Food Safety Inspections: Basic Compliance Checklists for GMPs ...
Food Safety Inspections: Basic Compliance Checklists for GMPs ...
Food Safety Inspections: Basic Compliance Checklists for GMPs ...
Sie wollen auch ein ePaper? Erhöhen Sie die Reichweite Ihrer Titel.
YUMPU macht aus Druck-PDFs automatisch weboptimierte ePaper, die Google liebt.
EC 708<br />
April 2002<br />
<strong>Food</strong> <strong>Safety</strong> <strong>Inspections</strong>:<br />
<strong>Basic</strong> <strong>Compliance</strong> <strong>Checklists</strong> <strong>for</strong><br />
<strong>GMPs</strong>, GAPs, SSOPs and HACCP<br />
© Clemson University<br />
Department of <strong>Food</strong> Science and Human Nutrition<br />
College of Agriculture, Forestry & Life Sciences<br />
224 Poole Agricultural Center<br />
Box 340371<br />
Clemson, SC 29634-037<br />
Phone: (864) 656-5694 Fax: (864) 656-0331
TABLE OF CONTENTS<br />
Purpose of This Publication .....................................................................................................1<br />
<strong>Food</strong> <strong>Safety</strong> <strong>Inspections</strong> ...........................................................................................................1<br />
GMP’s: Personnel ....................................................................................................................3<br />
Buildings and Facilities: Plant and Grounds.........................................................................4<br />
Buildings and Facilities: Sanitation Operations: Pest Control..............................................5<br />
Buildings and Facilities: Sanitary Facilities and Controls ....................................................6<br />
Equipment ............................................................................................................................7<br />
Production and Process Control ..............................................................................................8<br />
Good Manufacturing Practices (<strong>GMPs</strong>)<br />
Monthly Inspection Record Sheet.......................................................................................9<br />
Sanitation SOP’s Sanitation SOP’s (SSOPs):........................................................................10<br />
Monthly Inspection Record Sheet.....................................................................................12<br />
Good Agricultural Practices (GAPs):<br />
Applicable to the Field Operations. ..................................................................................13<br />
Good Agricultural Practices (GAPs):<br />
Monthly Inspection Record Sheet.....................................................................................15<br />
Good Manufacturing Practices (<strong>GMPs</strong>):<br />
Monthly Inspection Record Sheet: Percentage Look-Up Table.........................................16<br />
Inspectional Guide..................................................................................................................17<br />
HACCP Systems – <strong>Basic</strong> <strong>Compliance</strong> Checklist ..................................................................19<br />
Prepared by Felix H. Barron<br />
The Clemson University Cooperative Extension Service offers its programs to people of all ages, regardless of race,<br />
color, sex, religion, national origin, disability, political beliefs, sexual orientation, marital or family status and is an<br />
equal opportunity employer.<br />
Clemson University Cooperating with U.S. Department of Agriculture, South Carolina Counties. Issued in Furtherance of<br />
Cooperative Extension Work in Agriculture and Home Economics, Acts of May 8 and June 30, 1914
PURPOSE OF THIS PUBLICATION<br />
This document provides food processors with examples of basic checklists to per<strong>for</strong>m internal<br />
inspections of their food processing facilities. The ultimate goal of food inspections is to ensure<br />
the safety of all food products reaching commerce. To achieve this goal, a series of inspections<br />
are required be<strong>for</strong>e a HACCP inspection is per<strong>for</strong>med. These pre-HACCP inspections may<br />
include the current Good Manufacturing Practices (<strong>GMPs</strong>), Good Agricultural Practices (GAPs)<br />
and Sanitation Standard Operating Procedures (SSOPs). <strong>Food</strong> processors may be able to obtain<br />
other inspection list examples by contacting their food inspectors. By doing this, they can better<br />
prepare facilities <strong>for</strong> <strong>for</strong>mal inspection to comply with local, state and federal food laws and<br />
regulations.<br />
FOOD SAFETY INSPECTIONS<br />
The <strong>Food</strong> <strong>Safety</strong> inspection determines the hygiene conditions of the food establishment<br />
inspected. Traditional inspections focus on the general aspects related to visually inspected<br />
cleanliness and sanitation of equipment and facilities and the food handling habits of workers.<br />
This inspection is an important part of <strong>GMPs</strong> and the new federal requirements compliance.<br />
