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MAKING THE FOOD PLANT INSPECTION
CHAPTER 20 MAKING THE FOOD PLANT INSPECTION The most important aspect of any food plant sanitation program is the detailed food plant inspection itself. The inspection must be made daily by the food plant sanitarian and at regularly specified intervals by the food plant sanitation committee. The inspection is visible evidence to all personnel that management cares about the sanitation of the plant and operation. All employee committees and/or quality circledteams should put sanitation on their regular meeting agenda and alert management to potential problems that they may observe. If consumer complaints should occur, the sanitarian and or the committee should thoroughly investigate the problems and take all necessary corrective actions immediately. The food plant inspection should follow a regular routine, that is, buildings, yards and premises; followed by thorough inspection of housekeeping practices including floors, walls, ceilings, lockers, eating and rest areas; and the detailed inspection of all equipment used in the actual processes. The inspection should start with receiving and follow through to the actual shipping of the finished merchandise. The inspection should involve all areas and the inspection report should be in writing with copies to the committee members and the firm’s top management. The inspection should be much more detailed than the plant survey report as suggested in Chapter 4. A government inspection follows much the same details as does the plant inspection. When the government inspector arrives, he or she should be given the same cordial welcome that the firm extends to any other plant visitor. After presenting appropriate credentials, the frrm should designate a persods), usually the QA Manager or the Sanitarian to accompany the official inspector on a plant inspection. Prior to the plant inspection, it
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is highly suggested that the firm’s official representative provide the official inspector a flow chart of the operation starting with incoming materials. Every firm should always be prepared for an official government inspection. The government inspectorb) is there to make certain that the firm is in compliance with the food laws and regulations. There should be no worry by the firm, if the firm’s regular inspection is in detail and all problem areas are in compliance with the rules and regulations to produce safe and sound quality foods. The government inspector may be there only to do a routine factory inspection, or make a directed inspection (concentrate on one particular aspect of the operation), or conduct a consumer complaint inspection, or follow up on a contaminated product recall inspection, and/or conduct the Good Manufacturing Practice inspection. In any case, the inspector is entitled to enter and inspect, at reasonable times, within reasonable limits, and in a reasonable manner, establishments where foods are manufactured, processed, packed or held. They may also inspect vehicles used to transport food in interstate commerce. The word “reasonable” may cause some concern, but it has been interpreted as during normal business hours or any time a firm is in operation. The depth of the inspection is often left to the discretion of the inspector and from experience the degree of cooperation may play a significant role in defining the details of the inspection. There are a number of suggestions that may prove wise for the firm to follow when handling a government inspection: (1)The only person that should speak with the inspector should be the firm’s designated representative. (2)The firm should have firm policies relative to the use of photographic and audio equipment, types of records to be disclosed, and details of operational aspects of the process. (3) Should violations be found, the details of handling corrective actions should be declared. (4) Also, whether or not there will be a need for a search warrant. These matters should all be clarified ahead of time, but the inspector should be so notified of the fwm’s policy prior to making the inspection. Most importantly, if the inspector takes samples, the firm’s representative should likewise take samples (I believe in taking twice the quantity that the inspector took with one-half for in-
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house analysis and the other half for 3rd party analysis after being notified of the violation from FDA's Analysis report). Lastly, upon completion of the inspection by the official representative, he must provide the firm with a written report (INe observed report) if violations were found during the inspection. Management should meet with the government representative and his designated representative to discuss any concerns or suspected violations and even though a Form 483 report is not filed, he should ask for a written statement of the inspector's findings. Further, to avoid claims and disputes that the inspector may have been denied access to given areas or information, management should ask "Did we fail to provide you with any information to which you believe you are legally entitled?" In some cases following the inspection, the inspector may follow up with an Establishment Inspection Report (EIR) setting forth in narrative form details of and about the firm along with his or her recommendations. Under the Freedom of Information Act (FOIA), a firm may request a copy of the EIR report along with other documents prepared by the inspector. These documents should be reviewed and along with the FDA Form 483 report, the firm should immediately correct any and all deviations noted on these reports as a follow up inspection may be forth coming. As stated above, if your house is in order all your products, equipment, facility, methods and personnel are in compliance, you should welcome the inspection as another pair of eyes may be helpful to know that you are doing a good job-two heads are always better than one. Following are questions developed, in part, from those questions established by FDA and NFPA relative to food plant inspections. These questions are somewhat generic and a given processor should use these as building blocks to develop sanitation questions or inspection review for hidher particular firm and operations by the Sanitation Committee. All questions should be reviewed at each meeting of the sanitation committee. All negative responses must be explained and they should immediately be corrected by management. The food plant sanitation committee should follow the inspection process according to a previously developed flow chart for the process and note any hazards and or critical control points not in compliance.
