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Standard 3 Breakout Session Inspection Protocol & Recall Program. Robin Henderson, PhD, RD/LDN Maryland Department of Health & Mental Hygiene. Matthew Colson Florida State Department of Agriculture & Consumer Services. March 11, 2014 1:30 – 5:00 pm. Catherine Payne Feeney

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slide1

Standard 3 Breakout Session

Inspection Protocol & Recall Program

Robin Henderson, PhD, RD/LDN

Maryland Department of Health & Mental Hygiene

Matthew Colson

Florida State Department of Agriculture & Consumer Services

March 11, 2014

1:30 – 5:00 pm

Catherine Payne Feeney

Rhode Island Department of Health

Richard Stephens

Florida Department of Agriculture & Consumer Services

Catherine White

Rhode Island Department of Health

Tressa Madden

FDA ORA

Office of Partnerships

Michelle Motsinger

FDA ORA

Office of Partnerships

slide2

Agenda

  • Welcome, Introductions, & Housekeeping
  • Session Objectives
  • Current Status of Standard 3 Implementation
  • Inspection Protocol
    • Presentations, Exercise & Report Outs
  • Recall Program
      • Presentations, Exercise & Report Outs
  • Q & A
  • Summary
housekeeping
Housekeeping
  • Honor time schedule
  • Stay on topic
  • Get input from everyone
  • Be willing to share
  • Respect different program cultures
  • Do not reference specific audits
  • Be creative, ask questions – parking lot
  • Facilitators – responsible for process
  • Participants – responsible for content
session objectives
Session Objectives

Generate a list of resources, best practices, lessons learned and challenges/recommendations for developing, implementing and monitoring an inspection protocol and a recall program.

(Group Exercise Instructions)

Listen to presentations

Discuss and list suggestions on flip charts

Share your group’s suggestions with room

focus inspection protocol
FocusInspection Protocol
  • Standard Section 3.3.b1-22 or Program Element 2.b state:

Inspection Protocol

    • The State program has written policies and procedures for inspecting food plants that require the inspectors to: (items listed in Section 3.3.b1-22)
  • 31% Yes for conformance on this element
slide8

Standard 3: Inspection Protocol

Matt Colson

Environmental Administrator

Florida Department of Agriculture and Consumer Services

March 11, 2014

1:30 pm

background
Background
  • Inspection program overview
  • MFRPS background
  • Resources
    • RRT grant
    • FDA contract
standard 3 background
Standard 3 Background
  • Initially inspection procedures were based on retail
  • Added some language about manufactured food inspections to procedures
  • At same time worked on standard 4 inspection report audit component
inspections using old database
Inspections using old database
  • Had no way to document all items from Appendix 4.6 during inspections
  • Had coversheet for FDA contract inspections that was submitted with each inspection
    • Modified coversheet to add items from Appendix 4.6 that weren’t already being captured during inspection
inspections using new database
Inspections using new database
  • Developed inspection procedures based on new system and added 22 items
  • Identified requirement of capturing Appendix 4.6 elements in system
  • Developed addendum document to be attached to all manufactured food inspections
moving forward
Moving Forward
  • Recently developed new GMP inspection procedures based on IOM that address all 22 items in more detail than old procedures
  • Developing detailed procedures for all inspection types (acidified, juice, seafood, etc.)
  • Eventually revise inspection database to capture Appendix 4.6 information
slide15

