Preventive Controls Phase 2 Workgroup 1.
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Transcript of Preventive Controls Phase 2 Workgroup 1.
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Preventive ControlsPhase 2 Workgroup
http://www.fda.gov/fsma
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Results Oriented Management (ROM)
• Defines high level and supporting results to ensure we perform activities that have a direct or causal relationship with achieving those results
• Identifies metrics to monitor the progress of goals FDA wants to achieve– Tracking trends– Making appropriate adjustments
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Metrics• Four criteria used to select a good metric:
− Direct: Measure of the result− Objective: Stated in a way that is measurable,
precise and unambiguous− Practical: Data for the indicator can be collected in
a reliable, timely and cost-effective manner.− Adequate: Set of measures for any particular result
is sufficient to understand whether progress is being made toward the achievement of the goal.
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Guidance
• FDA will develop and make available guidance documents to help industry and food/feed safety staff identify significant hazards and develop preventive control strategies
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Technical Assistance
• Launch an internal technical assistance network that involves all food safety staff to help ensure consistent implementation in the field
• Supplement the internal technical assistance network by identifying Subject Matter Experts to help mentor food safety staff
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Training• Food Safety Preventive Controls Alliance
(FSPCA): Develop and deliver basic preventive controls training to show industry and regulatory staff how to develop a Food Safety Plan that would be acceptable to FDA
• FDA: Develop and deliver a training curriculum for regulatory staff on how to assess a facility against the requirements of the preventive controls rule.
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Training
• Overlay large, small and very small facility inventory and rollout training according to compliance dates.
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FSMA Training Work Group
• Formed in January 2015 to plan preventive controls (PC) regulator training for food and feed safety staff
• Development and delivery model to include curricula developers, Train the Trainers (TTT), and Instructor Cadre– Will consist of experts from ORA, CFSAN,
CVM, and States
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FSMA Training Work Group
• New training needed:− Food Safety Preventive Controls Alliance Core
Curriculum (prerequisite)− Good Manufacturing Practices (updated
regulations) overview for human and new for animal food (Subpart B of PC rules)
− Preventive Controls (Subpart C of PC rules)− FDA’s Food Hazards and Controls Guide for
Human and Animal Food
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Inspection Approach
• Need to consider staggered compliance timeframe
• Not a “one size fits all” approach• Two-tier approach
– Adequacy first, then implementation
• Feasibility study or pilot (corporate vs facility)
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Inspection Reporting System
• Streamline IT inspection reporting system to capture structured data and track corrective action
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Compliance• Rank violations based on regulatory requirement
AND public health impact (e.g., critical, major, minor)
• Regulatory strategy that is dynamic, i.e., different violations trigger different regulatory response, different industry timeframes for corrective action, and different timeframes for FDA or state verification
• Build in industry incentives for prompt and adequate corrective action
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Challenges
• Food Facility Establishment Inventory• Information Technology• Improving communication with
stakeholders• Change in Culture
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Breakout Sessions
• Session 1 Discussions− Technical assistance and outreach− Tools for developing Food Safety Plan
• Session 2 Discussions− Challenges to inspection and
compliance− Incentives for compliance− Inspection approaches
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