However, a more thorough and effective inspection <strong>for</strong> the meat and poultry industries (USDA)<br />
and the seafood industry (FDA) is necessary to ensure compliance with HACCP-based programs<br />
and SSOPs.<br />
HACCP-based inspections or audits verify that a particular facility has included correct<br />
implementation of GAPs, <strong>GMPs</strong>, SSOPs and a HACCP program as necessary. This results in<br />
having a system that ensures the production of safe and wholesome food products.<br />
This publication contains sample <strong>for</strong>ms of inspections <strong>for</strong> food establishments. Companies<br />
should develop their own inspection <strong>for</strong>ms <strong>for</strong> internal purposes and continuous improvements.<br />
The <strong>for</strong>ms can be computerized <strong>for</strong> easy rating calculations. Managers can then assess the status<br />
of the company at any time. It is recommended that a professional be assigned the responsibility<br />
<strong>for</strong> auditing. This reduces the possibilities of misunderstanding audit reports. It is recommended<br />
that an assigned company person be with the inspector or auditor throughout the whole<br />
inspection to avoid misunderstandings at reporting time.<br />
Besides producing a safe and wholesome food product, self-inspections can help companies to<br />
optimize operation, thus reducing production costs.<br />
Start your regular inspection and control activities with all the necessary tools as indicated below<br />
in the Inspection and Control Tools List. Each inspection checklist has several questions that<br />
need to be asked and answered during the actual audit.<br />
Record each answer on the Monthly Inspection Record Sheets. Calculate the percentage of<br />
“good” answers. The ideal “clean and sanitized” establishment will have a score of 100%. The<br />
lower the score, the more opportunities <strong>for</strong> improvement.<br />
1
Count the total number of “good” answers and write this number down. You may want to<br />
develop your rating scale <strong>for</strong> the HACCP checklist.<br />
Problems found during an inspection should be recorded in a notebook and corrected as soon as<br />
possible be<strong>for</strong>e the next inspection. Avoid having the same problems showing in your next<br />
inspection. Keep Monthly Inspection Record Sheets as document evidence of your food safety<br />
ef<strong>for</strong>ts..<br />
<strong>Basic</strong> Inspection Tools<br />
1. Pen and pencil 9. Flashlight<br />
2. Writing tablet 10. UV light (optional)<br />
3. Notebook 11. Thermometer<br />
4. Inspection <strong>for</strong>ms 12. Copies of Laws and Regulations<br />
5. Watch 13. Hair nets<br />
6. Gloves<br />
7. Aprons<br />
8. Microbiological Sample Kit <strong>for</strong><br />
Total Plate Count (by 3M) (optional)<br />
2
<strong>GMPs</strong>: Personnel<br />
21 CFR, Part 110 Section 110.10<br />
1. Are the employees well-trained in what they do? You can avoid many problems<br />
by making sure that your employees clearly understand their functions.<br />
2. In handling food products, do your employees wear the proper hair covering,<br />
beard covering, disposable gloves and clean uni<strong>for</strong>ms?<br />
3. Are your employees wearing jewelry, rings, watches, fingernail polish or<br />
bandages?<br />
Do your employees have any illnesses, infections or injuries (i.e., boils, cuts) that<br />
can contaminate foods in the production area?<br />
4. Do your employees wash and sanitize their hands after each visit to the toilet?<br />
Do you have washing facilities available <strong>for</strong> your employees near their work<br />
stations?<br />
Do they use them when their hands become soiled or contaminated?<br />
5. Do your employees maintain clean personal habits?<br />
6. Is the traffic within your plant controlled to prevent contamination of the<br />
production area?<br />
Do visitors wear proper outfits and hairnets?<br />
7. Have your employees been told the reasons why they should undertake the above<br />
precautions?<br />
Has this training been done through GMP classes?<br />
Is the training documented?<br />
Total Checked:<br />
Good Needs Work<br />
<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
-------- -----------------<br />
3
<strong>GMPs</strong>: Buildings and Facilities: Plant and Grounds<br />
21 CFR, Part 110, Section 110.20<br />
1. Is the area around your firm clear of litter, weeds, grass and brush?<br />
2. Is there any standing water on your grounds (which also attracts pests)?<br />
3. Are floors, walls, ceilings, windows and screens properly maintained and cleaned?<br />
There should be no flaking paint anywhere above the production area.<br />
4. Do production area doors and windows to the outside have fine mesh screens to<br />
keep out insects? If not, are they tightly sealed?<br />
5. Will a pencil pass under the door?<br />
6. Have all holes and cracks been filled so as not to provide hiding places or entry<br />
points <strong>for</strong> pests?<br />
7. Are there any evidence of the presence of domestic animals such as cats and<br />
