Sanitation SSOPs

1. Sanitation SSOPs

2. Sanitation Purpose Importance Not only safety Increase shelf-life Also address facilities, equipment design, and other issues Sanitation will control many chemical, physical and biological problems. Usually these are minor and are not addressed in HACCP plan Example Hygienic Practices Less significant items can be left out of HACCP plan only after there is assurance that sanitation and other support programs are effective Good sanitation � Increase in product quality an shelf-life as well as safetySanitation will control many chemical, physical and biological problems. Usually these are minor and are not addressed in HACCP plan Example Hygienic Practices Less significant items can be left out of HACCP plan only after there is assurance that sanitation and other support programs are effective Good sanitation � Increase in product quality an shelf-life as well as safety

3. What is Sanitation? Just equipment clean up?? Regulatory Requirements USDA-FSIS FDA SSOPs Important �pre-requisite� program Sanitation- Not just cleaning equipment. Also includes personnel practices, all facilities, equipment design, pest control and warehousing Regulations � USDA/FSIS Requires written SSOPs. These are recommended by FDA Detailed written procedures for sanitationSanitation- Not just cleaning equipment. Also includes personnel practices, all facilities, equipment design, pest control and warehousing Regulations � USDA/FSIS Requires written SSOPs. These are recommended by FDA Detailed written procedures for sanitation

4. Regulatory Requirements - SSOPs Meat and Poultry 9 CFR 416 � SSOPs Detailed Daily Procedures Monitor Sign and Date Must Address facilities, equipment and utensils Must define frequency Must identify person responsible for procedure 21 CFR 110 - FDA 21 CFR 123 � Fish an Fishery Products 9 CFR 308 and 381 � Meat and Poultry Meat and Poultry SSOPs Description of all procedures that will be conducted daily, before and during operations, that are sufficient to prevent direct contamination or adulteration of Products. Each establishment must monitor daily the implementation of all SSOP procedures. Must Sign and Date by individual with overall on-site authority or by higher level company official Procedures that are to be conducted prior to operations must be identified as such and must, at a minimum, address the cleaning of food contact surfaces of facilities, equipment, utensils. Each establishment must ensure that all pre-operational procedures are performed before the start of operations. Frequency must be identified � each procedure, employee responsible for conducting21 CFR 110 - FDA 21 CFR 123 � Fish an Fishery Products 9 CFR 308 and 381 � Meat and Poultry Meat and Poultry SSOPs Description of all procedures that will be conducted daily, before and during operations, that are sufficient to prevent direct contamination or adulteration of Products. Each establishment must monitor daily the implementation of all SSOP procedures. Must Sign and Date by individual with overall on-site authority or by higher level company official Procedures that are to be conducted prior to operations must be identified as such and must, at a minimum, address the cleaning of food contact surfaces of facilities, equipment, utensils. Each establishment must ensure that all pre-operational procedures are performed before the start of operations. Frequency must be identified � each procedure, employee responsible for conducting

5. Other SSOPS Requirements Maintenance Corrective Actions Recordkeeping Agency Verification Maintenance � routine evaluation to determine effectiveness in preventing contamination � revise as necessary Corrective Actions � Must be taken when the SSOP fails to prevent contamination. Must include procedures of how to dispose of adulterated product and how to re-establish sanitary conditions, how to prevent recurrence, re-evaluation and modification if necessary Recordkeeping Daily records must be maintained to document implementation, monitoring and corrective actions. Must be initialed and dated. Keep 48 h on site and then off site for 6 m. Agency Verification FSIS must verify the adequacy and effectiveness of the SSOPs. Record review, Direct observations of procedures, direct observation of testingMaintenance � routine evaluation to determine effectiveness in preventing contamination � revise as necessary Corrective Actions � Must be taken when the SSOP fails to prevent contamination. Must include procedures of how to dispose of adulterated product and how to re-establish sanitary conditions, how to prevent recurrence, re-evaluation and modification if necessary Recordkeeping Daily records must be maintained to document implementation, monitoring and corrective actions. Must be initialed and dated. Keep 48 h on site and then off site for 6 m. Agency Verification FSIS must verify the adequacy and effectiveness of the SSOPs. Record review, Direct observations of procedures, direct observation of testing

