Introduction to HACCP Alling H. Yancy, DVM Regulatory Compliance Group Manager Gold Kist Inc. Atlanta, GA HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) Goal To reduce the risk of foodborne illnesses associated with food to the maximum extent possible HACCP Framework for food safety through prevention Tested approach Clarifies and strengthens industry’s responsibility for food safety Benefits of HACCP Addresses chemical, physical and biological, especially microbiological, hazards Helps separate industry and regulatory responsibilities Benefits of HACCP IndustryHACCP + Regulatory Oversight = Safer Food Endorsed by a variety of stakeholders Stakeholders World Health Organization/United Nations (Codex) Canada Australia/New Zealand European Union Fast food chains Customers Food Safety Strategy Defines an acceptable level of food safety performance Holds each individual plant accountable for meeting that level of performance Food safety from farm to table Encourages technological development Role of FSIS and Industry FSIS- Setting criteria for food safety performance Industry - Testing and meeting target levels Responsibility of Industry Process control Producing safe and wholesome products Responsibility of the Regulatory Agencies Ensure that industry is meeting its food safety responsibilities OBLIGATIONS OF PLANT MANAGEMENT Create an environment of purpose toward improving products and services to provide for long-term needs rather than short-term profitability OBLIGATIONS OF PLANT MANAGEMENT Clearly communicate a permanent commitment to product safety OBLIGATIONS OF PLANT MANAGEMENT Focus supervision on helping people do a better job; ensure that immediate action is taken on conditions that effect the safety of the product OBLIGATIONS OF PLANT MANAGEMENT Encourage effective two-way communications to drive out fear and rumor “grapevine” throughout the organization OBLIGATIONS OF PLANT MANAGEMENT Breakdown barriers between departments by encouraging teamwork approach to problem solving OBLIGATIONS OF PLANT MANAGEMENT Set a good example; employees tend to emulate their boss OBLIGATIONS OF PLANT MANAGEMENT Askemployees for their suggestions; let them know they play a role in the decision making process OBLIGATIONS OF PLANT MANAGEMENT Giveemployees a sense of direction and goals; they need to know the why’s, what’s, when’s and how’s of their jobs OBLIGATIONS OF PLANT MANAGEMENT Make all employees feel like they belong and that they are a valued member of your team BIOLOGICAL HAZARDS BIOLOGICAL HAZARDS Disease producing organisms (pathogens) that can infect or intoxicate humans (and animals) and cause foodborne illness TYPES OF FOODBORNE DISEASE Foodborne Infection – A disease that results from eating food containing harmful living pathogens - Salmonella - Listeria monocytogenes TYPES OF FOODBORNE ILLNESS Foodborne Intoxication – A pathological condition that results when the toxins or poisons from pathogens are present in ingested food – Staphylococcus enterotoxin – Clostridium botulinum toxin BACTERIA ASSOCIATED WITH FOODBORNE ILLNESS Escherichia coli O157:H7 Salmonella Campylobacter jejuni Clostridium perfringens Shigella BACTERIA ASSOCIATED WITH FOODBORNE ILLNESS Listeria monocytogenes Clostridium botulinum Staphylococcus aureus Yersinia enterocolitica FACTORS AFFECTING GROWTH OF PATHOGENS Warm temperature Neutral pH (pH 7) High water activity Appropriate time Plentiful supply of nutrients Free of preservatives Presence or absence of oxygen Environmental Factors The Time/Temperature Relationship is VERY important!!! CONTROL OF BIOLOGICAL HAZARDS Prevent pathogen contamination - Good personnel hygiene - Avoid cross-contamination - Sanitation of work surfaces CONTROL OF BIOLOGICAL HAZARDS Destroy pathogens introduced into the food – Proper cooking time and temperature – Freezing (for parasites) – Irradiation CONTROL OF BIOLOGICAL HAZARDS Prevent growth of pathogens to harmful levels – Refrigeration or freezing – Avoid “DANGER ZONE” (40ºF - 140ºF) – Decrease pH and/or water activity – Hold food at elevated temperature (>140ºF) CONTROL OF BIOLOGICAL HAZARDS Reduce pathogens to acceptable levels – Lactic acid rinses – Trisodium phosphate (TSP) – Acidified sodium chlorite (Sanova) – Chlorine – Others BIOLOGICAL HAZARDS Most food poisoning is the result of improper handling and cooking CHEMICAL HAZARDS CHEMICAL HAZARDS Chemical Hazard – A