Preventive ControlsPhase 2 Workgroup

http://www.fda.gov/fsma

1

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

2

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.

4

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

5

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

6

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.

7

Training

• Overlay large, small and very small facility inventory and rollout training according to compliance dates.

8

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

9

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

11

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)

12

Inspection Reporting System

• Streamline IT inspection reporting system to capture structured data and track corrective action

13

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

14

Challenges

• Food Facility Establishment Inventory• Information Technology• Improving communication with

stakeholders• Change in Culture

15

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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