SIR #: 158
Standard: 2009 TNI
Section: V1M2, Section 18.104.22.168 and 22.214.171.124 (a)
At present, our laboratory has a NELAC Lab (Lead) Technical Director who fulfils the NELAC requirements as per referenced sections above. We also have three other Technical Directors whose responsibilities are either for environmental analysis of representative organic analytes or inorganic analytes for which our lab maintains NELAC accreditation. Our laboratory is in process of management change where current NELAC Lab Technical Director will be reassigned to other duties and no longer will have responsibility over the NELAC accredited lab. The annual renewals of the NELAC accreditations with our primary and secondary Accrediting Bodies require a "Certificate of Compliance" to be signed by a Lab Key Staff, often listing a Lead Technical Director as the one who needs to sign this document. The Lead Technical Director is also listed on each NELAC certification we maintain.
Although the NELAC standard allows for more than one Technical Director, do we must have a Lead Technical Manager/Director who fulfils above requirements for both inorganic and organic environmental analysis. At this time only our Lead Technical Director fulfils the requirements
TNI FINAL RESPONSE:
(Quality Systems Expert Committee and NELAP AC, 2-24-14)
There is no requirement for a "lead technical director". The standard requires that the individual (or individuals) who are identified as technical directors meet the applicable credentials for the areas over which he/she has oversight.