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Ruiqing Pamboukian, Ph.D.
Office of Regulatory Affairs/Office of Regulatory Science
U.S. Food and Drug Administration
2nd Governmental Food and Feed Laboratories Accreditation Meeting
Louisville, Kentucky
February 2-4, 2016
Laboratory Accreditation – a Key Building Block for the Integrated Food/Feed Safety System
-FDA’s Collaborative efforts on promoting laboratory accreditation for nation’s food/feed testing laboratories
Outline
• Why accreditation?
• Laboratory accreditation program timeline
• ISO CAP Program Review– Where are we now
– Where are we going
• Collaborative efforts to promote ISO/IEC 17025:2005 accreditation for the nation's food/feed testing laboratories
• Future direction
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Driving Forces of Laboratory Accreditation
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IFSS PFP
• Integrated Food/Feed Safety System• Partnership for Food Protection
MFRPS
AFRPS
• Manufactured Food Regulatory Program Standards
• Animal Feed Regulatory Program Standards
FSMA• Food Safety Modernization Act
Why accreditation?
• Laboratory Accreditation supports the production of reliable and defensible data
• Using accredited laboratories provides decision makers confidence when taking regulatory action
• Laboratory accreditation supports establishing and implementing national standards
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Accreditation Timeline
2010 2011 2012 2013 2014 2015 2016 2017 2020
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St. Louis Meeting (APHL, AFDO, AAFCO, USDA/FSIS, and FDA ) –initiation of the FDA/Sate laboratory accreditation plan
ISO CAP –5-yrs grant, awarded 31 state laboratories
Association CAP –awarded APHL, AAFCO, AFDO
ISO CAP 1st Annual meeting at Raleigh, NCFSMA Accreditation Rule is in the making•Model laboratory Standard
ISO CAP 2nd
Annual meeting in Irvine, CAAFRPS-Std.10
-ISO CAP 3rd Annual meeting joined w/ MFRPA in San Diego, CA-ISO Food CAP extended to 6 additional labs-AFRPS ISO CAP (20 new feed labs)-PFP regroup-Data Acceptance working group
2nd Governmental Food/Feed Lab Accreditation Meeting, Louisville, KY
All 30 ISO food CAP labs are accredited!
All food and feed ISO CAP labs are accredited!
IFSS & PFP
FSMA (section 202)
MFRPS- Standard 10 contract(23 labs) –
Section 202 of FSMALaboratory Accreditation for Analyses of Foods
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Key Deliverables• Establish lab accreditation program
– Develop a process and criteria for recognition and accreditation– Develop a process and criteria for periodic review– Develop model standards for testing labs– Develop internal database to support program
• Establish public registry of recognized ABs and accredited labs
• Accredited labs to conduct food testing– Develop process for electronic submission of data
• Develop process for reviewing State/local labs results for purposes of recall, CE activities
Section 202 of FSMALaboratory Accreditation for Analyses of Foods
202(b) – Testing Procedures
Required testing of Act to be done by accredited labs when testing is conducted “by or on behalf of an owner or consignee” in cases of:
– identified or suspected food safety problem
– Import Alerts
ISO CAP
• ISO 17025:2005 Accreditation CAP (Food)– Awarded 31 labs in 2012
– Expansion in 2015 w/ 6 new labs
• AFRPS CAP + ISO Option (Animal Food)– Awarded 20 labs in 2015
– Anticipated expansion in the near future
• OP, OAGS and ORS work together to provide management oversight and technical support
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ISO CAP labs (food) funded inyear 2012
AK Alaska Department of Environmental ConservationCA Department of Public HealthCT Agricultural Experiment StationCT Dept. of Public HealthFL Dept of Agriculture & Consumer ServicesGA Dept. of AgricultureIA University of IowaIL Department of Public HealthIN State Department of HealthKS State of KansasKY Cabinet for Health & Family ServicesMA Department of Public HealthMD Dept. of Health & Mental HygieneMI Dept of AgricultureMN Dept of AgricultureMO Dept of Health and Senior ServicesMS State UniversityNC State Dept of Agriculture and Consumer ServicesNE State of Nebraska, Dept of AgricultureNY State Dept. of Agriculture and MarketsOH Dept of AgricultureOR Dept of AgricultureRI State of RI and Providence PlantationsSC Dept. of Health and Environmental ControlTX Dept of State Health ServicesVA Division of Consolidated Laboratory ServicesVT State Agency of Human ServicesWA State Dept of AgricultureWI Dept of Agriculture, Trade & Consumer ProtectionWV State Dept of Agriculture
ISO CAP labs (food) extension-funded in 2015
Alabama Dept. of Health
Colorado Dept. of Public HealthLouisiana Dept. of Public Health
Nevada State Public HealthTennessee Dept. of Ag
Wyoming Dept. of Ag
AFRPS ISO CAP labs – newly funded in 2015
CA Dept. of Food & Agriculture
CO Dept. of Agriculture/Biochem. Lab
CT Ag. Experiment Station
FL Dept. of Agriculture & Consumer Services
GA Dept. of Agriculture
IA Dept. of Agriculture
IL Dept. of Agriculture
KS Dept. of Agriculture
LA Dept. of Agriculture & Forestry
MN Dept. of Agriculture
MO Dept. of Agriculture
NC Dept. of Agriculture
NE Dept. of Agriculture
NJ Dept. of AgricultureNew Mexico Department of Agriculture (NMDA)
Office of TX State Chemist
PA Dept. of Agriculture
TN Dept. of Agriculture
WA Dept. of Agriculture
WV Dept. of Agriculture (Regulatory and Environmental Affairs Division (READ)
Yellow – already accredited at the time received the grant
Green – accredited in the past two years
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Alabama
Arizona Arkansas
California
Colorado
Florida
Georgia
Idaho
Illinois Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
MassachusettsMichigan
Minnesota
Mississippi
Missouri
Montana
NebraskaNevada
New Hampshire
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Connecticut
