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______________________________________________________________ Slaughter/Processing Questionnaire Initials____ Date______ AUDIT CHECKLIST FOR SLAUGHTER/PROCESSING QUESTIONNAIRE For each question and request, verify that the information presented by Costa Rica is correct. If correct, check the yes block. If not correct, check the no block. If you checked the no block, please state what you found and any public health concerns. If you need more room, please continue on the back of the checklist and initial and date your entry. If you are not responsible for auditing information of a particular question, write “Not Applicable”. Please sign and date the checklist when you have completed your audit. Please initial and date each page. A. Program Organization 1. For each of the products under this application, what governmental agencies enforce the relevant laws and regulations relating to the testing, approval, and control of: (a) additives (including the use of irradiation), (b) packaging materials, (c) nonfood compounds, (d) residues, and (e) slaughter/processing requirements (canning, de-boning, grinding, etc.)? Include organizational charts for each of these agencies. ___YES ___NO 2. What is the functional relationship among these government agencies and between these agencies and any separate activities at state, provincial, or local levels? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 2 Slaughter/Processing Questionnaire Initials____ Date______ 3. What personnel, training, equipment/resources, and other facilities are utilized to enforce and fulfill the responsibilities of the meat and/or poultry inspection system regarding: (a) additives (including the use of irradiation), (b) packaging materials, (c) nonfood compounds, (d) residues, and (e) slaughter/processing requirements (canning, de-boning, grinding, etc.) for each of the products under this application? ___YES ___NO 4. Within the Meat and Poultry Inspection Program, who is responsible for setting and implementing microbial guidelines in the products produced? ___YES ___NO B. Additives 1. What authority determines if food additives are safe for human consumption? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 3 Slaughter/Processing Questionnaire Initials____ Date______ 2. What authority exists for enforcing and controlling the level and use of additives, including the use of irradiation, in meat and/or poultry products? ___YES ___NO 3. What are the permitted additives for meat and/or poultry and what are the allowable tolerances and limits for each additive? (Provide a comparison between your country and what is allowable in the United States.) ___YES ___NO 4. What controls are in place in establishments to ensure that only additives approved for use in meat and poultry establishments in the United States are used and that respective the United States tolerances and limits for each additive are not exceeded? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 4 Slaughter/Processing Questionnaire Initials____ Date______ 5. What are the testing frequencies and laboratory testing procedures used to test meat and/or poultry products and their ingredients for additives? (Provide a list of the additives that are tested for each applicable product or ingredient.) ___YES ___NO 6. What type of laboratory facility is used for the analyses (private, government, or company) of additives? ___YES ___NO 7. How are test results reported? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 5 Slaughter/Processing Questionnaire Initials____ Date______ Who receives these reports when allowable tolerances are exceeded? What preventative and corrective actions are taken to resolve problems revealed by test results? ___YES ___NO 8. How is the purity of additives determined and verified? ___YES ___NO Who sets the standards and what are the analytical methods used? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 6 Slaughter/Processing Questionnaire Initials____ Date______ Does the supplier certify, in writing, that a particular standard of purity is being met? ___YES ___NO C. Control of Packaging Materials 1. What laws and regulations control the adequacy and use of primary and secondary packaging materials as acceptable for use with product prepared for consumption in the United States? ___YES ___NO What part of the government is responsible for implementing and maintaining the United States, or equivalent, standards? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 7 Slaughter/Processing Questionnaire Initials____ Date______ 2. What procedures, tests, and/or criteria are used to determine material and chemical acceptability and to ensure that only authorized and approved packaging materials are used in each exporting establishment? ___YES ___NO 3. To what extent are manufacturers required to guarantee the composition of the packaging material they manufacture? ___YES ___NO 4. How are exporting establishments kept abreast of the current list of approved packaging materials and manufacturers? How often is the list updated? ___YES ___NO ______________________________________________________________ 8 Slaughter/Processing Questionnaire Initials____ Date______ D. Control of Nonfood Compounds 1. What laws and regulations control the use of nonfood compounds (such as cleaning/sanitizing compounds and pesticides) in establishments where the food products under this application are prepared for consumption in the United States? ___YES ___NO 2. What are the procedures used for approving nonfood compounds and how does the government ensure that only approved nonfood compounds are received and used in each establishment exporting to the United States? ___YES ___NO 3. To what extent are manufacturers required to guarantee the composition and/or strength of the nonfood compounds they manufacture? