1. Validus Auditor Training
January 2017
FSC36 Safe Feed/Safe Food: Guidance Document Version 7.0 Training June 2017

2. FSC36 Safe Feed/Safe Food Training
AGENDA
Very Quick Review Food Safety Modernization Act
Guidance Document: Old vs. New
Questions
Please ask Questions as we cover the information.
GOAL: address your questions and help you understand the version 7.0 Guidance Document

3. Validus Auditor Training
January 2017
FSMA Snap Shot
Signed into law January 4, 2011
The current food safety system has opportunity for improvement.
1 in 6 Americans (48 million) sickened; 128,000 hospitalized; 3,000 die each year from foodborne diseases (CDC, 2011)
Identified by FDA as the most sweeping reform of food safety laws in more than 70 years.
GOAL: Aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

4. Preventive Controls for Animal Food Timeline
Validus Auditor Training
January 2017
Preventive Controls for Animal Food Timeline
January 2011: FSMA signed into law
October 2013: First version issued (Proposed Rule)
September 2014: Second version issued (Revised Rule)
September 2015: Final rule published
Business Size
Subpart B
Current Good Manufacturing Practice
Subpart C
Hazard Analysis and Risk-Based Preventive Controls
All Others
Sept. 19, 2016
Sept. 18, 2017
Small Businesses
(< 500 FTE)
Sept. 17, 2018
Very Small Businesses
(< $2.5 million/year)
Sept. 17, 2019

5. Validus Auditor Training
January 2017
Who Must Comply?
Facilities that manufacture, process, pack, or hold animal food for consumption in the United States
In general, those that register under Section 415 of the Federal Food, Drug, and Cosmetic Act (Bioterrorism Act).
Not complying is considered a prohibited act.
Animal food covered by specific CGMP regulations must still comply with those regulations
Low-acid canned food
Medicated feed

6. 21 CFR Part 507 Preventive Controls for Animal Food
Validus Auditor Training
January 2017
21 CFR Part 507 Preventive Controls for Animal Food
Subpart A – General Provisions
Subpart B – Current Good Manufacturing Practice
Subpart C – Hazard Analysis and Risk-Based Preventive Controls
Subpart D – Withdrawal of a Qualified Facility Exemption
Subpart E – Supply-Chain Program
Subpart F – Requirements Applying to Records That Must Be Established and Maintained

7. Food Safety Modernization Act
More Quality & Food Safety Certifications
BENEFIT: Certified facilities are considered lower risk.
END RESULT: More facilities will obtain 3rd party certifications for quality & food safety to ensure compliance with FSMA requirements
FSMA
GOAL: Develop a proactive program to reduce potential animal food safety risks versus a reactive approach to failures or nonconformities
Facility

8. Good News! FSC36 Safe Feed/Safe Food Updates – Version 7.0
Requirements for FSC36 Safe Feed/Safe Food are not changing.
However, the expectations relative to FSMA compliance are clearer.

9. FSC36 Safe Feed/Safe Food Updates – Version 7.0
More direct references to FSMA animal food rule requirements
After comparing FSMA animal food rule to FSC36 guidance document, there seemed to be several gaps.
CGMP requirements were not specifically identified although the expectations were generally called out within the various requirements.  
The requirements for records (subpart F of the animal food rule) have been incorporated into clause 2.3 Records.
FSMA requirements for the food safety plan and preventive controls have been added to the guidance document.

10. FSC36 Safe Feed/Safe Food Updates – Version 7.0
“Auditing Guidance” was removed while “Implementation Guidance” was maintained
Within version 7.0, the auditing guidance will be removed because this has been a point of confusion for auditors as well as facilities seeking certification. 
Many auditors and auditees have interpreted this information as the only items that are relevant to the audit
Auditing guidance will be an individual/stand-alone document. This allows changes or additions as needed to help auditors maintain consistency and improve the quality of audits.

11. FSC36 Safe Feed/Safe Food Updates – Version 7.0
Reference to clauses has been updated
In version 6.0, there were sections with the same number within the document. As an example, Section 2.3 = “Auditing Duration Guide” while within the scheme requirements in Section 5.0, 2.3 = “Document Control (M)”. 
In version 7.0, “SF/SF” will be added in front of each clause for Safe Feed/Safe Food requirements in Section 5.0.

