ANNEX 2 GFSI- Compliant Prerequisite Program /
Preventive Controls Matrix
PAS Requirements
4 Construction and layout of buildings (Environment/Location)
4.1 General Requirements
4.2 Environment
4.3 Locations of establishments
5.1 General requirements
5.2 Internal design, layout and traffic
patterns
5.3 Internal structures and fittings
5.4 Location of equipment
5.5 Laboratory Facilities
5.6 Temporary/mobile premises and
vending machines
5.7 Storage of food, packaging materials,
ingredients and non food chemicals
6.1 General requirements
DOCUMENT NAME
REVISION #
EXAMPLES of SOME
APPLICABLE PREREQUISITE
DESCRIPTION
PROGRAMS &/or PREVENTIVE
CONTROLS
Facility Preventative Maintenance (PM)
Programs (building & roof maintenance &
Buildings shall be designed, constructed and
inspections; air handling; docks, etc.)
maintained in a manner appropriate to the nature of
Facility GMP Program
the processing operations to be carried out, the food
Monthly Sanitation/Food Safety Audits
safety hazards associated with those operations and
Environmental Sampling Program
the potential sources of contamination from the plant
Sanitation Program
environs. Buildings shall be of durable construction
Pest Control Program
which presents no hazard to the product.
Landscaping Program
Facility Security Program
Environmental Permit Review Program -
Consideration shall be given to potential sources of
(Air, Water, Hazardous Waste, etc.)
contamination from the local environment.
Review of "Google Earth"
The effectiveness of measures taken to protect against
GMP - Monthly Perimeter Inspection
potential contaminants shall be periodically reviewed.
Food Security Program
The site boundaries shall be clearly identified.
Access to the site shall be controlled. GMP - Monthly Perimeter Inspection
The site shall be maintained in good order. Vegetation Food Security Program
shall be tended or removed. Roads, yards and parking Landscaping Program
areas shall be drained to prevent standing water and P.M. Program - Parking Lots
shall be maintained.
5 Layout of premises and workspace
Internal layouts shall be designed, constructed
and maintained to facilitate good hygiene and Plant Layout Plans
manufacturing practices. The movement patterns Floor Plan Review & Traffic Control
of materials, products and people, and the layout Allergen Control Program
of equipment, shall be designed to protect against Food Security Program
potential contamination sources.
The building shall provide adequate space, with a
Plant Layout Plans
logical flow of materials, products and personnel, and
Floor Plan Review & Traffic Control
physical separation of raw from processed areas.
Allergen Control Program
Food Security Program
Openings intended for transfer of materials shall be
Pest Control Program
designed to minimize entry of foreign matter and pests.
Process area walls and floors shall be washable or
cleanable, as appropriate for the process or product
hazard. Materials shall be resistant to the cleaning
system applied.
Wall floor junctions and corners shall be designed to
facilitate cleaning. Internal Air Movement Control Program
Floors shall be designed to avoid standing water. Master Sanitation Program & Schedules
In wet process areas floors shall be sealed and drained. Drain Monitoring Program
Drains shall be trapped and covered. Facility GMP Program
Ceilings and overhead fixtures shall be designed to Pest Control Program
minimize build up of dirt and condensation.
External opening windows, roof vents or fan, where
present, shall be insect screened.
External opening doors shall be closed or screened
when not in use.
Equipment shall be designed and located so as to
Sanitation Program & Scheduling
facilitate good hygiene practices and monitoring.
Sanitary Equipment Design Program
Equipment shall be located to permit access for
Capital Project Approval Program
operation, cleaning and maintenance.
In-line and on-line test facilities shall be controlled to
minimize risk of product contamination.
Inline/Online Testing Control Program
Microbiology laboratories shall be designed, located
Microbiolgical Testing Control Program
and operated so as to prevent contamination of
Facility Design Control Program
people, plant and products. They shall not open
directly onto a production area.
Temporary structures shall be designed, located and
constructed to avoid pest harborage and potential Trailer Inspection Program Trailer
contamination of products. Sanitation Program & Schedules
Additional hazards associated with temporary Monthly GMP Inspection Program
structures and vending machines shall be assessed Pest Control Program
and controlled.
Facilities used to store ingredients, packaging and
products shall provide protection from dust,
condensation, drains, waste and other sources of
contamination.
Storage areas shall be dry and well ventilated.
Monitoring and control of temperature and humidity Temperature/Humidity Control Program
shall be applied where specified. Tote/Bulk Storage Control Programs
Storage areas shall be designed or arranged to allow GMP Program - Racks & Storage Areas
segregation of raw materials, work in progress and Master Sanitation Program & Scheduling
finished products. Warehouse Inspection Program
All materials and products shall be stored off the floor Pest Control Program
and with sufficient space between the material and the Segregation of Raw Materials and Finished
walls to allow inspection and pest control activities to Goods
be carried out. Chemical Storage Program
The storage area shall be designed to allow Food Security Program
maintenance and cleaning, prevent contamination and Chemical Control Program
minimize deterioration. Waste Control Program
A separate, secure (locked or otherwise access Sanitary Facility Design Program
controlled) storage area shall be provided for cleaning
materials, chemicals and other hazardous substances.
Exceptions for bulk or agricultural crop materials shall
be documented in the food safety management
system.
6 Utilities – air, water, energy
The provision and distribution routes for utilities to and
around processing and storage areas shall be designed
Plant Layout Plans
to minimize the risk of product contamination. Utilities’
Floor Plan Review & Traffic Control
quality shall be monitored to minimize product
contamination risk.

6.2 Water supply
6.3 Boiler Chemicals
6.4 Air quality and ventilation
6.5 Compressed air and other gases
6.6 Lighting
7.1 General Requirements
7.2 Containers for waste and inedible or
hazardous substances
7.3 Waste management removal
7.4 Drains and drainage
8.1 General requirements
• The supply of potable water shall be sufficient to meet
the needs of the production process(es). Facilities for
storage, distribution and, where needed, temperature
control of the water shall be designed to meet
specified water quality requirements.
• Water used as a product ingredient, including as ice
or steam (including culinary steam), or in contact with
products or product surfaces, shall meet specified
quality and microbiological requirements relevant to
the product.
• Water for cleaning or applications where there is a Water Quality Monitoring/Testing Program
risk of indirect product contact (e.g. jacketed vessels, (including Culinary Steam & Ice)
heat exchangers) shall meet specified quality and Water Filter PM Program
microbiological requirements relevant to the Deionizer PM Program
application. Sanitary Facility Design Program
• Where water supplies are chlorinated, checks shall
ensure that the residual chlorine level at the point
of use remains within limits given in relevant
specifications.
• Non potable water shall have a separate supply system
that is labelled, not connected to the potable water
system and is prevented from reflux into the potable
system.
Boiler chemicals, if used, shall be either:
a) approved food additives which meet relevant
additive specifications; or
b) additives which have been approved by the relevant
Chemical Control Program - Boilers
regulatory authority as safe for use in water
Food Security Program
intended for human consumption.
Boiler chemicals shall be stored in a separate, secure
(locked or otherwise access controlled) area when not
in immediate use.
The organization shall establish requirements for
filtration, humidity (RH%) and microbiology of air used
as an ingredient or for direct product contact. Where
temperature and/or humidity are deemed critical by
the organization, a control system shall be put in place
and monitored.
Ventilation (natural or mechanical) shall be provided to
remove excess or unwanted steam, dust and odours,
and to facilitate drying after wet cleaning.
Facility Humidity Control Program
Room air supply quality shall be controlled to minimize
PM Program - Air Filtration & Air Handling
risk from airborne microbiological contamination.
& Ventiliation System
Protocols for air quality monitoring and control shall
Environmental Air Testing Program
be established in areas where products which support
Environmental Micro. Testing Program
growth or survival are exposed.
Sanitary Facility Design Program
Ventilation systems shall be designed and constructed
such that air does not flow from contaminated or raw
areas to clean areas. Specified air pressure differentials
shall be maintained. Systems shall be accessible for
cleaning, filter changing and maintenance.
Exterior air intake ports shall be examined periodically
for physical integrity.
Compressed air, carbon dioxide, nitrogen and other
gas systems used in manufacturing and/or filling shall
be constructed and maintained so as to prevent
contamination.
Gases intended for direct or incidental product contact
(including those used for transporting, blowing or Chemical Control Program Air
drying materials, products or equipment) shall be from Filtration and Control Program
a source approved for food contact use, filtered to
remove dust, oil and water.
Where oil is used for compressors and there is potential
for the air to come into contact with the product, the
oil used shall be food grade.
Requirements for filtration, humidity (RH%) and
microbiology shall be specified.
The lighting provided (natural or artificial) shall allow
personnel to operate in a hygienic manner.
Glass & Brittle Plastic Program
Glass & Brittle Plastic Inventory
Light fixtures shall be protected to ensure that
cGMP Program - Monthly Audits
materials, product or equipment are not contaminated
in the case of breakages.
7 Waste disposal
Systems shall be in place to ensure that waste materials Waste Management Program
are identified, collected, removed and disposed of in a Hazardous Waste Handling, Storage &
manner which prevents contamination of products or Removal Programs
production areas. Color Coding Policy
Containers for waste and inedible or hazardous
substances shall be: Waste Management Program
a) clearly identified for their intended purpose; Facility Layout Plans
b) located in a designated area; Floor Plan Review & Traffic Control
c) constructed of impervious material which can be cGMP Program
readily cleaned and sanitized; Hazardous Waste Handling, Storage &
d) closed when not in immediate use; Removal Programs
e) locked where the waste may pose a risk to the Food Security Program
product.
Provision shall be made for the segregation, storage
and removal of waste.
Waste Management & Destruction
Accumulation of waste shall not be allowed in food
Program Facility
handling or storage areas. Removal frequencies shall
Layout Plans
be managed to avoid accumulations, with a minimum
Floor Plan Review & Traffic Control
daily removal.
cGMP Program
Labelled materials, products or printed packaging
Hazardous Waste Handling, Storage &
designated as waste shall be disfigured or destroyed to
Removal Programs
ensure that trademarks cannot be reused. Removal and
Food Security Program
destruction shall be carried out by approved disposal
contractors. The organization shall retain records of
destruction.
Drains shall be designed, constructed and located so
Facility Drain Layout Review
that the risk of contamination of materials or products
Drain Preventive Maintenance Program
is avoided. Drains shall have capacity sufficient to
Environmental Sampling & Testing
remove expected flow loads. Drains shall not pass over
Program
processing lines.
cGMP Program
Drainage direction shall not flow from a contaminated
Master Sanitation Program & Schedules
area to a clean area.
8 Equipment suitability, cleaning and maintenance
Food contact equipment shall be designed and
constructed to facilitate cleaning, disinfection and
Sanitary Facility Design Program
maintenance. Contact surfaces shall not affect, or be
Sanitary Equipment Design Program
affected by, the intended product or cleaning system.
Master Sanitation Program & Schedules
Food contact equipment shall be constructed of
durable materials able to resist repeated cleaning.
 Equipment shall be able to meet established principles
of hygienic design, including:
a) smooth, accessible, cleanable surfaces, self draining
in wet process areas;
Capital Project Approval Program
b) use of materials compatible with intended products
Maintenance Program
and cleaning or flushing agents;
8.2 Hygienic design Sanitary Facility Design Program
c) framework not penetrated by holes or nuts and
Sanitary Equipment Design Program
bolts.
Master Sanitation Program & Schedules
Piping and ductwork shall be cleanable, drainable, and
with no dead ends.
Equipment shall be designed to minimize contact
between the operator’s hands and the products.

