1. Awareness Training: ‘HARPC’ for Food Safety Complimentary Presentation by Quality Systems Enhancement 1790 Wood Stock Road Roswell GA-30075 E. mail: info@enhancequality.com www.enhancequality.com Phone: 770-518-9967 Fax: 770-518-9968 1

2. Focus  What is HARPC  Important Terms  Safety in Food Industry  FDA Requirements  Concept of Risk- Based Preventive Control  Principles of HARPC  Guidelines for implementation  Summary 11/19/2015 www.enhancequality.com2

3. What is HARPC? HARPC Stands for Hazard Analysis Risk-based Preventive Control Mandatory for all Entities Dealing with Food Processing, Packing or Storage as per final Rule of FSMA released on November13 2015. 11/19/2015 www.enhancequality.com3

4. Important Terms  Hazard: Hazard is Defined as a Biological, Chemical, Radiological or Physical Agent that is Reasonably Likely to Cause Illness or Injury in the Absence of its Control  Hazard Control Team is a Cross Functional Group formed for Hazard Analysis and to Decide Risk-Based Preventive Control Measures (RPC) 11/19/2015 www.enhancequality.com4

5. Terms (Cont’d.) Hazard Analysis:  Hazard Analysis is to Accomplish Following Objectives: 1. Identification of Hazards 2. Identification of Acceptable Levels 3. Identification of Risks and Potential Risks 4. Identification of Modifications to Process 5. Identification of Control Methods to Ensure Product Safety 6. Identification of Risk-Based Preventive Controls (RPC) 11/19/2015 www.enhancequality.com5

6. Risk Food Safety Risk is defined as: "The Scientific Evaluation of Known or Potential Adverse Health Effects Resulting from Human Exposure to Foodborne Hazards." 11/19/2015 www.enhancequality.com6 Terms (Cont’d.)

7. Safety in Food Industry  Safety in Food Industry is of Utmost Importance  Acceptable Limit as a Maximum and/or Minimum Risk Value to Which a Biological, Chemical Radiological or Physical Parameter Must be Controlled at a RPC to Prevent, Eliminate or Reduce to an Acceptable Level the Occurrence of a Food Safety Hazard  A Risk level is Used to Distinguish Between Safe and Unsafe Operating Conditions at a RPC 11/19/2015 www.enhancequality.com7

8. Safety in Food Industry (Cont’d.)  The RPC and Criteria for Food Safety may be Derived from Sources such as Regulatory Standards and Guidelines, Literature Surveys, Experimental Results, and Experts  FDA Requirements are all About Safety in Food Industry 11/19/2015 www.enhancequality.com8

9. FDA Requirements  Ingredients  FDA Maintains Multiple Databases and Listings Related to FSMA, Ingredients, Food Additives, and Colors. The Following Links also Include Overview and Educational Information  http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359436.htm http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359436.htm  Ingredients & Packaging Terms Ingredients & Packaging Terms  Food Allergens Food Allergens  Food Additives & Ingredients Food Additives & Ingredients  Consumer Information About Additives and Ingredients Including: Consumer Information About Additives and Ingredients  Caffeinated Alcoholic Beverages  Sweeteners  Sodium  Color Additives 11/19/2015 www.enhancequality.com9

10. Concept of Risk-Based Preventive Control Points (RPCs )  Concept of RPC is to Identify Risk and Prevent it  It is a Step Essential to Prevent or Eliminate a Food Safety Hazard or Reduce it to an Acceptable Level  The Potential Hazards that are Reasonably Likely to Cause Illness or Injury  Control of Potential Hazards Must be Addressed in Determining RPCs  Complete and Accurate Identification of RPCs is Fundamental to Controlling Food Safety Hazards  Hazard Analysis is First Step in Identifying RPCs  RPC is Essential for Safety in Food Industry 11/19/2015 www.enhancequality.com10

11. 7 Principles of HARPC HARPC Systems must be Based on the Seven Principles: (1) Identify Hazards and Hazard Analysis (2) Risk Based Preventive Controls (3) Monitoring and Effectiveness of Control (4) Corrective Actions (5) Verification (6) Record Keeping and Documentation (7) Reanalyze 11/19/2015 www.enhancequality.com11

12. Hazard Analysis  The Hazard Analysis Consists of Asking a Series of Questions which are Appropriate to the Process Under Consideration.  The Purpose of the Questions is to Assist in Identifying Potential Risk of Hazards  Ingredients  Does the Food Contain any Sensitive Ingredients that may Present Microbiological Hazards (e.g. Salmonella, Staphylococcus Aureus); Chemical Hazards (e.g. Aflatoxin, Antibiotic or Pesticide Residues) or Physical Hazards (Stones, Glass & Metal)? 11/19/2015 www.enhancequality.com12

