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Chapter: 8 Introduction to quality assurance of measurements
    Section: 8.8 Documentation and Records

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Updated: 28 October 2011
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8.8 Documentation and Records

The quality manual and related documentation is a major feature of all quality systems. There is no universal format for such material but detailed examples can be found in international quality standards, the guidance notes produced by external quality assessment schemes, and many of the numerous textbooks which have been published on the subject of "quality". As a result of the widespread use of ISO/IEC 17025:2005 for accreditation of testing and calibration laboratories, it is probably true that much of the quality system documentation found in measurement laboratories adheres to the requirements of that standard. Regardless of the approach adopted, it is advisable to adhere to a few general principles:

  • keep the scope of formal quality system documentation to the minimum necessary to achieve its purpose;
  • adopt a top-down hierarchy starting with a high level quality manual, which provides an overview of the organisation and its quality system, supported by quality procedures (QPs), standard operating procedures (SOPs), work instructions (WIs) etc with progressively more detailed descriptions of methods and processes;
  • make a clear distinction between the formal documentation, copies of which must be carefully controlled, and any supporting material which does not form a critical part of the quality system;
  • decide at an early stage how the documentation will be divided between paper and electronic records with particular attention to what will need to be controlled and/or archived;
  • the quality manager or department may take overall responsibility for documentation but closely involve key measurement staff in its preparation to ensure that what is written accurately describes current practice and is followed during day-to-day work;
  • ensure that the relevant documentation is updated in a timely manner when methods or processes change and not, for example, left until an annual audit.

It is important to note that a wide variety of material falls within the definition of "documents" that will need to be controlled by the quality management system. It may be internally generated or originate from a wide variety of external sources. The latter will include items such as regulations, standards or even text books where their contents form a critical part of the procedures which are being documented. Internal documents will clearly include items such as procedures for test or calibration methods but also other relevant material such as drawings, software, specifications, instructions and manuals. As mentioned above, documents may be hard copies (whether computer generated or handwritten), available only in an electronic format, or both but where there are multiple versions it must be clear which version of each document is controlled. This includes any unofficial copies of controlled documents which, for example, laboratory staff may need to use under some circumstances. Most organisations maintain a master document list identifying aspects such as authorship, authorisation, approved holders, current revision status etc. Such a list also helps in understanding and explaining the scope of the documentation and the relationship between different documents.

The primary purpose of the quality system documentation described above is to set out what should happen in the laboratory but it is also essential to maintain effective records of what has happened in delivering the work. These will include measurement results and other technical data but also material related to the effective operation of the quality system such as notes of audits (and any consequent corrective actions), training files, instrument maintenance records and complaint files. Maintenance of technical records represents a substantial undertaking for most measurement laboratories and it is essential to set up a system which is both efficient and reliable. In many laboratories the days when all aspects of a measurement were undertaken by a single person and manually recorded in his or her notebook are long gone. Thus the information underpinning a single measurement result may be spread across a number of paper and electronic records held in different locations or data systems by different members of staff. For example, original observations on sample preparation or weighing, instrumental files such as spectra, derived data held in spreadsheets, records of calibrants, and test reports or certificates. The record system must not only ensure security of this data for a specified period but also include the identity of personnel responsible for each item and facilitate establishing an audit trail. The latter provides a link between a sample or test piece, the final reported measurement result, and everything which contributed to that result. This is essential to ensure that the laboratory can take corrective and/or preventative actions if a problem should subsequently be identified with a result or some aspect of the operating procedures.

A single copy of paper records is generally regarded as sufficient except for critical applications. This is not, however, the case for electronic data which is widely regarded as especially vulnerable. Thus it is important that the quality system include formal procedures for the backup and archiving of electronic records. In many cases, accreditation bodies, regulatory authorities or customers will impose strict requirements for this aspect of the quality system specifying, for example, limitations on personnel with access to the electronic systems, multiple copies of all critical data or off-site repositories for at least one additional copy. Indeed, in some situations these requirements become so arduous that companies may decide it is easier to print the electronic data and maintain a paper record. Nevertheless, record keeping is a critical aspect of the quality organisation and except in very small organisations it may be desirable to designate appropriate staff with responsibility for maintaining and checking the system.

M. Sargent

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