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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: Tracing Support Equipment to Analytical Result

Question 1

Does TNI contend that all support equipment is required to be traced to individual results, or is there a distinction between analytical equipment, that is required to be traced to individual results, and support equipment, that is required to be calibrated and correctly maintained, but not necessarily traceable to individual results? If the former, then where exactly is the limitation on what is required to be traceable?

Having data of known and documented quality is the basic premise of the TNI Standard.  It is the lab's responsibility to assure that each analytical result can be reconstructed through a data trail or audit.

The laboratory must retain all records necessary to establish an audit trail and allow the history of the sample to be followed through its documentation and records.  To accomplish this, the laboratory must establish links to various activities such as equipment calibrations or verifications, standards source and preparation, etc.  These links may or may not be in a single record - it is up to the laboratory to ensure that the record system design meets the audit trail and history requirements of 4.13.2.1 and 4.13.3.a.

TNI doesn't require that support equipment must be traced to individual results. The TNI requirement is "The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued".  Note that this requirement does not require that any individual record be uniquely tied to any individual result. Further, the TNI requirement is "The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation" and "The quality manual shall contain or reference procedures for achieving traceability of measurements".


References:

ELV1M2 3.1 Traceability

The ability to trace the history, application, or location of an entity by means of recorded identifications. In a calibration sense, traceability relates measuring equipment to national or international standards, primary standards, basic physical constants or properties, or reference materials. In a data collection sense, it relates calculations and data generated throughout the project back to the requirements for the quality of the project.

4.2.8.4 h

The quality manual shall contain or reference procedures for achieving traceability of measurements

4.13.2.1 & 4.13.2.2

These are two sections of ISO language that can't be reproduced here. Both sections deal with recordkeeping and recording of data.

4.13.3 a)

The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation. This system shall produce unequivocal, accurate records that document all laboratory activities such as laboratory facilities, equipment, analytical methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts.

5.5.13.1

Support Equipment

This Standard applies to all devices that may not be the actual test instrument, but are necessary to support laboratory operations. These include, but are not limited to: balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors), thermal/pressure sample preparation devices and mechanical volumetric dispensing devices (such as Eppendorf® or automatic dilutor/dispensing devices).