ANNEX 1 - PREREQUISITE PROGRAM / PREVENTIVE CONTROLS MATRIX
FOOD SAFETY TEAM (FST)
PREREQUISITE
DESCRIPTION
PROGRAM
Requirements for personal
hygiene and behaviors, and
facility condition proportional to
the hazard posed to the process 4.1, 4.3, 5.3, 5.7, 10.2,
area or products shall be
GMP
established and documented.
All personnel, visitors and
contractors shall be required to
comply with the documented
requirements.
The maintenance program shall
include all devices used to
monitor or control food safety
hazards, follow GMPs and
ensure good condition of facility
Maintenance/PM and equipment and sanitation
hand-off of maintained
equipment.
PMs building & roof
maintenance & inspections; air
handling; docks
Program to randomly collect
and analyze environmental
samples for microbiological
Environmental Monitoring Program
organisms (both pathogenic and
indicator organisms like APC,
Y&M and Coliform)
Program to control and
Pest Control Program eradicate pests in and around
the building
Maintain weed, tree, shrub and
Landscaping grass control to prevent pest
harborage
Review of air permits
Review hazardous waste
Local Environment
permits in area
Review of "Google Earth"
Address the hazard to products
posed by potential acts of
sabotage, vandalism or
Security
terrorism by putting in place
proportional protective
measures.
Internal layouts shall be
designed, constructed and
maintained to facilitate good
hygiene and manufacturing
practices. The movement
Layout Premises/Floor Plans
patterns of materials, products
and people, and layout of
equipment, shall be designed to
protect against potential
contamination sources.
Program to control unintended
Allergen Control allergen cross contact with
product
FREQUENCY
PAS 220 ROUTINE FREQUENCY OF ROUTINE EVALUATION & ANALYSIS OF
PREVENTIVE CONTROLS RESPONSIBILITY RECORDS Quarterly
REQUIREMENTS VERIFICATION VERIFICATION INDIVIDUAL VERIFICATION
RESULTS
• All employees are responsible for
following GMP requirements Operations Managers
10.3, 10.4, 12.2, 12.3 12.4, FST review of re-occurring issues or issues
The cGMP Program • Cross-functional group of trained GMP Audit reports Packaging Managers Monthly occurring in multiple departments
Quarterly
13.1, 13.2, 13.3, 13.5, 13.6,
managers and team members Warehouse Managers
13.7, 13.8
perform periodic GMP audits
4.1, 4.3,6.2, 6.4, 7.4, 8.2, PM records Reports by Maintenance Manager to FST of
Maintenance Program issues affecting food safety
8.3, 8.6, 10.2, 10.3, 10.4, Maintenance Department Sanitation hand-off records Maintenance Manager Weekly Quarterly
Preventive Maintenance (PM) Program FST review of re-occurring food safety issues
12.3, 12.4 , 13.4, 18.2 Work Order records or issues occurring in multiple departments
1)Micro Lab - Quality
1) Micro. Lab Certificates of
Technologists 1) Micro. Lab - upon receipt of report
Analysis, FST review of reports/findings for trends or
4.1, 6.4, 7.4, 10.2, 11.5 Environmental Testing Procedure Quality Department 2) Results Log - Quality 2) Results Log - all positive results - on reoccurring events
Quarterly
2) Environmental Results Report
Management receipt
(electronic action log)
• Pest Control Records
• Fumigation Records
Pest Control Service Log
12.1, 12.2, 12.3, 12.4, 12.5, Subcontract or on-staff PCO • Raw Material Receiving Record Sanitation Manager Subcontract PCO - Weekly FST review of trending reports and structural
Insect Susceptible Product Inspection Annually
12.6, 4.1, 5.6, 5.7 Receiving/Distribution Mgmt. • Insect Susceptible Inventory Logistics Manager ISIR - Monthly items noted
