliers ( both food contact and non-food contact),
and processing aids used in ingredients and packaging for production of Yum!
Brands products. This evaluation shall include:
o the country of origin for raw materials
o food safety audits performed at the ingredient supplier’s facility containing the
minimum elements expected in a food safety audit that are listed below
o the Quality Assurance contact
o program for the control of non-conforming ingredients and products
o recall program
• defines how suppliers' performance will be monitored and tracked
• defines corrective actions for supplier performance problems
• a current dated approved supplier list
• criteria for disqualification
Records should be reviewed for monitoring raw material supplier performance.
Minimum elements expected in the food safety audit:

• Pest Control
• Sanitation
• Operations and Facility
• Good Manufacturing Practices
• Product protection
• Product Recovery
• Security
Minor non-conformance (18 points): One element in the approved supplier program is missing
or is incomplete.
Major non-conformance (9 points): Two elements in the approved supplier program

requirements are missing.
No points: No points will be awarded if any one of the following is encountered:

• more than two elements are missing
• no program
6.0 PRODUCT RECOVERY AND SECURITY
6.1 A documented Product Recall Program is established.

(Program)
All Points (15 points): Program shall have written procedures for the following elements:
• the identification and location of suspect product
• the reconciliation and disposition of recovered product
• notification of Yum! Brands Quality Assurance
• decision protocol defining when and if a regulatory agency will be notified
• outline of responsibilities for individuals on suppliers Recall Team
Minor non-conformance (10 points): one element of above is not clearly defined
Major non-conformance (5 points): one element of above is missing
No points: No points will be awarded if any of the following is encountered:

• more than one key element of the program is missing
6.2 Contact lists are maintained for product recoveries.

(Records)
All Points (10 points): Product Recovery Contact Lists shall be current, updated annually and
defined as below:
• Supplier's Contacts (within supplier's company): Each contact shall have copy of current
Recovery/Withdrawal Program and contact list.
• Supplier's Emergency Contacts are current in the Yum! Brands Supplier Management
Website.
• Second Tier Supplier's Contacts: (material or packing supplier to supplier being audited)
business and after hour phone/pager numbers required
• Appropriate Yum! Brands Contacts
NOTE: All lists should include contacts for 24-hour/7 day per week accessibility to a
minimum of two individuals. If both a Recovery Team and a Contact list exist, they both
shall be included in the program.
conformance.
• disorganized records
• contact list has isolated omissions
• contact list is not up to date
• supplier’s contact list in the Yum! Brands Supplier Management Website is not up to date
Major non-conformance (3 points): One of the following will constitute a major

nonconformance:
• one contact list is missing
• Supplier contact list is missing from the Yum! Brands Supplier Management Website
No points: No points will be awarded if the following is encountered:

• more than one contact list is missing
6.3 A Mock Recovery Program is established.

(Program)
All Points (10 points): Mock Recovery Program procedures to include the following:
• a mock recovery must trace either a raw material OR product contact packing material to
finished product and onto the first external customer within 2 hours
• frequency of Mock Recovery (at least annually)
• time of day Mock Recovery is to be conducted (at least once per year, test must be
conducted after normal business hours (8 am to 5 PM M-F)
• testing of individuals on contact list to confirm understanding of their responsibility during a
Recovery
• summary of traceability results which includes:
- identification of which raw material or product contact packing material traced
- date and time test initiated and completed
- overview of records that were reviewed to obtain the amounts of product involved
- a summary of calculations
- a documented review by the Recall Team
- the test's effectiveness including amount of product recovered
- list of who should be notified in the case of a real recovery
- a review of any issues uncovered or opportunities to improve the system
• provision for re-testing any part that fails within 60 days (failure, defined as taking longer
than 4 hours to complete and/or recovering <95% or > 105%)
First external customer - (defined as the first customer outside control of supplier; freight
forwarding warehouses contracted by the supplier are considered to still be in the supplier’s
control and are not the First External Customer). First external customer can be:
i) a distribution center that distributes directly to Yum! Brands restaurants
ii) another Yum! Brands approved supplier which uses the product for copacking
iii) an export facility that will export the product to another country
(Records will be reviewed in section 6.4)
conformance.
• one element of above is not clearly defined
• one element is missing
Major non-conformance (3 points): Two elements are missing

• more than two elements of the program are missing
6.4 Supplier conducts "annual" Internal Mock Recovery.

