HACCP - Hazard Analysis / Critical Control Points

1. HACCP - Hazard Analysis / Critical Control Points Food & Feed Product Protection

2. HACCP • Definition - development and implementation of hazard control system • Pioneered by The Pillsbury Company - 60’s • What is the worst thing that could happen to TPC • Army Research Laboratories • National Aeronautical and Space Admin. • Based on a concept of prevention-not testing • Design safety in product design and process

3. HACCP History • 1972 TPC trained FDA inspectors • Low acid canning regulations in 1974 • 1980s supported by several Gov. agencies • 1989 four gov. agencies formed committee to address food borne illnesses • 1990 FSIS of USDA - 2 year study • 1994 FDA proposed move to HACCP • 1998 FSIS mandating HAACCP for meats • Inspection service and customers

4. Definition CCP vs. CP • Critical control point • any point in process that is critical to food safety • Control Point • any point in process critical • regulatory - weight control, labeling • economic - customer quality, mold

5. HACCP Team • Team with assigned responsibility • normally includes • management • plant operating workers • quality management staff • sanitarian • microbiologist when appropriate

6. 7 Principles of HACCP • Hazard analysis and risk assessment • Determine critical control points • Establish specifications for each CCP • Monitor each CCP • Establish corrective action for deviations • Establish recordkeeping system • Establish verification system

7. 1. Hazard Analysis & CCP • Risk assessment for all ingredients, processes, finished products, transportation • Risks that may cause injury or illness • Physical • Biological • Chemical • Assessed by experts of different disciplines

8. 2. CCP’s • Identify any point in process (when out of control) that could contribute a hazard • Physical hazard • lack of temperature control, foreign material, product tampering, • Chemical Hazard • Pesticides, Sulfites, Allergens • Biological • Microorganisms, Aflotoxin,

9. 3. Establish Specifications • For each CCP • Specific tolerances • temperature controls for cook process • particle size range for calibration of metal detectors

10. 4. Monitoring CCP • Published testing procedures for each CCP • Established schedule for monitoring CCP • Responsibility for testing clearly assigned • Test results must be recorded • Insure tests are actually being performed

11. 5. Corrective Action • When there is a deviation corrective action must be: • Immediate • Must be clearly defined ahead of time • Responsibility for action must be assigned

12. 6. Recordkeeping System • Mandatory • Records of ingredients, processes, and finished products support trace & recall system • Regulatory agencies will demand records • Shows company responsibility in litigation

13. 7. Verifications • HACCP system in-place is functioning the same as the HACCP policy dictates • Periodic review of program • Frequency defined • Responsibility for review assigned • Serves as preparation for regulatory inspections

14. CP’s • May and probably should be handled in the similar manner as the CCP’s • However, regulatory control will require some separation of the two programs

15. Trace & Recall Programs

16. Initiation • Food Safety Issues • Internally - Preferable • can call in FDA • FDA Initiated • Non-food safety • Use the same recall procedures except: • media • communication

17. Recall Classification • Class I - Emergency Situation • adverse health consequences or death • examples • C. Botulinum in foods • Label mix-up of a potent drug • Excessive exposure to radiation

18. Classification Continued • Class II recall • Use of exposure to food may cause temporary or medically reversible health consequence • examples • Pathogenic bacteria exclusive of C. Botulinum • Labeling issue such as failure to label potential allergen

19. Classification Continued • Class III Recall • Not likely to cause adverse health problems • examples • labeling violations • Filth in food relating to aesthetics • Mold or wild yeast contaminations • Internal recall for quality issues

20. Recall Objectives • Determine if recall is required • Locate product • Remove product • Provide accurate information

21. Recall Responsibilities • Lies with the company’s officers and employees • full legal responsibility for safety, labeling and quality of food products • civil and criminal liabilities when illegal, unsafe or hazardous products are place in market • FDA, USDA FSIS - health threats are removed from the marketplace quickly and adequately

22. Recall Procedures • Recall organization in place • written policy • assigned responsibilities • recall coordinator assigned w/ alternates • reviews facts • call committee together if due cause • notify and communicate with FDA • coordinates all activities • log all events and co. response to events

23. Recall Procedure • Distribution coordinator • locate and coordinate retrieval of products • communicate throughout distribution system • designate location for & quarantine of product • final disposition of product consistent w/ FDA directives or recall committee

24. Product Traceability • Must be able to track ingredients by lot • Must be able to track ingredient to finished product • Must be able to track product by lot through to customer • Adequate records to track • Preferably computer support tied to distribution and inventory system

25. Public / Regulatory Notification • Written plans for dealing with the public • Plans for dealing with regulatory agency • Some recalls (most in our industries) will not require either public or reg. agency • Case by case management agreement • Management agreement on how to communicate to the customer • Damage control - company reputation