Addressing Missing Documentation

#1
What is the best way to address a large amount of missing and incomplete documentation spread over the course of multiple years? QA staff left suddenly, not on good terms, and apparently they were not closely supervised for quite some time. I've started a CAPA plan to identify the missing documents, and plan to categorize them by criticality and address them accordingly, either by redoing the work, or for things that happen on a scheduled basis, just waiting until the next scheduled event. I also plan to revise all QMS documents to require some form of secondary review and approval, and I'll be revising document control procedures to standardize storage and filing requirements. Any other suggestions or thoughts on how to adequately address this or ways to make it more manageable/less daunting would be greatly appreciated.
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
CAPA is the correct route imo. Not sure your governing QMS ISO standard. My experience with 13485 says we would need to do a risk review.

Things to consider:

Employee turnover during the time documents are missing
Contemporary files you do have to compare
Supplier changes during the time
Machinery changes
Design Changes
Training Files
Calibration logs
Customer complaints
Notebook or email review for the time period to capture any serious issues during that time.
 

contigo123

Involved In Discussions
#3
It sounds like you've got a good plan for correcting the issue. As part of the CAPA you can investigate how it was allowed to get so bad in the first place, like should QA have some metrics that would have helped identify the lack of documentation? Do you all do internal audits that could have identified this problem, and if so maybe that program needs to be improved? Sounds like a lot of cleanup, so you don't want it all to go to waste (especially if the company culture has been lacking these documents and there may be resistance to implementing them).
 

Tagin

Trusted Information Resource
#4
In 9001, I'd say this issue involves not only Control of Documented Information, but also more broadly is 7.1.6 Organizational Knowledge.

It sounds like you are addressing it in the CAPA process, but you may want to look at it in more comprehensive terms of capturing employee knowledge and company lore. From TS9002:2016:
Organizational knowledge is the specific knowledge of the organization coming either from its collective experience or from the individual experience of its persons. This knowledge is or can be used to achieve the organization’s quality objectives or its intended results.

The organization should consider how to determine and manage the organizational knowledge required to meet its present and future needs. Persons of the organization and their experience are the foundation of organizational knowledge. Capturing and sharing such experience and knowledge can generate synergies leading to the creation of new or updated organizational knowledge.
It's also rather surprising that "a large amount of missing and incomplete documentation" was not discovered during either internal or external audits.
 

Johnny Quality

Quite Involved in Discussions
#5
KBETH,

How has your organisation been running all these years? Are the "missing and incomplete documentation" even needed for the BMS and the running of the organisation?

Do you need to tell your customers? Recall output?
 

Tagin

Trusted Information Resource
#6
My main concern is how to justify continuation of operations while we work to remediate all of these deficiencies.
What are your QMS standard? 9001? 13485? etc. Are you making implantable medical devices? Dish towels? Rocket engines? etc.

Without knowing some more about your organization & QMS, its difficult for people here to offer more advice re risk.
 

John Broomfield

Staff member
Super Moderator
#7
The Cloud.

Update filing and archiving the take full advantage of AWS or similar.. Share one set of docs with all authorized users who can come and go as they please.
 

pbojsen

Involved In Discussions
#8
Preventive action would be a list of document deliverables for each project. Then at Stage Gate have it addressed.

CAPA is the way to go. I feel for you, the same thing happened at the company I worked for, and it took years to get things back up to an acceptable level.
 
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