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Complete Article from Edition 46 APG eNewsletter
Article written by Tom Coyner, President of APG
APG has been a NIST/NVLAP Accredited PT Provider since their first class in 1999. However, we recently had the opportunity to go through an A2LA audit in support of the NELAC PT Provider accreditation program. I am – of course – pleased to report that again APG has been accredited as part of the first class of A2LA accredited NELAC PT Providers. The new A2LA accreditation involved several new international standards and key sections of the NELAC Standard. In fact, the A2LA checklist was a total of 97 double sided pages. It was interesting to compare the two type of audits.
The NIST audits normally involved four technical experts from the Analytical Chemistry Division (ACD) of NIST and required a full four days on-site. Their “modus operandi” as they might say on CSI was to randomly select a PT study we had run and to review everything from the purchase of raw materials through the calculation and printing of final reports. As you might suspect, as the NIST scientists focused on the chemistry and technical details of how we do what we do to prepare, certify, distribute, and analyze PT samples. They reviewed verification, homogeneity, and stable data and calculations. They challenged Uncertainty calculations and EPA reporting. They were – we believed – highly technical and extremely thorough audits of our process.
The A2LA audit team was composed of three experienced environmental laboratory auditors and a statistician. Each of the environmental auditors were well trained and had A2LA experience in ISO 17025 audits. The statistician was Dan Tholen, an internationally recognized PT auditor. However, as a result of the time deadlines placed on A2LA by NELAC, the team had a very short two and a half days to perform the audit against the overwhelming 97 page checklist. As a result of their experience and the fundamental focus of A2LA, the audit was much more of a systems audit than a detailed data audit; as was accomplished by NIST. This was a dramatic change in emphasis.
The A2LA audit team also was struggling against redundant checklists from multiple standards and some very ambiguous guidelines and directions from the NELAC PT Board. Because of the rush to get the audits done within the NELAC timeframe, the PT providers were not given much of an opportunity to provide input into the selection of checklist items. There were numerous cases where it appeared to APG that selected or unselected sections of standards were inappropriate for what PT providers actual do. This was particularly true with the sections of the NELAC standard that were on the checklist. The PT providers are manufacturers and data analysis providers; they are not commercial environmental laboratories and are not bound by state or EPA methods and procedures. USEPA methods cannot achieve the level of precision and accuracy required to meet NELAC and EPA PT sample requirements.
While the A2LA audits were difficult, they were in their own way complete. As A2LA and their audit teams develop more experience and the requirements are simplified and standardized, they will become better. It is particularly important for the auditors to get much clearer instructions from NELAC as to the requirements of its programs. The greatest difficulty during the audit was confusion over what the actual NELAC requirements were and how they could be met. I am confident that this ambiguity leads to important inconsistencies in the application of the standards to the various PT providers. I am equally sure that A2LA will resolve the inconsistencies in the future.
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