dogs?<br />
8. Are rest rooms cleaned regularly?<br />
9. Are the hand-washing facilities furnished with paper or air hand dryers and soap?<br />
10. Are there any leaks in the roof, sky lights, windows, screens or overhead piping?<br />
11. Are the overhead lights covered with shields to prevent contamination of<br />
products by broken glass in case the lamps burst?<br />
Total Checked:<br />
GoodNeeds<br />
Work<br />
4
<strong>GMPs</strong>: Buildings and Facilities:<br />
Sanitation Operations: Pest Control<br />
21 CFR, Part 110 Section 110.35 (a)(c)<br />
1. Do you have professional pest control services?<br />
2. Do you check regularly on what the pest control operator is doing?<br />
3. Do you have documentation on what chemicals are being used?<br />
4. Are mites, weevils or roaches apparent in the plant? There should be no evidence<br />
of their presence.<br />
5. Do you have enough bait stations?<br />
6. Are you safety using fumigation safety?<br />
7. Are the pest control logs and documentation readily available?<br />
8. Are pesticides or application equipment stored safely?<br />
9. Are products stored on pallets and at least 18 inches away from the walls?<br />
10. Is your facility well-maintained?<br />
Total Checked:<br />
Good Needs Work<br />
<br />
5
<strong>GMPs</strong>: Buildings and Facilities:<br />
Sanitary Facilities and Controls<br />
21 CFR, Part 110 Section 110.37<br />
1. Is trash, debris and clutter picked up, both inside and outside the plant, so as not to<br />
provide hiding places <strong>for</strong> pests?<br />
2. Are all sanitation chemicals used in the plant USDA/FDA approved?<br />
3. Do employees eat, drink and use tobacco products only in designated areas, and<br />
not in the production area or warehouse?<br />
4. Is the food spilled or uneaten by employees cleaned up quickly so as not to attract<br />
pests or breed bacteria?<br />
5. Has old rodent excreta been cleaned up so you can spot any new activity?<br />
6. Is garbage quickly removed and dumped in appropriate bins? It should not sit<br />
around your facilities to attract pests and develop odors.<br />
7. Is the garbage kept covered? An open garbage pile is an excellent breeding ground<br />
<strong>for</strong> insects and rodents.<br />
8. Is the water used in your firm from an approved source (either municipal supply or<br />
tested private source)?<br />
9. Have you made sure there are no hoses left dangling in sinks or on the ground?<br />
Loss of pressure can cause a back flow that will contaminate your water supply.<br />
10. Do your facilities have back flow and vacuum breaker valves to prevent<br />
contaminate your water supply?<br />
11. Is there standing water around your firm (particularly in the production area,<br />
warehouse and pack-off area)?<br />
Total Checked:<br />
GoodNeeds<br />
Work<br />
6
<strong>GMPs</strong>: Equipment<br />
21 CFR, Part 110 Subpart C<br />
1. Is all equipment that comes in contact with food cleaned and sanitized as often as<br />
necessary to prevent contamination of the product? You should follow appropriate<br />
cleaning schedules <strong>for</strong> each piece of equipment.<br />
2. Is the equipment designed, or otherwise suitable, <strong>for</strong> use in a food plant? For<br />
example, equipment <strong>for</strong> handling or processing foods cannot contain<br />
polychlorinated biphenyls (PCBs), which are very toxic (this does not apply to<br />
electrical trans<strong>for</strong>mers and condensers containing PCBs in sealed containers).<br />
3. Is there a build-up of food or other material on the equipment? This can serve as<br />
a breeding place <strong>for</strong> insects and bacteria.<br />
4. Is there any build-up or seepage of cleaning solvents or lubricants on your<br />
equipment, which can contaminate foods? All repairs on equipment should be of a<br />
permanent nature (e.g., no bobby pins in place of cotter pins), as temporary repair<br />
parts can break or rupture and get in the food product.<br />
5. Is the equipment hard to disassemble <strong>for</strong> clean-up and inspection? The more<br />
difficult it is, the less inclined you or an employee will be to clean it.<br />
6. Is there a lot of “dead space” in or around the machinery where food and other<br />
debris can collect as a nest <strong>for</strong> insects and bacteria?<br />
7. Can the surface of the equipment be sanitized?<br />
Total Checked:<br />
Good Needs Work<br />
7
<strong>GMPs</strong>: Production and Process Control<br />
21 CFR, Part 110 Section 110.80<br />
1. Are products stored on a first-in, first-out basis to reduce the possibility of<br />
contamination through spoilage?<br />
Are old products kept in front of the new to help in the rotation process?<br />
2. Are all incoming products dated to ensure a proper rotation of stocks and <strong>for</strong><br />
internal tracking purposes?<br />
3. Are items overstocked? This increases the chances of spoilage and contamination.<br />
4. Are incoming vehicles inspected?<br />
5. Are dusty, faded or discolored containers checked regularly?<br />