6. Developing SSOPs Appendix A and B Pre-Operational Sanitation Operational Sanitation Appendix A, Guidelines for Developing a Standard Operating Procedure for Satiation Appendix B, Model of a Standard Operating Procedure for Sanitation Pre-Operational Sanitation � Sanitation prior to production. Facilities, equipment and utensils are free from soil, debris, chemicals, etc. Procedures � Daily. Cleaning of product contact surfaces, facilities, and utensils Detail equipment disassembly, re-assemply use of acceptable chemicals, and cleaning techniques Application of Sanitizers after cleaning Operational Sanitation � Procedures to be conducted during operation Procedures for sanitation during cleaning How equipment will be cleaned and sanitized during production, breaks, between shifts, mid-shift clean up, etc Describe employee hygiene program (personal hygiene, gloves, garments, hair, hand washing, health, etc). Handling of product in raw and cooked areasAppendix A, Guidelines for Developing a Standard Operating Procedure for Satiation Appendix B, Model of a Standard Operating Procedure for Sanitation Pre-Operational Sanitation � Sanitation prior to production. Facilities, equipment and utensils are free from soil, debris, chemicals, etc. Procedures � Daily. Cleaning of product contact surfaces, facilities, and utensils Detail equipment disassembly, re-assemply use of acceptable chemicals, and cleaning techniques Application of Sanitizers after cleaning Operational Sanitation � Procedures to be conducted during operation Procedures for sanitation during cleaning How equipment will be cleaned and sanitized during production, breaks, between shifts, mid-shift clean up, etc Describe employee hygiene program (personal hygiene, gloves, garments, hair, hand washing, health, etc). Handling of product in raw and cooked areas

7. Implementing SSOPs Identification of �Responsible� Individual Procedure Monitoring Define Procedures that Validate Effectiveness of SSOP Specify method, frequency and recordkeeping processes associated with the SSOP Corrective Actions Procedures for Effectiveness of SSOP Organoleptic (sight, smell) Chemical (check chlorine level) Microbiological Specify Method, frequency and recordkeeping processes associated with monitoring Pre-Op � Effectiveness of cleaning direct product contact surfaces will be evaluated and documented Op � Evaluate and document SSOP adherence. Include descriptions of actions that ID and correct instances of direct product contamination from environment or employees. Corrective Actions � Deviation Develop procedures for documenting CA. Record all actionsProcedures for Effectiveness of SSOP Organoleptic (sight, smell) Chemical (check chlorine level) Microbiological Specify Method, frequency and recordkeeping processes associated with monitoring Pre-Op � Effectiveness of cleaning direct product contact surfaces will be evaluated and documented Op � Evaluate and document SSOP adherence. Include descriptions of actions that ID and correct instances of direct product contamination from environment or employees. Corrective Actions � Deviation Develop procedures for documenting CA. Record all actions

8. Regulatory Expectations Do NOT need a detailed manual. Simple, step-by-step written descriptions are adequate. Examples �Approved Sanitizer� Equipment Disassembly Use �approved sanitizer� as opposed to detailing the type of sanitizer, manufacturer, etc. Instead of detailing how to disassemble equipment in a step by step format, just state that the equipment should be disassembled and reassembled. Other training can supplement SSOPs, but do not need to be a part of it. Failure to comply can result in administrative, criminal and civil actions by FSISUse �approved sanitizer� as opposed to detailing the type of sanitizer, manufacturer, etc. Instead of detailing how to disassemble equipment in a step by step format, just state that the equipment should be disassembled and reassembled. Other training can supplement SSOPs, but do not need to be a part of it. Failure to comply can result in administrative, criminal and civil actions by FSIS

9. Fish and Fishery Sanitation Must comply with cGMPs RECOMMENDED that SSOPs be developed Issues Records SSOPs in Fish: -Safety of water that comes into contact with food, food surfaces or used to make ice, -Cleanliness of food contact surfaces, -Prevention of cross-cont. -Maintenance of hand washing, hand sanitizing, and toilet facilities -Protection from adulterations � lubricants, fuel, cleaning compounds, etc. -Control of employee health conditions -Pest Control �sanitation controls may be included in the HACCP plan� � If, during the hazard analysis, the processors deems a sanitation issue as critical, a CCP may be implemented to control it. Records should be kept to validate that SSOPs have been followed. Must be retained for 1 year for refrigerated product and 2 years for frozen, preserved or shelf-stable products.SSOPs in Fish: -Safety of water that comes into contact with food, food surfaces or used to make ice, -Cleanliness of food contact surfaces, -Prevention of cross-cont. -Maintenance of hand washing, hand sanitizing, and toilet facilities -Protection from adulterations � lubricants, fuel, cleaning compounds, etc. -Control of employee health conditions -Pest Control �sanitation controls may be included in the HACCP plan� � If, during the hazard analysis, the processors deems a sanitation issue as critical, a CCP may be implemented to control it. Records should be kept to validate that SSOPs have been followed. Must be retained for 1 year for refrigerated product and 2 years for frozen, preserved or shelf-stable products.

10. Summary Importance of Sanitation NOT just Cleaning equipment!!! Sanitation can control many potential biological, chemical and physical hazards. It is essential for the successful implementation of HACCP. NOT limited to cleaning equipment -personnel practices -establishment facilities -equipment design -operations -pest control measures -warehousingSanitation can control many potential biological, chemical and physical hazards. It is essential for the successful implementation of HACCP. NOT limited to cleaning equipment -personnel practices -establishment facilities -equipment design -operations -pest control measures -warehousing