Posts: 70
From:Notts,United Kingdom
Registered: Mar 2000

posted 23 August 2000 07:08 AM               

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Currently inspection / tests are recorded on standard pre-printed forms (i.e. the inspector enters measured values into boxes & signs off the sheet)

Would, in your opinion, it be acceptable to
1)scan these forms, or
2)transfer the data to a spreadsheet

for electronic retention?

At the moment we have a large volume of paper retained for current year + 1. I'd like to get rid of it as part of a 5S project.

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Posts: 275
From:ILLINOIS
Registered: Mar 2000

posted 23 August 2000 07:41 AM               

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We scan ours in - (and we may have gone a little overboard but) we put our pre-printed (sign-off) dimensional Insp records, material lot certifications, all tests that apply for each job, into a dedicated computer for that purpose... this gives us the "option" to archive/backup to disk for as many years as will be needed - currently we keep them on hard drive for a minimum of a year - and plan to archive for a minimum of 3years. We do this "in case" a future customer would expect 5-7 years retention.

Regards
Jim

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Posts: 23
From:Sweden
Registered: May 2000

posted 23 August 2000 08:06 AM               

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Hi Don,

As far as ISO 9000 is concerned, 4.16 says you can save your records on any type of media, so I can see no reason not to use the methods you suggest.

/ Claes Gefvenberg

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Posts: 18
From:Grand Rapids, Michigan, USA
Registered: Aug 2000

posted 23 August 2000 02:41 PM               

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Have you thought about getting rid of the paper and just maintaining the spread sheet? Double work can cause backups and errors. Maybe a paperless system would work better for you. Bar coding and other types of electronic media might help. Or even typing in the results and then pitching the hard copy. Authorities can be set in the system to allow traceability to the individual. Just a thought. I hate double work but sometimes it is the neccesary evil.

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Posts: 16
From:Oregon
Registered: Apr 2000

posted 23 August 2000 03:06 PM               

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Am I missing something here? I know that having to deal with req'ts outside of 9001 (FDA/ISO13485/MDD) tends to make one a little anal (and I hate that word), but where would the spreadsheet provide proof of who did the inspection/testing? Unless you had some type of security program that would positively identify the person entering the results, probably by a PIN or logon, it could be argued that anyone could have entered or altered the information. Every registrar that I've dealt with has insisted on seeing signatures, handwritten initials or some other type of proof. This is their take on the "provide evidence" wording of 4.10.5.

Dissenting arguments that I can use to my advantage are most welcome.

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Posts: 244
From:
Registered: Sep 1999

posted 24 August 2000 08:48 AM               

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Password protected screens and electronic signatures are acceptable.

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