Capital Project Approval Program

Product contact surfaces shall be constructed from Maintenance Program
8.3 Product contact surfaces materials designed for food use. They shall be Sanitary Facility Design Program
impermeable and rust or corrosion free. Sanitary Equipment Design Program
Master Sanitation Program & Schedules

Equipment used for thermal processes shall be able to Capital Project Approval Program
meet the temperature gradient and holding conditions Maintenance Program
8.4 Temperature control and monitoring
given in relevant product specifications. Sanitary Equipment Design Program
equipment
Equipment shall provide for the monitoring and Product Specification Program
control of the temperature. Calibration Program

Wet and dry cleaning program shall be

Master Sanitation Program & Schedules
documented to ensure that all plant, utensils and
Equipment Cleaning & Sanitation
equipment are cleaned at defined frequencies.
Procedures
The program shall specify what is to be cleaned
8.5 Cleaning plant, utensils and equipment Drain Monitoring & PM Program
(including drains), the responsibility, the method of
cGMP Program
cleaning (e.g. CIP/COP), the use of dedicated cleaning
Allergen Control Program
tools, removal or disassembly requirements and
ATP Testing Program
methods for verifying the effectiveness of the cleaning.

A preventive maintenance program is in place. The preventive

maintenance program includes all devices used to monitor and/or
control food safety hazards.
NOTE: Examples of such devices include screens and filters CMMS Preventive Maintenance Program
(including air filters), magnets, metal detectors & X-ray detectors. - Temporary Repair Tracking Program
Corrective maintenance is carried out in such a way that - Equipment impacting food safety is
production on adjoining lines or equipment is not at risk of designated as a prioity within the CMMS
contamination. program
Maintenance requests impacting product safety are given priority. - Food-Grade lubricants are used where
Temporary fixes do not put product safety at risk. A request for there is any potential for food contact -
8.6 Preventive and corrective maintenance replacement with a permanent repair is included in the maintenance Equipment Hand-Off Protocols .
schedule. Master Sanitation Program & Schedules
Lubricants and heat transfer fluids are food grade where there is a Chemical Control Program
risk of direct or indirect contact with the product. Food Security Program
The procedure for releasing maintained equipment back to cGMP Program
production includes clean up, sanitizing (where specified in process Allergen Control Program
sanitation procedures) and pre-use inspection. Pre-Op Inspection Program
Local area PRP requirements shall apply to maintenance areas and Maintenance Program
maintenance activities occuring in processing areas. Maintenance
personnel shall be trained in the product hazards that are associated
with their activities.