substance that may cause an unacceptable health risk to the consumer through injury or illness LAWS AND REGULATIONS Food and Drug Administration (FDA) Department of Agriculture (USDA) Environmental Protection Agency (EPA) CHEMICAL HAZARDS Two major categories of chemicals: – Prohibited substances Cyclamates Adhesives and resins from packaging materials – Natural poisonous or deleterious substances Aflatoxin Lead, Mercury SOURCES OF CHEMICAL HAZARDS (Agricultural) Pesticides Fungicides Herbicides Antibiotics Fertilizers Insecticides SOURCES OF CHEMICAL HAZARDS (Food Processing) Preservatives Packaging materials Colors and dyes Processing aids Flavor enhancers Water additives SOURCES OF CHEMICAL HAZARDS (Plant Environment) Sanitizers Paints Pesticides Ammonia Lubricants Solvents Cleaners CONTROL OF CHEMICAL HAZARDS On-the-Farm HACCP plans Use only approved chemicals Control use of cleaners and sanitizers Integrated pest management program CONTROL OF CHEMICAL HAZARDS Use only food grade ingredients Use potable water Follow prerequisite programs for storage and shipping Letters of guarantee PHYSICAL HAZARDS PHYSICAL HAZARDS – Physical Hazards - Objects not normally found in food that can result in personal injuries (i.e. cuts to the mouth, choking, etc.) SOURCES OF PHYSICAL HAZARDS Important to separate those physical contaminates that can cause physical injury from those that are aesthetically unpleasing (ex. metal vs. hair) SOURCES OF PHYSICAL HAZARDS Metal Hypodermic needles Glass Bullets/Buckshot Wood splinters Twist ties Jewelry Bone Machine parts SOURCES OF PHYSICAL HAZARDS Contaminated raw materials Facilities and equipment Production practices Employee practices CONTROL OF PHYSICAL HAZARDS Magnets Riffle boards Metal detectors Prerequisite Screens/Sifters programs Bone separators Letters of guarantee Visual inspections Product specifications INITIAL STEPS IN DEVELOPING A HACCP PLAN GAIN MANAGEMENT SUPPORT HA CCP Plan ASSEMBLE THE HACCP TEAM The HACCP team includes – Coordinator – Ad hoc members – Outside experts Should be multidisciplinary MEMBERS OF THE HACCP TEAM Management Quality Control/Assurance Sanitation Maintenance/Engineering Production Supervisors Product Development/Sales EVALUATE CURRENT PROGRAMS Prerequisite programs and GMPs Sanitation Standard Operating Procedures (SSOPs) and SPSs Quality Control programs Training programs Compliance with regulations Prerequisite Programs/GMPs Play an important role when conducting the HACCP plan hazard analyses If used in the hazard analyses, ALL programs must be in writing, monitored and records maintained Records must support decisions reached in the hazard analyses HACCP PLANS Must be specific for both product and process Differences due to – Suppliers – Ingredients – Formulations – Processing equipment – Facilities – Preparation procedures HACCP PLAN DEVELOPMENT Describe the food and its’ intended use Develop a product description – Process/Product name or type – Important product characteristics – Packaging and shelf life – Where it will be sold – Labeling instructions – Special distribution control HACCP PLAN DEVELOPMENT Prepare detailed information on the formula and ingredients HACCP PLAN DEVELOPMENT Develop a flow diagram of the process HACCP PLAN DEVELOPMENT Flow diagrams must: Be developed for each product/process Include all processes from addition of raw materials through packaging and distribution Include rework and returned product (if applicable) HACCP PLAN DEVELOPMENT Verify the flow –On-site/hands-on verification –Keep it current Seven HACCP Principles 1. Hazard Identification and Assessment 2. Critical Control Point Identification 3. Establishing Critical Limits 4. Monitoring Procedures 5. Corrective Actions 6. Verification Procedures 7. Record Keeping Practices HACCP PRINCIPLE NO. 1 CONDUCT A HAZARD ANALYSIS HACCP PRINCIPLE NO. 1 Develop a list of hazards that are reasonably likely to cause injury or illness Identify appropriate control measures for each hazard HACCP PRINCIPLE NO. 1 Hazards are defined as biological, chemical or physical agents that are reasonably likely to cause injury or illness in the absence of control HACCP PRINCIPLE NO. 1 Control Measure - Any action, activity or device that can be used to prevent, eliminate, or reduce to an acceptable level a hazard HACCP PRINCIPLE NO. 1 Hazards associated with each step must be listed along with any control measures for them The term “control measure” is used because not all hazards can be prevented or eliminated Multiple control measures may be required for certain hazards HACCP PRINCIPLE NO. 1 When conducting a hazard analysis consider: – Ingredients and raw materials – Each step in the process – Product storage and distribution – Final preparation and use by the consumer HACCP PRINCIPLE NO. 1 When conducting a hazard analysis SAFETY concerns MUST be differentiated from QUALITY concerns HACCP PRINCIPLE NO. 1 Hazard Analysis is a Two Step Process: –Hazard Identification –Hazard Evaluation HACCP PRINCIPLE NO. 1 Hazard Identification – Brainstorming session – Review ingredients, process steps, storage/distribution and use – Develop a list of potential hazards which may be introduced, increased or controlled at each step HACCP PRINCIPLE NO. 1 Hazard Evaluation – Determines which potential hazards must be addressed in the HACCP plan – Based on the severity and likely occurrence of each hazard HACCP PRINCIPLE NO. 1 Severity - The seriousness of the consequences of exposure to the hazard Risk - The likely occurrence of the hazard based on experience, technical literature, epidemiological data, etc. HACCP PRINCIPLE NO. 1 Hazards identified in one facility may not be significant in another facility due to differences in equipment, preparation procedures, ingredients, etc. Maintain a summary of the hazard analyses for future reference and as required by regulation Control Measures for Chemical Hazards Hazard Control Measure Naturally Occurring Supplier warranty/guarantee; monitoring program to test for residues of hazardous substances Substances Supplier warranty/guarantee; specifications for each Added Hazardous raw material/ingredient; require suppliers to operate Chemicals with a HACCP plan; visit suppliers; monitoring program to test for residues of hazardous chemicals Identify all direct and indirect food & color additives used in the processing operation; assure that each In-Process Chemicals chemical is approved; assure that each chemical is properly used; record the usage of critical/restricted ingredients where over usage may cause a serious side effect Control Measures for Physical Hazards Hazard Control Measure Raw Materials Supplier’s HACCP plan; use of specs/guarantees; vendor inspections and certifications; in-line magnets, screens, traps, and filters; in-house inspection of raw materials Incoming Ingredients Supplier’s HACCP plan; use of specs/guarantees; vendor inspections and certifications; in-house inspection of ingredients Processing Operations In-line metal detectors; visual product examinations; frequent equipment inspections and proper equipment maintenance Control Measures for Biological Hazards Hazard Control Measure Campylobacter jejuni Proper cooking or pasteurization; avoiding cross- contamination by insanitary equipment or food handlers; freezing; controlled modified atmospheric packaging Escherichia coli O157:H7 Proper cooking; avoiding cross-contamination by insanitary equipment or food handlers Proper cooking or fermentation controls; avoiding cross-contamination by insanitary equipment or Salmonella spp. food handlers; proper feed withdrawal prior to slaughter; scalding procedures; decreased water activity; antimicrobial treatments; separation of raw & cooked products HACCP PRINCIPLE NO. 1 A hazard analysis and identification of control measures assures: – Hazards and associated control measures are identified – Any necessary process modifications are identified – A basis for determining the CCPs is provided HACCP PRINCIPLE NO. 2 Determine Critical Control Points (CCPs) HACCP PRINCIPLE NO. 2 Critical Control Point: – A step at which control can be applied, and is essential, to prevent, eliminate, or reduce to an acceptable level a food safety hazard HACCP PRINCIPLE NO. 2 Preventa food safety hazard Example - Modify a product formulation to reduce the pH below 4.6 HACCP PRINCIPLE NO. 2 Eliminate a food safety hazard Example - Thermally process a product to destroy a potential population of known pathogens HACCP PRINCIPLE NO. 2 Reducea food safety hazard to an acceptable level Example – Apply antimicrobial treatments (i.e. chlorine, Sanova, etc.) HACCP PRINCIPLE NO. 2 Examples of CCPs include: – Zero Fecal Tolerance – Chilling Raw Product – Cooking – Chilling Cooked Product Principle 2 - CCP Decision Tree Q1. Do control measure(s) exist for the identified hazard? Modify step, process or product. YES NO Is control at this step necessary for safety? YES NO Not a CCP STOP* Q2. Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level? NO YES Q3. Could contamination with identified hazard occur in excess of acceptable level(s) or increase to unacceptable level(s)? YES NO Not a CCP STOP* Q4. Will a subsequent step eliminate identified hazard(s) or reduce the likely occurrence to an acceptable level? YES Not a CCP STOP* NO CRITICAL CONTROL POINT *Proceed to next step in the described process Source: NACMCF. 1992. Principle 2 - Modified Tree Q1. Does this step involve a hazard of significant likelihood of occurrence and severity to warrant its control? YES NO Not a CCP Q2. Does a control measure for the hazard exist at this step? NO Modify the step, process, or product. Is control at this step necessary for YES safety? YES Q3. Is control at this step necessary to prevent, eliminate, or reduce the risk of the hazard to consumers? YES CCP NO Not a CCP HACCP PRINCIPLE NO. 3 Establish Critical Limits HACCP PRINCIPLE NO. 3 Critical Limit: – A maximum and/or minimum value to which a biological, chemical or physical hazard must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard HACCP PRINCIPLE NO. 3 Each CCP must have a critical limit in order to determine whether the CCP is IN or OUT of control A CCP may have one or more critical limits A critical limit is used to distinguish between safe and unsafe operations at a CCP – it defines the “Boundaries of Safety” HACCP PRINCIPLE NO.3 Criticallimits are established based on: – Evidence of the existence of a direct health hazard – Evidence that a direct health hazard could develop, or… HACCP PRINCIPLE NO. 3 – Indications that a product was not produced under conditions ensuring safety (i.e. metal detector kick-outs) HACCP PRINCIPLE NO. 3 Criticallimits should: – Indicate control of a CCP – Be simple, specific and clear – Be based on scientifically determined parameters – Be quantifiable (but may be sensory) – Be validated HACCP PRINCIPLE NO. 3 When setting critical limits you: – May consider operational/target limits by using statistical process control (SPC) – May require consultation with experts – May require research – Should consider variations in equipment operation HACCP PRINCIPLE NO. 3 Use of target limits (through SPC) – Provides tighter control than a simple maximum/minimum critical limit – Helps to minimize or avoid costly corrective actions – Helps identify trends toward non-compliance before a deviation occurs HACCP PRINCIPLE NO. 3 Example of variations in equipment operation: - The critical limit for cooked chicken patties is an internal temperature of 160ºF for 1 sec. - Equipment validation shows +/- 5ºF - The adjusted critical limit for internal chicken patty temperature would be 165ºF HACCP PRINCIPLE NO. 3 Criticallimits may be derived from: – Regulatory standards (USDA, FDA, etc.) – Literature surveys – Experimental results – Data from outside experts HACCP PRINCIPLE NO. 3 Examples of critical limits: – Time/Temperature (chilling, cooking, freezing, etc.) – Zero Fecal Tolerance – Metal detector sensitivity HACCP PRINCIPLE NO. 4 Establish Monitoring Procedures HACCP PRINCIPLE NO. 4 Monitoring is defined as: – Conducting a planned sequence of observations or measurements to assess whether or not a CCP is under control and producing an accurate record thereof for future use in verification HACCP PRINCIPLE NO. 4 Monitoring serves three main purposes: – It assesses control – It determines trends – It provides written documentation HACCP PRINCIPLE NO. 4 • Continuous Monitoring is best, however, Less Than Continuous Monitoring may be more practical • It is not necessary to always have continuous monitoring HACCP PRINCIPLE NO. 4 Continuous Monitoring: – Temperature – pH – Time – Chlorine level HACCP PRINCIPLE NO. 4 Less Than Continuous Monitoring: – Statistical sampling – Monitoring at set intervals of time HACCP PRINCIPLE NO. 4 LessThan Continuous Monitoring is often used: - When conditions are unknown (i.e. ingredient testing) - For troubleshooting (i.e. lot sampling) HACCP PRINCIPLE NO. 4 Important monitoring questions: – What is monitored – Who monitors (by title, not name) – How is monitoring performed – What is the frequency of monitoring HACCP PRINCIPLE NO. 4 Individuals must fully understand the