Professional Documents
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HACCP & GMP Audit Checklist
HACCP & GMP Audit Checklist
April 2002
Clemson University
Department of Food Science and Human Nutrition
College of Agriculture, Forestry & Life Sciences
224 Poole Agricultural Center
Box 340371
Clemson, SC 29634-037
Phone: (864) 656-5694 Fax: (864) 656-0331
TABLE OF CONTENTS
Purpose of This Publication ..................................................................................................... 1
Food Safety Inspections ........................................................................................................... 1
GMPs: Personnel .................................................................................................................... 3
Buildings and Facilities: Plant and Grounds ......................................................................... 4
Buildings and Facilities: Sanitation Operations: Pest Control .............................................. 5
Buildings and Facilities: Sanitary Facilities and Controls .................................................... 6
Equipment ............................................................................................................................ 7
Production and Process Control .............................................................................................. 8
Good Manufacturing Practices (GMPs)
Monthly Inspection Record Sheet ....................................................................................... 9
Sanitation SOPs Sanitation SOPs (SSOPs): ........................................................................ 10
Monthly Inspection Record Sheet ..................................................................................... 12
Good Agricultural Practices (GAPs):
Applicable to the Field Operations. .................................................................................. 13
Good Agricultural Practices (GAPs):
Monthly Inspection Record Sheet ..................................................................................... 15
Good Manufacturing Practices (GMPs):
Monthly Inspection Record Sheet: Percentage Look-Up Table......................................... 16
Inspectional Guide.................................................................................................................. 17
HACCP Systems Basic Compliance Checklist .................................................................. 19
The Clemson University Cooperative Extension Service offers its programs to people of all ages, regardless of race,
color, sex, religion, national origin, disability, political beliefs, sexual orientation, marital or family status and is an
equal opportunity employer.
Clemson University Cooperating with U.S. Department of Agriculture, South Carolina Counties. Issued in Furtherance of
Cooperative Extension Work in Agriculture and Home Economics, Acts of May 8 and June 30, 1914
Count the total number of good answers and write this number down. You may want to
develop your rating scale for the HACCP checklist.
Problems found during an inspection should be recorded in a notebook and corrected as soon as
possible before the next inspection. Avoid having the same problems showing in your next
inspection. Keep Monthly Inspection Record Sheets as document evidence of your food safety
efforts..
Basic Inspection Tools
1.
2.
3.
4.
5.
6.
7.
8.
9. Flashlight
10. UV light (optional)
11. Thermometer
12. Copies of Laws and Regulations
13. Hair nets
GMPs: Personnel
21 CFR, Part 110 Section 110.10
Good Needs Work
1. Are the employees well-trained in what they do? You can avoid many problems
by making sure that your employees clearly understand their functions.
2. In handling food products, do your employees wear the proper hair covering,
beard covering, disposable gloves and clean uniforms?
3. Are your employees wearing jewelry, rings, watches, fingernail polish or
bandages?
Do your employees have any illnesses, infections or injuries (i.e., boils, cuts) that
can contaminate foods in the production area?
-------- -----------------
4. Do your employees wash and sanitize their hands after each visit to the toilet?
-------- -----------------
Do you have washing facilities available for your employees near their work
stations?
-------- -----------------
-------- -----------------
-------- -----------------
-------- -----------------
7. Have your employees been told the reasons why they should undertake the above -------- ----------------precautions?
Has this training been done through GMP classes?
-------- -----------------
-------- -----------------
Total Checked:
1. Is the area around your firm clear of litter, weeds, grass and brush?
2. Is there any standing water on your grounds (which also attracts pests)?
3. Are floors, walls, ceilings, windows and screens properly maintained and cleaned?
There should be no flaking paint anywhere above the production area.
4. Do production area doors and windows to the outside have fine mesh screens to
keep out insects? If not, are they tightly sealed?
5. Will a pencil pass under the door?
6. Have all holes and cracks been filled so as not to provide hiding places or entry
points for pests?
7. Are there any evidence of the presence of domestic animals such as cats and
dogs?
8. Are rest rooms cleaned regularly?
9. Are the hand-washing facilities furnished with paper or air hand dryers and soap?
10. Are there any leaks in the roof, sky lights, windows, screens or overhead piping?
11. Are the overhead lights covered with shields to prevent contamination of
products by broken glass in case the lamps burst?
Total Checked:
1. Is trash, debris and clutter picked up, both inside and outside the plant, so as not to
provide hiding places for pests?
