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Author Topic:   Quality Records
Lurker (<10 Posts)

Posts: 1
Registered: May 2000

posted 04 May 2000 08:13 AM     Click Here to See the Profile for lcriscoe   Click Here to Email lcriscoe     Edit/Delete Message   Reply w/Quote
Can someone please help? The follwing AR was issued to me this past April. Not all parameters of clause 4.16 are defined in procedures. (e.g. indexing, accessing, filing and maintenance.) I had a spreadsheet, listed all the requirements across the top and answered them the best I could. I am unclear of exactly what they are looking for. When you detail how a record is indexed, such as by part number, date ect. Doesn't that also explain the filing system? If anyone has an example in excel and willing to share it, I would appreciate it. Thanks in advance.

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Roger Eastin
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Posts: 345
From:Greenville, SC

posted 04 May 2000 09:29 AM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
First off, I think you should ask your registrar (I assumed the auditor was third party) for clarification. It seems to me that your Excel spreadsheet attempts to define each of the requirements of 4.16, so your registrar should be able to clear things up for you. Depending on your retention system, your indexing system could be your filing system as well. For me, indexing is a "subsystem" of our filing system. My filing system allows me to find a general type of record whereas indexing allows me to find individual information.

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Posts: 17
Registered: Feb 99

posted 05 May 2000 10:29 AM     Click Here to See the Profile for waberens   Click Here to Email waberens     Edit/Delete Message   Reply w/Quote
Catagories that we have included on our Quality Record Table are: Record name, Collection, Access, Filing & Indexing, Storage, Maintenance, Minimum Retention, Disposition, and QS Reference. It may be overkill, but it certainly has caused us to think through the whole process of controlling quality records.


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