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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.

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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.


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 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; 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, § 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