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With the availability of modern video recorders, a video of the full operation should be made at each inspection for use in the post inspection discussion by the committee and management. The sanitation committee should assign all questions that were answered negatively to designated personnel for correction. A time schedule for correcting the problem areas must be established with a follow through report of appropriate actions by the food plant sanitarian.
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FIGURE 20.1 The Inspection Must Include The Tops Of The Tanks, Pipe Lines, And General Facilities.
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OUTSIDE PREMISES ADJACENT PROPERTY, GROUNDS, BUILDINGS, AND PARKING LOTS 1. Are there potential sanitation problems around the premises or from adjacent properties? 2. Are the parking lots kept clean and free of waste? 3. Are the hedges kept trimmed and is there any trash in or around the hedges, garden areas, etc? 4. Is the trash removed from the premises daily and are the trash receptacles kept clean and closed?
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RECEIVING AND SHIPPING AREAS 1.Do we have purchase specifications on all incoming materials? 2. Are all incoming materials sampled according to acceptance
sampling plans and inspected before receipt? 3. Do the receipt forms indicate the supplier and the quantity delivered? 4. Are the raw materials delivered according to the specified times? 5. Is there any potential of contamination of raw materials following harvest, during shipping, or while in storage waiting for processing? 6. Are inspections made for potential contamination of raw materials? 7. What is done with products that do not meet specifications? 8. If pesticides are used on raw materials, do we have records of what was applied, when it was applied, how it was applied, and what sampling and testing is completed on raw materials before receiving them in house? 9. Are stored raw materials in-house held according to recommended storage times and temperatures for each specific item? 10. Can we identify our finished products according to given lots of raw materials? 11. Is the receiving area kept clean and in satisfactory condition? 12. Is there any evidence of insects, birds, or rodent activity in the receiving areas?
RAW MATERIAL HANDLING AND STORAGE PRACTICES 1. Is there any evidence for potential contamination of raw materials by present handling methods? 2. Are flumes, conveyors, and dumping equipment free from any molds, slime, yeast, or other microbial agents? 3.If water is used in the handling of raw materials, is the water reused? If so, what checks are made on this to be certain that it is kept clean? Is there a specified chlorine residual maintained on water used for handling raw materials?
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4. If detergents are used in the flume water, is a given residual maintained and what records are kept? 5. Are emptied containers washed before returning to the field after each use? 6. Are spray washers and washing equipment maintained in good operating conditions? 7. What records are kept on washing practices, that is, water pressures, flow rates, water temperature, residual chlorine levels, and detergent residues? HANDLING OTHER INGREDIENTS 1. Do we have purchase specifications and guarantees on all other ingredients? 2. Do we have records according to suppliers as to delivery dates, quality, and quantity? 3. Are all ingredients sampled according to acceptance sampling methods and analyzed for compliance with specifications? 4. What happens to ingredients that do not meet specifications? 5. Are all ingredients handled and stored according to acceptable conditions of time, temperature, relative humidity, light, etc.? 6. Are any rodent proofing materials, insecticides, or other pesticides used in the storage areas and what records are kept on pesticide usage? 7.Are storage areas fumigated and, if so, is the application done according to accepted practices at specified dosage levels? What records are maintained on any practices used for fumigation? 8. Are outside pest control operators used? If so, what records are kept on their activities?
