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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: Proficiency Testing


Subject: Second PT Failure Means Loss of Certification for that Method

Question 1

The lab failed a second PT in a row and will likely lose certifications that effect work for many clients in different states. What now?

Determine why did the Corrective Action for the first PT not work, or was there one? Was there follow up to the first Corrective Action?  Examine training documents of analysts involved, review Standards and Reagents used for analysis, review QC on each batch with PT sample, QC charts/PT trending low or high.  Examine PT preparation - were instructions from PT provider followed?  Perhaps talk with PT provider to establish if there were different factors between PTs? The lab should already have a procedure in place to deal with this type of issue. Confirm that instruments are working correctly and that QC checks were successfully performed.

Involve analyst(s), QAO, Supervisor, Upper Management in the root cause investigation.  Timeliness is key to getting back on track.  The following notifications may be necessary if certification is lost: project manager/sales, affected clients and all secondary ABs.

Follow-Up Action:  Obtain quick response make-up PT from PT Provider.  Upon successful completion, perform an internal audit to ensure that the root cause has been effectively addressed and schedule any necessary follow-up on corrective action. Apply for re-certification if needed.  Identify which clients are impacted, including labs for which your lab does subcontract work.  Identify subcontractor labs to perform the de-certified analyses until re-certification is attained.


References:

2009 & 2016 TNI

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2
4.1 Organization (ISO/IEC 17025:2005(E), Clause 4.1) §4.1.2 and 4.1.5 a, f, g & h
4.2 Management §4.2.1 and 4.2.8.5
4.5 Subcontracting of Environmental Tests (ISO/IEC 17025:2005(E), Clause 4.5) §4.5.1 and 4.5.2
4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005, Clause 4.9) §4.9.1 a thru e
4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11) §4.11.1 thru 4.11.5
4.13 Control of Record  §4.13.2.1
5.2 Personnel (ISO/IEC 17025:2005, Clause 5.2) §5.2.1
5.9 Quality Assurance for Environmental Testing (ISO/IEC 17025:2005, Clause 5.9) §5.9.1 a thru e
5.10 Reporting the Results §5.10.9

2009 TNI, V1M1

4.2 Continued Accreditation

4.2.1 To maintain accreditation the laboratory shall:

a) analyze at least two TNI-compliant PT samples per calendar year for each accreditation FoPT for which the laboratory is accredited unless TNI-compliant PT samples are not available from any PTPA approved PT provider at least twice per year, in which case the laboratory shall analyze the PT samples in the minimum time frame in which the PT samples are available. The analysis dates of successive PT samples for the same accreditation FoPT shall be at least five (5) months apart and no longer than seven (7) months apart unless the PT sample is being used for corrective action to reestablish successful history in order to maintain continued accreditation, or is being used to reinstate accreditation after suspension, in which case the analysis dates of successive PT samples for the same accreditation FoPT shall be at least fifteen (15) days apart;

6.0 REQUIREMENTS FOR CORRECTIVE ACTION

6.1 When the laboratory receives a “not acceptable” performance score from a PTP or a Primary AB, the laboratory shall perform corrective action. The requirements for corrective action are described in Volume 1, Module 2. When the laboratory receives an evaluation of not acceptable for an accreditation FoPT in any study, the laboratory may choose to re-establish successful history for the accreditation FoPT with a PT sample from any study. The following requirements shall apply to the PT sample used to reestablish successful history:

a) The PT sample shall be obtained from any PTPA–accredited PTP unless there are not any PTPA-accredited PTP for the FoPT in which case the PT sample may be purchased from any PTP. The laboratory shall notify the PTP that the PT sample will be used for corrective action purposes so the PTP may ensure that the PT sample supplied meets the requirements for supplemental PT as defined in Volume 3 of this standard.

b) The laboratory shall ensure that there are at least fifteen calendar days between the analysis dates of successive PT samples for the same accreditation FoPT.

c) The PT sample shall be analyzed and reported in accordance with the requirements described this Module.

8.0 REQUIREMENTS FOR REINSTATEMENT OF ACCREDITATION AFTER SUSPENSION OR REVOCATION

8.1 To reinstate accreditation for an accreditation FoPT after suspension, the laboratory shall meet the requirements for continued accreditation as described in Section 4.2 of this module.

8.2 To reinstate accreditation for an accreditation FoPT after revocation, the laboratory shall meet the requirements for initial accreditation as described in Section 4.1 of this module.

2016 TNI Rev. 2.1, V1M1

5.2 Continued Accreditation

5.2.1 Chemical Testing, Radiochemical Testing, Asbestos, and Microbiology

5.2.1.1 The laboratory shall maintain a history of two (2) successful (acceptable scores) PT studies out of the most recent three (3) attempts for each field of accreditation specified in Section 4.1.1 for which the laboratory holds accreditation. Failure to do so may result in suspension of the affected field of accreditation. The laboratory’s accreditation for a field of accreditation may be revoked for failure of three (3) consecutive PT studies, either by failure to participate in the required PT study or due to failure to obtain acceptable results.

6.0 Requirements for Corrective Action

6.1 A laboratory that fails to successfully analyze a PT study for a particular FOA shall determine the root cause of the failure and take corrective action.

6.2 The laboratory shall document the root cause investigation and subsequent corrective action. NOTE: The requirements for corrective action are described in Volume 1, Module 2 of this Standard.

6.3 The laboratory shall provide the root cause investigation and corrective action documentation to the Primary AB within thirty (30) calendar days of a request from the AB.

6.4 Failure to submit documentation of the root cause investigation or corrective action records, or both, to the AB within thirty (30) calendar days of the request from the Primary AB is due cause for suspension of accreditation for a particular FOA.

6.5 Documentation for WET corrective actions shall include:

a) a copy of the raw data used for the study;

b) a copy of the current Standard Reference Toxicant (SRT) control chart relevant to the PT study.

8.0 Requirements for Reinstatement of Accreditation after Suspension or Revocation

8.1 A laboratory seeking to have its accreditation reinstated for an FoPT after suspension shall meet the requirements for continued accreditation as described in Section 5.2 of this module.

8.2 A laboratory seeking to have its accreditation reinstated for an FoPT after revocation shall meet the requirements for initial accreditation as described in Section 5.1 of this module.

8.3 A laboratory seeking to have its accreditation reinstated for an FoPT after suspension due to not supplying a requested corrective action report shall meet the requirements for continued accreditation as described in Section 5.2 of this module.