Definition Quality Records - 4.16 - Definitions for "identification, collecting, indexing....."



I have had auditors come into my facility and look at Section 4.16 "Control of Quality Records" and ask for evidence of the following for quality record(s):


I believe that I have addressed each of these in practice but can anyone give me some examples/definitions for them so that I could verify my practice?




Al Dyer

You must have a good system if they are trying to hone in on records. I guess it depends on what your stated retention times and execution are in your procedure. Otherwise I would give him/her a big kiss and try to prove it!!!!!!!!!!!!!1



Best way I found to address these is to develop a matrix for your controlled documents. It gives the auditor something to hold and gives a picture of how your documents are handled.

I am attaching a copy of our old matrix just to give you some ideas.



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Definitions and examples? I'll give it a shot...

1) Identification - how do people know that this form or piece of data is supposed to be kept as a record, and how do you distinguish one record from another? ex. they are listed in the applicable procedures and/or there is a master list. Records are uniquely identified with a number or other ID (like CAR #s)...

2) Collection - are the records actually collected as they are supposed to be? ex. weekly reports that are supposed to be submitted

3) Indexing - this sounds alot like filing to me...sort of like how do you compile your records so that they are distinguishable, available, and readily available

4) Access - If you have to get your hands on a particular record, can you do it? Where do you keep them

5) Filing - I don't know. Sounds the same as indexing to me.

6) Storage - do you remove records from a particular location after a period of time (but before disposal time) and where do you put them to keep them safe, identified, etc. Ex. the file cabinet fills up after one year but they must be kept for 3 years so they are boxed up and kept on a shelf in the warehouse

7) Maintenance - keeping them safe, clean, legible, making sure they are filed/indexed as appropriate

8) Disposition - after you no longer need them, what do you do with them? Are there any confidentiality issues regarding disposal methods, how does everyone know when and how to dispose of records, etc.

I'm not sure that I've pegged everything because I'm new at this, so this question is still very much open to all the experienced knowledgable folks here.

I agree with Dave that defining these points in a matrix is the easiest way to answer these questions for the auditor.
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