purpose and importance of monitoring Individuals must be trained in the monitoring techniques (i.e. SOP) Individuals must be unbiased in monitoring and reporting Individuals must accurately record the results of monitoring HACCP PRINCIPLE NO. 4 Employees should be trained in procedures to follow when there is a trend towards loss of control Allmonitoring records must be dated and initialed, or signed, by the person doing the monitoring HACCP PRINCIPLE NO. 4 Monitoring procedures need to be rapid, on-line and “real time” Microbiological tests are seldom effective for monitoring HACCP PRINCIPLE NO. 4 Monitoring Records: – Data entered must be accurate and timely – Free of errors or omissions – Free of whiteouts, erasures, blackouts, etc. HACCP PRINCIPLE NO. 4 Monitoring records must be: – Reviewed, dated and signed, or initialed, by someone other than the monitoring person (i.e. verification) – Reviewed prior to shipment of the associated product (i.e. pre-shipment review) – Made available to USDA personnel upon request – Retained as required by USDA regulations HACCP PRINCIPLE NO. 5 Establish Corrective Actions HACCP PRINCIPLE NO. 5 Deviation: – A failure to comply with a stated critical limit – Corrective actions must be developed for each CCP to remedy an associated deviation and assure product safety – Corrective actions “FIX” the deviation and assure compliance with the HACCP plan is maintained HACCP PRINCIPLE NO. 5 The HACCP plan shall describe the corrective actions to be taken, and assign the responsibility for taking each one HACCP PRINCIPLE NO. 5 Corrective actions must ensure: – The cause of the deviation is identified and eliminated – The CCP is/will be under control after corrective actions are taken – Measures to prevent recurrence are/have been established – No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce HACCP PRINCIPLE NO. 5 Inmany cases, critical limit monitoring will identify when a process is trending toward noncompliance prior to a deviation actually occurring HACCP PRINCIPLE NO. 5 Employees should be trained on the proper corrective actions to take in response to deviations of the CCPs for which they are responsible The first action that should be taken is to get control of/address the affected product (i.e. place it on HOLD, etc.) HACCP PRINCIPLE NO. 5 A person with a thorough knowledge of the process, products and HACCP plan should have oversight of the corrective actions HACCP PRINCIPLE NO. 5 All corrective actions must be thoroughly, and accurately, recorded Recommend designing a Corrective Action Form that forces employees to address all 4 requirements of HACCP Corrective Actions HACCP PRINCIPLE NO. 6 Establish Verification Procedures HACCP PRINCIPLE NO. 6 In a “perfect world” all that is needed is: – Flow diagrams & hazard analyses – Critical control points – Monitoring procedures HACCP PRINCIPLE NO. 6 In the “real world” HACCP requires periodic, independent, verification checks HACCP PRINCIPLE NO. 6 Verification evaluates the day-to-day compliance of the activities conducted at each CCP It assures we say what we do and do what we say HACCP PRINCIPLE NO. 6 An important aspect of verification is the initial validation of the HACCP plan that determines the plan is scientifically and technically sound HACCP PRINCIPLE NO. 6 Types of ongoing CCP verification activities: – Calibration of process-monitoring equipment HACCP PRINCIPLE NO. 6 – Review of records – Direct observations of the adequacy of monitoring activities and corrective actions HACCP PRINCIPLE NO. 6 Calibration of process-monitoring equipment – Checked at a frequency sufficient to ensure that all measurements are accurate HACCP PRINCIPLE NO. 6 – Frequency dependent on the likelihood that the instrument will go out of calibration – Frequency dependent on the level of process liability you are willing to accept HACCP PRINCIPLE NO. 6 Calibration records should include: – Identification of the equipment calibration checked – Date, time, and signature/initials of the person who checked the equipment calibration – Identification of the reference instrument used to check calibration HACCP PRINCIPLE NO. 6 – Results of calibration check – Date and signature/initials of who reviewed the record HACCP PRINCIPLE NO. 6 Monitoringand corrective action records should be reviewed: – By an individual other than the one who prepared the records HACCP PRINCIPLE