9 Management of purchased materials

Vendor Selection, Classification and Risk-

9.1 General requirements
Purchasing of materials which impact food safety shall
Based Approval Program
be controlled to ensure that the suppliers used have
Product Testing & Approval Program
the capability to meet the specified requirements.
Vendor Information Mgmt. Program
The conformance of incoming materials to specified
Vendor Evaluation/Audit Program
purchase requirements shall be verified.
Product Specification Program

There shall be a defined process for the selection,

approval and monitoring of suppliers. The process used
shall be justified by hazard assessment, including the
Vendor Selection, Classification and Risk-
potential risk to the final product, and shall include:
Based Approval Program
a) assessment of the supplier’s ability to meet quality
Vendor Information Mgmt. Program
and food safety expectations, requirements and
Vendor Evaluation/Audit Program
9.2 Selection and management of specifications;
Product Specification Program
suppliers b) description of how suppliers are assessed;
Product Testing & Approval Program
c) monitoring the performance of the supplier to
Vendor COA Program
assure continued approval status.
Purchase Order/Requisition Program
Control of Records Program
NOTE Monitoring may include conformance to material
or product specifications, meeting COA requirements,
satisfactory audit outcomes.

Delivery vehicles shall be checked prior to, and during,

9.3 Incoming material requirements
(raw/ingredients/packaging)
unloading to verify that the quality and safety of the
material has been maintained during transit (e.g. seals
are intact, free from infestation, temperature records
exist).
Product Specification Program
Materials shall be inspected, tested or covered by COA
Product Testing & Approval Program
to verify conformance to specified requirements prior
Purchase Order/Requisition Program
to acceptance or use. The method of verification shall
Allergen Control Program
be documented.
Logistics Trailer Inspection Program
NOTE The inspection frequency and scope may be based on
Vendor Selection, Classification and
the hazard presented by the material and the risk
Risk-Based Approval Program
assessment of the specific suppliers.
Materials which do not conform to relevant
Vendor Evaluation Program
specifications shall be handled under a documented
Vendor COA Program
procedure which ensures they are prevented from
Control of Records Program
unintended use.
Access points to bulk material receiving lines shall be
identified, capped and locked. Discharge into such
systems shall take place only after approval and
verification of the material to be received.

10 Measures for prevention of cross contamination

Allergen Control Program

10.1 General requirements
Cross contamination is prevented and controlled by product and
structural segregation, by management of allergens, by management Sanitary Facility Design Program
of glass and brittle plastic materials.
Glass & Brittle Plastic Control Program
Product Testing & approval Program
cGMP Programs - Monthly Audits
Master Sanitation Program & Schedules
Preventive Maintenance Program
Product Scheduling Protocols
Product Change-Over Matrices
Facility Layout Evaluation Program
Floor Plan Review & Traffic Control

