SIR #: 184
Standard: 2009 TNI
Section: V1M1, Section 4.2.1
NELAC 2003 2.7.2 says, "For continuing accreditation, completion dates of successive proficiency rounds for a given field of proficiency testing shall be approximately six months apart. Failure to meet the semiannual schedule is regarded as a failed study." TNI V1M1 4.2.1 says, "The analysis dates of successive PT samples for the same accreditation FOPT shall be at least five months apart and no longer than seven months apart unless the PT sample is being used for corrective action to establish successful history..." There is no language to describe what happens after 7 months have passed. The sentence is missing from TNI that was in NELAC that directed or allowed the addition of a "failed study" when the semiannual requirement was not met.
Is it the intent of the standard for ABs to continue treating a failure to meet the semiannual schedule as a failed study? This is a significant enforcement issue since a potential alternative seems to be in V2M2, 10.3: "The Primary AB shall revoke the accreditation of a laboratory for a FoPT when:(a) the laboratory does not participate in the PT program as required by this Standard." This penalty is too severe and problematic for what could be just a missed deadline.
TNI FINAL RESPONSE:
(PT Expert Committee and NELAP AC, 10-4-14)
If a laboratory fails to report a single proficiency testing result it is evaluated as "not acceptable" per V2M2 7.3 part b. If the laboratory fails to report results for 2 out of 3 proficiency testing study time frames, then the laboratory's accreditation shall be suspended per V2M2 10.1 for failing to participate in the timeframes specified in the standard.