2. Are all sanitation chemicals used in the plant USDA/FDA approved?
3. Do employees eat, drink and use tobacco products only in designated areas, and
not in the production area or warehouse?
4. Is the food spilled or uneaten by employees cleaned up quickly so as not to attract
pests or breed bacteria?
5. Has old rodent excreta been cleaned up so you can spot any new activity?
6. Is garbage quickly removed and dumped in appropriate bins? It should not sit
around your facilities to attract pests and develop odors.
7. Is the garbage kept covered? An open garbage pile is an excellent breeding ground
for insects and rodents.
8. Is the water used in your firm from an approved source (either municipal supply or
tested private source)?
9. Have you made sure there are no hoses left dangling in sinks or on the ground?
Loss of pressure can cause a back flow that will contaminate your water supply.
10. Do your facilities have back flow and vacuum breaker valves to prevent
contaminate your water supply?
11. Is there standing water around your firm (particularly in the production area,
warehouse and pack-off area)?
Total Checked:
GMPs: Equipment
21 CFR, Part 110 Subpart C
Good Needs Work
1. Is all equipment that comes in contact with food cleaned and sanitized as often as
necessary to prevent contamination of the product? You should follow appropriate
cleaning schedules for each piece of equipment.
2. Is the equipment designed, or otherwise suitable, for use in a food plant? For
example, equipment for handling or processing foods cannot contain
polychlorinated biphenyls (PCBs), which are very toxic (this does not apply to
electrical transformers and condensers containing PCBs in sealed containers).
3. Is there a build-up of food or other material on the equipment? This can serve as
a breeding place for insects and bacteria.
6. Is there a lot of dead space in or around the machinery where food and other
debris can collect as a nest for insects and bacteria?
Total Checked:
6. Are all products spoiled by damage, insects, rodents or other causes stored in a
designated Quarantine Area to prevent their contact with safe products?
7. Are such quarantined items disposed of quickly to prevent the development of
pest breeding places?
8. Are incoming materials inspected for damage or contamination so that they can be
rejected?
9. Are unused materials properly resealed to prevent contamination?
10.
7.
8.
9.
10.
6.
7.
8.
9.
10.
6.
Percentage: ______
Percentage: ______
Needs
Work
Percentage: ______
11.
10.
9.
8.
7.
6.
5.
4.
3.
2.
1.
Good
Production and
Process Control
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly.
Date: ____________________
Establishment Name: ______________________ Inspected by: __________________
Percentage: ______
Percentage: ______
7.
6.
5.
Needs
Work
Percentage: ______
11.
8.
7.
6.
5.
4.
3.
2.
1.
Good
5.
4.
Needs
Work
Equipment
Number Good:_____ Number Good: ____ Number Good: ____ Number Good: _____
11.
9.
6.
5.
5.
4.
3.
2.
4.
3.
2.
4.
1.
Good
3.
Needs
Work
3.
1.
Good
2.
Needs
Work
2.
Good
Pest Control
1.
Needs
Work
Plant / Grounds
1.
Good
Personnel
SANITATION SOPs
I. Preoperational Sanitation--Equipment and Facility Cleaning
All equipment will be cleaned and sanitized prior to starting production.
A. General Equipment Cleaning
(Simple equipment and hand tools are cleaned and sanitized in the same manner but they do
not require disassembly and reassembly.)
Established Sanitary Procedures for Cleaning and Sanitizing
Equipment:
Good
Needs Work
Good
Needs Work
Corrective Actions:
Overall Inspection by:
__________
, Date:
Needs Work
10
Needs Work
Good
Needs Work
___________
Corrective Actions:
Overall Inspection by:
_________________
, Date:
11
Needs
Work
Cleaning of Facilities
Good
Needs
Work
Handling Operations
Good
1.
1.
1.
2.
2.
2.
3.
3.
3.
4.
4.
4.
5.
Needs
Work
5.
6.
7.
8.
9.
10.
11.
Number Good: ______ Number Good: ______ Number Good: ______
Percentage: ______
Percentage: ______
Percentage: ______
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly.
Date: __________________ Establishment Name: _____________________________
Inspected by: ______________________________
12
Needs Work
Good
Needs Work
13
Needs Work
Good
Needs Work
Good
Needs Work
Corrective Actions:
Date:____________________
Approved by:______________________________
14
Good
Needs
Work
19.
18.
17.
