Record Retention - QS-9000 Element 4.5

What records from what departments must be retained and how long to meet element 4.5 of iso 9000. Would shipping retain picklists, bill of lading and packing slips and for how long? Where can I find specific answers /information like the above questions?

[Marc]

Are you talking about records in accordance with 4.16? If so - there is no requirement. Your company decides what is 'appropriate'. I have seen some companies which literally keep all records (one had close to 40 years worth) whilst others destroy them after a year.

Keep in mind to that some records may have retention periods for legal reasons. This may primarily be in employee files such as Training Records, Evaluations, etc..

Dependant on the industry and customer requirements, some manufacturing standards will stipulate retention periods for records.

[Marc]

This is true, however ISO9001 does not specify any specify any retention times.

I don't often see the phrase 'medical device' used in these postings. For those of us that have to deal with such things, both EN 46001 and ISO 13485 add the requirement to ISO 9001 that Quality Records must be kept for the life of the product (two year minimum). The good thing here is that the manufacturer defines what the lifetime is.

And what's a "Lurker" anyway?

------------------


[This message has been edited by Tom Parsons (edited 24 March 2000).]

We are a Metal Stamping facility down the supplier chain (2-3 levels)that have been reqistered to QS-9000 for a year now. Our Internal Audit System was performed and it was found that we have a difference of opinion on the phrase "length of time that the part (or family of parts) is active for production and service requirements plus one calendar year."

In our procedures we shorten this requirement to "Life of the Part + Service + One Year." During the audit participants were saying that the requirement is 'Life of the Tool + 1 Year." The practice is that the records are kept for as long as we have the job (tooling) and once it is stopped by the customer (tool is returned or scrapped)then we take the records out of our active retention system to our inactive retention for one year.

We have our follow up coming up in a week and we will get our registrar's perspective then, but thought I would get the forum participants view. Does our practice meet the QS requirement?

I think what you're doing now is just fine. The "life of the part" is the "life" in your plant that the job is active. Once the activity ceases, you keep the records for one year, then get rid of them. The approach you describe (until the tooling is pulled or scapped + one year) sounds fine.

I worked with a heat treater where customer tooling wasn't involved. We set the system up to review all PPAP jobs annually to make sure there was activity in the previous year. If there was no activity in the last twelve months, the PPAP records are placed in an inactive file (the customer is notified by letter). At the next annual review the inactive file is purged. Passed the audit with no problems.