haccp plan: what to do before, during, and after · consider resource requirements and plan ......

HACCP Plan: What to Do

Before, During, and After

Jon Kimble, Central District Manager

DFA of California

JonK@dfaofca.com

What to Do…

Before Determine Scope

Assessment

Training & Implementation

During Ongoing verification

Common Gaps

After Corrective actions

Root cause analysis

Continual improvement!

BEFORE IMPLEMENTATION

Determine Scope –

Where are You Headed?

Consider Where FDA is

Headed (Processed Foods)

Low-Risk

Commodities,

Processes

Most Food

Production

Facilities

Customer - driven

Which Way?

Establish criteria

1 - Basic GMP

2 - HARPC / HACCP

3 - GFSI (SQF, BRC, IFS, FSSC 22000)?

Minimum: regulatory requirements

Final direction often customer-driven

Consider resource requirements and plan

accordingly

Assessment –

Where Do We Stand?

Conduct A Gap Analysis

Use a checklist or standard

Team approach

Be thorough and honest

Engage help as necessary

Third-party pre-assessment a great option

Checklist Availability SQF: http://www.sqfi.com/documents/

BRC: http://www.brcglobalstandards.com/Manufacturers/Food/GuidanceandFAQs.aspx

HACCP: Codex Alimentarius Guidelines http://www.codexalimentarius.org/input/download/standards/23/CXP_001e.pdf

HARPC: Final rule not yet published, check FDA web site for draft

GMP: 21 CFR 110 (Codex also contains GMP guidance) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110

Now What?

Review & Implement

Food Safety Team

Review items identified

Propose corrections & responsibility

Management Team

Review proposed corrections

Approve & assign resources as needed

Follow up! Ongoing tracking - conduct review meetings / status updates.

Train, Train, Train

Success rests largely on people

Daily, consistent implementation of program

Understanding the “why”

Triggers participation, helps

drive food safety culture

Keep records

Implementation:

12 Easy Steps?

“The Five Preliminary Steps”

1. Assemble the HACCP Team

2. Describe the product

3. Identify intended use

4. Construct flow diagram

5. On-site verification of diagram

HACCP Steps Continued

“The Seven Principles”

6. Conduct hazard analysis

7. Determine CCPs

8. Establish critical limits

9. Establish monitoring system

10.Establish corrective actions

11.Establish verification procedures

12.Establish documentation system (policies, procedures, records)

“DURING” -

WE’RE DONE NOW, RIGHT?

On An On-Going Basis…

Verification of Programs

A core element of food safety programs

Physical Inspection – “the proof is in the pudding”

Recalls often traced to the basics

Verify implementation of procedures

Observe practices

Talk with employees

Cardinal rule: audit entire system once per year minimum. Frequency based on risk.

Verification Schedule

Topic Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Glass & brittle materials audit X X X X X X X X X X X X

Review document register X X X X X X X X X X X X

Document control audit X X X X

General GMP Audit X X X X

Pest control review X X X X X X X X X X X X

Review security measures X X X X

Review training programs

Shipping & Receiving programs X X X X

Supplier Management & product

development

X X

“Mock recall” exercise X X

HACCP Plan Review X X

Verification Risk Analysis

Audit SeverityLikelihood of

Hazard

Risk

Value

Frequency

Based on

Risk

1 Topic/Area 1 2 2 Annual

2 Topic/Area 5 5 25 Weekly

3 Topic/Area 4 1 4 Bi-Annual

4 Topic/Area 2 4 8 Monthly

5 Topic/Area 2 4 8 Monthly

6 Topic/Area 1 5 5 Annual

7 Topic/Area 1 4 4 Annual

8 Topic/Area 2 2 4 Annual

9 Topic/Area 3 1 3 Annual

10 Topic/Area 2 1 2 Annual

Definitions

Global Food Safety Initiative (GFSI) Definitions:

Validation

An activity to obtain evidence that a requirement is controlled effectively.

Verification

A confirmation, through the review of objective evidence, that requirements have been fulfilled.

Again… Train!

Schedule annual refresher training

Ensure nobody is missed

Verify effectiveness

Tests/quizzes

Direct observation

Recommend bite-size chunks

“tailgate meetings”

Document it

Common Gaps1. Absence of required HACCP step or

supporting procedure (PRP)

2. Flow diagram

3. Hazard analysis

4. Training

5. Supplier control

6. Incident management

7. Internal audit

8. Document control

9. Fundamental GMP issue

AFTER THE AUDIT

Corrective Actions –

Bring it Full circle

1. Initial correction

2. Root Cause Analysis

Identify “Real root cause”

Goal: prevent recurrence of issue

Sometimes obvious, sometimes not

Use your team!

3. Final corrective action

Note: For more guidance see BRC’s “Understanding Root Cause”

5-Why Using “Word Art”

Immediate cause

Next cause

#3

#4

#5 – Real root cause

Fishbone Using “Word Art”

• Cause

• CauseMan

• Cause

• CauseMethod

• Cause

• CauseMaterial

• Cause

• CauseManagement

• Cause

• CauseMachinery

• Cause

• CauseMother Nature

Continual improvement –

It’s all uphill from here!

Plan

DoCheck

Adjust

THANK YOU!

Jon Kimble

Central District Manager

DFA of California

JonK@dfaofca.com

209-216-9382