Program
Report (ISIR)
• Hold Log
Vendor Evaluations:
Facilities Management Landscaping Landscaping Vendor evaluations Quality Manager Vendor Evaluation: Annual FST review of issues that may affect food
4.1, 4.3, 12.2, 12.3, 12.4 Landscaping Contract Annual
Dept. or Company Chemical Use records Chemical use records: Chemical Use: Monthly with invoice safety
Sanitation Manager
Local Environment Risk Assessment
4.2 Food Safety Team (FST) Leader FST evaluation notes FST Review Annual FST Review Annual
Program
FST evaluation notes,
• All employees are responsible for
• Facility Access Controls Vulnerability assessment,
maintaining plant security. FST review of security program, drills,
4.1, 4.2, 4.3, 5.1, 5.5, 5.7, • IS Security Procedures Mock security drill records,
• Security Program: FST Leader FST Review vulnerability assessment - annual
6.3, 6.5, 7.3, 8.6, 11.2, • cGMP Program GMP audit reports FST Review Annually
• Cross-functional group of Manager Review
12.2, 16.2, 18.1, 18.2 • Key Control Program • Door access database
managers perform GMP audits GMP review - monthly
Visiter & Subcontractor Control Policy Door key list
• Maintenance - keys
IS user records
Operation Manager
Packaging Manager
Floor Plan Review Program Maintenance Manager Monthly (or as
Floor plan review records Warehouse Manager
5.1, 5.2, 10.2, 10.4 cGMP Program All Department Managers Semi-annually FST review for suitability and changes incidents of high risk
Risk assessment spreadsheets Quality Manager occur)
Change Management/ Risk Assessment
Food Safety Manager
Policy
A. Quality Management
A. Allergen Swab Test Results: B. & C.: Operations
Quality Management Electronic Management
Operations Management B. Operations Production Records C. Operations A. Monthly
Allergen Control Program
Logistics Management C. Pre-Operation Checklist for All Management. B.- E. Weekly
5.1, 5.2, 9.3, 10.1, 10.3, Allergen Change-Over Matrices FST review of reports/findings for trends or
Regulatory Department Operations Departments D. & F. Per incident reoccurring events
Quarterly
11.5, 14.1, 14.2, 14.3 cGMP Program
Sanitation Management D. Receiving Records: Bill of Lading E.:Logistics Management
Sanitation Program
E. Poor trailer condition report F. Sanitation
F. Facilities & Equipment (i.e. ATP) Management
Sanitation Records

Materials and products are
stored in clean, dry, well
ventilated spaces protected
Warehouse
from dust, condensation, fumes
odors or other sources of
contamination.
Chemicals used for production,
maintenance, cleaning and
facility operation are controlled 5.7, 6.3, 6.5, 8.6, 9.3, 11.2,
Chemical Control
to avoid the risk of the
contamination of food products
and food contact surfaces.
Addresses the handling and
processing and breakage
protocol of glass, brittle plastic,
Glass & Brittle Plastic Control ceramics and other shatter type
materials to avoid the risk of
contamination and the related
food safety issues.
Policy ensures the safe and
responsible handling of blades
and knives. It also helps to
Knife Control ensure a safe and wholesome
product is produced and limits
the possibility of extraneous
material in finished products.
Addresses requirements for
Management of Waste Program segregation, storage and
removal of waste.
This program ensures that
materials which impact food
safety are purchased from
approved suppliers based on an
Management of Purchased Materials
established selection &
& Services
management of suppliers
program. Incoming materials
are inspected to verify
conformance to requirements.
