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TNI Standards Guidance

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Module: Quality Systems


Subject: Failure to Qualify Results

Question 1

During an internal audit QA had found a CCV failure for several compounds that were not qualified on the report. What Now?

Prepare corrective action report and conduct follow-up internal audit. Investigate the analyst’s training, preparation of the standard, LIMS settings and quality control criteria.  Determine duration of non-conformance.

Involve the QAO, analyst, data reporter and section supervisor.  Notify client if report needs to be updated. Re-issue report to client if needed.


References:

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2

4.0 Management Requirements, §4.1.5 a, g and h

4.2 Management

§4.2.1 4.2.8.4 The quality manual shall contain or reference:
q) procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and are receiving any needed training;

4.2.8.5 Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities….

4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11) §4.11.1 through 4.11.5

4.13 Control of Records, §4.13.2.14.13.3 Additional Requirements
a) The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation.

4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005(E), Clause 4.9)

5.2 Personnel (ISO/IEC 17025:2005, Clause 5.2) §5.2.1

5.10 Reporting the Results, §5.10.9