Record retention for defunct customers?

[cubix rube]

As a contract manufacturer of medical device components, we often make parts for devices that never make it to Market, or make it to market, but flop. Many of these companies for whom we made these products are no longer in business. In nearly all cases, we would have no way to know if they still have any devices out in the field at all.

If we could verify that a customer is no longer in business, can we remove all of those records (mfg. and inspection docs, purchasing docs, etc.) from our system? I think just that alone could help us cut our doc storage in half. Thanks in advance!

 

[normzone]

I'm not answering your question, but I'm of the opinion that risk costs money and data storage is cheap. Why not back it up on a couple of mass storage devices, archive it, and forget about it secure in the knowledge that if it ever comes up you'll have it ?

 

[cubix rube]

I appreciate your position, and tend to agree, in general. If all we were talking about were electronic records, I'd agree completely. We have records going back nearly 30 years, and the first 15 of those (if not 20) were 100% paper records, with no digital back-up. We still file loads of paper docs (Not sure why, in this day and age), but at least for the past 10 years or so, they're all backed up digitally (scanned), as well.

 

[normzone]

Oh. Yeah, it's never as simple as you want it to be. We do both electronic and paper, so I understand.

Well, you know your product lines better than I do - If you have confidence you'll never be asked to produce them, then you have options.

You could have a parking lot bonfire - or you could have them scanned and then dump the originals. By now your records must comprise many cubic yards of good cover you could use in case of a gunfight.

I only have one FDA audit under my belt, and I was just there to provide emotional and tactical support. But the auditor expressed interest in design records that did not survive a transfer of ownership. She dug down to that level, acknowledged their absence, and we discussed possible places to hunt for them. It was a simple product, and she let it go, but advised the owner that should there be a next auditor, they would likely pick up where she left off.

 

[Ronen E]

I appreciate your position, and tend to agree, in general. If all we were talking about were electronic records, I'd agree completely. We have records going back nearly 30 years, and the first 15 of those (if not 20) were 100% paper records, with no digital back-up. We still file loads of paper docs (Not sure why, in this day and age), but at least for the past 10 years or so, they're all backed up digitally (scanned), as well.

Let’s see if I got it right (approximately):

You have about 15 years worth of paper-only documentation, which is at least about 15 years old. Let’s call it group A.
Then you have the last 10 years documentation scanned, as well as the paper originals. That’ll be group B.
In between you have perhaps about 5 years worth of a mixed bag, ie some are paper-only and others are also scanned and backed-up. That’s group C.

Based on the above -

I see no regulatory reason to keep group A, especially where your customer (device design owner) is totally out of business, meaning these models have not been manufactured for at least 15 years. 15 years is the longest retention time I can recall, and that’s normally for implants. Are you products related to implants, or otherwise to high-risk devices (eg class III)? Lower risk devices normally don’t require >10 years retention in any scenario.

That alone should resolve a big portion of the issue, right?

Next is group B. For these I would fully adopt normzone’s advice.

Now you’re left with group C. Depending on the size significance of this group, you could either leave them alone for 5 more years (until the newest among them are >15 YO) and then just get rid of the whole lot; or sort - treat scanned documents like group B and again, either leave the rest be if not many, or scan them and treat like the rest of the scanned docs.

Does it sound like a plan?

 

[Edward Reesor]

Interesting question. I am of the opinion that an arbitrary length of time is highly subjective to defend, rather than exploring the expected lifespan of the device, regardless of who initially purchased it. When your customers left the market, were the original products destroyed or purchased by others? Is there a chance that your product is out there, somewhere, being used in its intended form?

Here's an example: You make a housing for a medical device manufacturer, designed to last 50 years. The manufacturer goes bankrupt before his product was built. Your housing and all other assets were purchased by another company as part of the bankruptcy proceedings. If the housing was used in such a way that it was designed but for another product, shouldn't you retain any records for the intended lifespan of the product?

I think the answer depends on what you built, what it was specifically designed for and whether there is a chance that even one prototype could still be out there being used on a patient. Never underestimate the "McGyver-ability" of those in the healthcare field.

 

[Ronen E]

...If the housing was used in such a way that it was designed but for another product, shouldn't you retain any records for the intended lifespan of the product?

I think the answer depends on what you built, what it was specifically designed for and whether there is a chance that even one prototype could still be out there being used on a patient. Never underestimate the "McGyver-ability" of those in the healthcare field.

In my opinion component suppliers’ obligations are limited by explicit regulations, original contracts (consider a purchase order a contract, in the absence of an explicit one) and the original intended use of both component and original device.

 

[normzone]

Nice outlook - what does legal precedent have to say on the matter?

 

[Ronen E]

Nice outlook - what does legal precedent have to say on the matter?

If you have the time to research it I’d be glad to hear the conclusion.

 

[Al Rosen]

Here is the FDA Requirement for Records
PART 820 -- QUALITY SYSTEM REGULATION
Subpart M--Records
Sec. 820.180 General requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
(a) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
(c) Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.