Record retention for defunct customers?

cubix rube

Involved In Discussions
#1
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!
 
Elsmar Forum Sponsor

normzone

Trusted Information Resource
#2
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

Involved In Discussions
#3
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

Trusted Information Resource
#4
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

Problem Solver
Staff member
Moderator
#5
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

Trusted Information Resource
#6
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

Problem Solver
Staff member
Moderator
#7
...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.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#10
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.
 
Thread starter Similar threads Forum Replies Date
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
N ISO 13485 Quality Record Retention Period ISO 13485:2016 - Medical Device Quality Management Systems 4
Gman2 Quality Record Retention (Internal Audits, CA's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Mobile app data privacy - Length of record retention in a software app Medical Information Technology, Medical Software and Health Informatics 1
S. Moore Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
K Our local sterilizer is closing - Record Retention Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1 Records and Data - Quality, Legal and Other Evidence 15
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
WCHorn Flowdown of Aerospace record retention requirements (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Production Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 9
S Are there any new FDA requirements on Record Retention ? US Food and Drug Administration (FDA) 4
S Aerospace Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 5
D Question... Record retention Prior to FDA NDA application and approval Records and Data - Quality, Legal and Other Evidence 3
C Record retention/retrieval for 30+ years? (The lifespan of the medical device) ISO 13485:2016 - Medical Device Quality Management Systems 5
N Notification Sample Regarding Record Retention ISO 13485:2016 - Medical Device Quality Management Systems 5
M Record Retention requirements for Safety Items Document Control Systems, Procedures, Forms and Templates 7
S Electronic Record Retention per FDA Requirements - Electronic Data Capture (EDC) Records and Data - Quality, Legal and Other Evidence 4
K 820.180(b) Record Retention - Does it apply here? We act as the initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B 21 CFR 820.180 Quality Record Retention Requirements Document Control Systems, Procedures, Forms and Templates 1
W Calibration Record Retention Requirements Document Control Systems, Procedures, Forms and Templates 18
T Control of Records - API Q1 8th Edition Record Retention Requirements Oil and Gas Industry Standards and Regulations 7
A Canada Importer Record Retention Requirements - Disagreement with NB auditor Canada Medical Device Regulations 5
R Record Retention Requirements per FDA 820 Regulations Records and Data - Quality, Legal and Other Evidence 10
D MDD (Medical Device Directive) 6.1 Record Retention Requirements question Records and Data - Quality, Legal and Other Evidence 2
Q US Distributor Record Retention Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Record Retention requirements of Calibration and Verification Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 11
E Approval Signature Record Retention Document Control Systems, Procedures, Forms and Templates 2
C Record Retention Time for Sterile Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Customer Purchase Order: TS 16949 Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 4
S Minimum Record Retention Period for ISO 14001 Records and Data - Quality, Legal and Other Evidence 2
S Record Retention Log - What Records are required in a Record Retention Log Records and Data - Quality, Legal and Other Evidence 7
C What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers Records and Data - Quality, Legal and Other Evidence 9
B Training Record Retention Training - Internal, External, Online and Distance Learning 6
D Record Retention Requirements - TS 16949 Records and Data - Quality, Legal and Other Evidence 4
M Information Technology Record Retention time best practices Quality Management System (QMS) Manuals 2
Douglas E. Purdy Control of Disposition of Records - Record Retention - TS 16949 Clause 4.2.4.1 Records and Data - Quality, Legal and Other Evidence 8
T 21 CFR Part 11, "enforcement discretion" - Validation, Audit Trail, Record Retention Qualification and Validation (including 21 CFR Part 11) 4
Y Record Retention by R&D Shop After Handover ISO 13485:2016 - Medical Device Quality Management Systems 5
P ANSI NCSL Z540.1 Calibration Record Retention Period General Measurement Device and Calibration Topics 3
M Medical and Administration department Document and Record Retention policy Document Control Systems, Procedures, Forms and Templates 8
H Record Retention Time of Part Life + 1 Year Records and Data - Quality, Legal and Other Evidence 7
CarolX Record retention ideas for a sheet metal job shop supplying to a medical device mfg. ISO 13485:2016 - Medical Device Quality Management Systems 11
B Minimum retention or the date of destruction of a record - ISO 9001-2000 Para. 4.2.4 Records and Data - Quality, Legal and Other Evidence 13
J Record Control - Who are the Record Custodian and Retention Times - ISO9001 - 7.5.3 Records and Data - Quality, Legal and Other Evidence 9
M Record Retention - Obsolete revisions shall be maintained until the next revision Records and Data - Quality, Legal and Other Evidence 24
R Retention of records - Original Order Form vs. Computer Entry record - ISO 13485 Records and Data - Quality, Legal and Other Evidence 12
E Document and record retention periods for the different OEM's Customer and Company Specific Requirements 2
G Bombardier Aerospace Imposes Infinite Record Retention Period Records and Data - Quality, Legal and Other Evidence 2
K Is there an 'standard' for the length of calibration record retention General Measurement Device and Calibration Topics 7

Similar threads

Top Bottom