ISO 9001:2000 Clause 4.2.4 - Control of Quality Records - What constitutes a record?

[Fire Girl]

Quality Records. What?

Hello everyone!

Well I've really started to buckle down and start actually writing procedures (based on the ones I have from ISO 9K:1994). Anyway, I am at the part about quality records. Now I know that I don't have to do documented procedures on all of this stuff, but believe me, if you worked here, you might understand why.

I digress. So. I have procedures from my original "Control of Quality Records, Element 16". But quite frankly, they suck large. So, I am hoping that y'all can help me out a little. What exactly do you guys at home include in your record procedures. Do you include where,precisely (blue file cabinet in Bob's office, third drawer up) the records are kept. What constitutes a record? An inspection record? A bill of lading? A raw material certification?

HELP!

THANK YOU!

FG

 

[JIT]

My suggestion is that don't go into too much details. You will be confused. First, look into your procedures/work instructions and identify what records they generate when you work on procedure/work instruction. A document exists before the fact; a record exists after the fact. Or in other way, a record contains data and information resulting from activity. Then, identify who keeps the record. For example, in our company, Sales keeps the record for quotaion/ customer order copy etc. We do not specify where, drawer detail, Sales keeps record. Then, decide on the retention time of all these records. At the end, decide on disposition of the record.

Hope, this will help.

 

[Al Dyer]

FG,

Here is a file that might help. I had to do some inserting of recors and such and you might have to work on the formatting a bit but the esscence is there.

 

[Jamie]

I'm currently working on our procedure for Control of Records myself and was working off of the same format as Al has in the attachment. I was thinking that I'd simply create a table that identified the records retention periods and disposition.

I do have a question.....The standard states you have to have a documented procedure that identifies the controls needed for identification, storage, protection, retireval, retention time and disposition of records. With that said.... how would you cover the identification, storage and protection if you don't state where and how they are filed? Wouldn't you need to state that record "Supplier Evaluation" is maintained in the Quality Manager's office in the Vendor History Files indexed by Vendor's Name in alphabetical order? How do you cover the standard without putting to much detail?

 

[Jamie]

I just thought of something and was wondering if anyone had any comments regarding it. What would your opinions be if you said your retention period for a record was "indefinately"? Do you think this would satisfy and auditor?

 

[Nav]

What would be an example of indefinable? If that is what you put for most of your items I think it would be a flag. Even if it was for a couple items I think I would expect a question from an auditor as to "Why?"

 

[Nav]

Sorry my fingers got in the way of my typing. I meant to type indefinately.

 

[Jamie]

Records we would identify with and indefinately retention period would be our Training Records, Sales Orders, Purchase Orders, Receiving Reports, First Article Inspection Report and Tooling Verification Form. Our company is so small and our VP likes to hang on to things. To my knowledge we have never discarded any of these. We have always just boxed them up when necessary and put them in storage. When I asked her for the retention periods that is what she gave me for about 3/4 of the records. Do you have any suggestions to get around such as this?

Opinions anyone?

 

[Fire Girl]

Jamie & Nav

Right now, things like inspection records and old drawings I keep forever. Even parts that we no longer make. A couple of times, we've had customers ask us to start making parts again that we hadn't made in years! Plus it's nice to have to stuff for reference. Training records, I don't think you need to keep forever. Generally 5 years after they employee has left is sufficient. Some things to do with accounting like PO's, bills of lading etc. I think you have to keep that stuff for at least 7 years from an accounting point of view. Other than that I think it's pretty much up to you.

I like Al's table format too! As for procedures for retrievability, pull the files out of the file cabinet!
:ca:

FG

 

[Jamie]

FG

I agree with keeping stuff for future reference our customer's are bad about doing things like that too.

As far as training records and records relating to financial matters I don't want to be stepping on anyones toes with these retention periods. I was just talking with our HR Manager and she said that from her stand point the retention period from her HR laws for personnel records was in general 3 years and to not discard any records until consultation with your attorney.