13. Examples of Preventive Control Measures  Sanitation Procedures at Food Surface Contact Points  Sanitation of Utensils and Equipment  Staff Hygiene Training  Environmental Monitoring Program (for Pathogen Controls)  Food Allergen Control Program  Recall Plan  Current Good Manufacturing Practices (CGMPs)  Supplier Verification Activities  Control on Incoming Materials 11/19/2015 www.enhancequality.com13

14. Monitoring and Effectiveness of Control  Monitoring is Required to see if HARPC is Working  Food Facility to implement a Monitoring Program  Conduct Checks in Periodic Intervals  Draw up Check- Off Lists Covering all RPCs  Draw up Check- Off Lists Covering all PRPs  Include all Check- Off Lists as a Part of Employee Training Program  Train all Employees on Good Manufacturing Practices  Train all Employees on HARPC 11/19/2015 www.enhancequality.com14

15. Corrective Actions  Determine Scientifically the Acceptable Limits  Acceptable Limits are different from Operating Limits  Determine the Parameters that can Regulate Hazards  Modify the Process to Stay Within Acceptable Limits  Calibrate all Measuring Equipment as Required  Withdraw the Product if any Acceptable Limit is Exceeded  Maintain Record of all Corrective Actions  Incorporate Corrections to Prevent Reoccurrence 11/19/2015 www.enhancequality.com15

16. Verification  Draw up a Verification Program including Microbial Testing and Testing of water Quality  Place the Verification Under Supervisory Control  Periodically Verify the Performance of Machines for Accuracy  Verify the Regular, Breakdown and Preventive Maintenance Programs  Conduct Periodic Verification of all Monitoring Activities  Conduct Periodic Verification on Corrective Actions  Record all Verification Activities  Review Adequacy of Monitoring Periodically 11/19/2015 www.enhancequality.com16

17. Required HARPC Records Processing, Storage and Distribution Records Include:  Information that Establishes the Efficacy of a RPC to Maintain Product Safety  Data Establishing the Safe Shelf Life of the Product; If age of Product can Affect Safety  Records Indicating Compliance with RPC When Packaging Materials, Labeling or Sealing Specifications are Necessary for Food Safety  Monitoring Records.  Verification Records and Other Records 11/19/2015 www.enhancequality.com17

18. Reanalyze  Generally Validity for HARPC Plan Once Drawn and Verified is 3 Years  Reanalyze the Plan After 3 Years  Take in to Account all Customer Complaints Before Drawing up a fresh Plan  Take in to Account all Process Changes  Take in to Account all Modifications issued by FDA for Its Requirements  Take into Account all Amendments to FSMA 11/19/2015 www.enhancequality.com18

19. Guidelines for Implementation The Following are Simplified Steps for Implementation of HARPC:  Form a Cross Functional HARPC Team  Make a Detailed Process Flow Diagram  Identify all Potential Hazards  Identify Risk of Occurrence that could be Caused by the Hazards – Risk-Based Analysis  Identify all PRPs Required for the Facility  Identify Acceptable Control Points Scientifically  Incorporate Check-Off Lists and Monitoring Procedure  Identify Verification Procedures and Authority to Verify  Retain Records  Reanalyze After 3 Years 11/19/2015 www.enhancequality.com19

20. Summary  Hazard is a Physical, Chemical Biological or Radiological Contaminant Affecting Food Safety  Risk is the Possibility of Such Hazard Reaching Food at Some Point.  Concept of Risk-Based Preventive Controls (RPC)  Safety is Essential in Food Industry Ensure it.  FDA Requirements are Mandatory  7 Principles of HARPC  Monitoring for Effectiveness of Control is Essential  Verification at a Supervisory Level is part of HARPC  Retaining Records of all Check-Off Lists, Monitoring and Verification Activities is Essential 11/19/2015 www.enhancequality.com 20

21. Assistance Contact: 11/19/2015 www.enhancequality.com21 Quality Systems Enhancement 1790 Wood Stock Road Roswell GA-30075 E. mail: info@enhancequality.com www.enhancequality.com Phone: 770-518-9967 Fax: 770-518-9968 Call 770-518-9967 for Immediate Assistance

22. Thank You 11/19/2015 www.enhancequality.com22