10.2 Microbiological cross contamination
10.3 Allergen Management
10.4 Physical contamination
11.1 General requirements
11.2 Cleaning and sanitizing agents and
tools
11.3 Cleaning and sanitizing programs
11.4 Cleaning in place (CIP) systems
11.5 Monitoring sanitation effectiveness
12.1 General requirements
12.2 Pest control programs
12.3 Preventing access
Areas where potential for microbiological cross contamination exists Environmental Testing Program
(airborne or from traffic patterns) shall be identified and a segregation Product Testing & Approval Program
(zoning) plan implemented. A hazard assessment shall be carried out cGMP Program - Clothing Requirements
to determine potential contamination sources, susceptibility of the Product Specification Program - Spice
product and control measures suitable for these areas as follows: Microbial Reduction Requirements
a) separation of raw from finished or ready to eat (RTE) products; Master Sanitation Program & Schedules
b) structural segregation – physical barriers/walls/ separate buildings; Facility Layout Evaluation Program
c) access controls with requirements to change into required work Floor Plan Review & Traffic Control
wear; Maintenance:Facility Air Control Program
d) traffic patterns or equipment segregation – people, materials, Sanitary Facility Design Program
equipment and tools (including use of dedicated tools); Access Control Program
e) air pressure differentials. Food Security Program
Allergens present in the product, either by design or by potential
manufacturing cross contact, shall be declared. The declaration shall
be on the label for consumer products, and on the label or the
accompanying documentation for products intended for further
processing.
Allergen Control Program
Products shall be protected from unintended allergen cross contact
Product Testing & Approval Program
by cleaning and line change-over practices and/or product
cGMP Program - Monthly Audits
sequencing.
Master Sanitation Program & Schedules
NOTE Manufacturing cross contact may arise from either: a) traces
Facility Layout Evaluation Program
of product from the previous production run which
Floor Plan Review & Traffic Control
cannot be adequately cleaned from the product line due
Product Scheduling Protocols
to technical limitations; b) when contact is likely to occur, in the
Allergen Change-Over Matrices
normal
Maintenance:Facility Air Control Program
manufacturing process, with products or ingredients that are
Color Coding Policy Sanitary
produced on separate lines, or in the same or adjacent processing
Facility Design Program Access
areas.
Control Program Food
Rework containing allergen(s) shall be used only:
Security Program Product
a) in products which contain the same allergen(s) by design; or
Labeling Program
b) through a process which is demonstrated to remove or destroy the
allergenic material.
NOTE 1 For general rework requirements see Clause 14.
NOTE 2 Food handling employees should receive specific training in
allergen awareness and associated manufacturing practices.
Where glass and/or brittle material are used, periodic inspection Glass & Brittle Plastic Program
requirements and defined procedures in case of breakage shall be Contaminant Detection Using X-Ray
put in place. Metal Detection Program
NOTE Glass and brittle material (such as hard plastic components in cGMP Program - Monthly Audits & PPE
equipment) should be avoided where possible. Master Sanitation Program & Schedules
Glass breakage records shall be maintained. Facility Layout Evaluation Program
Based on hazard assessment, measures shall be put in place to Sanitary Facility Design Program
prevent, control or detect potential contamination. Product Screening Protocols
NOTE 1 Examples of such measures include: a) adequate covers Magnets Use & Control Program
over equipment or containers for exposed materials or products; b) Knife Control Program
use of screens, magnets, sieves or filters; c) use of detection/
rejection devices such as metal detectors or X-ray. Product Scheduling Protocols
NOTE 2 Sources of potential contamination include wooden pallets Maintenance: PM Program for Filters
