Transcript ISO 17025 Proficiency Testing – The WI Lab Perspective

Steve Sobek
State of Wisconsin
Department of Agriculture, Trade and Consumer Protection
Combined Lab Accreditation and MFRP Alliance Meeting
March 10, 2015
Integrated Food Safety System-Goals
 Establish and implement national standards to
ensure consistency across all jurisdictions.
 Maximize resource utilization and sharing across
jurisdictions.
Trust and
Certainty
MFRP Standard 10 – Laboratory Support
 “The State program has access to a laboratory that is
capable of analyzing a variety of samples including
food, environmental, and clinical samples.”
 “The State program maintains a list of services for
routine and non-routine analyses such as biological
hazard determinations.”
 “The State program has a contract or written
agreement with its primary servicing laboratories.”
Standard 10 is not a laboratory standard, it is
a program standard about laboratories
Standard 10 – Building Trust
 Standard 10 is guidance to program managers to
understand their own sampling needs and data quality
objectives, and assure that the labs they use can meet
those needs.
 Ultimately it is about maintaining a dialogue with the
laboratory so that we promote consistency and
develop trust and eliminate uncertainty.
Expectations of
Consistent Quality
Standard 10 - Accreditation
 “The State program utilizes laboratories that have a
current A2LA accreditation”
 “Or, the State program utilizes laboratories that have
quality assurance programs that incorporate
management and technical requirements found in
ISO/IEC 17025:2005”
Benchmarks
Something that can be used as a way to judge the quality
or levels of other, similar things.
To measure according to specified standards in order to
compare it with and improve one’s own product.
Across Jurisdictions – ISO 17025
 Accreditation standards are global – International
Standards Organization (ISO)
 Non-biased third party designation of quality
 Commercial labs and food manufacturers see it as
a normal course of business
 A2LA Biological – 233 Labs, 75% provide commercial
services
 A2LA Chemical – 160 Labs, 60% provide commercial
services
Accreditation – It’s Good Business
 Spinach 2006 – E. coli O157:H7
September 25, 2006 Wisconsin’s Department of
Agriculture Laboratory, detects and confirms the
presence of E coli O157:H7 in spinach samples collected
from patients by local health sanitarians.
 USDA – CIS, Cooperative Interstate Shipment
MFPR Standard 10
 Promotes consistent quality
 Consistency promotes trust and certainty
 Trust and certainty promotes acceptance of data across
jurisdictions
 Acceptance of data across jurisdictions is resource
sharing and integration