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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: Vendor Recall

Question 1

The laboratory receives notification that a reagent/standard that they have purchased has been recalled by the manufacturer. How should they proceed?

An investigation should involve the QAO, purchasing staff, lab director and analysts. Contact the vendor for details about the recall.  Determine if the reagent is actually in use, and if so, how long has the lab been using the reagent?  Then identify which batches the reagent was used in and how many samples were affected? If possible, determine whether there was any negative impact. If there is a potential negative impact notify analysts at the bench to cease using the product.  A work stoppage may be set in place until the lab is sure it is not using the recalled reagent/standard. Initiate a Corrective Action/non-conformance report.

Notify customers, clients of any potential issues impacting analytical results.

Find alternative source of reagents / standards, re-run samples with good reagents / standards if possible and if needed use a subcontract if needed for re-analysis.  Re-evaluate vendor suitability if needed, and consider more closely monitoring future purchases. Cancel scheduled analyses/tests if needed.  Re-evaluate and potentially revise reports.  Recall data if warranted.



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….

If necessary to subcontract work:  4.5 Subcontracting of Environmental Tests (ISO/IEC 17025:2005(E), Clause 4.5), §4.5.1

4.6 Purchasing Services and Supplies (ISO/IEC 17025:2005(E), Clause 4.6), §4.6.1 – 4.6.2

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

4.5.2 The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.

4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11), §4.11.1 – 4.11.3

4.13 Control of Records, §4.13.2.1

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 ….

5.9.3 Essential Quality Control Procedures
a) All laboratories shall have detailed written protocols in place to monitor the following quality controls: vi) selection and use of reagents and standards of appropriate quality; methods.

5.10 Reporting the Results, 5.10.9