Contact Information

Matt Colson

Environmental Administrator of Bureau of Food and Meat Inspections

Florida Department of Agriculture and Consumer Services

Matthew.Colson@FreshFromFlorida.com

slide16

MFRPS Standard 3

Robin Henderson PhD, RD

Chief, Center for Food Manufacturing

MD State DHMH

March 12, 2014

requirements of standard 3
Requirements of Standard 3
  • Systems for:
    • Inspections
    • Recalls
    • Responding to Consumer Complaints
    • Responding to Industry Complaints about inspections, and a
  • Recordkeeping System for all of the above
md risk priorities and inspection frequencies
MD Risk Priorities and Inspection Frequencies
  • High Priority:
    • Any food manufacturing plant (both PHF and non-PHF foods)
    • Inspect twice per year
  • Moderate Priority
    • Food warehouses for PHF foods
    • Inspect once per year
  • Low Priority
    • Ambient temperature food warehouses
    • Inspect once every other year
sop manual
SOP Manual
  • Contains our written protocols for all systems. Still a work in progress, particularly sections for recalls, complaints, sampling.
  • Distributed to each inspector on paper, on a shared drive, and google drive for reference.
  • Staff is trained using the elements contained in the SOP manual.
sop manual1
SOP Manual
  • The list of inspection protocol items in 3.3b are all incorporated into our SOP, but not in the order listed there.
  • Items in 3.3b can primarily be found in SOP Chapter 3, sections I-IV, and Chapter 6, sections II-VII.
  • Chapter 6, section VIII is our process for plan reviews, both office and field reviews to help build out food safety hazards.
staff training
Staff Training
  • Newly developed manual to define supervisory and field roles and responsibilities.
  • Our FPSO is a new position developed to train new inspection staff and standardize all field staff on a routine basis. This position will also be in charge of desk audits. The FPSO is critical to help validate the items listed in 3.3b and identify weaknesses in our system.
inspection report
Inspection Report
  • Set up to help assure that:
    • Critical itemsare identified and corrected or the firm must close
    • GMPs, HACCP, and other records, are reviewed
    • All necessary information about the firm and the PIC are identified
  • Report is uploaded to the office and the information captured in a database for management use
challenges
Challenges
  • Balancing time spent in the firm to adequately:
    • View processes and practices
    • Cover area of responsibility
  • Recordkeeping:
    • Inspection reports with detailed information
    • Clear and concise reports
  • Transitioning to a “paperless” system
    • IT struggles
    • Field Personnel struggles
    • Management struggles
successes
Successes
  • We have a vision, and we are moving forward to meet our goals:
    • A top notch program
    • Meeting the standards
    • Coordinated effort with RRT, Lab, Local jurisdictions, and FDA
slide25

Contact Information

Robin Henderson

Chief, Center for Food Processing

MD State Department of Health and Mental Hygiene

Email: Robin.Henderson@Maryland.gov

inspection protocol exercise objectives
Inspection ProtocolExercise Objectives

Generate and share a list of:

  • Resourcesfor developing an inspection protocol
  • Best practices to develop, implement and monitor/verify
  • Gaps identified in your plan and how you will address them
  • Challenges and recommendations
  • Lessons Learned - Program outcomes, measurements and/or benefits
focus recall program
FocusRecall Program
  • Standard 3.3.c or Elements 3.b-3.e State:
  • Recall System
    • Written procedures for sharing information
    • Written procedures for removing product
    • Written procedures for performing recall checks
    • Written procedures for maintaining records about recall information
slide29

Food Recalls

Standard 3.3(c)

Richard Stephens

Environmental Scientist III

Florida Department of Agriculture and Consumer Services

March 11th, 2014

1:30 PM

program elements
Program Elements
  • The state program has a Food Recall system.
  • Procedures for sharing information pertaining to recalls with other agencies.
  • Procedures for promptly removing recalled foods from the marketplace.
  • Procedures for performing recall audit checks.
  • Procedures for identifying and maintaining essential recall information records.
recall policy
Recall Policy
  • “Big Picture” document that outlines recall activities
    • Health Hazard Evaluation and Recall Classification
    • Recall Strategy
    • FIRM initiated vs. FDACS requested recalls
    • Recall Communications and Status Reports
    • Recall Coordinator duties
    • Broad procedure
sharing information
Sharing Information
  • Conveyed in our Bureau’s Communication Plan
  • Will notify appropriate state and federal agencies
  • Instruct firm to submit RFR
effecting the recall
Effecting the Recall
  • Outlined in the procedures section of our policy
  • FDACS has authority to STOP SALE any product deemed adulterated or held/produced in unsanitary conditions
  • FDACS can only request a recall
    • Policy allows for Press Releases
audit checks
Audit Checks
  • Historically:
    • FDA form 3177
    • Spreadsheet
  • Presently:
    • Information is captured in our Food Inspection Management System (FIMS)
    • Use 3177 if performing for FDA
records
Records
  • Historically
    • Spreadsheets
    • Case folders
    • Scanned copies of 3177’s
  • Presently - FIMS
recalls using fims
Recalls using FIMS
  • All information pertaining to a recall is captured in FIMS
    • Recalling Firm
    • Product Info
    • Invoices and Records (to be implemented)
    • Audit Checks
    • Visits (to be implemented)
fims updates
FIMS Updates
  • FIMS Recall items in development
    • Attachments
    • Visit Tracking
    • Request Tracking
moving forward1
Moving Forward
  • FIMS Enhancements
  • Step-by-Step procedures
  • Sharing data captured in FIMS with state/federal partners
slide43

Contact Information

Richard Stephens

Environmental Scientist III

Florida Department of Agriculture and Consumer Services

(FDACS)

