Transcript Ruiqing Pamboukian Ph.D., Laboratory

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
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
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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
IFSS
PFP
• Integrated Food/Feed Safety System
• Partnership for Food Protection
• Manufactured Food Regulatory Program
MFRPS Standards
• Animal Feed Regulatory Program Standards
AFRPS
FSMA
• Food Safety Modernization Act
3
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
5
Accreditation Timeline
St. Louis Meeting
(APHL, AFDO,
AAFCO, USDA/FSIS,
and FDA ) –
initiation of the
FDA/Sate laboratory
accreditation plan
2010
ISO CAP –5-yrs
grant, awarded 31
state laboratories
Association CAP –
awarded APHL,
AAFCO, AFDO
2011
IFSS & PFP
FSMA (section 202)
MFRPS- Standard 10
contract(23 labs) –
2012
2013
ISO CAP 2nd
Annual
meeting in
Irvine, CA
AFRPS-Std.10
2014
ISO CAP 1st Annual
meeting at Raleigh,
NC
FSMA Accreditation
Rule is in the making
•Model laboratory
Standard
2nd Governmental
Food/Feed Lab
Accreditation
Meeting, Louisville, KY
2015
2016
-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
2017
All food
and feed
ISO CAP
labs are
accredited!
2020
All 30 ISO
food CAP
labs are
accredited!
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Section 202 of FSMA
Laboratory Accreditation for Analyses of Foods
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
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Section 202 of FSMA
Laboratory 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 in
year 2012
AK Alaska Department of Environmental
Conservation
CA Department of Public Health
CT Agricultural Experiment Station
CT Dept. of Public Health
FL Dept of Agriculture & Consumer Services
GA Dept. of Agriculture
IA University of Iowa
IL Department of Public Health
IN State Department of Health
KS State of Kansas
KY Cabinet for Health & Family Services
MA Department of Public Health
MD Dept. of Health & Mental Hygiene
MI Dept of Agriculture
MN Dept of Agriculture
MO Dept of Health and Senior Services
MS State University
NC State Dept of Agriculture and Consumer
Services
NE State of Nebraska, Dept of Agriculture
NY State Dept. of Agriculture and Markets
OH Dept of Agriculture
OR Dept of Agriculture
RI State of RI and Providence Plantations
SC Dept. of Health and Environmental Control
TX Dept of State Health Services
VA Division of Consolidated Laboratory Services
VT State Agency of Human Services
WA State Dept of Agriculture
WI Dept of Agriculture, Trade & Consumer
Protection
WV State Dept of Agriculture
ISO CAP labs (food) extensionfunded in 2015
Alabama Dept. of Health
Colorado Dept. of Public Health
Louisiana Dept. of Public Health
Nevada State Public Health
Tennessee 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 Agriculture
New 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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Washington
Montana
Maine
North Dakota
Minnesota
Oregon
Idaho
New Hampshire
Wisconsin
South Dakota
Michigan
Wyoming
Nebraska
Nevada
Pennsylvania
Iowa
Utah
Illinois
Colorado
California
Vermont
New York
Kansas
Indiana
Ohio
West Virginia
Delaware
Virginia
Maryland
Missouri
Arizona
New Mexico
Tennessee
Arkansas
Alabama
Mississippi
Connecticut
New Jersey
Kentucky
Oklahoma
Massachusetts
Rhode Island
North Carolina
South Carolina
Georgia
Texas
Alaska
Louisiana
Florida
Sates in both MFRPS and AFRPS ISO CAP
MFRPS ISO CAP only
AFRPS ISO CAP only
Neither MFRPS ISO CAP nor AFRPS ISO CAP
Hawaii
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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
•
•
•
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
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Deliverables
Mentormentee
program
ISO
Training
eLEXNET
data
sharing
Establish
QA
manager
Scope of
Accreditati
on
Action
Plan
FERN
activities
Proficiency
Testing
Sampling
Agreement
and Plan
Internal
Audit/Man
agement
Review
Quality
Manual/SO
Ps
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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
• 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.
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Acknowledge
ORS:
OP:
Timothy McGrath
Don Burr
Abe Brown
Erin Woodom-Coleman
Teresa Bill
Angele Smith
Karen Blickenstaff
Peggy Carter
Dean Turco
Shari Kahn
Srinivasulu Chigurupati
Sarah Skorupsky
Heather Hawk
Tina Cai
OP SIS
Auditing Team
APHL
AFDO
AAFCO
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ORS ISO:
[email protected]
OP MFRPS ISO:
Erin Woodom-Coleman
[email protected]
OP AFRPS ISO
Teresa Bills
[email protected]
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