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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: Control of Records

Question 1

Are forms used only as simple data collection devices, and do not contain any instructions, governed under the requirements for document control? The forms in questions are blank and contain only rows, columns, and simple headers. These forms are used for various laboratory records.

Answer:
This document does need to be controlled but not in the strictest sense.  This type of form needs a revision number or revision date (at a minimum, and possibly more information depending on what the lab’s own quality system mandates for forms) so that when the contents or type of form changes, the historical progression is maintained.  This also helps to guarantee that old or outdated forms are not used.  It would not be necessary to track the location of every single blank copy of this form, but once the laboratory begins to enter data into the form, then the form would need to be tracked and once all entries are made the competed form must be maintained.



References:

2009 TNI V1M2
4.3.1

General- The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.

2009 TNI V1M2
4.13.2.1

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, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.

NOTE 1: In certain fields it may be impossible or impractical to retain records of all original observations.

NOTE 2: Technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers' notes, papers and feedback.