SIR #: 170
Standard: 2009 TNI
Section: V1M4, Section 1.6.2-1.6.3
Current Situation: Currently our laboratory uses Work Groups for IDOC and DOC of the sample preparation methods (i.e., EPA 3005, EPA 3510, ... etc.) and the we perform IDOC and CDOC on individual analysts for the test methods (i.e., EPA 6020, EPA 8270, ... etc.). This represents well our actual practice of having a formalized group of employees performing sample prep as a team effort, and then subsequent actual instrument analysis is performed by an individual.
Question: Because the 2009 Standard has been revised to no longer explicitly describe work groups, will it be required to DOC our prep group personnel individually under the 2009 Standard, or are these types of work groups still allowed to be DOCed as a formal team?
As an alternative, under the 2009 Standard is it permissible to maintain DOC on the analyst as the individual responsible for the sample(s) for that test, with the prep team working under that DOCed analyst’s oversight? This essentially wraps the sample prep and analysis together under a designated analyst who utilizes “assistant” individuals within the process.
TNI FINAL RESPONSE:
(Quality Systems Expert Committee and NELAP AC, 2-24-14)
Each individual analyst must have documentation on file that indicates that he/she is competent to perform the portion of the analysis for which he/she is responsible. Work cells may be used. The laboratory needs to define how the concept is used to demonstrate individual competence.