Email: richard.stephens@freshfromflorida.com

slide44

Rhode Island‘s Food Recall Project

Catherine Payne Feeney

Catherine White

Supervising Environmental Health Food Specialists

RI Department of Health

March 11, 2014

3:00 pm

food recall problems challenges
Food Recall Problems & Challenges
  • CDC epi curves reveal….
      • outbreaks and illnesses continue after a recall
  • Recall audit checks reveal…products not always removed from commerce
  • How can we…
  • identify where product is
  • remove it from commerce
  • prevent Illnesses, deaths, disabilities reduce economic impact to industry
grant opportunity
Grant Opportunity
  • Improving Capacity to Protect Public Health in Response to a FD&C 1008 Notification
  • 3 year grant
  • RI proposed a project to…
    • Improve Recall Effectiveness
    • Improve Customer Notification
    • Ensure that RI Manufacturers/Stores have a Recall Plan
    • Minimize the Need for Recalls
    • Measure the Effectiveness of Recalls
new ri law to register out of state processors
New RI Law to Register Out of State Processors
  • Already register out of state bottlers and frozen dessert manufacturers
  • Last year, legislature mandated all out-of-state food processors selling food in RI be registered
  • Opportunity to Identify foods products sold in RI so if a recall occurs, we will know where the product is and where it came from
first steps
First Steps
  • Create Searchable Data Base to capture products and where they are sold
    • Letter to licensees regarding registration needed to be an approved source
    • New applicants asked to submit list of suppliers
    • Seasonal employees started scanning items in stores
recall policy and procedures
Recall Policy and Procedures
  • Policy
    • Product Recall Triggers
    • Roles including State, Federal Partners
  • Procedures
    • Recall Responses for Multiple Situations
    • Communications during a Recall
    • Conducting Audit Checks
    • Expanding a Recall
    • Terminating a Recall
    • After Action Meeting and Report
information sharing
Information Sharing
  • Communications Plan that includes…
    • Department of Health Public Information Office
    • Federal Partners
    • Other States
    • Industry including licensees and associations
    • Public via press releases and/or website
  • Press Release Template Attachment to P&P
contact list
Contact List
  • State Partners
  • Federal Partners
  • Northeast State Partners
  • Industry Associations
  • Grocery Store Chain Operators
recall response
Recall Response
  • Specific protocols were developed and/or revised for:
    • Product Seizure
    • Limiting Future Production
    • Controlling Product Distribution Channels
  • Criteria to consider regarding expanding the recall
recall audit checks
Recall Audit Checks
  • Documentation regarding…
    • When audit check is warranted
    • Methods used to do audits (store visit, phone call, email, letter)
    • How to conduct audit check using form 3177
    • What to do if recall ineffective
  • Not just a survey, always get recalled product removed from commerce!
information collected record keeping
Information Collected & Record Keeping
  • Staff person assigned to manage all recalls
  • Database created to track recalls
  • Information included…
    • product information
    • recall related activities
      • Communications
      • Findings
      • Press Release
metrics
Metrics
  • Metric 1: Number of illnesses from consuming contaminated/recalled product in Rhode Island after a recallIf illnesses occur, why?
    • Did the consumer not learn of the recall?
    • Did the consumer buy recalled product after the recall and, if so, why?
  • Metric 10: Name and number of food store chains with shopper/loyalty cards who directly notify consumers who bought recalled products and method of notification
  • Notify FDA of findings, Share with other states
next steps
Next Steps
  • Work with retail chains with shopper/loyalty cards
    • Identify and directly notify consumers who purchased unsafe foods through:
      • Text messaging
      • Emails
      • Automatic phone calling
      • Other direct notification techniques
slide58

Contact Information

Catherine Payne Feeney

Catherine White

Supervising Environmental Health Food Specialists

Rhode Island Department of Health

Email: catherine.payne-feeney@health.ri.gov

catherine.white@health.ri.gov

recall program exercise objectives
Recall ProgramExercise Objectives

Generate and share a list of:

  • Resourcesfor developing a recall program
  • Best practices to develop, implement and monitor/verify
  • Gaps identified in your program and how you will address them
  • Challenges and recommendations
  • Lessons Learned - Program outcomes, measurements and/or benefits
slide61

Contact Information

Robin Henderson, PhD, RD/LDN

Robin.Henderson@maryland.gov

410.767.8451

Matthew Colson

Matthew.Colson@FreshFromFlorida.com

850.245.5544

Richard Stephens

Richard.Stephens@freshfromflorida.com

850.245.5520

Catherine Payne Feeney

Catherine.Payne-Feeney@health.ri.gov

401.222.7717

Catherine White

Catherine.White@health.ri.gov

Tressa Madden

Tressa.Madden@fda.hhs.gov

405.609.8738

Michelle Motsinger

Michelle.Motsinger@fda.hhs.gov

303.236.3057