Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery

[carlossv]

Dear forum members:

Please, could somebody show me a way in which could it be complied with requirement 8.4.2 of ISO 17025 standard?:
"The laboratory shall implement the controls needed for the identification, storage, protection,
back-up, archive, retrieval, retention time, and disposal of its records".

Since in my tests lab we manage physical and digital records, Specifically I don't have idea about how to demonstrate to auditors the point of records recovery.

Many thanks in advance.

 

[Ajit Basrur]

Refer this procedure on Record and Data Management from the FDA as an example - from https://www.fda.gov/media/73870/download

 

[John Broomfield]

If you are archiving your records with an obsolescent (soon to be obsolete) technology then have available your purchase order and plans to replace the equipment or to update the technology.

Your colleagues may be asked to retrieve certain records from your filing system.

Piles of as yet unfiled records may attract some probing questions.

You get the idea.

 

[dwperron]

I don't have idea about how to demonstrate to auditors the point of records recovery.

Typically this will be covered multiple times, as they will be asking you to produce various records. You produce the records then you have a vaible record recovery system.
Another test is that they will probably go through at least one traceability exercise, where they will choose a standard and have you trace its calibration history back to NIST. Your records will need to be in place to demonstrate this.

You will need to show how you are protecting your data (password protection?), you will show them how you back up records and keep those records secure as well.
You will need to document your lab policies for retention time, archiving policy, and disposal of records.

 

[John Broomfield]

Do not leave untested your backups of electronic records.

Many organizations have misplaced faith in their backups. When they test they find the records are irretrievable.

So, also be ready to show the results of your periodic testing of backups.