Delaware
Maryland
New Jersey
Rhode Island
Alaska
Hawaii
Sates in both MFRPS and AFRPS ISO CAP
MFRPS ISO CAP only
AFRPS ISO CAP only
Neither MFRPS ISO CAP nor AFRPS ISO CAP
ORS Laboratory Accreditation Program
Objectives:
• Provide technical assistance to the awarded laboratories that are seeking and/or maintaining their accreditation
• Provide OP with administrative and technical support in managing the grant by monitoring the laboratory progress and making recommendations for future funding
• Oversee and provide guidance on the laboratory accreditation component of the three lab associations’ cooperative agreement program (AFDO, AAFCO and APHL)
– Efforts focused on coordinating ISO accreditation training, improving mentor-mentee program, overseeing the Ad Hoc laboratories accreditation assistance and facilitating the planning of yearly national laboratory accreditation program meeting
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Program Efforts
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• Developed and implemented yearly program guidance outlining all deliverable timelines – e.g. quarterly action plan required
• One-to-one assistance by assigning ORS personnel to each of the labs, conducting monthly and quarterly calls
• On-site assessment and technical assistance (e.g. 23 on-site visits in 2012)– Expected 16 on-site visits in 2016 (January to May)
• GAP analyses on lab quality systems
• Instituted the Mentor-mentee program
• Organized and hosted program face-to-face meetings (2013 and 2014)
• Organized educational webinars targeting hard to understand ISO concepts
• Reviewed mid-year and end-of-year report for each of the awardee and provided written ORS evaluation reports every mid-year and end-of-year for each of the lab
• Worked closely with OP project officers to resolve issues and approve carryover and purchase request
• Made recommendations to OP based on the progress of each individual lab
Deliverables
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Action Plan
ISO Training
Establish QA
manager
Scope of Accreditati
on
Proficiency Testing
Quality Manual/SO
PsInternal Audit/Man
agement Review
Sampling Agreement
and Plan
FERN activities
eLEXNET data
sharing
Mentor-mentee
program
Mentor – Mentee Program
• Each non-accredited lab is paired up with an accredited lab
• Mentor labs work together with their mentee labs and their ORS advisor to make a plan of their accreditation needs
• Quarterly group technical call for Q & A’s are held
• Examples of best practices for program:
– Invited mentee labs for on-site visit
– Scheduled conference call with mentee labs to answer questions and address specific issues
– Provide documents that can be tailored for lab’s own need - SOPs, Quality Manual, forms, work instructions, etc.
– Answer question on ad hoc basis
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Sampling Agreement Successful Stories
• The Blue Bell Ice Cream recall
• South Carolina Department of health
• Jen’s Splendid Ice Cream recall
• Nebraska Department of Agriculture
– Their good quality system ensured data accountability and acceptance.
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Examples of collaborative efforts with the associations on supporting ISO accreditation
• FDA funded three associations: APHL, AFDO, AAFCO
• Co-Ag steering committee (APHL, AFDO, AAFCO and FDA)
• Collaborative training efforts (FDA, APHL,AAFCO, AFDO)
• Governmental Laboratory Accreditation Meeting (AFDO, APHL, FDA)
• Web based repository resource center and discussion board (APHL) – new features added to the discussion board
• Ad Hoc Labs assistance (APHL, FDA)
• Data Acceptance working group (APHL, FDA)
• PFP Laboratory Task Group – Best practices document (APHL, FDA)
• Sampling working group – GOODSample document (AAFCO)
• Check Sample Program (AAFCO)
• QA/QC guidelines (AAFCO)
• Development of a competency based career spanning training curriculum framework (AFDO)
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Program Impacts and Outcomes
• Building strong collaborations among partners from federal, state, industry and associations
– Three annual program face-to-face meetings were held since 2013• Best practices on laboratory quality systems were shared with grant awardees,
accreditation bodies and three food safety associations (APHL, AFDO, AAFCO)• Meetings served as a forum for educational and training opportunities for ISO
accreditation-related topics through presentations and technical sessions• Served as a forum providing networking opportunities
– Training provided in collaboration with associations and accreditation bodies
• Enhancing state-to-state relationship through the mentor-mentee program
• Increasing number of accredited food/feed testing laboratories– Improved data quality and thus data acceptance– Increased laboratory testing capability and capacity
• Enhancing Federal-State partnerships in building the Nation’s Integrated Food/Feed Safety System.
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Vision for the Future
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• Continuation of laboratory accreditation program– Implementation of PFP best practices– Implementation of MFRPS and AFRPS lab standards
• Increased utilization of accredited state labs:
– participation in National Surveillance Programs
– Greater use of state data for regulatory action
• Sustaining accreditation
• Increased collaboration with FDA laboratory
Coordinated, faster and more effective response to food safety events due to production and acceptance of laboratory analytical data.
Acknowledge
ORS:Timothy McGrath
Don Burr
Angele Smith
Karen Blickenstaff
Peggy Carter
Dean Turco
Shari Kahn
Srinivasulu Chigurupati
Sarah Skorupsky
Heather Hawk
Tina Cai
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OP:Abe Brown
Erin Woodom-Coleman
Teresa Bill
OP SIS
Auditing Team
APHL
AFDO
AAFCO
