Lack of transparency root cause

QEinTraining

Registered
I am looking for advice on handling pressure from upper management not to document the actual problem statement or root cause on CAPA files.

Essentially, the organization does not have a QMS in place. There is some recording of complaint data, but the intake is not compliant with 21 CFR 820.198 (device ID/lot not identified, lack of failure investigations, issues from the same customer for various products documented in a single complaint...). A CAPA was opened due to high complaint rates.

To even start addressing the high complaint rate, it would be necessary to have actual rates reported, but only complaint volume is tracked, and there is no trending of shipped/sold units. Additionally, there are no product specifications.

So the actual root causes, based on regulatory review for the high complaint rate, would be (1) distribution of nonconforming units due to lack of specifications (2) lack of quality data to adequately identify sources of nonconforming product.

The problem is that management does not want me to explicitly state the root cause because the record, if audited, would bring additional scrutiny to the whole QMS. However, management's goal is to reduce complaint volume without calling attention to the QMS.

What advice do you have as far as defining the root cause? My concern is that this CAPA, as currently written, is not specific and is a recipe for failing any sort of effectiveness check.
 
Many places like that today, I have worked for a few, as a rule, I always keep my resume on line and have job alerts sent to my email address, ... just in case. Good luck walking the fine line, but this shows not just "lack" of management commitment but outright "anti improvement" full commitment, again, not all that rare. Some can walk this line diplomatically, many cannot. You do have my sympathy, been there.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
Agreed, I always felt like I was walking on a tight rope. I did manage to do enough "right stuff" that I socked away enough money to retire (early) on mutual concurrence when my employer declared they had no more work for me. I would suggest keep records, and at least provide your boss an email that says - OKAY, we collectively went with this answer, but if we are ever audited, we are liable to receiving the following findings - X, Y, and Z" And keep a copy of that email outside of the company email system.
 

John Broomfield

Leader
Super Moderator
Essentially, the organization does not have a QMS in place

Are you sure? Most mature organizations develop enough of a management system to more or less pay the bills. Given the necessary leadership the system may not be beyond repair.

If you are planning to leave anyway why not give top management both barrels when you have your letter of recommendation? From what you say it is their lack of visible and enthusiastic commitment to requirements that has resulted in this malaise.

Years of soft soaping this primary root cause with other “technical” root causes has brought you to this place.

You may just find they respond well to someone giving them this hard but essential message. Just choose the leader who has the most influence instead of blasting the lot.
 

Sidney Vianna

Post Responsibly
Leader
Admin
The problem is that management does not want me to explicitly state the root cause because the record, if audited, would bring additional scrutiny to the whole QMS. However, management's goal is to reduce complaint volume without calling attention to the QMS.
The very moment the management of an organization asks underlings to be accomplices in ethical (and possibly legal) breaches you have a glimpse of the corporate soul. There is no escaping from the moral fork on the road ahead of you.

Let your conscience be your guide and good luck.
 

QEinTraining

Registered
Are you sure? Most mature organizations develop enough of a management system to more or less pay the bills. Given the necessary leadership the system may not be beyond repair.

Yes, 100%. The organization is distributing medical devices (albeit low risk and thankfully no serious injuries to date) without regulatory clearances.
 

blackholequasar

The Cheerful Diabetic
I've been in this same position before. We created blades/trocars/and other precision cutting instruments for four MAJOR medical device manufacturers. We did not have a QMS and when I was hired on to help create one, the owner literally pulled my computer out of my desk one morning and told me that writing work instructions was "stealing knowledge" from him. From a quality standpoint, it was a terrible place to work for and when we met with an ISO 13485 consultant, the owner told him that he was a "filthy communist" and locked himself in his office and refused to listen to reason.

I left. You should strongly consider the same. There is some toxic culture in workplaces that you cannot win against and you will gain nothing in your battles. Not only for legalities, but for your own sanity!
 
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