6. Are all products spoiled by damage, insects, rodents or other causes stored in a<br />
designated “Quarantine Area” to prevent their contact with safe products?<br />
7. Are such quarantined items disposed of quickly to prevent the development of<br />
pest breeding places?<br />
8. Are incoming materials inspected <strong>for</strong> damage or contamination so that they can be<br />
rejected?<br />
9. Are unused materials properly resealed to prevent contamination?<br />
10. Are materials stored in a safe manner?<br />
<strong>Food</strong> related items should not be stored with non-food related items.<br />
Materials should be stacked so that vents and blowers are not blocked.<br />
Stacks of materials should be orderly <strong>for</strong> safety purposes.<br />
11. Do you have an effective recall procedure set up?<br />
Total Checked<br />
GoodNeeds<br />
Work<br />
8
Good Manufacturing Practices (<strong>GMPs</strong>)<br />
Monthly Inspection Record Sheet*<br />
Personnel Plant / Grounds Pest Control Sanitary Facilities and Equipment Production and<br />
Control<br />
Process Control<br />
Good Needs Good Needs Good Needs Good Needs Good Needs Good Needs<br />
Work<br />
Work<br />
Work<br />
Work<br />
Work<br />
Work<br />
1. 1. 1. 1. 1. 1.<br />
2. 2. 2. 2. 2. 2.<br />
3. 3. 3. 3. 3. 3.<br />
4. 4. 4. 4. 4. 4.<br />
5. 5. 5. 5. 5. 5.<br />
6. 6. 6. 6. 6. 6.<br />
7. 7. 7. 7. 7.<br />
8. 8. 8. 8.<br />
9. 9. 9. 9.<br />
10. 10. 10. 10.<br />
11. 11. 11.<br />
Number “Good”:_____ Number “Good”: ____ Number “Good”: ____ Number “Good”: _____ Number “Good”: ____ Number “Good”: _____<br />
Percentage: ______ Percentage: ______ Percentage: ______ Percentage: ______ Percentage: ______ Percentage: ______<br />
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly.<br />
Date: ____________________ Establishment Name: ______________________ Inspected by: __________________
SANITATION SOPs<br />
I. Preoperational Sanitation--Equipment and Facility Cleaning<br />
All equipment will be cleaned and sanitized prior to starting production.<br />
A. General Equipment Cleaning<br />
(Simple equipment and hand tools are cleaned and sanitized in the same manner but they do<br />
not require disassembly and reassembly.)<br />
Established Sanitary Procedures <strong>for</strong> Cleaning and Sanitizing<br />
Equipment:<br />
1. The equipment is disassembled<br />
2. Parts are placed in the designated tubs, racks, etc.<br />
3. Product debris is removed<br />
4. Equipment parts are rinsed with water to remove remaining<br />
debris.<br />
5. An approved cleaner is applied to parts and they are cleaned<br />
according to manufacturer’s directions<br />
6. Equipment parts are rinsed with potable water.<br />
7. Equipment is sanitized with an approved sanitizer and rinsed with<br />
potable water if required.<br />
8. The equipment is reassembled.<br />
9. The equipment is reassembled with an approved sanitizer and rinsed<br />
with potable water if required<br />
Per<strong>for</strong>med Evaluations:<br />
10. Organoleptic (smell, sight, touch)<br />
11. Chemical (chlorine level or others)<br />
12. Microbiological (swabs <strong>for</strong> TPC, or others<br />
Good Needs Work<br />
Good Needs Work<br />
Description of Evaluations: __________<br />
Corrective Actions:<br />
Overall Inspection by: , Date:<br />
B. Cleaning of Facilities (including floors, walls and ceilings)<br />
Cleaning Procedures:<br />
1. Debris is swept up and discarded.<br />
2. Facilities are rinsed with potable water as necessary.<br />
3. Facilities are cleaned with an approved cleaner, according to<br />
manufacturers directions.<br />
4. Facilities are rinsed with potable water as necessary.<br />
Good Needs Work<br />
10
II. Operational Sanitation<br />
Handling of the product and packaging materials will be per<strong>for</strong>med under sanitary conditions<br />
and in a manner to prevent contamination of the product.<br />
Handling Operations<br />
Established Methods <strong>for</strong> <strong>Food</strong> Handling:<br />
1. Employees will clean hands, arms, gloves, aprons, boots, etc.,<br />
as often as necessary during the handling procedures<br />
2. Employees will clean and then sanitize any equipment as often<br />
as necessary during handling procedures to prevent contamination<br />
of foods or packaging materials<br />
Per<strong>for</strong>med Evaluations:<br />
Good Needs Work<br />
3. Organoleptic (sight, smell, feel, etc.) Good Needs Work<br />
4. Chemical (chlorine level or others)<br />
5. Microbiological (swabs <strong>for</strong> TPC, or others<br />
Description of Evaluations: ___________<br />
Corrective Actions: _________________<br />
Overall Inspection by: , Date:<br />
11
General Equipment<br />
Cleaning<br />
Good<br />
Needs<br />
Work<br />
Sanitation SOPs (SSOPs)<br />
Monthly Inspection Record Sheet*<br />
Cleaning of Facilities Handling Operations<br />
Good<br />
Needs<br />
Work<br />
1. 1. 1.<br />
2. 2. 2.<br />
3. 3. 3.<br />
4. 4. 4.<br />
5. 5.<br />
6.<br />
7.<br />
8.<br />
9.<br />
10.<br />
11.<br />
Number “Good”: ______<br />
Percentage: ______<br />
Number “Good”: ______<br />
Percentage: ______<br />
Good<br />
