PMA A&P Document (i.e. Promotional Brochures, Flyers) Retention Requirements

[Dan in RA]

Hi Guys,

Should A&P materials (i.e. promotional brochures, flyers -- not device label, device manuals, etc) for a PMA device be kept both electronically and hardcopy? Note: Not Part 11 compliant.

Thanks,
Dan Reese

 

[Ajit Basrur]

Dan,

When you say "kept", are you referring to retention periods of the advertising and promotional materials?

 

[Dan in RA]

A&P materials are currently printed and stored in filing cabinets. I'd like to think we can scan these documents and store on the network -- with the intent of doing away with the hard copies and filing cabinets altogether.

These A&P materials are currently kept indefinitely.

 

[dsanabria]

Why are you keeping them indefinitely?

Who are what is your authority to come to that conclusion.

Note: Most FAA docs are requires to be kept for 2 years.

 

[Dan in RA]

Not my decision -- they retain everything A&P well beyond 2 years, looking for options.

Thanks,
Dan

 

[dsanabria]

Who is "They" - your company?

 

[Dan in RA]

Management

 

[dsanabria]

AH!!! so you have management telling you to keep all brochure indefinitely...

So your question is - how can I educate management that I am not required to store data longer than 2 years - time to educate yourself and do some research as to retention period of FAA documents.

It does not guarantee that management will listen to you or to FAA requirements - this is what they want to do and this is the ignorance that they will follow.

 

[Al Rosen]

AH!!! so you have management telling you to keep all brochure indefinitely...

So your question is - how can I educate management that I am not required to store data longer than 2 years - time to educate yourself and do some research as to retention period of FAA documents.

It does not guarantee that management will listen to you or to FAA requirements - this is what they want to do and this is the ignorance that they will follow.

dsanabria, it's a medical device, not an aircraft.

 

[Al Rosen]

The FDA quality systems (820.180) records retention requirement is the life of the device, but no less than 2 years. The requirement for the Corrections & removals, I believe is 2 years beyond the life of the device. There are other parts that have retention requirements, but it' the life of the device which governs the retention period.