The systems and practices to
maintain clean, sanitary
Cleaning & Sanitation utensils, food contact surfaces
& facilities for safe food
manufacturing
Training Programs to ensure
that all employees have the
Training knowledge and skills to produce
a safe/ quality products that
meet regulatory requirements
• Process Control for Receiving
• Process Control for Shipping
• cGMP Program
5.7, 9.3, 12.2, 12.3, 12.4,
• Sales Order Shipment Processing
16.2,
• Warehouse Sanitation Program •
Inventory Control Program
Chemical Control Procedure
12.2, 12.6, 16.2, 18.1, 18.2
• Essential Glass, Brittle Plastic and
Ceramics Handling and Breakage Policy Operations Management
6.6, 8.5, 10.4
• cGMP Program
Knife Control Policy
8.5, 10.4 Allergen Change-Over Matrices
Allergen Control Program
• Waste Management Program
• Color Coding Policy
• Waste Hauler Contract
5.5, 7.1, 7.2, 7.3 • Drain Design plans – for capacity and
direction
• Drain location maps
• cGMP Program
• Vendor Selection, Classification and
Requirements Program
• Vendor Evaluation/Audit Program
• Vendor Information Mgmt. Program
9.1, 9.2, 9.3 • Vendor/Item Approval Program
• Purchasing Requisition Program
• Program for Inspection of Incoming and
Outgoing Trailers
• Master Sanitation Program with
Schedules
Sanitation Program Grinding/Spice Re-
cleaning Department
• Sanitation Program - Logistics
Departments
4.1, 5.3, 5.4, 5.6, 5.7, 10.2, • Sanitation Program - Blending
10.3, 10.4, 11.2, 11.3, 11.5, Department
12.4, 16.2, 16.3 • Sanitation Program - Set-up
Department
• Sanitation Program - Flavor Production
• Sanitation Program - Packaging
• Procedures for Cleaning & Sanitizing
of Processing and Packaging Equipment
& Utensils
• Corporate-Level and Temporary
ISO 22000, 6.2.1, 6.2.2 Employee Training Guidelines
• Departmental Training Checklists
Logistics
Sanitation
Maintenance
Flavors
Food Safety Team
Logistics Management
Quality Management
Operations Department Managers
Logistics Department Managers
Quality Department
All employees are responsible to
follow waste management
requirements
Food Safety Team Leader
• All employees are responsible to
purchase from approved suppliers
• Department are responsible to
approve and evaluate the
performance of their suppliers; and
outsourced process providers.
• Purchasing is responsible for
maintaining records; approving raw
material, ingredient suppliers and
packaging; and outsourced process
providers.
• Logistics employees are
responsible for inspecting incoming
and outgoing trailers.
•
Department Managers
Sanitation Management
• Human Resources
• Department Managers
Warehouse Inspection records
GMP Audit reports
Inventory Condition reports
Sanitation Records/inventory
Maintenance Chemical Records
Flavors: Batch Tickets/Inventory
Chemical Receiving & Inventory
Records
Essential Glass, Brittle Plastic, and
Ceramics Inventory List
GMP Audit Records
Knife Check In/Out Records
• Hazardous Waste Inventory &
Destruction Records
• Records of Destruction
GMP Audit Records
• Risk Assessment Records
• Vendor Evaluation Form
• Service Vendor Review Form
•Purchase Order (paper or
electronic)
•Purchase Requisitions
•Vendor Information Packet
•Vendor-Item Approval Records
•Proof of Insurance Certificate
•Vendor Food Safety/Quality System
Reviews
•3rd Party Audit Reports
•Vendor Performance Evaluation
Form
• Master Sanitation Schedule for
Grinding/Spice Re-cleaning
• Master Sanitation
Schedule for Packaging
• Master Sanitation Schedule for
Set-Up Department
•Master Sanitation for the Flavor
Production Department
•Master Sanitation Schedule for the
Blending Department
•Master Sanitation Schedule for the
Receiving Department
•Master Sanitation Schedule for
Shipping Department
Personnel training records
Corporate training records
Department training records
Inspection Records - Monthly FST review of the inspection results for
Logistics Management incidents and trends.
Semi-annually
GMP - Monthly
Sanitation Manager
Sanitation - every two weeks
Flavors Management FST Review of any trends or issues that would
Flavor batch records - daily increase risk of a food safety nature
Semi-annually
Maintenance Manager
Maintenance - monthly
FST Leader
Inventory records - FST
Leader FST Review of any trends or issues that would
Monthly Quarterly
GMP- Department increase risk of a food safety nature
Managers
Operations Management
Monthly FST review for suitability and changes Quarterly
Logistics Management
• Department • Weekly
• Management • Records of Destruction - as generated FST review for suitability and changes Annually
• Sanitation Management by subcontract hauler
Vendor Evaluations:
Dept. Managers and
Purchasing (quarterly)
Vendor Evaluations - quarterly
PO: Buyer, upon placing FST review of vendor issues that may impact
food safety
Quarterly
order, electronic signature
PO/PR upon placing orders
Purchase Requisition:
Buyer, upon placing
order, electronic signature
Review and sign-off of
sanitation records by As schedule is completed (weekly,
Department Managers monthly, quarterly, semi-annually, FST review for suitability and changes Annually
and Sanitation annually)
Management
• Internal Audits • Quarterly Management review
• Personnel Performance • Minimum of Annual Evaluations FST review for suitability and changes Quarterly
Reviews

To ensure product meets
Product Testing and Approval
specifications
The systems in place to ensure
Change Management
food safety through changes
To ensure employees meet food
safety/quality competence
Employee Services Programs requirements.
