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Food Safety Inspections: Basic Compliance Checklists for GMPs, GAPs, SSOPs and HACCP
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. Pen and pencil Writing tablet Notebook Inspection forms Watch Gloves Aprons Microbiological Sample Kit for Total Plate Count (by 3M) (optional) 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? -------- ------------------------ -----------------
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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? Do they use them when their hands become soiled or contaminated? 5. Do your employees maintain clean personal habits? 6. Is the traffic within your plant controlled to prevent contamination of the production area? Do visitors wear proper outfits and hairnets?
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7. Have your employees been told the reasons why they should undertake the above -------- ----------------precautions? Has this training been done through GMP classes? Is the training documented? 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.
4. Is there any build-up or seepage of cleaning solvents or lubricants on your equipment, which can contaminate foods? All repairs on equipment should be of a permanent nature (e.g., no bobby pins in place of cotter pins), as temporary repair parts can break or rupture and get in the food product. 5. Is the equipment hard to disassemble for clean-up and inspection? The more difficult it is, the less inclined you or an employee will be to clean it.
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:
1. Are products stored on a first-in, first-out basis to reduce the possibility of contamination through spoilage? Are old products kept in front of the new to help in the rotation process? 2. Are all incoming products dated to ensure a proper rotation of stocks and for internal tracking purposes? 3. Are items overstocked? This increases the chances of spoilage and contamination.
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. Are materials stored in a safe manner? Food related items should not be stored with non-food related items. Materials should be stacked so that vents and blowers are not blocked. Stacks of materials should be orderly for safety purposes. 11. Do you have an effective recall procedure set up? Total Checked
Personnel
Needs Work
Plant / Grounds
Equipment
Good
Needs Work
Good
1. 2. 3. 4. 5. 6. 7. 8. 9. 6. 7. 5. 4. 3. 2. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
1.
1.
1.
1.
2.
2.
3.
3.
4.
4.
5.
5.
6.
6.
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8.
9.
10.
11.
Number Good:_____ 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: __________________
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 1. The equipment is disassembled 2. Parts are placed in the designated tubs, racks, etc. 3. Product debris is removed 4. Equipment parts are rinsed with water to remove remaining debris. 5. An approved cleaner is applied to parts and they are cleaned according to manufacturers directions 6. Equipment parts are rinsed with potable water. 7. Equipment is sanitized with an approved sanitizer and rinsed with potable water if required. 8. The equipment is reassembled. 9. The equipment is reassembled with an approved sanitizer and rinsed with potable water if required Performed Evaluations: Good 10. Organoleptic (smell, sight, touch) 11. Chemical (chlorine level or others) 12. Microbiological (swabs for TPC, or others Description of Evaluations: __________ Needs Work Needs Work
, Date:
B. Cleaning of Facilities (including floors, walls and ceilings) Cleaning Procedures: Good 1. Debris is swept up and discarded. 2. Facilities are rinsed with potable water as necessary. 3. Facilities are cleaned with an approved cleaner, according to manufacturers directions. 4. Facilities are rinsed with potable water as necessary. Needs Work
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II. Operational Sanitation Handling of the product and packaging materials will be performed under sanitary conditions and in a manner to prevent contamination of the product. Handling Operations Established Methods for Food Handling: Good 1. Employees will clean hands, arms, gloves, aprons, boots, etc., as often as necessary during the handling procedures 2. Employees will clean and then sanitize any equipment as often as necessary during handling procedures to prevent contamination of foods or packaging materials Performed Evaluations: 3. Organoleptic (sight, smell, feel, etc.) 4. Chemical (chlorine level or others) 5. Microbiological (swabs for TPC, or others Description of Evaluations: Good Needs Work Needs Work
___________
_________________
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Sanitation SOPs (SSOPs) Monthly Inspection Record Sheet* General Equipment Cleaning
Good Needs Work
Cleaning of Facilities
Good Needs Work
Handling Operations
Good Needs Work
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
1. 2. 3. 4.
1. 2. 3. 4. 5.
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: ______________________________
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Worker Health and Hygiene Good 9. Are employees who work with fresh produce infected? 10. Are employees trained to follow good hygienic practices? 11. Are training programs established and directed towards health and hygiene including basics such as proper hand washing techniques and the importance of using toilet facilities? 12. Are you familiar with typical signs and symptoms of infectious diseases? 13. Is protection offered to workers with cuts or lesions on parts of the body that may make contact with fresh produce? 14. Are gloves properly used so hands will not become a vehicle for spreading pathogens? Field Sanitation Good 15. Are harvest storage facilities and containers or bins cleaned prior to use? 16. Is harvesting and packing equipment appropriately and kept clean? Trace Back Good 17. Is there a procedure in place to track produce containers from the farm to the packer, distributor and retailer? 18. Does this documentation indicate the source of the product and other information, such as date of harvest, farm identification and who handled the produce? 19. Is this establishment partnering with transporters, distributors and retailers to facilitate the trace back process? Needs Work Needs Work Needs Work
Corrective Actions:
Date:____________________
Approved by:______________________________
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Good Agricultural Practices (GAPs) Monthly Inspection Record Sheet* Animal Feces
Good Needs Work Good Needs Work Good Needs Work Good
Agricultural Water
Worker Health and Hygiene 9. 10. 11. 12. 13. 14. Number Good: ______ Percentage: ______ 19. 18. 17. 16. 15.