9. What cleaning schedule is used for ingredient storage areas
and is this maintained? 10. Do we use the practice of First In, First Out with ingredients? 11. What happens to any spilled ingredients in the warehouse? 12. Are all ingredient containers cleaned before removal of ingredients?
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PRODUCT PREPARATION 1. Do we have adequate control on all preparation unit operations that have a bearing on the safety and sanitation quality of all materials in process? This includes storage time and temperature, removal of foreign substances, adequate washing and sorting, removal of any detergent residues, and the further contamination protection of all raw materials. 2. Are all unit operations checked for cleanliness before the start of shift operations? 3. Are all production rates compatible with equipment capacity? 4. Do we use in-plant chlorination? If so, what checks are made on the residuals and at what frequency? 5. Are any holding periods used in the preparation areas? If so, what controls are in place for assurance of retention of product quality? 6. What quality assurance controls are in place on each unit operation in the preparation area? 7. Do we have a clean-up schedule and procedure for each piece of equipment in the process? 8. What sampling schedule and what quality control practices are used for assuring the quality of the product during the production run?
FILLING 1. Are all empty containers accepted on the basis of acceptance sampling practices and are empty containers cleaned before filling? What records are maintained on empty containers? 2. Do we have fill specifications including temperatures for all containers by size? 3. Are all fill weight records kept and charted on a regular basis? 4. Are filled containers evaluated on a regular basis for integrity of closures? 5. Are all empty containers removed from the production line during shutdowns? 6. Are fillers and closure machines and handling equipment kept in good sanitary conditions at all times?
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7. Are all containers properly coded as to a given scheme to identify commodity, type, style, size, quality, date, shift, line, plant, etc. 8. Are records maintained of filler temperature, initial temperature (IT), code, and quality per container size, style, product, by date, line, filler, etc. by products in process? 9. Are records maintained of container inspection, tear down, and integrity of closure? PROCESSING OPERATIONS
1. Are all processing systems in compliance with "Current Good Manufacturing Practices"? 2. Are the operators certified by an approved school? 3. Are all processing times and temperatures and venting schedule posted in the processing areas for each product by style and container size? 4. Are all recorders in good working order and properly used? Are the records properly filed? 5. Are products cooled according to given schedules? Is chlorine used in the cooling water? Is there a chlorine residual maintained in the cooling water? WAREHOUSING 1.Are proper temperatures and humidities maintained throughout the warehouse? 2. Is the warehouse maintained in according to Current G o d Manufacturing Practices at all times? 3. Are doors and entry ways kept closed when not in use? 4. If air curtains, insect screens or other precautions are used, are they properly maintained and doing the job intended? 5. Are all products stored 6 inches off the floor and 18 inches away from walls? 6. Are all shipping vehicles inspected before loading and are they maintained in sanitary conditions? 7. Is there any refuse or spilled products in the warehouse or shipping areas? If so, what practice is used to remove or clean-up these areas?
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CLEAN-UP PROCEDURES
1. Do we have written clean up procedures and manuals available for all cleaning personnel? Are these manuals used by cleaning personnel? 2. Are cleaning agents available to the clean-up personnel and have they been trained in how to use these chemical agents? Do they know where the MSDS sheets are and are these available to authorized users? 3. Does the cleaning supervisor have check lists for the evaluation of adequacy of cleaning each unit operations and the total facility? Who audits this check list? 4. Do cleaning personnel have sufficient time and training to keep the plant clean? Every firm should develop questions that are suitable to their operation and they should use these to make their own inspection rather than wait for an official inspection that could prove costly. Inspections are a must in the food industry and they must be accomplished on a regularly scheduled basis with complete and thorough follow through to assure that the plant is clean and safe at all times. REFERENCES Anon. Do Your Own Establishment Inspection. U. 9. Department Of Health and Human Services. HHS Publi. No.(FDA) 82-2163. Bryan, Frank L. 1974 MicrobiologicalFood Hazards today-Based on Epidemiological Information. Food Technology Sept. 69-84. Corlett, Donald A. Jr. 1989. Refrigerated Foods and Use of Hazard Analysis and Critical Control Point Principles. Food Technology. February 91-94. Gould, Wilbur A. 1980. Good Manufacturing Practices for Snack Food Manufacturers. Snack Food Association, Alexandria, VA. Ito, Keith. 1974. Microbiological Critical Control Points in Canned Foods. Food Technology Sept. 46-47. Kauffman, F. Leo. 1974 How FDA Uses HACCP. Food Technology Sept. 61-62. Peterson, A. C. and R. E. Gunnerson. Microbiological Critical Control Points in Frozen Foods. Food Technology Sept. 37-44. Somers, Ira I. 1973 FDA-HACCP Inspection, Suggestions for the Canner. NCA Bull. 36 L. Washington, D. C.