16.
15.
Good
Date: __________________
Good
Percentage: ______
Needs
Work
Trace Back
Needs
Work
Field Sanitation
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly.
14.
13.
11.
10.
9.
5.
8.
3.
Needs
Work
12.
7.
2.
Good
Animal Feces
4.
6.
Needs
Work
1.
Good
Agricultural Water
19
11
10
Number
of
Questions
5%
9%
10%
11%
13%
14%
17%
20%
25%
10%
18%
20%
22%
25%
29%
33%
40%
50%
16%
27%
30%
33%
38%
43%
50%
60%
75%
21%
36%
40%
44%
50%
57%
67%
80%
100%
26%
45%
50%
56%
63%
71%
83%
100%
31%
55%
60%
67%
75%
86%
100%
37%
64%
70%
78%
88%
100%
42%
73%
80%
89%
100%
47%
82%
90%
100%
53%
91%
100%
10
58%
100%
11
63%
12
68%
13
74%
14
79%
15
84%
16
89%
17
95%
18
Good Manufacturing Practices (GMPs): Monthly Inspection Record Sheet; Percentage Look-Up Table
100%
19
Inspectional Guide
The Guide has been
adapted from the FDA
Food Code. It is to be used
during the internal
inspection of an
establishment.
Management and Personnel
SUPERVISION
2-101.11 Assignment of Responsibility*
2-102.11 Demonstration of Knowledge*
2-103.11 Duties of Person in Charge
EMPLOYEE HEALTH
Disease or Medical Condition
2-201.11 Responsibility of Person in
Charge*
2-201.12 Exclusions and Restrictions*
2-201.13 Removal of
Exclusions/Restrictions
2-201.14 Reporting by
Employee/Applicant*
2-201.15 Reporting by Person In
Charge*
PERSONAL CLEANLINESS
Hands and Arms
2-301.11 Clean Condition*
2-301.12 Cleaning Procedure*
2-301.13 Special Hand wash
Procedures*
2-301.14 When to Wash*
2-301.15 Where to Wash
2-301.16 Hand Sanitizers
2-302.11 Fingernail Maintenance
2-303.11 Jewelry Prohibitions
2-304.11 Outer Clothing Cleanliness
HYGIENIC PRACTICES
2-401.11 Eating, Drinking, or Using
Tobacco*
2-401.12 Discharges-Eye, Nose, Mouth*
2-402.11 Hair Restraint Effectiveness
2-403.11 Animal Handling Prohibition*
Food
CHARACTERISTICS
3-101.11 Safe/Unadulterated./Honestly
Presented*
SOURCES/SPECIFICATIONS/ORIGI
NAL
CONTAINER/RECORDS
Sources
3-201.11 Compliance with Food Law*
PROTECT. FROM
CONTAMINATION AFTER
RECEIVING
3-301.11 Contamination from
Employees' Hands*
Contamination from Other
Foods/Ingredients
3-302.11
Separation/Packaging/Segregation*
3-302.12 Containers Identified/Common
Name
3-302.14 Unapproved Additives*
3-302.15 Washing Fruits and Vegetables
Contamination from Ice Used as a
Coolant
3-303.11 Exterior Ice Prohibited
Ingredient
3-303.12 Food in Contact with Water or
Ice
Contamination from
Equip./Utensils/Linens
3-304.11 Food Contact with Soiled
Items*
3-304.12 In-Use Utensils/Between-Use
Storage
3-304.14 Wiping Cloths, Use Limitation
3-304.15 Gloves, Use Limitation
3-304.17 Refilling Returnable
Contamination from the Premises
3-305.11 Food Storage
3-305.12 Food Storage, Prohibited Areas
3-305.13 Vended Food, Original
Container
Contamination from Other Sources
3-307.11 Miscellaneous Sources
FOOD ID./PRESENTATION/ ONPREMISES LABELING
Accurate Representation
3-601.11 Standards of Identity
3-601.12 Honestly Presented
Labeling
3-602.11 Food Labels
3-602.12 Other Forms of Information
CONTAMINATED FOOD
Disposition
3-701.11 Discarding Contaminated
Food*
Equipment, Utensils, and Linens
MATERIALS FOR CONSTRUCTION
AND REPAIR
Multiuse
4-101.11 Characteristics*
4-101.12 Cast Iron
4-101.13 Lead in Ceramic, China,
Crystal Utensils
4-101.14 Copper*
4-101.15 Galvanized Metal*
4-101.16 Sponges
4-101.17 Lead in Pewter
4-101.18 Lead in Solder and Flux
4-101.19 Wood
4-101.110 Nonstick Coatings
4-101,111 Nonfood-Contact Surfaces
Single-Service and Single-Use
4-102.11 Characteristics*
DESIGN AND CONSTRUCTION
Durability and Strength
4-201.11 Equipment and Utensils
4-201.12 Food Temperature Measuring
Devices*
Cleanabilty
4-202.11 Food-Contact Surfaces*
4-202.12 CIP Equipment
4-202.13 "V" Threads
4-202.14 Hot Oil Filtering Equipment
4-202.16 Nonfood-Contact Surfaces
4-202.18 Ventilation Hood, Filters
Accuracy
4-203.11 Food Temperature Measuring
Devices
4-203.12 Ambient Temp. Measuring
Devices
4-203.13 Pres. Meas. Dev., Mech. Ware.
