Lack of transparency root cause

I worked in an environment just like that for six years. When I approached the CEO/VP/Managing Partners I was always asked is this was an orange jumpsuit question. There was ZERO quality culture. I was the one who sat in front of the FDA to respond to why or how we did something. I left last year because ethics are very important to me and what I stand for. My point is if you have top management that doesn't believe in proactive quality, then you need to cut your losses.
 

John Broomfield

Leader
Super Moderator
I worked in an environment just like that for six years. When I approached the CEO/VP/Managing Partners I was always asked is this was an orange jumpsuit question. There was ZERO quality culture. I was the one who sat in front of the FDA to respond to why or how we did something. I left last year because ethics are very important to me and what I stand for. My point is if you have top management that doesn't believe in proactive quality, then you need to cut your losses.

What training do top managers receive to become competent in safeguarding the integrity of their system so it provides confidence that requirements will be fulfilled?
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
What training do top managers receive to become competent in safeguarding the integrity of their system so it provides confidence that requirements will be fulfilled?

In my experience, none. This comes from job experience and teaching MBA students. Making a profit (unfortunately, short-term profit) rules. There generally is not the realization that long term success requires establishing sustainability and risk management.
 

John Broomfield

Leader
Super Moderator
In my experience, none. This comes from job experience and teaching MBA students. Making a profit (unfortunately, short-term profit) rules. There generally is not the realization that long term success requires establishing sustainability and risk management.

And, of course, top managers are not exempt from the competence requirements.
 

Tidge

Trusted Information Resource
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.

My advice is: "Take baby steps".

Many of us here are true believers in something like "total quality" and it can be very frustrating when management doesn't appear to support what we would consider foundational aspects of our own "house of quality". The good news (in the USA): unless you are a member of MWER, or are the Management Representative, you personally can't be legally held responsible should the "worst" happen. This might not make you feel any better, but none of us is Atlas.

I get the sense that you feel like you know what the specific problem is, and that there are actions you can take to address the problem... but I am not surprised that MWER choked when they heard you say "we need a QMS to fix this problem." That may not be what you said, but it is probably what they heard. It is very likely that the precise action that would correct this issue would more naturally follow from a well-implemented QMS.

Based on what is written in the OP, and the general sense that MWER is pushing back against broad structural changes, in this scenario I recommend that you focus on the lack of (approved) specifications, and develop an action plan to (a) establish specifications and (b) verify CtQ specifications in process. I would not immediately try to implement Control Plans as part of the action plan, as meaningful CP take some critical thinking and data analysis that your org may not have the aptitude (or appetite) for. You absolutely could try to leverage containment activities of verification of effectiveness into an eventual control plan.

I don't think that a "bottom up" improvement of a QMS will be ultimately effective in sweetening a sour business, but in a regulated industry it may be possible to limit regulatory exposure. If you demonstrate success in the small area, it is possible that MWER will allow you to expand the approach to other areas as a PA rather than as a CA.
 

FRA 2 FDA

Involved In Discussions
I made several proposals that were disregarded. There has not been much progress on the CAPAs, as expected.

I decided to leave the organization and will be starting my new position next week.
BEST OF LUCK!!!! And thanks for the update :bighug:
 
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