NO. 6 – By a Supervisor, or other member of management, who has received HACCP training HACCP PRINCIPLE NO. 6 Reviewof monitoring records is intended to verify: – The record was prepared correctly – Activities and frequencies were performed as required by the HACCP plan HACCP PRINCIPLE NO. 6 – No monitoring activities were missed – Findings were within critical limits and all deviations were identified HACCP PRINCIPLE NO. 6 Review of corrective action records is intended to verify: – The record was prepared correctly – The nature and extent of the deviation was clearly documented HACCP PRINCIPLE NO. 6 – Affected product was identified and isolated – Corrective actions followed those stated in the HACCP plan – Final disposition of product and individuals involved are stated HACCP PRINCIPLE NO. 6 Review of monitoring/corrective action records should ensure: – All entries have been made in pen – There are no whiteouts, erasures, blackouts, etc. HACCP PRINCIPLE NO. 6 – There is no evidence of falsification – Person making the entries has signed or initialed the record HACCP PRINCIPLE NO. 6 Direct observations of the adequacy of monitoring activities and corrective actions should be conducted – Actual results of these observations must be recorded HACCP PRINCIPLE NO. 6 Targeted sampling and testing – It may, at times, be necessary to verify a process by performing periodic sampling and testing independent of the monitoring activity HACCP PRINCIPLE NO. 6 Microbiological Testing – Not recommended for HACCP monitoring Length of time required to obtain results Detection sensitivity – If used for HACCP verification, sampling and testing frequency must be specified in the HACCP plan HACCP PRINCIPLE NO. 6 Microbiological test results are only as reliable as the sampling and analytical methods used HACCP PRINCIPLE NO. 6 Extensivesampling is required to achieve reliable detection in samples containing low levels of pathogens HACCP PRINCIPLE NO. 6 Validation and reassessment of the HACCP plan are the most complex verification activities that must be performed HACCP PRINCIPLE NO. 6 and reassessment of the Validation HACCP plan answer the questions – Is it the right thing to do – Is it STILL the right thing to do HACCP PRINCIPLE NO. 6 HACCP plan validation occurs: – During development/initial implementation of the HACCP plan – Following implementation of modifications to the HACCP plan HACCP PRINCIPLE NO. 6 HACCP plan validation is supported by: – Regulatory requirements – Scientific data and literature – Plant test data/results HACCP PRINCIPLE NO. 6 Eventsthat trigger a HACCP plan reassessment – Length of time since the last reassessment (conducted annually, at a minimum) – Whenever any changes occur that could affect the hazard analysis or alter the HACCP plan (system modifications, etc.) HACCP PRINCIPLE NO. 6 - Whenever a deviation not covered by a specified corrective action occurs (aka an unforeseen hazard) Foodborne disease outbreak Recall of products - Repetitive failures of the same CCP HACCP PRINCIPLE NO. 7 Establish Effective Record Keeping Practices HACCP PRINCIPLE NO. 7 Records are kept for several reasons: – Evidence of product safety – Regulatory compliance – Tracing product – Review of procedures/processes HACCP PRINCIPLE NO. 7 The HACCP plan should be included as part of the plant’s records HACCP PRINCIPLE NO. 7 Active HACCP records include: - CCP monitoring records - CCP verification records - Calibration records - Corrective action records - Other records (ex. sample results, etc.) HACCP PRINCIPLE NO.7 Content of the HACCP records: – Form title and date of issue – Production date/product code – Observations and measurements – Critical limits/corrective actions – Monitor’s signature/initials and date – Reviewer’s signature/initials and date HACCP PRINCIPLE NO.7 OtherHACCP files include: – HACCP Team Members Listing Responsibilities Outside experts/contacts HACCP PRINCIPLE NO.7 – Reference/supporting data related to selection of CCPs, critical limits, monitoring procedures, corrective actions, etc. HACCP PRINCIPLE NO.7 – Standard Operating Procedures (SOPs) for each CCP – HACCP training information Who was trained Types of training received Training certificates PRE-SHIPMENT REVIEW Priorto shipping product, the establishment shall review the records associated with the production of that product… PRE-SHIPMENT REVIEW To determine/assure: – All critical limits were met – Appropriate corrective actions were taken, including the proper disposition of product PRE-SHIPMENT REVIEW Review should be conducted, dated and signed by someone other than the person that produced the records, and trained in accordance with § 417.7 HACCP RECORD RETENTION One Year – Slaughter – Refrigerated products Two Years – Frozen, preserved, shelf stable products On-site – 6 months Off-site after 6 months if they can be retrieved/provided within 24 hrs. of the FSIS request ACCESS TO HACCP RECORDS USDA/FSIS must have access to all HACCP plans, procedures and records Copies of HACCP plans, procedures, records and supporting documentation should not be given to FSIS inspector for their files ACCESS TO HACCP RECORDS AllHACCP documents should be marked “Confidential Proprietary Information” (or its equivalent) and treated as such RECORDS MAINTAINED ON COMPUTERS Acceptable, provided appropriate controls are implemented to ensure the integrity of the electronic data and signatures HACCP DOCUMENT CONTROL Maintain a list of controlled copies of the HACCP plan Anyproposed amendments to the HACCP plan must go through a planned sequence for approval (SOP) HACCP DOCUMENT CONTROL A system of auditing needs to be in place to ensure that all copies of the HACCP plan are updated when any amendments are made Amended pages of the HACCP plan must be indicated in some manner HACCP DOCUMENT CONTROL An amendment form could include: Date; Subject; Sub-section or page number; Comments; Approval signatures/initials Pages of the HACCP plan could show: Amendment number; Date; Approved signatures/initials HACCP DOCUMENT CONTROL Once the number of amendments becomes excessive, consider reissuing the HACCP plan Save“old” HACCP plans to correlate with the HACCP records produced under them HACCP DOCUMENT CONTROL – Establish a filing system for the HACCP plan, associated records & supporting materials Accessible to plant and FSIS personnel Provide adequate security Signout sheet if removed from location (including the FSIS inspector) 9 CFR PART 417 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS § 417.1 Definitions a. Corrective action b. Critical limit c. Food safety hazard d. HACCP System e. Hazard f. Preventive measure g. Process-monitoring instrument h. Responsible establishment official § 417.2 Hazard Analysis and HACCP Plan a) Hazard Analysis 1) Every official establishment shall conduct a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures that can be applied to control those hazards 2) A flow chart describing the steps of each process and product flow shall be prepared, and the intended use or consumers shall be identified 3) Food safety hazards might be expected to arise from: a. Natural toxins b. Microbiological contamination c. Chemical contamination d. Pesticides e. Drug residues f. Zoonotic diseases g. Decomposition h. Parasites i. Physical hazards b) The HACCP plan 1) Every establishment shall develop and implement a written HACCP plan covering each product produced by the establishment 2) A single HACCP plan may encompass multiple products within a single processing category Process Categories Slaughter – all species Raw product – ground Raw product – not ground (ex. steaks, chops, parts, etc.) Thermally processed – commercially sterile (ex. canned meat and poultry) Process Categories Not heat treated – shelf stable (ex. dried, dehydrated and freeze dried products, etc.) Heat treated – shelf stable (ex. rendered products, lard, etc.) Fully cooked – not shelf stable (ex. hams, roast beef, cooked beef, etc.) Process Categories Heat treated but not fully cooked – not shelf stable (ex. partially cooked battered, breaded and ready-to-cook products, etc.) Product with secondary inhibitors – not shelf stable (ex. fermented, dried, salted and brine treated products, etc.) c) The contents of the HACCP plan – the HACCP plan shall: 1) List the food safety hazards that must be controlled for each process 2) List the critical control points for each identified food safety hazard 3) List the critical limits that must be met at each CCP 4) List the procedures and frequency used to monitor each CCP 5) Include all corrective actions to be followed in response to any deviation from a critical limit at a CCP 6) Provide for a record keeping system that documents the monitoring of the CCPs 7) List the verification procedures and