Determining Retention Period for Medical Device QMS documents

[A1S2H3I4T5H]

Hi,

As mentioned in the standard, we have to retain the documents/records related to Medical device till the life of Medical Device.

But, on what basis should we determine the Retention period of documents/records which are not related directly to medical device (Ex: Obsolete QSM, QSP, WI, MRM minutes, Internal AUdit reports, Training reports etc.) ??

Please provide some clarity on this !!

Thank You.

 

[yodon]

I don't think there's a difference. After all, the product is built in accordance with the QMS at the time. Management Reviews address any known issues with current product (product conformity). Internal Audits will look at product compliance. Training records may show that those building product were properly trained to do so.

 

[BoardGuy]

[FONT=&quot]Couple of factors are at play here. What retention requirements have been flown down by your customers, what are the regulatory requirements imposed for the product produced and what are the needs of your organization? Knowing this information will allow you to determine retention times.[/FONT]

 

[Mark Meer]

As mentioned in the standard, we have to retain the documents/records related to Medical device till the life of Medical Device.

Be cautious: depending on your target markets, some local regulations have specific retention periods (often for specific types of documents).

To simplify things here, we simply identified the longest required retention period and applied it to all our records.

In practice, this isn't a big deal as most of our records are archived electronically (so their retention period is pretty much indefinite).

Otherwise, the space and resources we invest in binders/filing-cabinets for storing paper records is minor compared to the overhead involved in trying to establish case-by-case retention and disposition rules for specific types of documents/records, the devices they're associated with, and the applicable markets.

(granted, we are a small organization, so the volumes haven't, so far, been an issue.. )

 

[A1S2H3I4T5H]

Thank You Guys for feedback.

But is it required to maintain obsolete QSP, QSM for 10+ years ?? Anyhow latest version of these documents we will be maintaining.
Can we define it as " Latest 3 versions will be retained ??"

Even MRM, Intenal Audit reports, Machine Maintenance Reports (Ex: CNC, Lathe, Drilling Machines etc) what is the point of maintaining it for 10+ years ?? Would 3~5 years not be sufficient ??

 

[Mark Meer]

...what is the point of maintaining it for 10+ years ?? Would 3~5 years not be sufficient ??

In principle, for the purpose of audit, recall, and investigation.

In practice (depending on your risk-level), there is likely little point except to comply with regulations.

Are you mostly paper-based? If so, it might be worthwhile looking into how your records/documents can be digitized. Assuming a good system of archiving, organization, and backups, retaining records digitally allows you to not worry about retention periods (as all documentation is maintained for the life of the system).