MFRPS 10 Laboratory Support: Relationship to the Sampling Agreement Requirement Steven M. Sobek...
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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
MFRPS 10 Laboratory Support: Relationship to the Sampling Agreement Requirement Steven M. Sobek Director - Bureau of Laboratory Services State of Wisconsin
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
Slide 2
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
Slide 3
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
Slide 4
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
Slide 5
ISO/IEC 17025:2005
Slide 6
Slide 7
Standard 10 Or Have quality assurance programs that incorporate
the requirements found in ISO\IEC 17025:2005 Can be compliant
without accreditation.
Slide 8
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
Slide 9
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
networkwhich can provide ongoing surveillance, rapid detection,
surge capacity for food related emergencies
Slide 10
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.
Slide 11
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.
Slide 12
Funding Opportunity RFA-FD-12-008 Also known as ISO 17025
Grants
Slide 13
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.
Slide 14
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.
Slide 15
Systems Approach Institute a holistic quality assurance and
standardization program.
Slide 16
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.
Slide 17
The Disconnect Labs dont 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
Slide 18
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.
Slide 19
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.
Slide 20
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.
Slide 21
Plans can be agreements that cover more than just sampling
Slide 22
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Agreement
Slide 25
QUESTIONS?
Slide 26
Contact Information Steven M. Sobek Director - Bureau of
Laboratory Services State of Wisconsin Department of Agriculture,
Trade and Consumer Protection [email protected]