(Hiring/Personnel Practices) To ensure employee practices
are consistent with GMP
requirements
To ensure water used in product
Water Quality Program and for clearing meets
requirements
To control evidence of conformity
4, 5, 6, 7, 8, 9, 10, 11, 12, Creating and Controlling Food Safety &
to requirements and evidence of
Records effective operation of the food
safety management system
To ensure testing equipment is
Calibration calibrated to ensure accurate
test results
To ensure all products are
Specification Control:
prepared to customer
a) Finished Product
specification and regulatory
b) Manufacturing
requirements
To ensure processes are under
Process Control Plans control to ensure safe/quality
products
Program to track customer
complaints, take appropriate
Customer Complaint Process actions and determine if a
potential food safety issue has
occurred
Product Specifications Product Control Plans
Production Batch sheets Testing Records
ISO 9001 Quality Department Quality Management Weekly FST review for suitability and changes Semi-annually
Test Protocols and Methods Completed Batch Sheets
Nonconforming Product Control Certificates of Analysis
R&D Department
Routing & Approval System for
Food Safety Team Routing & Approval records
Communication of New or Revised
Operations Design Control Project Records
Products
8.2, 8.3, 10.3 Quality New Ingredient Reqts. Form Project Manager Upon completion FST review for suitability and changes Quarterly
Routing System for Communication of
Regulatory Finished Goods Reqts. Form
Approved Design Control Projects
Logistics Management of Change Record
Change Management Procedure
Purchasing
Defined Hiring Protocols
HR - hiring records
Pre-employment drug screening &
ISO 22000, 6.2.1, 6.2.2 Human Resources Employee application & pre-hire (confidential) FST review of re-occurring issues or issues
background check program Upon hire Annually
PAS 13.5, 13.6 Department Managers evaluations (confidential) GMP - Department occurring in multiple departments
Illness reporting policy GMP Monthly
GMP Audit reports Managers
cGMP Program
Review of testing results
City Water Monitoring Results by Quality Manager
Quality Department Water testing records Quality - Upon completion
6.2 Water Testing Program Review of Maintenance FST review for suitability and changes Quarterly
Maintenance Maintenance records Maintenance - Weekly
Water Filtration & Treatment Program Records by Maintenance
Manager
All employees are responsible to
follow records requirements
Assigned employees are responsible Records Retention and Disposition
13, 14, 15, 16, 17, 18 Quality System Documentation, Records Internal Audit Program All audits Review of audit results Annually
for verification of records Table Matrix
ISO 22000, ISO 9001 and Data
Assigned employees are responsible
for records storage and disposition
Maintenance
Calibration Procedure Calibration records (internal & Maintenance
ISO 22000, 8.3 Quality Department. Upon completion FST review for suitability and changes Semi-annually
Lab Procedures external) Quality Department
R&D Labs
Specification Development and Revision
ISO 22000,4.2.2, 5.6.1, R&D Referene individual
Procedure Routing & Product Specification Sheets • Regulatory Dept.
7.3-7.10, 8.2, 8.4, 8.5 Quality Department Upon Receipt FST review for suitability and changes PRP evaluation
Approval System for Communication of Production Batch tickets • Quality Management requirement
ISO 9001, 7.2, 7.5 XX Food Safety Team
New or Revised Products Routing/Approval System Records
Flavors Process Control
Set-Up Process Control Blending
Process Control Grinding Process
ISO 9001, Department Managers Referene individual PRP evaluation
Control Receiving Process Control, Reference to PRP Matrix Reference to PRP Matrix Reference to PRP Matrix requirement
Quarterly
ISO 22000, 7.3.5.2 Department Supervisors
Packaging Process Control Shipping
Process Control
Distribution Center Process Control
Customer Complaint Records
Complaint Summary Form
ISO 22000, 5.5.1 Corrective Action, Preventive Action and Customer Service Department FST review of the complaints and incidents for
Completed Corrective & CA/PA Team Weekly trends.
ISO 9001, 5.2, 7.2, 8.2 Complaint Procedure & Protocol Quality Department
Preventative Action Forms (including
root cause analysis)