Needs<br />
Work<br />
Number “Good”: ______<br />
Percentage: ______<br />
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly.<br />
Date: __________________ Establishment Name: _____________________________<br />
Inspected by: ______________________________<br />
12
Good Agricultural Practices (GAPs): Applicable to the Field<br />
Operations.<br />
Agricultural Water<br />
1. Are sources and distribution of water usage identified?<br />
2. Are you aware of current and historical use of the land?<br />
3. Are existing practices and conditions <strong>for</strong> potential success of<br />
contamination identified?<br />
4. Are wells in good working condition?<br />
5. Is the irrigation water contaminated?<br />
Animal Feces<br />
6. Is all animal life excluded from fresh produce production areas?<br />
7. Are GAPs followed to ensure that animal waste from adjacent<br />
fields, pastures or waste storage facilities does not contaminate fresh<br />
produce production areas? Where necessary, consider physical barriers<br />
such as ditches, mounds, grass/sod waterways, diversion berms and<br />
vegetative buffer areas.<br />
8. Are you considering practices to deter or redirect wildlife to areas<br />
where crops are not destined <strong>for</strong> fresh produce markets?<br />
(Continue next page)<br />
Good Needs Work<br />
Good Needs Work<br />
13
Worker Health and Hygiene<br />
9. Are employees who work with fresh produce infected?<br />
10. Are employees trained to follow good hygienic practices?<br />
11. Are training programs established and directed towards health<br />
and hygiene – including basics such as proper hand washing<br />
techniques and the importance of using toilet facilities?<br />
12. Are you familiar with typical signs and symptoms of infectious<br />
diseases?<br />
13. Is protection offered to workers with cuts or lesions on parts of<br />
the body that may make contact with fresh produce?<br />
14. Are gloves properly used so hands will not become a vehicle<br />
<strong>for</strong> spreading pathogens?<br />
Field Sanitation<br />
15. Are harvest storage facilities and containers or bins cleaned<br />
prior to use?<br />
16. Is harvesting and packing equipment appropriately and kept<br />
clean?<br />
Trace Back<br />
17. Is there a procedure in place to track produce containers from<br />
the farm to the packer, distributor and retailer?<br />
18. Does this documentation indicate the source of the product and<br />
other in<strong>for</strong>mation, such as date of harvest, farm identification and<br />
who handled the produce?<br />
19. Is this establishment partnering with transporters, distributors<br />
and retailers to facilitate the trace back process?<br />
Corrective Actions:<br />
Good Needs Work<br />
Good Needs Work<br />
Good Needs Work<br />
Date:____________________ Approved by:______________________________<br />
14
Good Agricultural Practices (GAPs)<br />
Monthly Inspection Record Sheet*<br />
Field Sanitation Trace Back<br />
Agricultural Water Animal Feces Worker Health and<br />
Hygiene<br />
Needs<br />
Work<br />
Good<br />
Needs<br />
Work<br />
Good<br />
Needs<br />
Work<br />
Good<br />
Needs<br />
Work<br />
Good<br />
Needs<br />
Work<br />
Good<br />
1. 6. 9. 15.<br />
2. 7. 10. 16.<br />
3. 8. 11. 17.<br />
4. 12. 18.<br />
5. 13. 19.<br />
14.<br />
Number “Good”: ______<br />
Percentage: ______<br />
* Any questions that are not applicable should be eliminated to calculate the percentage accordingly.<br />
Date: __________________ Establishment Name: _____________________________ Inspected by: ____________________
Good Manufacturing Practices (<strong>GMPs</strong>): Monthly Inspection Record Sheet; Percentage Look-Up Table<br />
Percentages <strong>for</strong> number of “Good” answers<br />
Number<br />
of<br />
Questions<br />
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19<br />
25% 50% 75% 100%<br />
4<br />
20% 40% 60% 80% 100%<br />
5<br />
17% 33% 50% 67% 83% 100%<br />
6<br />
14% 29% 43% 57% 71% 86% 100%<br />
7<br />
13% 25% 38% 50% 63% 75% 88% 100%<br />
8<br />
11% 22% 33% 44% 56% 67% 78% 89% 100%<br />
9<br />
10% 20% 30% 40% 50% 60% 70% 80% 90% 100%<br />
10<br />
9% 18% 27% 36% 45% 55% 64% 73% 82% 91% 100%<br />
11<br />
5% 10% 16% 21% 26% 31% 37% 42% 47% 53% 58% 63% 68% 74% 79% 84% 89% 95% 100%<br />
19
Inspectional Guide<br />
The Guide has been<br />
adapted from the FDA<br />
<strong>Food</strong> Code. It is to be used<br />
during the internal<br />
inspection of an<br />
establishment.<br />
Management and Personnel<br />
SUPERVISION<br />
2-101.11 Assignment of Responsibility*<br />
2-102.11 Demonstration of Knowledge*<br />
2-103.11 Duties of Person in Charge<br />
EMPLOYEE HEALTH<br />
Disease or Medical Condition<br />
2-201.11 Responsibility of Person in<br />
Charge*<br />
2-201.12 Exclusions and Restrictions*<br />
2-201.13 Removal of<br />
Exclusions/Restrictions<br />
2-201.14 Reporting by<br />
Employee/Applicant*<br />
2-201.15 Reporting by Person In<br />
Charge*<br />
PERSONAL CLEANLINESS<br />
Hands and Arms<br />
2-301.11 Clean Condition*<br />
2-301.12 Cleaning Procedure*<br />
2-301.13 Special Hand wash<br />
