How do you retain Obsolete Documents?

[Nort1]

What ever you do with your obsolete documents, make sure that the process is described in your 'Document Control Procedure'. Also observe any required record retention time. This is especially important if you are in a regulated industry, like Medical Devices.

(See ISO 13485:2003 under 4.2.4 Control of records)

[SteelMaiden]

We only keep superceded work instructions when the owner thinks there is a good chance that we may need to revert back to them. i.e., we are changing a process but in the long run, we may find that the original methods were better, or we are making a long term, but not permanent change and will go back to the original after, say, we get a piece of equipment replaced. In tose cases, we file them electronically in an "obsolete documents" folder.

[alk26]

I work for a medical device manufacturing company.

[Groo3]

We retain our electronically, all versions of our documents that were ever approved for use, for a minimum of our retention periods.

[jkuil]

Obsolete documents need to be retained for the lifetime of the product it relates to. For medical devices the obsolete documents are part of the design history file. You need to be able to provide evidence of the methods applied to manufacture a specific batch / lot of products as long as the product/device can or is used (special consideration for implantable devices).

If approval signatures are applied on hard copies of the instructions, then you need to retain the hard copy or a certified copy of it. The latter means that you can scan the original hard copy and retain the scan. You have to be able to demonstrate and assure that the scanned copy is an exact, complete and legible copy of the original. So put appropiate controls in place while scanning.

[Wes Bucey]

In Reply to Parent Post by jkuil

Obsolete documents need to be retained for the lifetime of the product it relates to. For medical devices the obsolete documents are part of the design history file. You need to be able to provide evidence of the methods applied to manufacture a specific batch / lot of products as long as the product/device can or is used (special consideration for implantable devices).

If approval signatures are applied on hard copies of the instructions, then you need to retain the hard copy or a certified copy of it. The latter means that you can scan the original hard copy and retain the scan. You have to be able to demonstrate and assure that the scanned copy is an exact, complete and legible copy of the original. So put appropiate controls in place while scanning.

I would accept all of you post IF you replace the phrase "need to be retained" with "may need to be retained" since "need" is only appropriate where the industry or product is regulated by a government authority or by terms of an express contract between buyer and seller.

For example, I still have and use the official Boy Scout hand ax (logo stamped on ax head not quite worn off after years of use, cleaning, sharpening) my dad used when he was a boy scout in the late 1920's and which I used in the 1950's, which my daughters [Girl Scouts] used in the late 1970s and early 1980s.

The company that made it went out of business in the 1940s. I can think of lots of products with lifetimes which far exceed a human lifetime. My grandson still uses the woodworking tools of my grandfather which were manufactured between 1890 and 1910.

I have no expectations that any company making unregulated products would maintain records for the projected life of that product.

Conversely, does your phrasing mean no drug company should bother to keep any record relating to a product past its expiration date [lifetime?]

[jkuil]

I agree with the may need part. I was cariied away, as I am in regulated industries. However, every product that might face a quality issue for which investigation in the manufacturing of that product is needed, may need production records being retained. That also applies for critical studies (clinical, laboratory, etc)

For drugs, regulators have specified the retention period in their legislation, which is commonly longer than the expiry date. These rules differ from area to area, so read the applicable regulations and guidance documents.

[paulag]

What is the right procedure for superseded standards in medical device industry? Like, the new ISO 13485 and 14971 are here - do I need to archive the superseded editions as long as the other quality documents in accordance to internal procedure? Or, if I can dispose them, when?

Thanks a lot!