Equip.
NUMBERS AND CAPACITIES
Utensils and Measuring/Testing Devices
4-302.12 Food Temperature Measuring
Devices
17
Quality
5-102.11 Standards*
5-102.12 Nondrinking Water*
5-102.13 Sampling
5-102.14 Sample Report
Quantity and Availability
5-103.11 Capacity*
5-103.12 Pressure
Distribution, Delivery, and Retention
5-104.11 System
5-104.12 Alternative Water Supply
PLUMBING SYSTEM
5-201.11 Materials, Approved*
Design, Construction, and Installation
5-202.11 Approved System/Cleanable
Fixtures*
5-202.12 Handwashing Facility, Installation
Numbers and Capacities
5-203.13 Service Sink
5-203.14 Backflow Prevention Device
REFUSE, RECYCLABLES, AND
RETURNABLES
Facilities on the Premises
5-501.11 Outdoor Storage Surface
5-501.12 Outdoor Enclosure
5-501.13 Receptacles
5-501.15 Outside Receptacles
5-501.16 Areas-Receptacles,
Capacity/Avail.
5-501.17 Toilet Room Receptacle, Covered
5-501.18 Cleaning Implements and
Supplies
5-501.19 Storage Areas and Units/Location
5-501.110 Storing
Refuse/Recyclables/Return.
5-501.111 Areas/Enclosures/Receptacles,
Repair
5-501.112 Outside Storage Prohibitions
5-501.113 Covering Receptacles
5-501.114 Using Drain Plugs
5-501.115 Maintaining Refuse
Areas/Enclosures
5-501.116 Cleaning Receptacles
Removal
5-502.11 Frequency
5-502.12 Receptacles or Vehicles
Facilities for Disposal/Recycling/Refilling
5-503.11 Community or Individual Facility
Physical Facilities
MATERIALS FOR CONSTRUCTION
AND REPAIR
6-101.11 Indoors, Surface Characteristics
6-102.11 Outdoors, Surface Characteristics
DESIGN, CONSTRUCTION, AND
INSTALLATION
Cleanability
6-201.11 Floors, Walls, and Ceilings
6-201.12 Floors/Walls/Ceilings,Utility
Lines
6-201.13 Junctures, Coved/Enclosed/Sealed
6-201.14 Carpeting,Restriction/Installation
6-201.15 Floor Covering, Mats and
Duckboards
6-201.16 Wall, Ceiling, Coverings/Coatings
6-201.17 Walls and Ceilings, Attachments
6-201.18 Wall, Ceiling, Studs/Joists/Rafters
Functionality
6-202.11 Light Bulbs, Protective Shielding
6-202.12 Ventilation System, Exhaust
Vents
6-202.13 Insect Contr. Dev., Design/Install.
6-202.14 Toilet Rooms, Enclosed
6-202.15 Outer Openings, Protected
6-202.16 Exterior Walls/Roofs, Barriers
6-202.19 Outdoor Walk/Drive Surfaces,
Drained
6-202.110 Outdoor Refuse Areas,
Curbed/Drained
NUMBERS AND CAPACITIES
Handwashing Facilities
6-301.11 Hand Cleanser, Available
6-301.12 Hand Drying Provision
6-301.13 Handwash Aids and Devices, Use
Restrictions
6-301.14 Handwashing Signage
Toilets and Urinals
6-302.11 Toilet Tissue, Availability
6-303.11 Lighting, Intensity
6-304.11 Ventilation, Mechanical
6-305.11 Dressing Areas/Lockers,
Designation
LOCATION AND PLACEMENT
6-402.11 Toilet Rooms,
Convenient/Accessible
6-403.11 Employee Accommodations,
Designated
6-404.11 Distressed Merchandise,
Segregated
MAINTENANCE AND OPERATION
Premises/Fixtures - Methods
6-501.11 Repairing
6-501.12 Cleaning, Frequency/Restrictions
6-501.13 Cleaning Floors, Dustless
Methods
6-501.14 Clean. Vent. Sys., Prev. Discharge
6-501.15 Clean. Maint. Tools, Prev.