Procedures*<br />
2-301.14 When to Wash*<br />
2-301.15 Where to Wash<br />
2-301.16 Hand Sanitizers<br />
2-302.11 Fingernail Maintenance<br />
2-303.11 Jewelry Prohibitions<br />
2-304.11 Outer Clothing Cleanliness<br />
HYGIENIC PRACTICES<br />
2-401.11 Eating, Drinking, or Using<br />
Tobacco*<br />
2-401.12 Discharges-Eye, Nose, Mouth*<br />
2-402.11 Hair Restraint Effectiveness<br />
2-403.11 Animal Handling Prohibition*<br />
<strong>Food</strong><br />
CHARACTERISTICS<br />
3-101.11 Safe/Unadulterated./Honestly<br />
Presented*<br />
SOURCES/SPECIFICATIONS/ORIGI<br />
NAL<br />
CONTAINER/RECORDS<br />
Sources<br />
3-201.11 <strong>Compliance</strong> with <strong>Food</strong> Law*<br />
PROTECT. FROM<br />
CONTAMINATION AFTER<br />
RECEIVING<br />
3-301.11 Contamination from<br />
Employees' Hands*<br />
Contamination from Other<br />
<strong>Food</strong>s/Ingredients<br />
3-302.11<br />
Separation/Packaging/Segregation*<br />
3-302.12 Containers Identified/Common<br />
Name<br />
3-302.14 Unapproved Additives*<br />
3-302.15 Washing Fruits and Vegetables<br />
Contamination from Ice Used as a<br />
Coolant<br />
3-303.11 Exterior Ice Prohibited<br />
Ingredient<br />
3-303.12 <strong>Food</strong> in Contact with Water or<br />
Ice<br />
Contamination from<br />
Equip./Utensils/Linens<br />
3-304.11 <strong>Food</strong> Contact with Soiled<br />
Items*<br />
3-304.12 In-Use Utensils/Between-Use<br />
Storage<br />
3-304.14 Wiping Cloths, Use Limitation<br />
3-304.15 Gloves, Use Limitation<br />
3-304.17 Refilling Returnable<br />
Contamination from the Premises<br />
3-305.11 <strong>Food</strong> Storage<br />
3-305.12 <strong>Food</strong> Storage, Prohibited Areas<br />
3-305.13 Vended <strong>Food</strong>, Original<br />
Container<br />
Contamination from Other Sources<br />
3-307.11 Miscellaneous Sources<br />
FOOD ID./PRESENTATION/ ON-<br />
PREMISES LABELING<br />
Accurate Representation<br />
3-601.11 Standards of Identity<br />
3-601.12 Honestly Presented<br />
Labeling<br />
3-602.11 <strong>Food</strong> Labels<br />
3-602.12 Other Forms of In<strong>for</strong>mation<br />
CONTAMINATED FOOD<br />
Disposition<br />
3-701.11 Discarding Contaminated<br />
<strong>Food</strong>*<br />
Equipment, Utensils, and Linens<br />
MATERIALS FOR CONSTRUCTION<br />
AND REPAIR<br />
Multiuse<br />
4-101.11 Characteristics*<br />
4-101.12 Cast Iron<br />
4-101.13 Lead in Ceramic, China,<br />
Crystal Utensils<br />
4-101.14 Copper*<br />
4-101.15 Galvanized Metal*<br />
4-101.16 Sponges<br />
4-101.17 Lead in Pewter<br />
4-101.18 Lead in Solder and Flux<br />
4-101.19 Wood<br />
4-101.110 Nonstick Coatings<br />
4-101,111 Nonfood-Contact Surfaces<br />
Single-Service and Single-Use<br />
4-102.11 Characteristics*<br />
DESIGN AND CONSTRUCTION<br />
Durability and Strength<br />
4-201.11 Equipment and Utensils<br />
4-201.12 <strong>Food</strong> Temperature Measuring<br />
Devices*<br />
Cleanabilty<br />
4-202.11 <strong>Food</strong>-Contact Surfaces*<br />
4-202.12 CIP Equipment<br />
4-202.13 "V" Threads<br />
4-202.14 Hot Oil Filtering Equipment<br />
4-202.16 Nonfood-Contact Surfaces<br />
4-202.18 Ventilation Hood, Filters<br />
Accuracy<br />
4-203.11 <strong>Food</strong> Temperature Measuring<br />
Devices<br />
4-203.12 Ambient Temp. Measuring<br />
Devices<br />
4-203.13 Pres. Meas. Dev., Mech. Ware.<br />
Equip.<br />
NUMBERS AND CAPACITIES<br />
Utensils and Measuring/Testing Devices<br />
4-302.12 <strong>Food</strong> Temperature Measuring<br />
Devices<br />
4-302.13 Wash/San. Temp. Measuring<br />
Devices<br />
4-302.14 Sanitizing Solution Testing<br />
Devices<br />
LOCATION AND INSTALLATION<br />
4-401.11 Equip. Location/Preventing<br />
Contam.<br />
Installation<br />
4-402.11 Fixed Equipment, Spacing/Sealing<br />
4-402.12 Fixed Equipment,<br />
Elevation/Sealing<br />
MAINTENANCE AND OPERATION<br />
Equipment<br />
4-501.11 Good Repair and Proper<br />
Adjustment<br />
4-501.14 Equipment, Cleaning Frequency<br />
4-501.15 Warewasher, Operating<br />
Instructions<br />
4-501.16 Warewashing Sinks, Use<br />
Limitation<br />
4-501.17 Warewashing, Cleaning Agents<br />
4-501.18 Warewashing, Clean Solutions<br />
4-501.19 Warewashing, Wash Sol.<br />
Temperature<br />
4-501.110 Warewasher, Wash Sol.<br />
Temperature<br />
4-501.111 Warewashing, San. Water<br />
Temp.*<br />
4-501.112 Warewasher, San. Water Temp.<br />
4-501.113 Warewasher, Sanitization<br />
Pressure<br />
4-501.114 Chem.San.,<br />
Temp./pH/Concentr./Hard.*<br />
4-501.115 Chem.San., Detergent-Sanitizers<br />
4-501.116 Determining Chem.San.<br />
Concentration<br />
Utensil/Temperature/Pressure Measuring<br />
Device<br />
4-502.11 Good Repair and Calibration<br />
CLEANING OF EQUIPMENT AND<br />
UTENSILS<br />
Objective<br />
4-601.11 Clean Sight/Touch-No<br />
Accum/Encrust.*<br />
Frequency<br />
4-602.11 <strong>Food</strong>-Contact Surfaces and<br />
Utensils*<br />
4-602.13 Nonfood-Contact Surfaces<br />
SANITIZATION OF EQUIPMENT AND<br />
UTENSILS<br />
Objective<br />
4-702.11 Frequency-Be<strong>for</strong>e Use After<br />
Cleaning*<br />
4-703.11 Methods-Hot Water and<br />
Chemical*<br />