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is highly suggested that the firm’s official representative provide the official inspector a flow chart of the operation starting with incoming materials. Every firm should always be prepared for an official government inspection. The government inspectorb) is there to make certain that the firm is in compliance with the food laws and regulations. There should be no worry by the firm, if the firm’s regular inspection is in detail and all problem areas are in compliance with the rules and regulations to produce safe and sound quality foods. The government inspector may be there only to do a routine factory inspection, or make a directed inspection (concentrate on one particular aspect of the operation), or conduct a consumer complaint inspection, or follow up on a contaminated product recall inspection, and/or conduct the Good Manufacturing Practice inspection. In any case, the inspector is entitled to enter and inspect, at reasonable times, within reasonable limits, and in a reasonable manner, establishments where foods are manufactured, processed, packed or held. They may also inspect vehicles used to transport food in interstate commerce. The word “reasonable” may cause some concern, but it has been interpreted as during normal business hours or any time a firm is in operation. The depth of the inspection is often left to the discretion of the inspector and from experience the degree of cooperation may play a significant role in defining the details of the inspection. There are a number of suggestions that may prove wise for the firm to follow when handling a government inspection: (1)The only person that should speak with the inspector should be the firm’s designated representative. (2)The firm should have firm policies relative to the use of photographic and audio equipment, types of records to be disclosed, and details of operational aspects of the process. (3) Should violations be found, the details of handling corrective actions should be declared. (4) Also, whether or not there will be a need for a search warrant. These matters should all be clarified ahead of time, but the inspector should be so notified of the fwm’s policy prior to making the inspection. Most importantly, if the inspector takes samples, the firm’s representative should likewise take samples (I believe in taking twice the quantity that the inspector took with one-half for in-
MAKING THE FOOD PLANT INSPECTION
25 1
house analysis and the other half for 3rd party analysis after being notified of the violation from FDA's Analysis report). Lastly, upon completion of the inspection by the official representative, he must provide the firm with a written report (INe observed report) if violations were found during the inspection. Management should meet with the government representative and his designated representative to discuss any concerns or suspected violations and even though a Form 483 report is not filed, he should ask for a written statement of the inspector's findings. Further, to avoid claims and disputes that the inspector may have been denied access to given areas or information, management should ask "Did we fail to provide you with any information to which you believe you are legally entitled?" In some cases following the inspection, the inspector may follow up with an Establishment Inspection Report (EIR) setting forth in narrative form details of and about the firm along with his or her recommendations. Under the Freedom of Information Act (FOIA), a firm may request a copy of the EIR report along with other documents prepared by the inspector. These documents should be reviewed and along with the FDA Form 483 report, the firm should immediately correct any and all deviations noted on these reports as a follow up inspection may be forth coming. As stated above, if your house is in order all your products, equipment, facility, methods and personnel are in compliance, you should welcome the inspection as another pair of eyes may be helpful to know that you are doing a good job-two heads are always better than one. Following are questions developed, in part, from those questions established by FDA and NFPA relative to food plant inspections. These questions are somewhat generic and a given processor should use these as building blocks to develop sanitation questions or inspection review for hidher particular firm and operations by the Sanitation Committee. All questions should be reviewed at each meeting of the sanitation committee. All negative responses must be explained and they should immediately be corrected by management. The food plant sanitation committee should follow the inspection process according to a previously developed flow chart for the process and note any hazards and or critical control points not in compliance.
