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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.

This guidance does not establish or affect legal rights or obligations and is not finally determinative of the issues it addresses. It does not create any rights enforceable by any party in litigation with TNI, its accreditation bodies, or affiliated institutions. Any decisions made by TNI regarding requirements addressed in this guidance will be made by applying the applicable standards, policies or procedures to the relevant facts.

 

Module: Quality Systems


Subject: Failure to Implement Corrective Action

Question 1

You are preparing for an external agency audit and checking over past corrective actions. You realize that one of the actions was never implemented even though the response said it was. What do you do now?

Immediately undertake the proposed and approved corrective action.  Involve management, QAO, supervisors and analysts.  Review the verification stage of the lab’s corrective action system. Was it not followed? Or does it not exist? Where was the ball dropped?  Was any data affected by incomplete corrective action?  Is the original non-conformance still in place?
Review and revise the corrective action process as necessary. Review lessons learned/training. Initiate a new Corrective Action related to this situation.

Notify client if data were affected.


References:

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2

4.2 Management §4.2.1§4.2.8.5 Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints, and all methods.

4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005, Clause 4.9) §4.9.1

4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11)

4.16 Data Integrity Investigations
All investigations resulting from data integrity issues should be conducted in a confidential manner until they are completed. These investigations shall be documented, as well as any notifications made to clients receiving any affected data.

5.2 Personnel

5.2.7 Data Integrity Training
Data integrity training shall be provided as a formal part of new employee orientation and shall also be provided on an annual basis for all current employees. Employees are required to understand that any infractions of the laboratory data integrity procedures shall result in a detailed investigation that could lead to very serious consequences…. At a minimum, the following topics and activities shall be included:
b) training, including discussion regarding all data integrity procedures;