and tools, rubber seals, personal protective clothing and equipment, Pallet Inspection & Repair Program
etc.
11 Cleaning and sanitizing
Master Sanitation Program & Schedules
Equipment Cleaning & Sanitation
Cleaning and sanitizing programs have been established to ensure
Procedures
food processing equipment and environment are maintained in a
Drain Monitoring & PM Program
hygienic condition. Programs include cleaning and sanitizing agents,
cGMP Program
cleaning and sanitizing schedule and monitoring of sanitation
ATP Testing Program
effectiveness
Environmental Testing Program
Facilities and equipment shall be maintained in a condition which Master Sanitation Program & Schedules
facilitates wet or dry cleaning and/or sanitation. Utensil Color-Coding Policy
Cleaning and sanitizing agents and chemicals shall be clearly Chemical Control Program
identified, food grade, stored separately and used only in accordance Sanitation Chemical Strength/Usage Log
with the manufacturer’s instructions. cGMP Program
Tools and equipment shall be of hygienic design and maintained in a Food Security Program
condition which does not present a potential source of extraneous Maintenance Program - Tool Usage
matter. Knife Control Program
Cleaning and sanitizing programs shall be established and validated
by the organization to ensure that all parts of the establishment and Master Sanitation Program & Schedules
equipment are cleaned and/or sanitized to a defined schedule, Facility and Equipment Cleaning and
including the cleaning of cleaning equipment. Sanitation Procedures
Cleaning and/or sanitizing programs shall specify at a minimum: Utensil Color-Coding Program
a) areas, items of equipment and utensils to be cleaned and/or Process Control Procedures - Start-Up
sanitized; Pre-Op Inspection Programs
b) responsibility for the tasks specified; c) cleaning/sanitizing method ATP Testing Programs
and frequency; d) monitoring and verification arrangements; e) post- Allergen Residue Testing Program
clean inspections; f) pre start-up inspections.
Master Sanitation Program & Schedules
CIP systems shall be separated from active product lines.
CIP System Sanitation Program
Parameters for CIP systems shall be defined and monitored
Chemical Control Program
(including type, concentration, contact time and temperature of any
Facility and Equipment Cleaning and
chemicals used).
Sanitation Procedures
Environmental Testing Program
Master Sanitation Program & Schedules
Cleaning and sanitation programs shall be monitored at frequencies Facility and Equipment Cleaning and
specified by the organization to ensure their continuing suitability and Sanitation Procedures
effectiveness. Pre-Op Inspection Program ATP
Testing Program Allergen
Residue Testing Program
12 Pest control
Pest Control Program
Hygiene, cleaning, incoming materials inspection and monitoring
Master Sanitation Program & Schedules
procedures shall be implemented to avoid creating an environment
Trailer/Product Inspection Programs
conducive to pest activity.
Process Control Plans - Logistics
Pest Control Program
Landscaping
Process Control Plans - Logistics
The establishment shall have a nominated person to manage pest
cGMP Program - Monthly Audits
control activities and/or deal with appointed expert contractors.
Warehouse Inspection Program
Pest management programs shall be documented and shall identify
Trailer/Product Inspection Programs
target pests, and address plans, methods, schedules, control
Insect Susceptible Product Monitoring
procedures and, where necessary, training requirements.
Program
Programs shall include a list of chemicals which are approved for use
Chemical Inventory & Control Program
in specified areas of the establishment.
Food Security Program
Pest Control Program - Weekly Audits
Preventive Maintenance Program
Buildings shall be maintained in good repair. Holes, drains and other Sanitary Faciltiy Design Program
potential pest access points shall be sealed. Process Control Plans - Logistics
External doors, windows or ventilation openings shall be designed to cGMP Program - Monthly Audits
minimize the potential for entry of pests. Warehouse Inspection Program
FIFO Inventory Control Program
Aging Inventory/Shelf-Life Program

