preparing for the food safety modernization act. agenda 1.introduction to the food safety...
TRANSCRIPT
Preparing for the Food Safety Modernization Act
Agenda1. Introduction to the Food Safety
Modernization Act (FSMA)
2. Common Non-Conformances a) PrimusGFSb) SQFc) Global GAP
3. Improvement Strategies
I Promise This Will Be Fun!
HACCPFSMAGFSI
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?
• Manufacturers and processors• Farmers and growers• Transporters• Retailers• Importers• Laboratories• Third party certification bodies• Foreign governments
Who is Exempt from this Rule?• 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
Monitoring
Corrective Actions
Verification
Reanalysis
Documentation
HARPC for FacilitiesFSMA Section 103 Hazard Analysis and Risk-Based PreventiveControls (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
Prerequisite Programs/ GMPs
HACCP Plan
Prerequisite Programs/ GMPs
Elevated Prerequisite Programs
HACCP + Elevated PRPs=
HARPC Plan
Produce RuleSec. 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
Import Safety Importer accountability Third Party Certification Certification for High Risk Foods Voluntary Qualified Importer Program (VQIP)Authority to Deny Entry
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Steps to FSMA Compliance
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• 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
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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
Source: SQFI
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
SQF Facility
Source: SQFI
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
SQF Quarterly Report
Source: SQFI
Minor Major Critical
GlobalGAP IFA v4.0
Food Safety Related
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
