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

Dan in RA · Mar 30, 2017

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 · Mar 30, 2017

Dan,

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

Dan in RA · Mar 30, 2017

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 · Mar 30, 2017

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 · Mar 30, 2017

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

Thanks,
Dan

dsanabria · Mar 30, 2017

Who is "They" - your company?

Dan in RA · Mar 30, 2017

Management

dsanabria · Mar 30, 2017

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 · Mar 30, 2017

dsanabria said:
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 · Mar 30, 2017

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.

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

Dan in RA

Ajit Basrur

Dan in RA

dsanabria

Quite Involved in Discussions

Dan in RA

dsanabria

Quite Involved in Discussions

Dan in RA

dsanabria

Quite Involved in Discussions

Al Rosen

Al Rosen

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