Production Record Retention Requirements

So I have been hired by a medium sized company to bring it up to ISO 9001 standards. They design and manufacture product, have some product manufactured offshore, and operate warehouse functions of said product.

Their customers are inclined to think of them more as a distributor.

Here is my issue- they retain production records for about 6 month, AND THEN THROW THEM AWAY. Yes, I am a little horrified- but I can't seem to find any customer requirement to retain records, nor does ISO specifically require record retention for a period of time- it's up to you to define the controls needed for retention.

I would like to see these records scanned and maintained for 7 years, but I am going to need to build a case.

I know it's just a good business practice, but how do I sell it?

Re: Record Retention

But why do you WANT to sell it? Is there a valid reason for retaining production records for 7 years?

I currently retain all of my records (other than those regulated by Federal or Provincial statutes) for 1 year. Yes, some of them are retained longer, particularly those that are electronic, but there is no NEED to keep them longer.

You may want to rethink your stance on this. If there isn't a GOOD reason for doing it, then don't do it.

Re: Record Retention

What kind of product is it that you produce? We produce medical compounds which are made into medical devices.

We retain our records for 15 years because the material is medical and traceability is HUGE. But if your products are not medical - I don't see why you need to push for a long retention time.

Re: Record Retention

What kinds of products do you manufacture? Medical devices, drugs, cosmetics, consumer goods? Each of these have certain retention requirements by regulation. Also, do you have warranties? That's what you have to look for - the regulation for retention requirements by product type AND where you're distributing them. If you export them, then you need to find out what the retention requirements are for the country you're shipping to.

Tax records have certain requirements of 7 years, but you're not dealing with tax records. Medical devices are two years minimum retention for history records, depending upon the device (if I recall correctly). The general rule and best business practice is to keep records no longer than you have to.

Re: Record Retention

We keep extensive records on SOME of our product for up to 75-years, (power plants, pressure vessels, etc.).

Not knowing what your product(s) is(are), about the only reasons I could argue for longer record retention would be liability issues, how long is it warrantied for, what is the product's life expectancy, or included as part of a larger assembly.

These records could assist in identifying a bad batch of product or proving their product was not at fault for a failure.

Re: Record Retention

Well, just my opinion, but if you end up in court for any reason, you may wish you had those records.

Re: Record Retention

NikkiQSM said:

What kind of product is it that you produce? We produce medical compounds which are made into medical devices.

We retain our records for 15 years because the material is medical and traceability is HUGE. But if your products are not medical - I don't see why you need to push for a long retention time.

Click to expand...

Let's call it "Safety Equipment"

Re: Record Retention

You started your post stating that you are tasked to "bring it up to ISO 9001 standards."
There is nothing in that standard that says they must retain records for any specific length of time. That is at their discretion absent any contractual or regulatory requirements.

Where does the "7 years" thing come from anyway? I've always heard this, too, but no one seems to know whence it came.

Is it a good idea to keep records longer than 6 months? Maybe. Maybe not. You seem to be intentionally vague about the industry. That's fine. But unless there is some special record retention requirement in that industry, all you need to do is document their 6 month retention schedule, and voila ... they are compliant with that part.

record retention time will depend on:
any legal/ statuary requirements
customer specified requirements
traceability requirements
internal review or analysis requirements
any retention period decided on an objective criteria is easy to sell.

I recently begin working as a Document Control Specialist at a start-up DNA synthesis company. There is no quality system in place in regards to a QA department, document control, QC testing, etc... The production currently has a manufacturing batch record they produce, but retaining and protecting is not in place.

While creating a whole new electronic document management system, I am also asked to assist with implementing ISO 9001:2015 , to prep for certification...

So this leads me to record retention. How do you determine a record retention for our MBR, for DNA, which has no shelf life? I come from medical device industry where it is set at product shelf life, plus 5 or more years....

Any feedback on MBR record retention for a product with no shelf life , would be much appreciated.

Thanks,
Michelle