TNI Logo The NELAC Institute

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: Wrong ID on Bench Sheet

Question 1

During your assessment the assessor finds that the wrong unique ID for a standard has been prerecorded on a printed bench sheet. What do you do now?

The analyst, the supervisor and QAO should be involved. Determine how long the bench sheet has been in use. Investigate to see if the issue is limited to the standard’s identity only.  Discuss the situation with the analyst. Determine what standard / prepared standard was actually in use at the time. Check the certificate of analysis of the standard used. Initiate a corrective action report. Update the ID numbers on the bench sheet if possible. If a systemic problem is identified, then all preprinted bench sheets must be reviewed in all sections. A document control/traceability training session can be held to inform analysts of error. Notify affected clients if results are negatively impacted.



References:

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2

4.0 Management Requirements, §4.1.5 a, f, g and h

4.2 Management

§4.2.1

4.2.8.4 The quality manual shall contain or reference:
h) procedures for achieving traceability of measurements;
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….

4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005(E), Clause 4.9) §4.9.1 – 4.9.2

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

4.13 Control of Records, §4.13.2.1 and 4.13.2.3

4.13.3 Additional Requirements
f) All information necessary for the historical reconstruction of data shall be maintained by the laboratory.
xi.)  standard and reagent origin, receipt, preparation, and use;

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

5.6 Measurement Traceability

5.6.4.2. c) Records shall be maintained on standard, reference material, and reagent preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials.