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Standard Interpretation



SIR #: 64
Standard: 2003 NELAC
Section: 5.4.2.6
Link to relevant standard

REQUEST:

This standard calls for "3) in-depth, periodic monitoring of data integrity". What is TNI's interpretation of "periodic"?

ELAP suggested "Each calendar quarter the QAO audits 5 % or 5 data packages, which ever is more" in the DI plan template we provide to labs. However, the monitoring should be dependent upon the lab's scope (chemistry, microbiology, asbestos) and workload (number of samples analyzed).

Does TNI leave it up to the lab to decide at what frequency they perform the monitoring?

Thank you.

TNI FINAL RESPONSE:

(Quality System Expert Committee/NELAP Accreditation Council, x-x-10)

There is no definition of periodic. The laboratory must clarify its intentions for complying with this requirement in the QAM or elsewhere. If the laboratory hasn't defined its requirements sufficiently, it could be cited for failure to comply with this section.