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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 - PowerPoint PPT Presentation
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Standard 3 Breakout Session Inspection Protocol & Recall Program
March 11, 20141:30 – 5:00 pm
Richard StephensFlorida Department of Agriculture
& Consumer Services
Robin Henderson, PhD, RD/LDNMaryland Department of Health
& Mental Hygiene
Matthew ColsonFlorida State Department of
Agriculture & Consumer Services
Catherine Payne FeeneyRhode Island Department of Health
Tressa MaddenFDA ORA
Office of Partnerships
Michelle MotsingerFDA ORA
Office of Partnerships
Catherine WhiteRhode Island Department
of Health
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• 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
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)1. Listen to presentations2. Discuss and list suggestions on flip charts 3. Share your group’s suggestions with room
Standard Three
Full Conformance
(100%)80-99% 60-79% 40-59% <39%
PE Conformance Rating
1 11 14 5 83 28 36 13 21
Total StatesPercentage (%)
Standard Three
1.a 1.b 1.c 1.d 1.e 2.a 2.b 3.a 3.b 3.c 3.d 3.e 4.a 4.b 4.c 5.a 5.b 5.c 6.a 6.b
Risk Based Inspection System Inspection Protocol Recall System Consumer Complaint System Food Industry Complaint Resolution System Self Assessment
No. of YES 35 26 38 23 23 14 13 25 18 20 19 15 35 29 26 24 19 18 37 31No. of NO 4 11 1 16 16 25 26 14 21 19 20 24 4 10 13 15 20 21 2 8No. of NA 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
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
Standard 3: Inspection Protocol
March 11, 20141:30 pm
Matt ColsonEnvironmental Administrator
Florida Department of Agriculture and Consumer
Services
Background
• Inspection program overview• MFRPS background• Resources
– RRT grant– FDA contract
Standard 3 Program Element 2.b
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
• 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
• 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
• 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
Contact InformationMatt Colson
Environmental Administrator of Bureau of Food and Meat Inspections Florida Department of Agriculture and Consumer Services
MFRPS Standard 3
Robin Henderson PhD, RDChief, Center for Food Manufacturing
MD State DHMH
March 12, 2014
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
• 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
• 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 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
• 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
• Set up to help assure that:– Critical items are 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• 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
• 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
Contact Information
Robin Henderson
Chief, Center for Food Processing
MD State Department of Health and Mental Hygiene
Email: [email protected]
Inspection ProtocolExercise Objectives
Generate and share a list of:
1. Resources for developing an inspection protocol
2. Best practices to develop, implement and monitor/verify
3. Gaps identified in your plan and how you will address them
4. Challenges and recommendations
5. Lessons Learned - Program outcomes, measurements and/or benefits
Standard Three
1.a 1.b 1.c 1.d 1.e 2.a 2.b 3.a 3.b 3.c 3.d 3.e 4.a 4.b 4.c 5.a 5.b 5.c 6.a 6.b
Risk Based Inspection System Inspection Protocol Recall System Consumer Complaint System Food Industry Complaint Resolution System Self Assessment
No. of YES 35 26 38 23 23 14 13 25 18 20 19 15 35 29 26 24 19 18 37 31No. of NO 4 11 1 16 16 25 26 14 21 19 20 24 4 10 13 15 20 21 2 8No. of NA 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
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 information3b 46% yes on conformance
3c 51% yes on conformance
3d 49% yes on conformance
3e 38% yes on conformance
Food RecallsStandard 3.3(c)
Richard StephensEnvironmental Scientist III
Florida Department of Agriculture and Consumer Services
March 11th, 20141:30 PM
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
• “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
• Conveyed in our Bureau’s Communication Plan
• Will notify appropriate state and federal agencies
• Instruct firm to submit RFR
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
• Historically:– FDA form 3177– Spreadsheet
• Presently:– Information is captured in our Food Inspection
Management System (FIMS)– Use 3177 if performing for FDA
Records
• Historically– Spreadsheets– Case folders– Scanned copies of 3177’s
• Presently - 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 Recall Tab
Recall Details
Audit Details
Audit Details – Action and Status
FIMS Updates
• FIMS Recall items in development– Attachments– Visit Tracking– Request Tracking
Moving Forward
• FIMS Enhancements• Step-by-Step procedures• Sharing data captured in FIMS with
state/federal partners
Contact Information
Richard Stephens
Environmental Scientist III
Florida Department of Agriculture and Consumer Services(FDACS)
Email: [email protected]
Rhode Island‘s Food Recall Project
Catherine Payne FeeneyCatherine White
Supervising Environmental Health Food Specialists
RI Department of Health
March 11, 20143:00 pm
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 isremove it from commerce
prevent Illnesses, deaths, disabilitiesreduce economic impact to industry
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
• 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• 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• 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
• 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
• State Partners • Federal Partners• Northeast State Partners• Industry Associations• Grocery Store Chain Operators
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
• 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
• Staff person assigned to manage all recalls• Database created to track recalls• Information included…
– product information– recall related activities
• Communications• Findings• Press Release
Data Tracking
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
• 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
Contact Information
Catherine Payne FeeneyCatherine White
Supervising Environmental Health Food Specialists
Rhode Island Department of Health
Email: [email protected]@health.ri.gov
Recall ProgramExercise Objectives
Generate and share a list of:
1. Resources for developing a recall program
2. Best practices to develop, implement and monitor/verify
3. Gaps identified in your program and how you will address them
4. Challenges and recommendations
5. Lessons Learned - Program outcomes, measurements and/or benefits
Q & A
Contact Information
Richard [email protected]
850.245.5520
Robin Henderson, PhD, RD/[email protected]
410.767.8451
Matthew [email protected]
850.245.5544
Catherine Payne [email protected]
401.222.7717
Tressa [email protected]
405.609.8738
Michelle [email protected]
303.236.3057
Catherine [email protected]