12.4 Harborage and infestations
12.5 Monitoring and detection
12.6 Eradication
13.1 General requirements
13.2 Personnel hygiene facilities and toilets food use and equipment cleaning stations;
Staff canteens and designated areas for food storage and
consumption shall be situated so that the potential for cross
contamination of production areas is minimized.
Staff canteens shall be managed to ensure hygienic storage of
13.3 Staff canteens and designated eating
ingredients and preparation, storage and serving of prepared foods.
areas
Storage conditions and storage, cooking and holding temperatures,
and time limitations, shall be specified.
Employees’ own food shall be stored and consumed in designated
areas only.
13.4 Work wear and protective clothing
13.5 Health Status
13.6 Illness and injuries
13.7 Personal cleanliness
Landscaping
Process Control Plans - Logistics
cGMP Program - Monthly Audits
Warehouse Inspection Program
Storage practices shall be designed to minimize the availability of
Trailer/Product Inspection Programs
food and water to pests.
Insect Susceptible Product Monitoring
Material found to be infested shall be handled in such a way as to
Program
prevent contamination of other materials, products or the
Pest Control Program - Weekly Audits
establishment.
Preventive Maintenance Program
Potential pest harbourage (e.g. burrows, undergrowth, stored items)
FIFO Inventory Control Program
shall be removed.
Aging Inventory/Shelf-Life Program
Where outside space is used for storage, stored items shall be
Trailer Sanitation & Cleaning Program
protected from weather or pest damage (e.g. bird droppings).
Pest monitoring programs shall include the placing of detectors and
traps in key locations to identify pest activity. A map of detectors and
traps shall be maintained. Detectors and traps shall be designed and
located so as to prevent potential contamination of materials, Pest Control Program
products or facilities. cGMP Program - Monthly Audits
Detectors and traps shall be of robust, tamper resistant construction. Warehouse Inspection Program
They shall be appropriate for the target pest.
The detectors and traps shall be inspected at a frequency intended to
identify new pest activity. The results of inspections shall be analysed
to identify trends.
Eradication measures shall be put in place immediately after Pest Control Program
evidence of infestation is reported. Warehouse Inspection Program
Pesticide use and application shall be restricted to trained operatives Records Control Program
and shall be controlled to avoid product safety hazards. Insect Susceptible Product Monitoring
Records of pesticide use shall be maintained to show the type, Program
quantity and concentrations used; where, when and how applied, and Chemical Inventory/Usage Program
the target pest. On-Staff PCO Training Program
13 Personal hygiene and employee facilities
Requirements for personal hygiene and behaviors proportional to the
cGMP Program
hazard posed to the process area or product shall be established and
Visitor & Contractor Policy
documented. All personnel, visitors and contractors shall be required
to comply with the documented requirements.
Personnel hygiene facilities shall be available to ensure that the
degree of personal hygiene required by the organization can be
maintained. The facilities shall be located close to the points where
hygiene requirements apply and shall be clearly designated.
Establishments shall: Facility Layout Plans
a) provide adequate numbers, locations and means of hygienically Floor Plan Review & Traffic Control
washing, drying and, where required, sanitizing hands (including Sanitary Facility Design Program cGMP
wash basins, supply of hot and cold or temperature controlled water, Program:
and soap and/or sanitizer); -Work Clothing/Uniform Program
b) have sinks designated for hand washing, separate from sinks for -Handwash
Stations/Hot Water
NOTE: Taps at hand wash stations should not be hand operated. -Segregated Restrooms
c) provide an adequate number of toilets of appropriate hygienic -Locker Rooms
design, each with hand washing, drying and, where required, -Locker Inspection Program
sanitizing facilities; cGMP Training Program
d) have employee hygiene facilities that do not open directly onto Master Sanitation Program & Schedules
production, packing or storage areas;
e) have adequate changing facilities for personnel;
f) have changing facilities sited to enable food handling personnel to
move to the production area in such a way that risk to the cleanliness
of their work wear is minimized.
Facility Layout Plans
Floor Plan Review & Traffic Control
Sanitary Facility Design Program cGMP
Program:
-Break/Eating Areas
-Locker Inspection Program
cGMP Training Program
Master Sanitation Program & Schedules
Personnel who work in, or enter into, areas where exposed products
and/or materials are handled shall wear work clothing that is fit for
purpose, clean and in good condition (e.g. free from rips, tears or
fraying material).
Clothing mandated for food protection or hygiene purposes shall not
be used for any other purpose.
Work wear shall not have buttons. Work wear shall not have outside cGMP Program:
pockets above waist level. -Captive Work Clothing/Uniform
NOTE Zips or press stud fastenings are acceptable. Program -Visitor/Contractor
Work wear shall be laundered to standards and at intervals suitable Clothing Program
for the intended use of the garments. -Work Clothing Laundering Program
Work wear shall provide adequate coverage to ensure that hair, -Hair Restraint Policy
perspiration, etc. cannot contaminate the product. -Glove Policy
Hair, beards and moustaches shall be protected (i.e. completely -Captive Shoe Policy
enclosed) by restraints unless hazard analysis indicates otherwise. -Personal Protective Equipment Policy
Where gloves are used for product contact, they shall be clean and in cGMP Training Program
good condition.
NOTE Use of latex gloves should be avoided where possible. Shoes
for use in processing areas shall be fully enclosed
and made from non absorbent materials.
Personal protective equipment, where required, shall be designed to
prevent product contamination and maintained in hygienic condition.
Employees shall undergo a medical examination prior to employment
in food contact operations (including site catering), unless New Employee Testing Policy
documented hazard or medical assessment indicates otherwise. cGMP Program
Additional medicals shall be carried out at intervals defined by the Pandemic Planning Program
organization, subject to legal restrictions in the country of operation.
Where permitted by law, employees shall be required to report the
following conditions to management for possible exclusion from food
handling areas: jaundice, diarrhoea, vomiting, fever, sore throat with
fever, visibly infected skin lesions (boils, cuts or sores) and
cGMP Program:
discharges from the ear, eye or nose.
-Illness Reporting & Exclusion Policy
People known or suspected to be infected with, or carrying, a disease
-Wound Covering Policy
or illness transmissible through food shall be prevented from handling
-Metal Detectable Bandage Policy
food or food contact materials.
Pandemic Planning Program
In food handling areas, personnel with wounds or burns shall be
cGMP Training Program
required to cover them with specified dressings. Any lost dressing
shall be reported to supervision immediately.
NOTE Dressings should be brightly coloured and metal detectable
where appropriate.
Personnel in food production areas shall be required
to wash and, where required, sanitize hands:
cGMP Program:
a) before starting any food handling activities;
-Required Hand Washing Policy
b) immediately after using the toilet or blowing the nose;
-Employee Bodily Fluid Control Policy
c) immediately after handling any potentially contaminated material.
-Hand-Covering Policy
Personnel shall be required to refrain from sneezing or coughing over
cGMP Training Program
materials or products. Spitting (expectorating) shall be prohibited.
Fingernails shall be kept clean and trimmed.

