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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: Required Frequency for Review of Data and Formal Reports

Question 1

What does the standard require regarding depth and frequency of review for data and formal reports?

The 2003 NELAC standard and the 2009 TNI standard do not state a specific frequency with which data review of reports or laboratory documents must be done.  The standards were written to give laboratories guidance on what areas of laboratory operations and quality control/assurance are essential for producing defensible data.  Laboratories are responsible for writing and maintaining quality documents (Quality Manual and SOPs) that address how the laboratory will address these items.

The 2003 NELAC standard states that the laboratory shall establish procedures for audits, data review, including review for transcription errors, calculation errors and manual integration through the QAM (Sec 5.4.2.3 (s) or SOPs (Sec 5.5.4.7.1).  The standard does not specify a frequency with which this information needs to be reviewed but in order for the results of each test to be reported accurately (Sec 5.5.10.1) to the client, the laboratory would, at a minimum, need to verify that there are no transcription or calculation errors and that any necessary manual integrations were performed correctly.  The final report is required to include information ( Sec. 5.5.10.2 and 5.5.10.3) that the client would need to make decisions or  for validators/auditors to re-create the results, if necessary.  To ensure that this information is being delivered to the client, the final report would need to be reviewed for all the elements listed.  The standard also requires any lab record (analytical reports, test results, final report) be signed off on by the responsible individual (Sec 5.4.12.2.5.3).  The individual signing any documents, including the final client report, is responsible for verifying that the documents conform to the NELAC Standard and method and for answering questions regarding data/documents, if needed.  Ideally the required items are reviewed at the time of generation in order to ensure that all of the requirements in the references listed above are being met.  If during review the reviewer finds that the requirements are not met, the report must be issued with appropriate data qualifiers. If the report was already issued, it must be amended and re-issued. 

The 2009 TNI Standard addresses the above information as well, in V1M2 Sections 4.2.8.4 (Requires QAM to have procedures for data review/audits), 4.13.3 (record keeping, signatures), 5.10.1 (each test be reported accurately) and 5.10.2 (elements required for final data report, with signature of person authorizing the release).



References:

2003 NELAC 5.4.2.3

The quality manual shall include or make reference to the supporting procedures
including technical procedures. It shall outline the structure of the documentation used in the quality system…………..
…The quality manual and related quality documentation shall also contain:
a)……
s) procedures for audits and data review;

2003 NELAC  5.5.4.7.1

Calculations and data transfers shall be subject to appropriate checks in a systematic manner.

2003 NELAC  5.5.10.1

General
The results of each test, or series of environmental tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the environmental test.

The results shall be reported, in a test report, and shall include all the information requested by the client and necessary for the interpretation of the environmental test or calibration results and all information required by the method used. This information is normally that required by 5.5.10.2, and 5.5.10.3.

2003 NELAC 5.4.12.2.5.3

Analytical Records
The essential information to be associated with analysis, such as strip charts, tabular printouts,
computer data files, analytical notebooks, and run logs, shall include:
a)……..
f) analyst's or operator's initials/signature;

2009 TNI V1M2 4.2.8.4

The quality manual shall contain or reference:
                a)…….
                p) procedures for audits and data review;

2009 TNI V1M2  4.13.3

Additional Requirements
f)             All information necessary for the historical reconstruction of data shall be maintained by the laboratory.

viii) analyst's or operator's initials/signature or electronic identification;

2009 TNI V1M2  5.10.1

General (ISO/IEC 17025:2005(E), Clause 5.10.1)
The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.

2009 TNI V1M2  5.10.2

Test Reports and Calibration Certificates (ISO/IEC 17025:2005(E), Clause 5.10.2)
Each test report or calibration certificate shall include at least the following information, unless the
laboratory has valid reasons for not doing so:

                a) – k)  Multiple requirements are listed
j)          the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate;