FOOD MANUFACTURING OPERATIONS

POLICIES, PROCEDURES, AND STANDARDS MANUAL

Table of Contents
PREFACE Recalls 13. Corrective action report
Traceability 14. System capability monthly audit
Log of changes to the manual
Enclosures (A) 15. USDA HACCP evaluation criteria
Food HACCP definitions
1. Employee-customer report of quality or 16. HACCP reassessment
References
hazard problem and disposition
Training Program
2. Foodborne illness information form
Training plan
3. Analysis of an alleged foodborne illness
SYSTEM AND OPERATIONS DESCRIPTION Training for performance mastery
4. Usual incubation / onset period ranges for
New employee training
Operation description select foodborne disease
Cross training
Products meet regulatory standards
QA, QC, and HACCP Team Continuing education and correct procedure
Organization and job responsibilities
QA, QC reinforcement
Environment and facilities description
Control of non-conformity Employee training records
Methods for adequate grounds
Facilities, equipment, and procedures Enclosures (C)
maintenance
MAP (Modified Atmosphere Packaging) 1. Training plan
Plant construction and design
Thermometer calibration 2. Lesson plan form
Water supply
Slush ice calibration 3. New employee training record
Plumbing
High-temperature calibration 4. Continuing education training record
Sewage disposal
Verifying refrigerator temperatures
Toilet facilities for employees
Sanitizing solutions
Hand washing facilities
Microbiological testing PREREQUISITE PROCESSES (SSOP /
Waste disposal
New product formulation and development GMP)
Facility plan and food flow
Enclosures (B)
Equipment and utensils Personal Hygiene
1. Equipment / instrument calibration and
Major equipment items Employee personal hygiene policies
verification log
Design, construction and use Individual illness and disease control
2. Refrigerator temperature log
Processes and controls Cuts and abrasions
3. Sanitizing solution verification log
Enclosures Personal cleanliness
4. Microbiological testing of production plant
1. Operation description Fingernails
food items
2. (a-c) USDA- / FDA- / FDA Fisheries- Hair restraint
5. Sample identification sheet
inspected products Jewelry and hard objects in pockets
6. Microbiological environmental testing
3. Organization chart and job responsibilities Handkerchiefs and facial tissues
report
4. Environment surrounding the facility Chewing gum, smoking, and eating
7. Product formulation (recipe) change
5. Facility plan and food flow Gloves
8. Product formulation (recipe) change
6. Major equipment items How to use gloves
checklist
Disposable gloves
9. New product development project
Heavy-duty gloves
schedule
MANAGEMENT Hand washing
10. New product / process development
Employee hand washing policies
AMC-HACCP Management HACCP Team
Double hand wash
Food safety policy Self-inspection and food hazard control
Single hand wash
Control of documents checklists
Medicines
Management responsibility and commitment HACCP team operations
First aid
Food safety management plan Member code of conduct
Hand cuts and abrasions
Evaluation of unit performance; HACCP team functioning
Contact with blood or body fluids from
management review Team membership
another person
Food safety improvement program Team leader
Enclosures (A)
Supervisor / Person In Charge (PIC) Roles individuals play in groups
Holding subordinates responsible Some major areas for HACCP team action Facility and Equipment Cleaning,
Product complaints Problem solving Sanitation, and Pest Control
Foodborne illness complaints and hoaxes HACCP team meeting, report, and Substances used in cleaning and sanitizing;
Food security corrective action storage of toxic materials
Management Filling the report Cleaning and sanitation GMPs
Human element – staff HACCP team's measures of success Pest control GMPs
Human element – public Operational improvement Pest control program
Facility HACCP reassessment Enclosures (B)
Operations Enclosures (B) 1. Cleaning and sanitizing schedule and
Food sabotage 11. Daily QA checklist pre-operations report
Emergencies 12. HACCP team monthly meeting report 2. Sanitation procedures and standards
F:ppsm-HITM: mfg-ppsm-2008-Mar tofc-3-08 rev 3/26/08 12:26 PM print 7/30/08 Table of contents 1
3. Chemicals list and material safety data FOOD PROCESS HACCP (USDA; FDA; FDA APPENDIX
sheets FISH / FISHERIES) HACCP plans
4. Pest control schedule and report HACCP recipes
General
5. Floor plan / bait placement Product specifications
Determination if a production step is a CCP
Validation studies
Facility and Equipment Maintenance Quality control operations
Technical reports
Maintenance plan and schedule, including Methods of verification
equipment calibration Ingredient hazards
Food contact surface equipment construction Food products HACCP control groups
Non-food contact surface equipment Chemical additives
construction Allergies and adverse food reactions
Equipment operation HACCP recipe, group process flow charts, and
Gaskets HACCP plans
Cooling and refrigeration units Physical hazards
Freezers Chemical hazards
Surplus equipment and items for repair Food manufacturing hazard and control rules
Dunnage racks, shelving, pallets, dollies, etc. Unprotected food items
Backflow prevention valves for plumbing Physical (hard foreign) objects
CO2 backflow prevention valves pH
Warewashing equipment Ice
Enclosures (C) Food tasting
1. Preventive maintenance schedule Surface heat blanching
2. Maintenance procedures and standards Food washing
Pasteurization
Supplies
Production process control log
Qualified suppliers
Cooling
Hazard identification of food items
Assembly and packaging
Ingredient specification
Handling
Defect action levels
Labeling
Natural or unavoidable defects at low levels
Finished products
Mixing food
Unused food
Receiving and storage
Use-by date
Receiving
Discards
Storage
Water activity
Adulteration
Shelf life validation
Aflatoxin
Frozen food
Contamination
Refrigeration units
Raw materials and other items
Thawing
Shelf-stable products
Batters, breading, sauces, gravies,
Cold storage products
dressings, and other similar preparations
Dating and use
Metal detection
Single-service articles
Food transport
Finished product storage
Hold program
Shipping
Rework
Enclosures (D)
Returned product
1. Major suppliers of products used in the
Non-human food
operation and their HACCP qualification
Packaging
2. Supplier letter – example
Enclosures
3. Supplier hazard control of items
1. Food products HACCP control groups
4. Cook controls for safe products
2. Five USDA-based food process flows
5. Supplier controls for safe products
3. Quality-assured HACCP recipe
6. Food item allergen analysis
procedures
7. Detailed list of food allergens and food
4. Food control group process flow charts
intolerance
5. Food HACCP plans
8. Ingredient specifications
6. Production schedule
9. Receiving report
7. Production process control log
10. Receiving quality control
8. Cooked product monitoring form
9. Assemble / package production record
10. Product specifications
11. Product disposal record

F:ppsm-HITM: mfg-ppsm-2008-Mar tofc-3-08 rev 3/26/08 12:26 PM print 7/30/08 Table of contents 2