13.8 Personal behavior
14.1 General Requirements
14.2 Storage, identification and traceability Rework shall be clearly identified and/or labelled to allow traceability.
14.3 Rework usage
15.1 General requirements
15.2 Product recall requirements
16.1 General requirements
16.2 Warehousing requirements
Vehicles, conveyances and containers shall be maintained in a state
of repair, cleanliness and condition consistent with requirements
given in relevant specifications.
Vehicles, conveyances and containers shall provide protection
against damage or contamination of the product. Control of
temperature and humidity shall be applied and recorded where
16.3 Vehicles, conveyances and containers required by the organization.
Where the same vehicles, conveyances and containers are used for
food and non food products, cleaning shall be carried out between
loads.
Bulk containers shall be dedicated to food use only. Where required
by the organization, bulk containers shall be dedicated to a specified
material.
17.1 Product information
17.2 labeling of pre-packaged foods
18.1 General requirements
18.2 Access control
A documented policy shall describe the behaviours required of
personnel in processing, packing and storage areas. The policy shall
at a minimum cover:
a) permissibility of smoking, eating, chewing in designated areas
only;
cGMP Program:
b) control measures to minimize hazards presented by permitted
-Eating, Smoking, Chewing Policy
jewellery;
-Jewelry & Cosmetic Device Policies
NOTE Permitted jewelery includes specific types of jewellery which
-Personal Items
may be worn by the personnel in processing and storage areas,
Policy -Hand Covering
taking into account religious, ethnic, medical and cultural imperatives.
Policy cGMP Training
c) permissibility of personal items, such as smoking materials and
Program
medicines, in designated areas only;
Locker Inspection Program
d) prohibition of the use of nail polish, false nails and false eyelashes;
e) prohibition of carrying of writing implements behind the ears;
f) maintenance of personal lockers so that they are kept free from
rubbish and soiled clothing;
g) prohibition of storage of product contact tools and equipment in
personal lockers.
14 Rework
Quality Hold & Release Program
Control of Non-Conforming Product
Rework shall be stored, handled and used in such a way that product
Allergen Control Program - Rework
safety, quality, traceability and regulatory compliance are maintained.
Product Rework Control Program
Product Traceability Program
Stored rework shall be protected from exposure to microbiological,
chemical or extraneous matter contamination.
Process Control Plans - Logistics Quality
Segregation requirements for rework (e.g. allergen) shall be
Hold & Release Program
documented and met.
Control of Non-Conforming Product
Allergen Control Program - Rework
Traceability records for rework shall be maintained.
Product Rework Control Program
The rework classification or the reason for rework designation shall
Product Traceability Program
be recorded (e.g. product name, production date, shift, line of origin,
shelf life).
Where rework is incorporated into a product as an ”in-process” step,
Process Control Plan - Extraneous Matter
the acceptable quantity, type and conditions of rework use shall be
Control Quality
specified. The process step and method of addition, including any
Hold & Release Program
necessary pre-processing stages, shall be defined.
Control of Non-Conforming Product
Where rework activities involve removing a product from filled or
Allergen Control Program - Rework
wrapped packages, controls shall be put in place to ensure the
Product Traceability Program - Rework
removal and segregation of packaging materials and to avoid
Product Rework Control Program
contamination of the product with extraneous matter.
15 Product recall procedures
Product Recall Program
Systems shall be in place to ensure that products failing to meet
Mock Recall Program
required food safety standards can be identified, located and
Contingency Plan
removed from all necessary points of the supply chain.
Crisis Management Plan
A list of key contacts in the event of a recall shall be maintained. Product Recall Program
Where products are withdrawn due to immediate health hazards, the Mock Recall Program
safety of other products produced under the same conditions shall be Contingency Plan
evaluated. The need for public warnings shall be considered. Crisis Management Plan
16 Warehousing
Materials and products shall be stored in clean, dry, well ventilated Cycle counts
spaces protected from dust, condensation, fumes, odours or other Aging inventory eval program
sources of contamination. Obsolete inventory program
Effective control of warehousing temperature, humidity and other
environmental conditions shall be provided where required by product
Chemical storage program
or storage specifications.
Dust control, air control
NOTE It is recommended that where products are stacked,
Waste program
consideration is given to measures necessary to protect the lower
Hold program, tagged, electronic
layers.
FEFO
Waste materials and chemicals (cleaning products, lubricants, and
Fork lift training, cleaning
pesticides) shall be stored separately.
Master sanitation schedule
A separate area or other means of segregating materials identified as
Warehouse inspection
non-conforming shall be provided.
Insect susceptible inventory inspections
Specified stock rotation systems (FIFO/FEFO) shall be observed.
Security
Gasoline or diesel powered fork lift trucks shall not be used in food
ingredient or product storage areas.
Electric fork lifts
Master sanitation schedule, fork lift
cleaning record
17 Product information/consumer awareness
Information regarding product is provided to our consumers through
Regulatory & label programs
labeling, company websites, and advertisements.
Procedures shall be in place to ensure the application of correct Label inspection practices
labels to products. QC label inspection program
18 Food defense / Biovigilance / Bioterrorism
Building access restrictions/security
Each establishment shall assess the hazard to products posed by Trailer seal program
potential acts of sabotage, vandalism or terrorism and shall put in Truck driver identification
place proportional protective measures. Chemical control
NOTE For further information and guidance on approaches to the Background checks
protection of food businesses from all forms of malicious attack see Visitor & contractor policies
PAS 96. Supplier evaluation program
Incoming raw material inspection program
Security
Potentially sensitive areas within the establishment shall be identified, Chemical control
mapped and subjected to access control. Lab
NOTE Where feasible, access should be physically restricted by use of All building
locks, electronic card key or alternative systems. Nitrite
Maintenance
Computer access controls