252
CGMP’SE’OOD PLANT SANITATION
With the availability of modern video recorders, a video of the full operation should be made at each inspection for use in the post inspection discussion by the committee and management. The sanitation committee should assign all questions that were answered negatively to designated personnel for correction. A time schedule for correcting the problem areas must be established with a follow through report of appropriate actions by the food plant sanitarian.
-
FIGURE 20.1 The Inspection Must Include The Tops Of The Tanks, Pipe Lines, And General Facilities.
-
OUTSIDE PREMISES ADJACENT PROPERTY, GROUNDS, BUILDINGS, AND PARKING LOTS 1. Are there potential sanitation problems around the premises or from adjacent properties? 2. Are the parking lots kept clean and free of waste? 3. Are the hedges kept trimmed and is there any trash in or around the hedges, garden areas, etc? 4. Is the trash removed from the premises daily and are the trash receptacles kept clean and closed?
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RECEIVING AND SHIPPING AREAS 1.Do we have purchase specifications on all incoming materials? 2. Are all incoming materials sampled according to acceptance
sampling plans and inspected before receipt? 3. Do the receipt forms indicate the supplier and the quantity delivered? 4. Are the raw materials delivered according to the specified times? 5. Is there any potential of contamination of raw materials following harvest, during shipping, or while in storage waiting for processing? 6. Are inspections made for potential contamination of raw materials? 7. What is done with products that do not meet specifications? 8. If pesticides are used on raw materials, do we have records of what was applied, when it was applied, how it was applied, and what sampling and testing is completed on raw materials before receiving them in house? 9. Are stored raw materials in-house held according to recommended storage times and temperatures for each specific item? 10. Can we identify our finished products according to given lots of raw materials? 11. Is the receiving area kept clean and in satisfactory condition? 12. Is there any evidence of insects, birds, or rodent activity in the receiving areas?
RAW MATERIAL HANDLING AND STORAGE PRACTICES 1. Is there any evidence for potential contamination of raw materials by present handling methods? 2. Are flumes, conveyors, and dumping equipment free from any molds, slime, yeast, or other microbial agents? 3.If water is used in the handling of raw materials, is the water reused? If so, what checks are made on this to be certain that it is kept clean? Is there a specified chlorine residual maintained on water used for handling raw materials?
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4. If detergents are used in the flume water, is a given residual maintained and what records are kept? 5. Are emptied containers washed before returning to the field after each use? 6. Are spray washers and washing equipment maintained in good operating conditions? 7. What records are kept on washing practices, that is, water pressures, flow rates, water temperature, residual chlorine levels, and detergent residues? HANDLING OTHER INGREDIENTS 1. Do we have purchase specifications and guarantees on all other ingredients? 2. Do we have records according to suppliers as to delivery dates, quality, and quantity? 3. Are all ingredients sampled according to acceptance sampling methods and analyzed for compliance with specifications? 4. What happens to ingredients that do not meet specifications? 5. Are all ingredients handled and stored according to acceptable conditions of time, temperature, relative humidity, light, etc.? 6. Are any rodent proofing materials, insecticides, or other pesticides used in the storage areas and what records are kept on pesticide usage? 7.Are storage areas fumigated and, if so, is the application done according to accepted practices at specified dosage levels? What records are maintained on any practices used for fumigation? 8. Are outside pest control operators used? If so, what records are kept on their activities?
9. What cleaning schedule is used for ingredient storage areas
and is this maintained? 10. Do we use the practice of First In, First Out with ingredients? 11. What happens to any spilled ingredients in the warehouse? 12. Are all ingredient containers cleaned before removal of ingredients?
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PRODUCT PREPARATION 1. Do we have adequate control on all preparation unit operations that have a bearing on the safety and sanitation quality of all materials in process? This includes storage time and temperature, removal of foreign substances, adequate washing and sorting, removal of any detergent residues, and the further contamination protection of all raw materials. 2. Are all unit operations checked for cleanliness before the start of shift operations? 3. Are all production rates compatible with equipment capacity? 4. Do we use in-plant chlorination? If so, what checks are made on the residuals and at what frequency? 5. Are any holding periods used in the preparation areas? If so, what controls are in place for assurance of retention of product quality? 6. What quality assurance controls are in place on each unit operation in the preparation area? 7. Do we have a clean-up schedule and procedure for each piece of equipment in the process? 8. What sampling schedule and what quality control practices are used for assuring the quality of the product during the production run?