PROTECTION OF CLEAN ITEMS<br />
Drying<br />
4-901.11 Equipment and Utensils, Air-<br />
Drying<br />
4-901.12 Wiping Cloths, Air-Drying<br />
Lubricating and Reassembling<br />
4-902.11 <strong>Food</strong>-Contact Surfaces<br />
4-902.12 Equipment<br />
Storing<br />
4-903.11 Equip./Uten./Lin./Sing.-Ser/Use<br />
Art.<br />
4-903.12 Prohibitions<br />
Water, Plumbing, and Waste<br />
WATER<br />
Source<br />
5-101.11 Approved System*<br />
5-101.12 System Flushing and<br />
Disinfection*<br />
5-101.13 Bottled Drinking Water.*<br />
17
Quality<br />
5-102.11 Standards*<br />
5-102.12 Nondrinking Water*<br />
5-102.13 Sampling<br />
5-102.14 Sample Report<br />
Quantity and Availability<br />
5-103.11 Capacity*<br />
5-103.12 Pressure<br />
Distribution, Delivery, and Retention<br />
5-104.11 System<br />
5-104.12 Alternative Water Supply<br />
PLUMBING SYSTEM<br />
5-201.11 Materials, Approved*<br />
Design, Construction, and Installation<br />
5-202.11 Approved System/Cleanable<br />
Fixtures*<br />
5-202.12 Handwashing Facility, Installation<br />
Numbers and Capacities<br />
5-203.13 Service Sink<br />
5-203.14 Backflow Prevention Device<br />
REFUSE, RECYCLABLES, AND<br />
RETURNABLES<br />
Facilities on the Premises<br />
5-501.11 Outdoor Storage Surface<br />
5-501.12 Outdoor Enclosure<br />
5-501.13 Receptacles<br />
5-501.15 Outside Receptacles<br />
5-501.16 Areas-Receptacles,<br />
Capacity/Avail.<br />
5-501.17 Toilet Room Receptacle, Covered<br />
5-501.18 Cleaning Implements and<br />
Supplies<br />
5-501.19 Storage Areas and Units/Location<br />
5-501.110 Storing<br />
Refuse/Recyclables/Return.<br />
5-501.111 Areas/Enclosures/Receptacles,<br />
Repair<br />
5-501.112 Outside Storage Prohibitions<br />
5-501.113 Covering Receptacles<br />
5-501.114 Using Drain Plugs<br />
5-501.115 Maintaining Refuse<br />
Areas/Enclosures<br />
5-501.116 Cleaning Receptacles<br />
Removal<br />
5-502.11 Frequency<br />
5-502.12 Receptacles or Vehicles<br />
Facilities <strong>for</strong> Disposal/Recycling/Refilling<br />
5-503.11 Community or Individual Facility<br />
Physical Facilities<br />
MATERIALS FOR CONSTRUCTION<br />
AND REPAIR<br />
6-101.11 Indoors, Surface Characteristics<br />
6-102.11 Outdoors, Surface Characteristics<br />
DESIGN, CONSTRUCTION, AND<br />
INSTALLATION<br />
Cleanability<br />
6-201.11 Floors, Walls, and Ceilings<br />
6-201.12 Floors/Walls/Ceilings,Utility<br />
Lines<br />
6-201.13 Junctures, Coved/Enclosed/Sealed<br />
6-201.14 Carpeting,Restriction/Installation<br />
6-201.15 Floor Covering, Mats and<br />
Duckboards<br />
6-201.16 Wall, Ceiling, Coverings/Coatings<br />
6-201.17 Walls and Ceilings, Attachments<br />
6-201.18 Wall, Ceiling, Studs/Joists/Rafters<br />
Functionality<br />
6-202.11 Light Bulbs, Protective Shielding<br />
6-202.12 Ventilation System, Exhaust<br />
Vents<br />
6-202.13 Insect Contr. Dev., Design/Install.<br />
6-202.14 Toilet Rooms, Enclosed<br />
6-202.15 Outer Openings, Protected<br />
6-202.16 Exterior Walls/Roofs, Barriers<br />
6-202.19 Outdoor Walk/Drive Surfaces,<br />
Drained<br />
6-202.110 Outdoor Refuse Areas,<br />
Curbed/Drained<br />
NUMBERS AND CAPACITIES<br />
Handwashing Facilities<br />
6-301.11 Hand Cleanser, Available<br />
6-301.12 Hand Drying Provision<br />
6-301.13 Handwash Aids and Devices, Use<br />
Restrictions<br />
6-301.14 Handwashing Signage<br />
Toilets and Urinals<br />
6-302.11 Toilet Tissue, Availability<br />
6-303.11 Lighting, Intensity<br />
6-304.11 Ventilation, Mechanical<br />
6-305.11 Dressing Areas/Lockers,<br />
Designation<br />
LOCATION AND PLACEMENT<br />
6-402.11 Toilet Rooms,<br />
Convenient/Accessible<br />
6-403.11 Employee Accommodations,<br />
Designated<br />
6-404.11 Distressed Merchandise,<br />
Segregated<br />
MAINTENANCE AND OPERATION<br />
Premises/Fixtures - Methods<br />
6-501.11 Repairing<br />
6-501.12 Cleaning, Frequency/Restrictions<br />
6-501.13 Cleaning Floors, Dustless<br />
Methods<br />
6-501.14 Clean. Vent. Sys., Prev. Discharge<br />
6-501.15 Clean. Maint. Tools, Prev.<br />
Contam.*<br />
6-501.16 Drying Mops<br />
6-501.17 Floors - Absorbent Materials<br />
6-501.18 Maintaining/Using Handwashing<br />
Facilities<br />
6-501.19 Closing Toilet Room Doors<br />
6-501.110 Using Dressing Rooms and<br />
Lockers<br />
6-501.111 Controlling Pests*<br />
6-501.112 Removing Dead or Trapped Pests<br />
6-501.113 Storing Maintenance Tools<br />
6-501.114 Unnecessary Items and Litter<br />
6-501.115 Prohibiting Animals*<br />
Poisonous or Toxic Materials<br />
LABELING AND IDENTIFICATION<br />
Original Containers<br />
7-101.11 Identifying In<strong>for</strong>mation,<br />
Prominence*<br />
7-102.11 Working Containers, Common<br />
Name*<br />
OPERATIONAL SUPPLIES AND<br />
APPLICATIONS<br />
7-201.11 Storage, Separation*<br />
Presence and Use<br />
7-202.11 Restriction*<br />
7-202.12 Conditions of Use*<br />
Container Prohibitions<br />
7-203.11 Poisonous/Toxic Material<br />
Containers*<br />
Chemicals<br />
7-204.11 Sanitizers*<br />
7-204.12 Washing Fruits and Vegetables*<br />
7-204.13 Boiler Water Additives*<br />
7-204.14 Drying Agents*<br />
7-205.11 Lubricants, Incidental <strong>Food</strong><br />