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 9 Slaughter/Processing Questionnaire Initials____ Date______ 3. How are exporting establishments advised of recently approved (or unapproved) nonfood compounds and manufacturers? ___YES ___NO Is an updated list or notice provided and how often is the list or notice updated? ___YES ___NO E. Processing Requirements (Canning, Deboning, Grinding, etc.) 1. What is the organizational name, function, responsibility, and authority of those responsible for approving the formulations, methods of preparation, and product standards of processed products, including thermally processed products? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 10 Slaughter/Processing Questionnaire Initials____ Date______ 2. What is the approval process for thermal and other processing procedures/activities (schedules) that require government approval? What documentation formally states that a thermal, or other, processing schedule is approved? ___YES ___NO 3. Where applicable, how do you verify that specific and/or approved processing schedules and/or procedures are being followed? How often are records reviewed and how are process deviations handled? ___YES ___NO 4. Where applicable, what are the requirements to ensure that rigid, and other, product containers are properly closed and/or sealed? Is lead solder used in can seams? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 11 Slaughter/Processing Questionnaire Initials____ Date______ 5. What are the requirements and procedures to ensure that thermal, dry cured, or other processing systems are properly constructed, instrumented, and operated? ___YES ___NO 6. What are the record-keeping requirements to document the adequacy of each approved process. What records ensure the adequacy of other critical control factors in thermal, or other, processing operations? ___YES ___NO 7. What are the food processing standards for processing meat and poultry products to render them shelf-stable? What are the allowable limits for pH and Aw? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 12 Slaughter/Processing Questionnaire Initials____ Date______ 8. What are the procedures used to incubate cans, pouches, or their equivalent from lots of shelf-stable processed products prior to shipping and/or during shipping? ___YES ___NO 9. What are the standards for non-retorted foods that do not require refrigeration? ___YES ___NO 10. What are the refrigerated storage standards for products requiring refrigeration? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 13 Slaughter/Processing Questionnaire Initials____ Date______ F. Testing/Monitoring Programs 1. What microbiological monitoring programs cover applicable meat and poultry products. ___YES ___NO Describe these programs in detail and provide examples of the data that is recorded. ___YES ___NO How is the data used/analyzed? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 14 Slaughter/Processing Questionnaire Initials____ Date______ 2. How are microbial guidelines and monitoring programs used as a measure of effective sanitation? ___YES ___NO Specify what guidelines or programs apply to each product under this application. Describe guidelines not covered in 1. above. ___YES ___NO 3. What other (non-microbiological) monitoring procedures are used to ensure the proper preparation, processing, and handling of product, e.g., the incubation of cans or pouches of shelf stable processed products prior to shipping and/or during shipping? ___YES ___NO ______________________________________________________________ 15 Slaughter/Processing Questionnaire Initials____ Date______ 4. For each of the products under this application, what procedures do you follow for analyzing can or container defects, e.g., how are lots of shelf stable product examined for “condition of container” prior to shipping? ___YES ___NO 5. What are the criteria for “Potable” water? ___YES ___NO What requirements do you have for ensuring that potable water is used during the canning and processing of meat and poultry products? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 16 Slaughter/Processing Questionnaire Initials____ Date______ What requirements do you have for the water used to clean and rinse processing equipment? ___YES ___NO 6. How are privately owned laboratories involved in microbiologic testing to determine and/or monitor the compliance meat and poultry of products? ___YES ___NO 7. For the testing and monitoring programs stated above, what procedures or guidelines are used when corrective actions are required? What are the action levels for these programs? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 17 Slaughter/Processing Questionnaire Initials____ Date______ 8. For each product, how many samples are analyzed per year for microbiologic characteristics, pathogens, and foreign particle contamination before, during, and after processing under each testing program? Describe the statistical analysis used to determine the frequency and type of sample taken. Provide a copy of at least one full year’s data (from current year) from each program. ___YES ___NO 9. For each microbiologic characteristic that is not part of a routine, on-going sampling program, how many samples are analyzed per year and how are the results reported? Provide a summary of most recent full year’s data. ___YES ___NO G. Laboratories 1. How many laboratories are used to perform microbiologic testing? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 18 Slaughter/Processing Questionnaire Initials____ Date______ For each laboratory, indicate whether it is a federal, private, or ‘other’ type of laboratory and describe the tests that are performed there. ___YES ___NO 2. Is each laboratory approved to perform applicable microbiologic testing? What is the approval process? ___YES ___NO 3. What are the requirements and qualifications of the microbiology supervisor and of the bench microbiologist? If you have a microbiology staff at headquarters, describe and list their functions and responsibilities. ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 19 Slaughter/Processing Questionnaire Initials____ Date______ 4. Are standardized analytical methods used in the laboratories? ___YES ___NO Are the analytical methods AOAC approved or internationally recognized? ___YES ___NO Describe the microbiologic procedures/methods and provide a copy of the worksheets that are used. ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 20 Slaughter/Processing Questionnaire Initials____ Date______ 5. How do the quality control or quality assurance programs in approved laboratories ensure accurate and consistent analyses? ___YES ___NO Describe how the government ensures that the programs produce accurate results and provide examples of the data obtained from this program. ___YES ___NO 6. If applicable, how does the government ensure that the results of analyses performed at privately owned laboratories are accurate? ___YES ___NO ______________________________________________________________ ______________________________________________________________ 21 Slaughter/Processing Questionnaire Initials____ Date______ H. Control of Non-compliant Product 1. What procedures and instructions do you follow for the control and disposition of product that does not comply with the United States, or equivalent, standards? ___YES ___NO 2. If applicable, who authorizes the reprocessing of non-compliant product and how is the integrity of the product maintained? ___YES ___NO 3. What procedures do you follow to certify acceptable products or re-certify previously non-compliant products for export? ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 22 Slaughter/Processing Questionnaire Initials____ Date______ 4. What tests are performed and what do you do with the results when cans and other product containers are submitted to a laboratory because they are swollen or otherwise defective? ___YES ___NO 5. What are the procedures for investigating consumer complaints or consignor/ consignee complaints? ___YES ___NO 6. What actions are taken to protect the United States and other consumers when violative product has already left the processing establishment? Provide a copy of the directives and procedures used for recalling product. ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 23 Slaughter/Processing Questionnaire Initials____ Date______ I. Generic Escherichia coli (E. coli) Testing 1. What are the laws, regulations, and official directives that mandate that export establishments validate their process controls through microbiological testing during slaughter operations to prevent fecal contamination? The program documents must describe and mandate that the program will: a) be supported by analytical test results, nationwide microbiological baseline surveys and other scientific data. ___YES ___NO b) identify sample sites, frequency of sampling, and sampling techniques. ___YES ___NO c) use approved analytical methods. ___YES ___NO ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 24 Slaughter/Processing Questionnaire Initials____ Date______ d) require the use of reputable laboratories which adhere to quality control/quality assurance programs. ___YES ___NO e) require that results be recorded and used to control fecal contamination by the establishment. ___YES ___NO 2. What are the laws, regulations, and official directives that mandate an effective enforcement program? The program documents must describe and mandate that: a) establishments take action to prevent product contamination and take corrective action when contaminated product is found. ___YES ___NO ______________________________________________________________ ______________________________________________________________ 25 Slaughter/Processing Questionnaire Initials____ Date______ b) the foreign inspection system takes effective enforcement action, including suspension and withdrawal of inspection of those establishments which fail to control fecal contamination or fail to take corrective actions based on the results of the establishment’s microbiological testing program. ___YES ___NO J. HACCP Plans 1. How does the government inspection system describe, specify, and mandate a system whereby meat and poultry establishments must identify and evaluate the food safety hazards that can affect the safety of their products, institute controls necessary to prevent those hazards from occurring or keeping them within acceptable limits, monitor the performance of controls, and maintain records routinely? How is this system firmly established in the government’s requisite laws and regulations? ___YES ___NO ______________________________________________________________ 26 Slaughter/Processing Questionnaire Initials____ Date______ 2. How does the government inspection system verify the effectiveness of processes and process controls designed to ensure food safety? How does the government inspection system ensure that the government will: a) carry out a general review of establishment plans to identify, evaluate, and prevent food safety hazards? ___YES ___NO b) continuously verify establishment production, processes, and controls? ___YES ___NO 3. How does the government inspection system ensure an effective enforcement program? How does the government enforcement program ensure that: ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ 27 Slaughter/Processing Questionnaire Initials____ Date______ a) the establishments take action to correct process deviations that result in food safety hazards, determine how non-compliant product would be handled, ensure that no safety hazards exist after the corrective actions are taken, and define measures to prevent recurrence? ___YES ___NO b) the appropriate government regulatory agency takes effective enforcement actions, as required; including suspension, withdrawal of inspection, and, in the case of falsification of records, criminal prosecution? ___YES ___NO OTHER COMMENTS: ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ ________________________________ __________________________________ __________________________________ 28 Slaughter/Processing Questionnaire Initials____ Date______ (NAME OF AUDITOR) (SIGNATURE OF AUDITOR) (DATE)