FILLING 1. Are all empty containers accepted on the basis of acceptance sampling practices and are empty containers cleaned before filling? What records are maintained on empty containers? 2. Do we have fill specifications including temperatures for all containers by size? 3. Are all fill weight records kept and charted on a regular basis? 4. Are filled containers evaluated on a regular basis for integrity of closures? 5. Are all empty containers removed from the production line during shutdowns? 6. Are fillers and closure machines and handling equipment kept in good sanitary conditions at all times?
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7. Are all containers properly coded as to a given scheme to identify commodity, type, style, size, quality, date, shift, line, plant, etc. 8. Are records maintained of filler temperature, initial temperature (IT), code, and quality per container size, style, product, by date, line, filler, etc. by products in process? 9. Are records maintained of container inspection, tear down, and integrity of closure? PROCESSING OPERATIONS
1. Are all processing systems in compliance with "Current Good Manufacturing Practices"? 2. Are the operators certified by an approved school? 3. Are all processing times and temperatures and venting schedule posted in the processing areas for each product by style and container size? 4. Are all recorders in good working order and properly used? Are the records properly filed? 5. Are products cooled according to given schedules? Is chlorine used in the cooling water? Is there a chlorine residual maintained in the cooling water? WAREHOUSING 1.Are proper temperatures and humidities maintained throughout the warehouse? 2. Is the warehouse maintained in according to Current G o d Manufacturing Practices at all times? 3. Are doors and entry ways kept closed when not in use? 4. If air curtains, insect screens or other precautions are used, are they properly maintained and doing the job intended? 5. Are all products stored 6 inches off the floor and 18 inches away from walls? 6. Are all shipping vehicles inspected before loading and are they maintained in sanitary conditions? 7. Is there any refuse or spilled products in the warehouse or shipping areas? If so, what practice is used to remove or clean-up these areas?
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CLEAN-UP PROCEDURES
1. Do we have written clean up procedures and manuals available for all cleaning personnel? Are these manuals used by cleaning personnel? 2. Are cleaning agents available to the clean-up personnel and have they been trained in how to use these chemical agents? Do they know where the MSDS sheets are and are these available to authorized users? 3. Does the cleaning supervisor have check lists for the evaluation of adequacy of cleaning each unit operations and the total facility? Who audits this check list? 4. Do cleaning personnel have sufficient time and training to keep the plant clean? Every firm should develop questions that are suitable to their operation and they should use these to make their own inspection rather than wait for an official inspection that could prove costly. Inspections are a must in the food industry and they must be accomplished on a regularly scheduled basis with complete and thorough follow through to assure that the plant is clean and safe at all times. REFERENCES Anon. Do Your Own Establishment Inspection. U. 9. Department Of Health and Human Services. HHS Publi. No.(FDA) 82-2163. Bryan, Frank L. 1974 MicrobiologicalFood Hazards today-Based on Epidemiological Information. Food Technology Sept. 69-84. Corlett, Donald A. Jr. 1989. Refrigerated Foods and Use of Hazard Analysis and Critical Control Point Principles. Food Technology. February 91-94. Gould, Wilbur A. 1980. Good Manufacturing Practices for Snack Food Manufacturers. Snack Food Association, Alexandria, VA. Ito, Keith. 1974. Microbiological Critical Control Points in Canned Foods. Food Technology Sept. 46-47. Kauffman, F. Leo. 1974 How FDA Uses HACCP. Food Technology Sept. 61-62. Peterson, A. C. and R. E. Gunnerson. Microbiological Critical Control Points in Frozen Foods. Food Technology Sept. 37-44. Somers, Ira I. 1973 FDA-HACCP Inspection, Suggestions for the Canner. NCA Bull. 36 L. Washington, D. C.