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TNI Standards Guidance

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Module: Quality Systems


Subject: Sample Cooler Overlooked & Melted

Question 1

While cleaning up in the sample receipt area a cooler is found that hasn't been checked in. Further inspection indicates that the ice has melted, and that some of the samples are outside of holding time. What should I do now?

Notify project manager, lab manager, QAO, sample receiving and contact client.  Client must be informed and will determine how they would like the lab to proceed either by rejecting the samples or flagging the results appropriately on the report if the client still wants them analyzed.

Initiate formal corrective action. Investigate how the container got missed.  Was it a missing chain of evidence, were there multiple coolers, or did the courier drop it off and not have someone sign for it? Review the lab’s sample acceptance policy.  How do we prevent it from reoccurring? Include a review of sample acceptance procedures and update accordingly.  Possibly create a sample receipt log if not already in use, and consider retraining involved personnel.


References:

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2

4.0 MANAGEMENT REQUIREMENTS, §4.1.5.a

4.2 Management §4.2.1

4.2.8.5 Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities….

4.13 Control of Records, §4.13.2.1

4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11) §4.11.1 – 4.11.4

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

5.8 Handling Samples and Test Items (ISO/IEC 17025:2005(E), Clause 5.8)

5.8.6 Additional Requirements – Sample Acceptance Policy
The laboratory shall have a written sample acceptance policy that includes the following:
b) proper sample labeling to include unique identification
d) adherence to specified holding times;

5.8.7 Additional Requirements – Sample Receipt Protocols

5.8.7.2 If the sample does not meet the sample receipt acceptance criteria listed in this Standard, the laboratory shall either:
a) … or b) fully document any decision to proceed with the analysis of samples not meeting acceptance criteria.
i) ….  ii) The analysis data shall be appropriately qualified on the final report.

5.8.9 Additional Requirements – Sample Storage and Disposal
a) Samples shall be stored according to the conditions specified by preservation protocols.