haccp plan: what to do before, during, and after · consider resource requirements and plan ......
TRANSCRIPT
HACCP Plan: What to Do
Before, During, and After
Jon Kimble, Central District Manager
DFA of California
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
209-216-9382