Transcript Preparing for the Food Safety Modernization Act Agenda 1. Introduction to the Food Safety Modernization Act (FSMA) 2.

Preparing for the Food
Safety Modernization Act
Agenda
1. Introduction to the Food Safety
Modernization Act (FSMA)
2. Common Non-Conformances
a) PrimusGFS
b) SQF
c) Global GAP
3. Improvement Strategies
I Promise This Will Be Fun!
HACCP
FSMA
GFSI
Food Safety Modernization Act
http://www.fda.gov/Food/GuidanceRegulation/FSMA/
Key Themes and Concepts
Common Acronyms
FSMA
Food Safety Modernization Act
HACCP
Hazard Analysis and Critical Control Points
HARPC
Hazard Analysis and Risk Based Preventative Controls
FSVP
Foreign Supplier Verification Program
PHF
Potentially Hazardous Food
RTE
Ready to Eat
RLTO
Relatively Likely to Occur
QAR
Qualitative Assessment of Risk
VQIP
Voluntary Qualified Importer Program
SAHCODHA
Serious Adverse Health Consequences or Death of Humans or Animals
Prevention
• Mandatory Preventive
Controls for Food
Facilities
• Mandatory Produce
Safety Standards
• Intentional
Adulteration Standards
• Foreign Supplier
Verification/Transport
safety
FSMA Implementation Dates
Who is Affected by FSMA?
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Manufacturers and processors
Farmers and growers
Transporters
Retailers
Importers
Laboratories
Third party certification bodies
Foreign governments
Who is Exempt from this Rule?
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Juice and Seafood HACCP programs
Low acid canned foods
Alcoholic beverage processing
Dietary supplement manufacture,
processing or holding
• Storing raw agricultural products other
than fruits and vegetables (Grain)
• Storing unexposed packaged food at
ambient temperatures
Qualified Individual
• Prepares and Manages the
Food Safety Plan
• Validates Preventive
Controls
• Reviews Records
• Determines Appropriate
Corrective Actions
• Reviews Food Safety Plan
FSMA Preventive Controls
Hazard
Analysis
Preventive
Controls
Reanalysis
Documentation
Verification
Monitoring
Corrective
Actions
HARPC for Facilities
FSMA Section 103
Hazard Analysis and Risk-Based Preventive
Controls (HARPC)
• Evaluate Food Safety Hazards
• Identify and Implement Preventive
Controls
• Monitor Controls
• Maintain Monitoring Records
• Conduct Verification Activities
HACCP vs HARPC
What is the difference between
HACCP and HARPC?
HACCP
Plan
HACCP+
HACCP
Elevated
Plan
PRPs= HARPC
Plan
Elevated Prerequisite Programs
Prerequisite Programs/ GMPs
Prerequisite Programs/ GMPs
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Produce Rule
Sec. 105. Standards for Produce Safety
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Agricultural Water
Soil Amendments
Health and Hygiene
Hazards in the growing area
(Animals)
• Equipment, Tools and Facilities
• Sprout Production Enhancements
Sanitary Transport
Sec. 111. Sanitary Transportation of Food
• Sanitary transportation practices
• Documentation
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Import Safety
 Importer accountability
 Third Party Certification
 Certification for High Risk Foods
 Voluntary Qualified Importer Program (VQIP)
Authority to Deny Entry
Steps to FSMA Compliance
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Inspection and Compliance
• Mandated inspection
frequency
(At least every 3 years if high risk)
• Records Access
• Potential Testing of
Products
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Regulatory Response
• Mandatory Recall
• Expanded Administrative
Detention
• Suspension of Registration
• Record Retention
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Foreign Supplier Verification Program
• Importers will be required to develop,
maintain and follow FSVP for each food
imported
• Requirements vary based on
• Type of food product
• Category of importer (small, very small)
• Nature of the hazard identified in food
• Who controls the hazard
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FSVP Requirements: Activities
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Compliance Review of Foods and Suppliers
Hazard Analysis (Biological, Chemical and Physical)
Supplier Verification Activities
Corrective Actions (if needed)
Periodic Reassessment of the FSVP
Importer Identification at Entry
Recordkeeping
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Third Party Certification Programs
 Tool for importers to obtain needed assurances under FSVP
 Participate in the VQIP to expedite movement of food
 Can be required by FDA to accompany high-risk foods
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Enhanced Partnerships
Inspection by Other Agencies
 International Capacity Building
 Improved Foodborne Illness Surveillance
So what are our collective challenges?
PrimusGFS Documentation NCs
Source: Azzule PrimusGFS v2.1
PrimusGFS Documentation NCs
PrimusGFS Facility NCs
PrimusGFS Facility NCs
SQF Document
Certification
Re-Certification
Surveillance
Interesting to note which NCs occur in every certification scenario:
2.5.7.1 – Internal Audits
Specifically a routine internal inspection program shall be
implemented and documented
2.4.5.4 – Incoming goods and services
Specifically approval should be based on performance
Source: SQFI
SQF Facility
Certification
Re-Certification
6 Mo Surveillance
Which NCs occur in every cert scenario?
•11.2.13 – Cleaning and Sanitation (*This clause has 8 subparts)
•11.7.5 – Control of Foreign Material
•11.2.3 – Walls, Partitions, doors, and Ceilings
•11.2.12 – Equipment, Utensils, and Protective Clothing
Source: SQFI
SQF Quarterly Report
Minor
Source: SQFI
Major
Critical
GlobalGAP IFA v4.0
How to improve your GFSI performance?
How to improve your GFSI performance?
How do you measure the success of your Program?
 Key Performance Indicators (KPIs)
• Internal Audit Findings
•3rd Party Audit Score
•Customer Complaints
•Sanitation Performance
•Maintenance Program Review
•Training Program Performance
How to improve your GFSI performance?
Do you have a strong TEAM?
 Do you have the right hierarchy?
Are the right people in the right positions?
•Proper balance of personality types
 Do employees communicate well?
Do you have a commitment to excellence that is humane?
•How is your employee turnover in key positions?
How to improve your GFSI performance?
Focus on Fundamentals
 This is Food you produce
 Keep your process simple and try not to do too much
 Use data to guide your decisions
Thank You
Greg Komar
NSF Agriculture
[email protected]
www.nsf.org