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: Inadvertent Use of Expired Standard
During data review (or internal audit) it is found that analysts have been utilizing an expired standard. What responses are needed?
Review logbooks to determine start/stop date of use as well as traceability of the standard – how far back in time does the misuse go? Is there a recertification of the standard? Evaluate the lab’s chemical retention policy and processes. Notify those responsible for chemical inventory records, and oversight of LIMS records (if applicable). Interview personnel regarding use. If there is no records of recertification perform immediately to determine the integrity of the expired Standard (low, high, or no bias).
If the results of the recertification indicate that the standard has a statistically significant bias, determine which data and which batches were affected, and notify affected client(s). If possible, retest samples (if sample does not exceed hold time). Reissue amended reports with appropriate narratives/data qualifiers for all affected data
Involve the analyst(s), QAO, lab/section supervisor and any staff that may be involved with sample procurement. Review the lab’s ordering system ensure that personnel understand expiration rules; retrain if needed. Notify Management, and when data are impacted, the client and regulatory agency.
Ensure that the acceptability of the standard is document for further use or remove standard from use. Verify whether the expired standard is actually altered (or just out-of-date); manufacturer may be able to provide additional information. Review chemical inventory processes. Determine which analytical results might have been affected, and Discuss lessons learned. Consider internal management system modifications to prevent repeat scenario.
2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2
4.2 Management §4.2.1
126.96.36.199 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(E), Clause 4.9) §4.9.1
4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11) §4.11.1 - 4.11.3
4.13 Control of Records §188.8.131.52
5.2 Personnel (ISO/IEC 17025:2005, Clause 5.2) §5.2.1
5.6 Measurement Traceability
184.108.40.206. 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.
5.10 Reporting the Results §5.10.9