(Records)
All Points (15 points): Supplier shall conduct an annual after-hours Internal Mock Recovery. It
is suggested that the Mock Recovery be impromptu and initiated by the supplier's corporate
QA. An actual recall does not eliminate the need for a Mock Recovery.
The auditor will verify the following elements are included:

• Mock Recovery to include a raw material OR a product contact packing material traced to
finished product and onto the first external customer (defined as the first customer outside
the control of the supplier) all within 2 hours.
• Mock Recovery shall be tested annually after normal business hours (generally 8 am to 5
PM M-F) Testing must start at least one hour prior to the beginning of normal business
hours or at least one hour after the normal business hours listed.
• traceability shall include product held, shipped, work in-process, reworked and destroyed, if
applicable
• a summary of the test shall include the following and be provided to the auditor:
- identification of which raw material or product contact packing material traced
- date and time test initiated and completed
- overview of records that were reviewed to obtain the amounts of product involved
- a summary of calculations
- a documented review by the Recall Team
- the test's effectiveness including amount of product recovered
- list of who should be notified in the case of a real recovery
- a review of any issues uncovered or opportunities to improve the system
• documented re-test any part of the mock recovery that fails within 60 days
Note: a failure is defined as taking longer than 4 hours to complete and/or
recovering <95% or >105%
AUDITOR NOTE: Review the supplier's last Mock Recovery records. If a supplier locates more
product during a Mock Recovery than was actually produced, the supplier shall not receive full
points (see standards below). However, for bulk materials such as products stored/received in
silos, rail cars, supplier is allowed to trace raw materials to finished product using estimated
amounts of bulk materials.
Suppliers are asked to NOT phone contacts on the lists during a Mock Recovery, as
confusion between a Mock Recovery and an Actual Recall may occur.
Minor non-conformance (10 points):

• single/isolated instances of incomplete or missing records
• supplier's test recall did not include one of the required elements
• (100.5% - 105%) or (99.5% - 95%) of product is located within 2 hours.
• 100% of product traced, but tracing took 2-4 hours
conformance:
• re-test of a recall deficiency was not conducted within the required 60 days
• supplier's test recall did not include more than one of the required elements
• supplier's last Mock Recall test was conducted 13-18 months ago
• (100.5% - 105%) or (99.5% - 95%) of product is located in 2 - 4 hours
No points: No points shall be awarded if any one of the following is encountered:

• a combination of major non-conformance criteria
• supplier does not have the elements necessary to track and locate product or
packaging
• supplier hasn't tested the system in over 18 months
• <95% or >105% of the product is located
• product recovery takes more than 4 hours
NOTE: The auditor will initiate a test of the suppliers’ product recovery during the course of
this audit, and is required to begin the recovery a minimum of 4 hours prior to close of day, to
assure the supplier enough time for recovery completion and to correct any issues that may
arise.
6.5 Auditor verifies supplier can identify, track and locate 100% of raw materials used
in Yum! Brands product to finished Yum! Brands product lots, and on to first
external customer "within 2 hours.”
All points (15 points): Auditor will select a single raw material or product contact packing
material code number or lot number and ask the supplier to trace it to finished product lots,
rework, any work in process, product on hold or destroyed (if applicable) onto the first external
customer within 2 hours.
If supplier does not track raw materials and/or product contact packing materials, a
finished product lot code will be chosen and the score begins at a minor non-
conformance.
AUDITOR GUIDELINE: When tracing a raw material, first identify total quantity of raw material
received by supplier. This raw material quantity must be 100% reconciled to initial raw material
production records, including portions used or still in storage. From this point on, only
percentage of raw material product used for Yum! Brands product is to be traced through to
finished product and to first external customer. No need to trace non- Yum! Brands used raw
material amount to finished product/external customer. Supplier's procedure shall include the
ability to trace product contact packing materials as raw materials.
To receive full points, 100% of the raw material or product contact packing material must be
traced to finished product, as well as 100% of the finished product lots to first external customer
within the 2-hour time frame.
conformance:
• process does not or cannot track product contact packing materials to finished product lots
• isolated instances of incomplete or missing records.
• combined total variation of the amount of raw material traced plus the amount of finished
product tracked, is > 0% but < 5% of the 100% target in two hours (see calculation table
below for reference)
conformance:
• the combined total variation of the amount of raw material traced plus
the amount of finished product tracked, is > 0% but < 5% of the 100% target in 2-4 hours
• recall takes more than 2 hours but less than 4 hours to complete
No Points: No points will be awarded if any of the following is encountered:

• supplier does not have the ability to track and locate product
• process cannot or does not track one raw material or rework
• the combined total variation of the amount of raw material traced plus the amount of
finished product tracked is more than 5% of the 100% target
• recall takes more than 4 hours to complete
A B C D E F
Amount of Amount of B/A * 100 = % Total Amount of Total Amount E/D * 100 = %
Material Material Located of Materials Product of Product of Product
Received at in Product, in Recovered Produced Recovered Located
Plant Storage or
Disposed
Total Difference [(100-C)] + [(100-

from Target F)] = Total
Variation
6.6 A documented Product Security Program is established.