12. Updated FSC36 Safe Feed/Safe Food
84 clauses with requirements for compliance divided among 10 areas
QUALITY & FOOD SAFETY AREAS
V. 7.0
V. 6.1
SF/SF 1 MANAGEMENT COMMITMENT AND RESPONSIBILITY 6
SF/SF 2 QUALITY AND FEED SAFETY MANAGEMENT SYSTEM 3 4
SF/SF 3 FSMA CURRENT GOOD MANUFACTURING PRACTICE (CGMP) REQUIREMENTS 9
SF/SF 4 PERSONNEL AND TRAINING 5
SF/SF 5 INFRASTRUCTURE
SF/SF 6 PRODUCT REALIZATION 23
SF/SF 7 PURCHASING PROCESSES AND CONTROLS
SF/SF 8 VALIDATION AND VERIFICATION 13
SF/SF 9 ANIMAL FOOD SAFETY PLAN 11
SF/SF 10 FSC36 SAFE FEED/SAFE FOOD SEAL REQUIREMENTS 1
TOTAL 84 77

14. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 1 MANAGEMENT COMMITMENT AND RESPONSIBILITY
SF/SF 1.1 Management Policy (M)
SF/SF 1.2 Management Responsibility (M)
SF/SF 1.3 Responsibility, Authority and Communication (M)
SF/SF 1.4 Management Review
SF/SF Management Review Process
SF/SF Management Review Inputs and Outputs
SF/SF Records for Management Review
Remains the same with 2017 update
OBJECTIVE: Ensure management commitment and engagement with the quality and animal food safety program

15. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 2 QUALITY AND FEED SAFETY MANAGEMENT SYSTEM
SF/SF 2.1 General Requirements
SF/SF 2.2 Quality and Feed Safety Manual (M)
SF/SF Document Control (M)
SF/SF 2.4 Records (M)
Clause removed in update
Updated with FSMA language (more detail)
OBJECTIVE: Ensure the facility maintains the “tools” to implement an effective quality and animal food safety program

16. FSC36 Safe Feed/Safe Food Updates – Version 7.0
New Clauses Added to Cover CGMP’s

17. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 3 FSMA CGMP REQUIREMENTS
SF/SF 3.1 Personnel
SF/SF 3.2 Plant and Grounds
SF/SF Facility Grounds
SF/SF Facility Structure
SF/SF Outside Storage
SF/SF 3.3 Sanitation
SF/SF 3.4 Water Supply and Plumbing
SF/SF 3.5 Equipment and Utensils (Tools)
SF/SF 3.6 Facility Operations
SF/SF 3.7 Holding and Distribution
ALL NEW CLAUSES – LANGUAGE TAKEN FROM FSMA
OBJECTIVE: Ensure the facility complies with FSMA CGMP requirements
(less emphasis on “records” – more emphasis on “actions”)

18. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 4 PERSONNEL AND TRAINING
SF/SF 4.1 Competency and Job Descriptions (M)
SF/SF 4.2 Requirements for a Preventive Controls Qualified Individual (PCQI) (M)
SF/SF 4.3 Personnel Policies and Behavior
SF/SF 4.4 Personnel Facilities
SF/SF 4.5 Visitors
NEW
OBJECTIVE: Ensure the personnel are properly prepared, facilities are adequate and visitors are controlled

19. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 5 INFRASTRUCTURE
SF/SF 5.1 Maintenance
SF/SF 5.2 Lighting and Work Areas
SF/SF 5.3 Pest Management and Control
SF/SF Pest Management (M)
SF/SF Pest Control Chemicals (M)
SF/SF Pest Management Personnel
SF/SF 5.4 Cleaning and Housekeeping (M)
REMOVED
SF/SF 4.1 Facility Construction and Surfaces
SF/SF Equipment
SF/SF 4.6 Exterior
OBJECTIVE: Ensure the facility is properly designed and maintained for its intended purpose, ensure work areas are sufficient and pest management is properly implemented

20. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 6 PRODUCT REALIZATION
SF/SF 6.1 Product Development
SF/SF 6.2 Packaging and Raw Materials Receiving Processes
SF/SF Receiving Processes for Packaging Materials
SF/SF Receiving Processes for Raw Materials and Ingredients
SF/SF Equipment at Receiving
SF/SF 6.3 Manufacturing Processes
SF/SF Process Control (M)
SF/SF Control of Raw Materials and Ingredients
SF/SF Product Release (M)
SF/SF 6.4 Finished Products
SF/SF Finished Products Specifications (M)
SF/SF Product Formulation (M)
No changes in Product Realization

