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MFRPS 10 Laboratory Support: Relationship to the
Sampling Agreement Requirement
Steven M. Sobek
Director - Bureau of Laboratory Services
State of Wisconsin
Department of Agriculture, Trade and
Consumer Protection
03/10/2014
1:30 pm
Standard 10-Laboratory Support
Key Elements
• d. The State program utilizes laboratories
that have a current A2LA accreditation
• e. Or, the State program utilizes laboratories
that have quality assurance programs that
incorporate management and technical
requirements found in ISO/IEC 17025:2005
A2LA Accreditation
• American Association of Laboratory
Accreditation (A2LA)
• Intent- Accreditation to a recognized
standard by a recognized accrediting body
• A2LA accredits food testing laboratories to
international standards – ISO 17025
ISO/IEC 17025:2005
• Standards which prescribe the processes a lab
must have in place
• Standards which prescribe how the laboratory
must document its practices and procedures
• Standards which prescribe the activities
needed to assure the laboratory processes
function as described
ISO/IEC 17025:2005
ISO/IEC 17025:2005
Standard 10
• Or – Have quality assurance programs that
incorporate the requirements found in ISO\IEC
17025:2005
• Can be compliant without accreditation.
Food Safety Modernization Act (FSMA)
• Sec. 202 – Laboratory Accreditation for
Analyses of Foods
“food testing shall be conducted by Federal
laboratories or non-Federal laboratories that
have been accredited for the appropriate
sampling or analytical testing methodology or
methodologies by a recognized accreditation
body”
Food Safety Modernization Act (FSMA)
Sec 202
• Also has a goal of increasing the number of
accredited laboratories
• Also requires progress toward implementing a
national food emergency response
network…which can provide ongoing
surveillance, rapid detection, surge capacity for
food related emergencies
Funding Opportunity RFA-FD-12-008
Also known as ISO 17025 Grants
• Food analyses performed on behalf of State
manufactured food regulatory programs be conducted
by ISO/IEC 17025:2005 accredited laboratories
• Advancement towards a national integrated food
safety system
• Increase laboratory analyses from accredited labs,
adding to FDA capacity
• Lab data will be available to FDA
• Also assist State manufactured food regulatory
programs achieve conformance with MFRPS.
Funding Opportunity RFA-FD-12-008
Also known as ISO 17025 Grants
• Accreditation objective links MFRPS to FSMA
• Year One - 31 labs receive grants, 8 of the labs
hold ISO 17025 Accreditation
• Year Two – additional objective embedded in the
grant renewal document
“The laboratory must develop and execute a
detailed Sampling Agreement, which will fulfill the
commitment to analyze surveillance samples.”
Funding Opportunity RFA-FD-12-008
Also known as ISO 17025 Grants
FDA-MFRPS and Sampling Plans
• “Successful programs will exhibit integrated
planning and enhanced/routine
communications between the Laboratory and
Food program regarding sampling.”
• “Sampling Agreements requires and
enhances communications among state (Food
and Laboratory) agencies for improved State
and Federal routine and emergency food
safety response and actions.”
FDA Goals – 2013 Sampling Agreement
• “The Sampling Agreement must be developed
in conjunction with the State manufactured
food regulatory program supported by the
laboratory and FDA.”
• The sampling agreement must be risk-based
and support the food safety priorities of FDA.
• “Must support the food safety priorities of
FDA, State manufactured foods program, and
laboratory.”
Systems Approach
• “Institute a holistic quality assurance and
standardization program.”
The Good
• The ISO accreditation standards are rigorous,
yet achievable. FDA support to labs through
the grant process is good.
• Objective of enhancing communication
between the inspection side of the system
with the laboratory side of the system is good.
• The concept of a sampling plan promotes risk
based sampling and testing.
The Disconnect
• Labs don’t drive the discussion about what the
inspection side inspects and samples. It is
driven by risk assessment, which is in the
domain of the inspection side of the house.
• Laboratory side of the house is about support
providing capability, capacity, and confidence
MFRPS and Sampling Plans
• MFRPS- Standard 10 does not mention
sampling plans, nor found in Standards 1-9
• FDA auditors doing state program audits of
MFRPS standards are not auditing for the
presence of a sampling plan
• Sampling plan is an artifact of ISO
accreditation grants, not an artifact of MFRPS
standards.
Food for Thought
• The labs will get accredited, and the ISO
grants will end.
• If the idea of a sampling plan is to be
sustainable, the MFRP standards should
include the concept.
• A sampling plan is neither wholly a lab
function, nor wholly an inspection function
• A communication component and a
documentation component should be
reflected in the standards.
Holistic is a Good Word
• The totality of something is much greater than
the sum of its component parts and they
cannot be understood by the isolated
examination of their parts
• A well conceived sampling plan requires the
separate parts to be treated as one within the
surveillance system.
Plans can be agreements that cover
more than just sampling
Plans can be agreements that cover
more than just sampling
Plans can be agreements that cover
more than just sampling
Agreement
QUESTIONS?
Contact Information
Steven M. Sobek
Director - Bureau of Laboratory Services
State of Wisconsin
Department of Agriculture, Trade and Consumer Protection
[email protected]