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How long we should retain measurement system records?

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Guest user Created:   Jul 09, 2020 Last commented:   Jul 10, 2020

How long we should retain measurement system records?

How long we should retain measurement system records? Calibration?MSAs?Gage R&Rs
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jul 10, 2020

Measurement system records are technical records so the laboratory needs to comply specifcially with the requirements of ISO 17025 clauses 8.2 and 7.5.

The laboratory needs to establish what a suitable retention time is for different types of records, based on contractual and legal requirements.  The potential risk or impact to the laboratory should be evaluated if the period selected is too short, or even too long.  Consideration should be given to the medium  of the records as all requirements of ISO 17025 must be met during the retention period in terms of data confidentiality, security and integrity.  You need to considering both paper, scanned and electronic records. This also includes being able to “read” the record either with the human eye or a computer process, throughout the retention period,  i.e. format ands medium must be contemporaneous. Consider for example if there was a legal dispute over a result or report years down the line, the results would need to be traceable to legible (readable) measurement system records to verify validity of the reported results. 

It is interesting to note that most laboratories do not define the concept of archiving. By definition retention period is the period of time that records (documents) should be retained in their offices of origin or in records centres before they are transferred to an archive(s) <organization>  or otherwise disposed of  (SOURCE: ISO 5127:2017(en) Information and documentation - Foundation and vocabulary). In other wordsm to mitigate risk, a laboratory could consider keeping a particular hand written raw data record for say 6 months, then scanning it and retaining the electronic file with quick access by the laboratory say for 3 years. Thereafter it could be archived for a suitable period, before disposal. Costs need to be considered as a factor in the risk assessment too.

For further information, have a look at the ISO 17025 document template: Document and Record Control Procedure at https://advisera.com/17025academy/documentation/document-and-record-control-procedure/

For supporting information regarding actions to address risks and opportunities, see: 

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Jul 09, 2020

Jul 10, 2020

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