Food Safety Management Solutions

HARPC: What You Need To Know

Chris Domenico, Safefood 360°

Food Safety Management Solutions

HARPC: What You Need To KnowChris Domenico / May 06, 2016

Food Safety Management Solutions

Agenda

• Introduction

• What Are the New Rules?

• HACCP vs HARPC

• HARPC• Qualified Individual• Food Safety Plan

• More FSMA!

• Q & A

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What are the new rules?

Food Safety Management Solutions

Food Safety Management Solutions

Food Safety Plan (PCP/HARPC)

Food Defense Plan

Foreign Supplier Verification Programs

FSMA RULES INCLUDE:

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Food Safety Management Solutions

• There is no easy silver bullet!

• Compliance with the Preventive Controls rules requires significant time and internal resources

• Far reaching legislation which covers food manufacturers and suppliers from the farmer’s market on up to the large ‘big box’ retailer

• “All facilities engaged in manufacturing, processing, packaging, or holding food for consumption in the United States” are required to conduct Hazard Analysis and Risk-Based Preventive Control reviews and implementations to establish science-based measures to reduce the risk of food contamination

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• In general, facilities required to register with FDA under

Sec. 415 of the FD&C Act must comply

• Applies to domestic and imported foods(some exemptions and modifications apply)

• The PCP (PCHF) intention: to modernize the

longstanding current Good Manufacturing Practices

(cGMP) requirements

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What is the

biggest

challenge your

company faces

in regards to

FSMA

compliance?

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HACCP –vs- HARPC

HARPC is very similar to HACCP in many waysException: HAZARD EVALUATION

• HACCP: Risk is determined with Preventive Controls in mind-Results in a lower risk

• HARPC: Risk is determined in the absence of Preventive Controls-Will result in a (sometimes significantly) higher risk

• Basic mitigation controls may be promoted to CCP or oPRP status

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Food Safety Plan (PCP/HARPC)

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Identify Qualified Individual

Identify the Food

Follow a Flow

Diagram

Identify the Hazards

Evaluate Hazards

Identify Preventive Controls

Validate Preventive Controls

and Establish

Parameters

MonitorImplement Corrective

Actions

Verify Activities

HARPC Steps

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What is new in PCP/HARPC?

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Qualified Individual

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• A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safey system

• The QI may be, but is not required to be an employee of the establishment

Qualified Individual

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Qualified Individual

• Must do or oversee the following: • Preparation of the Food Safety Plan• Validation of Preventive Controls• Review of Records• Reanalysis

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HACCP Plan

Food Safety Plan (PCP/HARPC)

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Have you

conducted a gap

analysis to

determine

current

compliance /

deficiencies?

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• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

Food Safety Management Solutions

• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

Food Safety Management Solutions

•Hazard identification must consider known or reasonably foreseeable biological, chemical and physical hazards• These could occor naturally, be unintentionally

introduced, or be intentionally introduced for economic gain

•Hazard evaluation must consider severity of illness/injury and probability of occurence in absence

of preventive controls

Food Safety Plan: Hazard Analysis

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Hazards

Biological Chemical Physical

Process MaterialsOperational Environment

HACCP

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Hazards

Biological Chemical Physical

Process MaterialsOperational Environment

Food FraudEconomically

Motivated Adulteration

Terrorism

HARPC / PCP

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Unintentional

Intentional

Naturally Occuring

Scope ofHazard Analysis

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HACCP

PRP CCP

Monitoring Verification CAPA Review

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HACCP

PRP CCP

Monitoring Verification CAPA Review

PCP/HARPC

Preventive Control

Monitoring Verification CAPA Review

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• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

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•Measures required to ensure that hazards are significantly minimized or prevented• Process controls• Food Allergen controls• Sanitation controls• Supply Chain controls• Recall plan

Food Safety Plan: Preventive Controls

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• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

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•Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (”supply-chain applied control”)

Food Safety Plan: Supply Chain Program

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Food Safety Plan: Supply Chain Program

Use Approved

Suppliers

Determine

Supplier

Verification

Activities

Conduct

Supplier

Verification

Activities

Document

Supplier

Verification

Activities

When applicable, verify a

supply-chain-applied

control applied by an

entity other than your

supplier

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•Onsite audits

•Sampling and testing

•Review of relevant food safety records

•Other as appropriate

Activity and frequency based on nature of hazard, where it is controlled and supplier performance

Food Safety Plan: Supply Chain Verification Activities

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• For serious hazards requiring a supply-chain-applied control:• Documented onsite audit before using the raw material

• At least annually after the initial audit

• Exception:• You document that other verification activities or less frequent

auditing provides adequate assurance

Food Safety Plan: Supply Chain -Onsite Audits

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• Must be performed by a qualified auditor• Governement employee

• 3rd Part (CB)

• Employee of receiving facility

• Inspection may substitute for audit in certain cases

Food Safety Plan: Supply Chain -Onsite Audits

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• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

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• Facility must have written procedures, including the frequency they are to be performed, for monitoring the preventive controls (as appropriate to the nature of the preventive control)

• Monitoring must be documented in records subject to verification

Food Safety Plan: Monitoring

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• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

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• Facility must have written procedures for steps to be taken when preventive controls are not properly implemented• Identify and correct problem

• Reduce the likelihood of occurence

• Evaluate food for safety

• Prevent adulterated food from entering commerce

Food Safety Plan: Corrective Actions and Corrections

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• Hazard Analysis

• Preventive Controls

• Supply Chain Program

• Procedures for Monitoring

• Corrective Action Procedures

• Verification Procedures

Food Safety Plan

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• Included as appropriate to the facility, food, and nature of the preventive control• Validation of preventive controls (Process Controls)

• Verification of monitoring and corrective action

• Calibration of process monitoring and verification instruments

• Product testing, environmental monitoring

• Records review

Food Safety Plan: Verification

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• Review at least every 3 years

• Whenever there is a significant change that creates the potential for a new hazard

• When there is new information about potential hazards associated with a food

• When a preventive control is ineffective

Food Safety Plan: Review

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We’re Ready!

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Is your facility

ready for a

FSMA

compliance

audit?

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But wait...there’s more FSMA!

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Food Defense Plan

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ConductVulnerability

Assessment (VA) and Food Defense

Audit

Identify gapsIdentify mitigation

strategiesrequired

Food DefensePlan

Food Defense Plan

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FSVP

Initial Hazard

Analysis of

Product

Full Risk

Assessment

of Product

Supplier

Evaluation

Verification of

Program

Determination

Verification of

Program

Implementation

Approval of

Supplier

Corrective

ActionsRe-Evaluation

Food Safety Management Solutions

Food Safety Plan (HARPC)

Food Defense Plan

Foreign Supplier Verification Programs

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Are you

considering

using software to

assist you with

building FSMA

compliant

programs?

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Safefood 360° is thesoftware for FSMA

Visit us at: www.safefood360.com

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