21. FSC36 Safe Feed/Safe Food Updates – Version 7.0
No changes in Product Realization
SF/SF 6 PRODUCT REALIZATION
SF/SF 6.5 Customer Related Processes
SF/SF Customer Requirements
SF/SF Customer Communication
SF/SF 6.6 Labeling (M)
SF/SF 6.7 Nonconforming Products and Materials (M)
SF/SF 6.8 Rework (M)
SF/SF 6.9 Inventory Stock Rotation

22. FSC36 Safe Feed/Safe Food Updates – Version 7.0
No changes in Product Realization
SF/SF 6 PRODUCT REALIZATION
SF/SF Storage of Materials and Finished Products
SF/SF Storage of Raw Materials and Ingredients
SF/SF Storage of Packaging
SF/SF Storage of Finished Products
SF/SF Storage of Nonconforming Materials
SF/SF Bulk Storage of Ingredients and Finished Products
SF/SF Storage of Hazardous Chemicals
SF/SF Hazardous Chemical Storage Process (M)
SF/SF Hazardous Chemical Storage Area (M)
SF/SF Loading, Transport and Unloading Practices
OBJECTIVE: Ensure food safety concerns are considered and records maintained for developing products, receiving materials and manufacturing finished products; ensure appropriate information is received from and provided to customers; ensure food safety is maintained during storage

23. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 7 PURCHASING PROCESSES AND CONTROLS
SF/SF 7.1 Vendors for Incoming Goods and Services
SF/SF Approved Vendors (M)
SF/SF Unapproved Vendors or Temporary Sourcing
SF/SF 7.2 Raw and Packaging Materials Specifications (M)
SF/SF 7.3 Contract Service Providers
SF/SF Specifications for Contract Service Providers
SF/SF Contract Manufacturing
No changes in Purchasing Processes and Controls
OBJECTIVE: Ensure processes are implemented for vendor (supplier) approval and that appropriate communications are maintained to provide the desired materials

24. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 8 VALIDATION AND VERIFICATION
SF/SF 8.1 Responsibility, Frequency and Methods
SF/SF 8.2 Validation
SF/SF 8.3 Equipment Calibration
SF/SF 8.4 Verification of Implementation and Effectiveness
SF/SF 8.5 Product Sampling, Inspection and Analysis
SF/SF Processes for Product Sampling
SF/SF Inspection and Analysis of Raw Materials
SF/SF Inspection and Analysis of Finished Products
Updated with FSMA language
Changed
Changed
OBJECTIVE: Ensure appropriate validation and verification is completed for equipment, monitoring devices and finished products

25. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 8 VALIDATION AND VERIFICATION
SF/SF 8.6 Internal Audits
SF/SF Internal Audit Process
SF/SF Internal Auditors
SF/SF Internal Audit Corrective Actions
SF/SF 8.7 Product Identification (M)
SF/SF 8.8 Product Traceability (M)
SF/SF 8.9 Animal Food Defense and Biosecurity Plan
No changes
OBJECTIVE: Ensure appropriate validation and verification is completed for equipment, monitoring devices and finished products through internal auditing, product identification and traceability; ensure an animal defense/biosecurity plan has been developed

26. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 9 ANIMAL FOOD SAFETY PLAN
SF/SF 9.1 Components of a Food Safety Plan (M)
SF/SF 9.2 Records for the Food Safety Plan (M)
SF/SF 9.3 Hazard Analysis (M)
SF/SF 9.4 Preventive Controls (M)
SF/SF 9.5 Corrective and Preventive Actions (M)
SF/SF 9.6 Supply-Chain Program for FSMA Subpart E Compliance
SF/SF 9.7 When Implementation of Preventive Controls Is Not Required
Updated with FSMA language
OBJECTIVE: Ensure an animal food safety plan has been developed
CAUTION: Animal Food Safety Plan is not required by FSMA until Sept 2017 for Large Businesses and Sept 2018 for Small Businesses

27. FSC36 Safe Feed/Safe Food Updates – Version 7.0
SF/SF 10 FSC36 SAFE FEED/SAFE FOOD SEAL REQUIREMENTS
SF/SF 10.1 Compliance with Safe Feed/Safe Food Seal Licensing Agreement
OBJECTIVE: Ensure the Safe Feed/Safe Food logo is used appropriately and proper statements are provided on packaging or labels

29. THANK YOU