Contact*<br />
Pesticides<br />
7-206.11 Restricted-Use, Criteria*<br />
7-206.12 Bait Stations*<br />
7-206.13 Tracking Powders*<br />
Medicines<br />
7-207.11 Restriction and Storage*<br />
7-207.12 Medicines, Refrigerated Storage*<br />
7-208.11 First Aid Supplies, Storage*<br />
7-209.11 Other Personal Care Items,<br />
Storage<br />
STOCK AND RETAIL SALE<br />
7-301.11 Storage and Display, Separation*<br />
<strong>Compliance</strong> and En<strong>for</strong>cement<br />
CODE APPLICABILITY<br />
Variances<br />
8-103.11 Documentation and Justification<br />
8-103.12 Con<strong>for</strong>mance with Procedures*<br />
PLAN SUBMISSION AND APPROVAL<br />
Facility and Operating Plans<br />
8-201.11 When Plans Are Required<br />
8-201.12 Contents of Plans/Specifications<br />
8-201.13 HACCP Plan/When Required<br />
8-201.14 Contents of a HACCP Plan<br />
INSPECTION AND CORRECTION OF<br />
VIOLATIONS<br />
Critical Violation<br />
8-405.11 Timely Correction<br />
Noncritical Violation<br />
8-406.11 Time Frame <strong>for</strong> Correctio<br />
18
HACCP SYSTEMS – BASIC COMPLIANCE CHECKLIST<br />
ESTABLISHMENT: PROCESS:<br />
PRODUCTS COVERED BY PROCESS:<br />
IMPLEMENTATION DATE: NEW PRODUCT: REASSESSMENT DATE:<br />
(Yearly; check <strong>for</strong> dated<br />
signature only)<br />
I – HAZARD ANALYSIS AND HACCP PLAN DEVELOPMENT<br />
REQUIREMENT YES<br />
(X)<br />
INITIAL HAZARD ANALYSIS<br />
The establishment has not conducted a hazard analysis or had a hazard<br />
analysis conducted <strong>for</strong> it.<br />
The hazard analysis does not include food safety hazards that are reasonably<br />
likely to occur in the production process, or<br />
does not identify the preventive measures the establishment can apply to<br />
those food safety hazard(s)<br />
The hazard analysis does not include a flow chart that describes (diagrams)<br />
the steps of each process and product flow in the establishment.<br />
The hazard analysis does not identify the intended use or consumers of<br />
finished product(s).<br />
INITIAL PLAN DEVELOPMENT<br />
The establishment’s hazard analysis revealed one or more food safety<br />
hazards that are reasonably likely to occur, and the establishment does not<br />
have a written HACCP plan <strong>for</strong> each of its products.<br />
The establishment has not conducted validation activities to determine that a<br />
HACCP plan is functioning as intended.<br />
The establishment’s record do not include: multiple results that verify the<br />
monitoring of CCPs and con<strong>for</strong>mance with critical limits, or after a deviation<br />
from a critical limit (if any), subsequent results that support the adequacy of<br />
corrective action(s) in achieving control at the CCP.<br />
SUBSEQUENT ANALYSIS AND PLAN DEVELOPMENT<br />
(HAZARD ANALYSIS REASSESSMENT)<br />
After an estabIishment hazard analysis revealed no food safety hazards that<br />
are reasonably likely to occur, there was a change that could reasonably affect<br />
whether a food safety hazard exists, the establishment did not reassess the<br />
adequacy of the hazard.<br />
(NEW PRODUCT)<br />
(1) Be<strong>for</strong>e producing new product <strong>for</strong> distribution, the establishment did not<br />
conduct a hazard analysis (or have a hazard analysis conducted <strong>for</strong> it) or did<br />
not have an applicable HACCP plan <strong>for</strong> the product.<br />
(2)The establishment began distributing a new product more than 90 days ago,<br />
and it has not validated the HACCP plan that covers the new product.<br />
19
HACCP SYSTEMS – BASIC COMPLIANCE CHECKLIST<br />
(continued)<br />
II – CONTENTS OF HACCP PLAN(S)<br />
REQUIREMENT YES<br />
(X)<br />
MULTIPLE PRODUCTS<br />
A HACCP plan covers more than one product and the products are not all<br />
similar.<br />
FOOD SAFETY HAZARD(S)<br />
The HACCP plan does not list the food safety hazard(s) identified in the hazard<br />
analysis.<br />
HAZARD CONTROL<br />
The HACCP plan does not list CCPs <strong>for</strong> each food safety hazard.<br />
The HACCP plan does not list critical limits to be met at each CCP.<br />
MONITORING<br />
The HACCP plan does not list the procedures to be used to monitor each CCP<br />
and the frequency with which these procedures will be per<strong>for</strong>med.<br />
CORRECTIVE ACTIONS<br />
The HACCP plan does not identify the corrective action to be followed in<br />
response to a deviation from a critical limit at a CCP.<br />
III – RECORDKEEPING<br />
REQUIREMENT YES<br />
(X)<br />
The HACCP plan’s record keeping system does not document the monitoring<br />
of CCPs and/or does not include records with the actual values and<br />
observations.<br />
IV – DATED SIGNATURE<br />
REQUIREMENT YES<br />
(X)<br />
ACCEPTANCE AND REASSESSMENT<br />
The responsible establishment official did not sign and date the HACCP plan<br />
(1) upon initial acceptance, or<br />
(2) at least annually thereafter upon required plan reassessment.<br />
MODIFICATION<br />
The HACCP plan was modified, and the responsible establishment official did<br />
not sign and date the plan.<br />
20