TNI Standards Guidance
Disclaimer: This material represents the opinion of its authors. It is intended solely as guidance and does not include any mandatory requirements except where such requirements are referenced. This guidance does not establish expectations of being implemented universally, exclusively, in whole, or in part.
This guidance does not establish or affect legal rights or obligations and is not finally determinative of the issues it addresses. It does not create any rights enforceable by any party in litigation with TNI, its accreditation bodies, or affiliated institutions. Any decisions made by TNI regarding requirements addressed in this guidance will be made by applying the applicable standards, policies or procedures to the relevant facts.
Module: Quality Systems
Subject: New Scope but Old Methods Used
You get your new certification scope and share it with the lab. Apparently, the lab staff did not realize that the state was updating to newer version of some methods. The scope was effective five days before you received it in the mail and the lab has run and reported numerous samples under the old method. What should you do?
Determine which methods need to be updated and do so immediately. Investigate the difference between methods, which analyses were affected and whether analyses were performed for regulatory or non-regulatory purposes. Are the results compliant under both methods, old and new? What communication occurred regarding new methods? Was the lab notified ahead that this was happening?
Consider asking the AB to change accreditation date. Some ABs will give labs an updated Scope. Is there an implementation plan for new methods? If not, one should be created.
Involve the QAO, technical director, project manager and analysts in the resolution process. Where appropriate, notify affected clients and end users as well as AB.
Ensure that all reports list the method actually used? Determine whether the lab needs to run new PTs since the method changed? DW is method specific. Prepare new SOPs. Establish whether MDL and DOC need to be validated? Is it based on MUR? Re-analyze samples if still within hold time limits.
2009 & 2016 TNI
2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2
EL-V1M1-2009 Proficiency Testing
4.0 REQUIREMENTS FOR ACCREDITATION
4.1 Initial Accreditation
4.1.1 To obtain initial accreditation, the laboratory shall successfully analyze two unique TNI compliant PT samples for each accreditation FoPT that correspond to the fields of accreditation for which it seeks accreditation.
EL-V1M1-2016-Rev. 2.1Proficiency Testing
5.0 PT Study Frequency Requirements for Accreditation
5.1 Initial Accreditation
5.1.1 Chemical Testing, Radiochemical Testing, Asbestos, and Microbiology
a) The laboratory shall achieve a history of two (2) successful (acceptable scores) PT studies out of the most recent three (3) attempts for each field of accreditation specified in Section 4.1.1 for which the laboratory seeks accreditation.
4.3 Reporting Requirements
4.3.2 The laboratory shall, on or before the closing date of the study, direct the PT Provider to report the PT study performance results directly to the AB(s) designated by the laboratory. For initial accreditation(s), the laboratory shall direct the PT Provider to provide all relevant PT study results to the AB to support their accreditation application.