their frequency d) Signing and dating the HACCP plan 1) The HACCP plan shall be signed and dated by the responsible establishment individual 2) The HACCP plan shall be signed and dated: upon initial acceptance; upon any modification; and at least annually upon reassessment e) Failure of an establishment to develop and implement a HACCP plan may render the products produced under those conditions adulterated § 417.3 Corrective actions a) The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit, and assign responsibility for taking corrective action, to ensure… 1) The cause of the deviation is identified and eliminated 2) The CCP will be under control after the corrective action is taken 3) Measures to prevent recurrence are established 4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce b) If a deviation not covered by a specified corrective action occurs: 1) Segregate and hold the affected product 2) Perform a review to determine the acceptability of the affected product 3) Take action to ensure that no product that is injurious to health or otherwise adulterated enters commerce 4) Perform a reassessment to determine whether or not the newly identified deviation should be incorporated into the HACCP plan c) All corrective actions taken shall be documented in records that are subject to verification and record keeping requirements of this part § 417.4 Validation, Verification, Reassessment a) Every establishment shall validate the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented (1) Initial validation Designed to determine that the HACCP plan is functioning as intended (2) Ongoing verification activities The calibration of process-monitoring instruments Direct observation of monitoring activities and corrective actions Review of records (3) Reassessment of the HACCP plan At least annually, and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan The HACCP plan shall be modified immediately whenever reassessment reveals the plan no longer meets regulatory requirements § 417.5 Records a) The establishment shall maintain the following records documenting the establishment’s HACCP plan: 1) The written hazard analysis including all supporting documentation 2) The written HACCP plan including decision-making documents 3) Records documenting the monitoring of CCPs and their critical limits b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs c) Prior to shipping product, the establishment shall review the records associated with the production of that product, then sign and date each record d) Records maintained on computers - Acceptable, provided appropriate controls are implemented to ensure integrity of electronic data/signatures e) Record retention: 1) Slaughter and refrigerated products – 1 year Frozen, preserved, or shelf stable products - 2 years 2) Off-site storage of records – Permitted after 6 months if they can be retrieved and provided within 24 hrs. of request f) Official review – All records, plans and procedures required by this part shall be available for official review § 417.6 Inadequate HACCP Systems A HACCP system may be found to be inadequate if: a) The HACCP plan in operation does not meet the requirements of this part b) Establishment personnel are not performing tasks specified in the HACCP plan c) The establishment fails to take corrective actions d) HACCP records are not being maintained e) Adulterated product is produced or shipped § 417.7 Training a) Only an individual who has met the requirements of paragraph (b) of this section shall be permitted to perform the following functions: 1) Development of the HACCP plan 2) Reassessment and modification of the HACCP plan b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat and poultry product processing, including a segment on the development of a HACCP plan for a specific product and on record review § 417.8 Agency Verification FSIS verification of the adequacy of the HACCP plan(s) may include: a) Reviewing the HACCP plan b) Reviewing the CCP records c) Reviewing and determining the adequacy of corrective actions d) Reviewing the critical limits e) Reviewing other records pertaining to the HACCP plan or system f) Direct observations or measurements at CCPs g) Sample collection and analysis h) On-site observations and record reviews Thank you very much and Best wishes for your future endeavors!!!
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