Contam.*
6-501.16 Drying Mops
6-501.17 Floors - Absorbent Materials
6-501.18 Maintaining/Using Handwashing
Facilities
6-501.19 Closing Toilet Room Doors
6-501.110 Using Dressing Rooms and
Lockers
6-501.111 Controlling Pests*
6-501.112 Removing Dead or Trapped Pests
6-501.113 Storing Maintenance Tools
6-501.114 Unnecessary Items and Litter
6-501.115 Prohibiting Animals*
Poisonous or Toxic Materials
LABELING AND IDENTIFICATION
Original Containers
7-101.11 Identifying Information,
Prominence*
7-102.11 Working Containers, Common
Name*
OPERATIONAL SUPPLIES AND
APPLICATIONS
7-201.11 Storage, Separation*
Presence and Use
7-202.11 Restriction*
7-202.12 Conditions of Use*
Container Prohibitions
7-203.11 Poisonous/Toxic Material
Containers*
Chemicals
7-204.11 Sanitizers*
7-204.12 Washing Fruits and Vegetables*
7-204.13 Boiler Water Additives*
7-204.14 Drying Agents*
7-205.11 Lubricants, Incidental Food
Contact*
Pesticides
7-206.11 Restricted-Use, Criteria*
7-206.12 Bait Stations*
7-206.13 Tracking Powders*
Medicines
7-207.11 Restriction and Storage*
7-207.12 Medicines, Refrigerated Storage*
7-208.11 First Aid Supplies, Storage*
18
ESTABLISHMENT:
PROCESS:
NEW PRODUCT:
REASSESSMENT DATE:
(Yearly; check for dated
signature only)
I HAZARD ANALYSIS AND HACCP PLAN DEVELOPMENT
REQUIREMENT
YES
(X)
INITIAL HAZARD ANALYSIS
The establishment has not conducted a hazard analysis or had a hazard
analysis conducted for it.
The hazard analysis does not include food safety hazards that are reasonably
likely to occur in the production process, or
does not identify the preventive measures the establishment can apply to
those food safety hazard(s)
The hazard analysis does not include a flow chart that describes (diagrams)
the steps of each process and product flow in the establishment.
The hazard analysis does not identify the intended use or consumers of
finished product(s).
INITIAL PLAN DEVELOPMENT
The establishments hazard analysis revealed one or more food safety
hazards that are reasonably likely to occur, and the establishment does not
have a written HACCP plan for each of its products.
The establishment has not conducted validation activities to determine that a
HACCP plan is functioning as intended.
The establishments record do not include: multiple results that verify the
monitoring of CCPs and conformance with critical limits, or after a deviation
from a critical limit (if any), subsequent results that support the adequacy of
corrective action(s) in achieving control at the CCP.
SUBSEQUENT ANALYSIS AND PLAN DEVELOPMENT
(HAZARD ANALYSIS REASSESSMENT)
YES
(X)
MULTIPLE PRODUCTS
A HACCP plan covers more than one product and the products are not all
similar.
FOOD SAFETY HAZARD(S)
The HACCP plan does not list the food safety hazard(s) identified in the hazard
analysis.
HAZARD CONTROL
The HACCP plan does not list CCPs for each food safety hazard.
The HACCP plan does not list critical limits to be met at each CCP.
MONITORING
The HACCP plan does not list the procedures to be used to monitor each CCP
and the frequency with which these procedures will be performed.
CORRECTIVE ACTIONS
The HACCP plan does not identify the corrective action to be followed in
response to a deviation from a critical limit at a CCP.
III RECORDKEEPING
REQUIREMENT
The HACCP plans record keeping system does not document the monitoring
of CCPs and/or does not include records with the actual values and
observations.
IV DATED SIGNATURE
REQUIREMENT
YES
(X)
YES
(X)
20