(Program)
All Points (15 points): An individual is assigned responsibility for product security. The
program shall have written procedures addressing the following elements:
(Note: further information can be obtained on the FDA website www.fda.gov in the security
guidance document):
• management of product security
• physical facility
• employees
• computer systems
• raw materials and packaging
• operations (security of water and air)
• finished products
• security strategies
• evaluation
Minor non-conformance (10 points): One or two of above areas is not addressed
Major non-conformance (5 points): Three of above areas are not addressed

• more than three areas of the program are not addressed
• no person at the facility or in the company is assigned responsibility for product
security
6.7 An annual program is established to review the Product Security Program. Records with
corrective actions are available.
(Program - Records)
All Points (10 points): A self-audit program to review product security shall include:
• who is responsible for conducting the internal review
• self audit is conducted at least annually
• areas of improvement are identified
• corrective actions with timelines are developed to address areas of improvement
conformance:
• responsibility for updating the program or auditing is not defined, but self audits are
conducted annually
• single/isolated instances of incomplete or missing records
conformance:
• frequency of auditing and updating is not followed

• no self audit program
• no defined corrective actions
• self audits not conducted
6.8 Measures are in place to ensure product and facility security.

(Records - Observation)
All Points (10 points): Measures to ensure product and facility security shall include:
• supplier shall record whether incoming materials, packaging, and finished product are
received in locked and/or sealed vehicles/containers/railcars. Seal numbers are recorded.
Supplier to encourage secondary suppliers to ship raw materials in locked
vehicles/containers/railcars
• outgoing vehicles should be locked and/or sealed before leaving the supplier’s dock
• entries to product storage areas are secured or access restricted
• adequate interior and exterior lighting of the facility
• access to computer process control systems is restricted
Minor non-conformance (7 points): The following will constitute a major non-conformance:

• one element of the above missing
• single/isolated instance of missing records

• two elements of the above missing
• numerous instances of missing records
No points: No points will be awarded if the following is encountered:

• more than two elements of the above missing
• systematic failure to keep records

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Yum! Brands Global Restaurants, Inc.

Packaging Facility Audit Guidelines

1. Points noted in parentheses (10 points) represent points earned.

7. All Systems/procedures must be in place prior to a plant attaining Approved Status.

For the purposes of this audit/evaluation:

1.1 A documented pest control program is established.

The program shall include:

Major non-conformance (6 points): The following will constitute a major non-conformance:

No points: No points will be awarded if the following situations is encountered:

If pesticides are kept on site, they:

Hard copies of MSDS sheets shall be located in the plant.

No points: No points will be awarded if the following situation is encountered:

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

1.5 There is no evidence of INTERNAL pest activity.

No points: No points will be awarded if one of the following situations is encountered:

1.6 There is no evidence of EXTERNAL pest activity.

Minor non-conformance (7 points): Single/isolated instance of reoccurring/existing rodent

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

2.1 A master sanitation program is established.

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

Major non-conformance (5 points): The following will constitute a major non-conformance:

No points: No points will be awarded if one of the following situations is encountered:

2.4 Cleaning equipment and chemicals are properly stored.

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

2.7 Water quality testing and monitoring

No points: No points will be awarded if one of the following situations is encountered:

2.8 Equipment design and condition allow for proper cleaning.

Note: Wooden handled cleaning equipment is acceptable in a Packaging facility.

No Points: No points will be awarded if one of the following situations is encountered:

3.0 OPERATIONS AND FACILITY:

3.1 A maintenance related product safety program is established. Records are

Minor non-conformance (7 points):

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

3.3 Housekeeping is acceptable for INTERIOR of the facility.

No points: No points will be awarded if one of the following situations is encountered:

3.4 Housekeeping is acceptable for EXTERIOR grounds of facility.

(Equipment storage outside is addressed in Element 3.13.)

No points: No points will be awarded if one of the following situations is encountered:

No points: No points will be awarded if one of the following situations is encountered:

Minor non-conformance (3 points): The following will constitute a minor non-conformance:

Major non-conformance (1 point): The following will constitute a major non-conformance:

No points: No points will be awarded if one of the following situations is encountered:

3.7 Doors and openings are pest resistant.

Major non-conformance (1 point): Isolated instances of non-conformance to above

No points: Numerous instances of non-conformance to above requirements

Minor non-conformance (3 points): Single/isolated instance of unshielded ladders, walkways or

Major non-conformance (1 point): Numerous instances of unshielded ladders, walkways or

No points: Any observation of direct contamination of product or packing materials

Glass Policy shall include:

The only exception to this glass policy is a fire extinguisher housing.