Auditing HACCP Programs

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Roger Roeth

Executive Technical Officer 2016

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 This training is applicable to both:

• HACCP Plans

• Preventive Control Plans (FSMA)

Overview

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 Types of Audits

• First Party – Internal audit

• Second Party – Customer or supplier audits

• Third Party – External audit where auditor is unrelated to business

Types of Audits

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 Internal Audits

• To evaluate the organization’s own process, procedures, and products

• Undertaken by the organization on its own QMS and FSMS

• How many parties involved = 1 (the organization)

• The organization gets the report

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 Also known as external audits, customer audits or supplier audits

 Parties involved – two

• Organization and the customer or supplier

 Audit is completely flexible – based on what the customer wants

 Report goes to the customer

Second Party Audits

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 Also known as registration audit

 Parties involved – three

• Organization, customer and the certification body

 Carried out by an independent organization

 Very inflexible as it must follow the audit process completely

 Report goes to the organization and the certification body

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How to Audit HACCP

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 The method to audit HACCP, or any type of audit, follows the same basic process with some minor differences.

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Auditor Main Requirements

How to Audit HACCP

Understand the Principles of HACCP

Understand the Process and Product that is

Being Produced

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Steps to Audit

Audit the Entire HACCP Plan

• Include prerequisite programs

• Review the entire 12 Step HACCP Process AND address each component separately

• Compare to Codes or NACMCF

Communicate to all Parties being

Audited

Use the Process Audit Approach

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 Audit Technique

• Incorporate interviews of personnel

Open ended questions

Base questions off of HACCP Plan and PRPs

• Observations of all staff

Step back and watch

• Inspect the surroundings and equipment

• Review records on the floor

• Audit to the documented plan and procedures

• Understand regulatory requirements

How to Audit HACCP

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 Documenting the Audit

• Write legibly

• Document clearly any issues or non-conformances observed

Location

Activity

Staff

Describe failure

• Document positives

•

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Understanding the HACCP Plan

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 HACCP

• Includes 12 step process (five initial steps and the seven HACCP principles)

• Five initial steps (preliminary steps)

1.

Assemble Food Safety Team

2.

Describe the Product

3.

Identify Intended Use

4.

Flow Diagram

5. On-Site Verification of Flow Diagram

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 Seven HACCP Principles 1. Hazard Analysis 2. Identify CCP

3. Establish Critical Limit

4. Establish Monitoring Procedure for Each CCP 5. Establish Corrective Action

6. Establish Verification Procedure

7. Establish Documentation and Record Keeping

Understanding the HACCP Plan

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 Audit the FIVE preliminary steps

1. HACCP Team Cross Functional

• Training completed

• Interview a member of team

• Do they hold meetings?

2. Product Description – Ensure Completeness

• Finished product

• Raw material, packaging, process aids

• Very specific for ISO 22000

HACCP Team

Control Purchasing

Production Management

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 Audit the FIVE preliminary steps (continued) 3. Intended Use

• Does it cover the consuming population 4. Flow Diagram

• Are the steps of the process on the flow chart?

• Take to floor for verification

5. On-site Verification of Flow Diagram

• Has the HACCP team performed verification?

• Is the flow chart signed?

Auditing the HACCP Plan

Sample Flow Diagram

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 Auditing the 7 Principles - Review written plan first 1. Hazard Analysis

• Hazards reasonably likely to occur identified

• Does the hazard analysis match the steps of flow chart

• Hazard analysis for raw materials, packaging, and process aids completed

• Justification seem logical

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 Auditing the 7 Principles (Continued) 2. Identify CCP

• Documentation available that shows how CCPs identified 3. Critical Limit

• Supported by regulatory or scientific document 4. Monitoring Procedure

• Ensure it includes the who, what, when and how 5. Corrective Action

• Does it include the four steps

• Does it make sense

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 Auditing the 7 Principles (Continued) 6. Verification Procedures

• Are they complete

• Define who, what, when and how

7. Record Keeping

• What records generated

• Controlled documents

• Where maintained

• Retention time

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 Review the documentation to:

• Understand the details of the HACCP Plan

Both preliminary steps and 7 principles

• Take notes on important procedures

• Ask for a copy of the flow chart and HACCP Plan so you can take to the floor

• Helps you prep for the actual audit of plan

 Facility Inspection

• Verify documentation to what is really occurring

• Condition of facility

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 Monitoring - Observe employee performing task

• Compare to written procedures

• Use of calibrated instruments

• Interview the employee

Ask open ended questions?

What are their authority?

Do they understand what and why they are doing their task?

• Review their training records

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 Corrective Actions

• Review past deviations

• Look for trends

• Were actions complete?

• Was suspect product contained?

• Review records

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 Verification

• Does plan include all expected verification activities?

• Observe and compare to plan

• Review records

• Who is verifying?

• How were deviations handled?

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 Recordkeeping

• If it is not recorded, assume it is not being done!

• Review records for completeness

Signature of person monitoring

Time and date

Critical limit recorded

Correcting mistakes on paperwork

• Electronic data

Assurance of integrity

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 Validation

• Biggest challenge for small and very small plants

• Review documentation

• Supporting documents sufficient and credible

 Reassessment

• Review records

• Frequency

• Ask about changes in process

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Common HACCP Failures

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 CCP Identification

• Too many CCPs identified

 Ineffective Monitoring

• CCP not monitored frequently enough to control

• Personnel unsure of task

• Not performed as described in HACCP Plan

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 Records

• Records not complete

– missing times, signatures

• False times recorded

• Recorded prior to completion of task

• Use of whiteout or pencil

• Use of obsolete forms

• Not quickly accessible

Common HACCP Failures

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 Missing HACCP Plan

• Each product or product group has to have their own plan

 Lack of Training

• General staff

• Quality Assurance/HACCP Monitors

• Do not understand the “whys”

• Lack of documentation to support training

• Proper monitoring procedures

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 Instruments Used in Monitoring

• Not calibrated

• Frequency not acceptable

• Not calibrated correctly

• Calibrated inconsistently

• Record of calibration missing

• No procedure or action for handling an instrument found to be out of calibration

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 Documentation Missing

• CCP decision tree

• Hazard analysis

• Identification of food safety team

 Corrective Action Not Complete

• Root cause not identified

• Observe reoccurrence of problem

• Four criteria of corrective action not met

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 Methods not Validated

• Is there scientific proof to support control measures and critical limits?

• Is supporting documents from a credible source?

• Does the scientific proof actually match what is in the plan?

 Lack of HACCP Plan Review

• Minimum requirement is annually

• Required to review whenever there is a change in the system

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 Training your Auditors

• HACCP training

Internal

External – meet SQF requirements

• Internal audit training

Audit technique

Use of checklist

Documenting issues

Corrective action process

Importance of verification

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 Best practice for training

• Combination training that includes

Classroom

Observation audit

Witness audit

 Document training

 Provide method for sharing updates

HACCP Audit Training

Classroom

Observation

Witness

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800.795.3641

info@eaglecertificationgroup.com roger.roeth@eaglecertificationgroup.com.