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Awareness Training: ‘HARPC’ for Food Safety

Complimentary Presentation byQuality Systems Enhancement

1790 Wood Stock RoadRoswell GA-30075

E. mail: [email protected]

Phone: 770-518-9967 Fax: 770-518-9968

1

http://www.enhancequality.com/

www.enhancequality.com 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

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What is HARPC?

HARPC Stands for

Hazard Analysis Risk-based Preventive Control

Mandatory for all Entities Dealing with FoodProcessing, Packing or Storage as per final

Rule of FSMA released on November13 2015.

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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)

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Terms (Cont’d.)

Hazard Analysis:

Hazard Analysis is to Accomplish Following Objectives:

1. Identification of Hazards2. Identification of Acceptable Levels3. Identification of Risks and Potential Risks4. Identification of Modifications to Process5. Identification of Control Methods to Ensure Product Safety6. Identification of Risk-Based Preventive Controls (RPC)

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RiskFood Safety Risk is defined as:

"The Scientific Evaluation of Known or Potential Adverse Health Effects Resulting from Human Exposure to Foodborne Hazards."

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Terms (Cont’d.)


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

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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

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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 Ingredients & Packaging Terms Food Allergens Food Additives & Ingredients Consumer Information About Additives and Ingredients Including:

Caffeinated Alcoholic Beverages Sweeteners Sodium Color Additives

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http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359436.htm

http://www.fda.gov/Food/IngredientsPackagingLabeling/Definitions/default.htm

http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm

http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/default.htm

http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm094210.htm


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 Industry11/19/2015


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

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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

IngredientsDoes 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)?

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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

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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

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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

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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


Required HARPC RecordsProcessing, 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

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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

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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

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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 11/19/2015www.enhancequality.com


Assistance• Contact:

11/19/2015

Quality Systems Enhancement1790 Wood Stock Road

Roswell GA-30075E. mail: [email protected]

www.enhancequality.comPhone: 770-518-9967 Fax: 770-518-9968

Call 770-518-9967 for Immediate Assistance

http://www.enhancequality.com/


Thank You

11/19/2015

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