Field Sanitation
Trace Back
Needs Work
Good
Needs Work
1. 7. 8.
6.
2.
3.
4.
5.
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly. Establishment Name: _____________________________ Inspected by: ____________________
Date: __________________
Good Manufacturing Practices (GMPs): Monthly Inspection Record Sheet; Percentage Look-Up Table
Number of Questions 3
75% 100%
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11
12
13
14
15
16
17
18
19
4
60% 80% 100%
25%
50%
5
50% 67% 83% 100%
20%
40%
6
43% 57% 71% 86% 100%
17%
33%
7
38% 50% 63% 75% 88% 100%
14%
29%
8
33% 44% 56% 67% 78% 89% 100%
13%
25%
9
30% 40% 50% 60% 70% 80% 90% 100%
11%
22%
10
27% 36% 45% 55% 64% 73% 82%
10%
20%
11
16% 21% 26% 31% 37% 42%
9%
18%
91%
100%
19
5%
10%
47%
53%
58%
63%
68%
74%
79%
84%
89%
95%
100%
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
4-302.13 Wash/San. Temp. Measuring Devices 4-302.14 Sanitizing Solution Testing Devices LOCATION AND INSTALLATION 4-401.11 Equip. Location/Preventing Contam. Installation 4-402.11 Fixed Equipment, Spacing/Sealing 4-402.12 Fixed Equipment, Elevation/Sealing MAINTENANCE AND OPERATION Equipment 4-501.11 Good Repair and Proper Adjustment 4-501.14 Equipment, Cleaning Frequency 4-501.15 Warewasher, Operating Instructions 4-501.16 Warewashing Sinks, Use Limitation 4-501.17 Warewashing, Cleaning Agents 4-501.18 Warewashing, Clean Solutions 4-501.19 Warewashing, Wash Sol. Temperature 4-501.110 Warewasher, Wash Sol. Temperature 4-501.111 Warewashing, San. Water Temp.* 4-501.112 Warewasher, San. Water Temp. 4-501.113 Warewasher, Sanitization Pressure 4-501.114 Chem.San., Temp./pH/Concentr./Hard.* 4-501.115 Chem.San., Detergent-Sanitizers 4-501.116 Determining Chem.San. Concentration Utensil/Temperature/Pressure Measuring Device 4-502.11 Good Repair and Calibration CLEANING OF EQUIPMENT AND UTENSILS Objective 4-601.11 Clean Sight/Touch-No Accum/Encrust.* Frequency 4-602.11 Food-Contact Surfaces and Utensils* 4-602.13 Nonfood-Contact Surfaces SANITIZATION OF EQUIPMENT AND UTENSILS Objective 4-702.11 Frequency-Before Use After Cleaning* 4-703.11 Methods-Hot Water and Chemical* PROTECTION OF CLEAN ITEMS Drying 4-901.11 Equipment and Utensils, AirDrying 4-901.12 Wiping Cloths, Air-Drying Lubricating and Reassembling 4-902.11 Food-Contact Surfaces 4-902.12 Equipment Storing 4-903.11 Equip./Uten./Lin./Sing.-Ser/Use Art. 4-903.12 Prohibitions Water, Plumbing, and Waste WATER Source 5-101.11 Approved System* 5-101.12 System Flushing and Disinfection* 5-101.13 Bottled Drinking Water.*
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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*
7-209.11 Other Personal Care Items, Storage STOCK AND RETAIL SALE 7-301.11 Storage and Display, Separation* Compliance and Enforcement CODE APPLICABILITY Variances 8-103.11 Documentation and Justification 8-103.12 Conformance with Procedures* PLAN SUBMISSION AND APPROVAL Facility and Operating Plans 8-201.11 When Plans Are Required 8-201.12 Contents of Plans/Specifications 8-201.13 HACCP Plan/When Required 8-201.14 Contents of a HACCP Plan INSPECTION AND CORRECTION OF VIOLATIONS Critical Violation 8-405.11 Timely Correction Noncritical Violation 8-406.11 Time Frame for Correctio
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PROCESS:
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)
NEW PRODUCT:
After an estabIishment hazard analysis revealed no food safety hazards that are reasonably likely to occur, there was a change that could reasonably affect whether a food safety hazard exists, the establishment did not reassess the adequacy of the hazard. (NEW PRODUCT) (1) Before producing new product for distribution, the establishment did not conduct a hazard analysis (or have a hazard analysis conducted for it) or did not have an applicable HACCP plan for the product. (2)The establishment began distributing a new product more than 90 days ago, and it has not validated the HACCP plan that covers the new product.
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YES (X)
YES (X)
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