QA insight needed: baffled non QA person

[millychantilly]

Dear QA experts! Please tell me if I’m crazy in feeling shocked at how the QA department operates at my newish employer. I’d love the benefit of some insight from experienced professionals in pharma-adjacent fields: and suggestions you have.

After moving to a different job at a major pharma logistics player (can’t provide too many details), I’m struggling. As a Product Manager, I’ve always worked closely with QA. You’ve been terrific partners, who have brought not just regulatory and subject matter knowledge but also client-facing and execution skills. I’ve admired my former QA colleagues tremendously. And I was expecting more of the same.

But no. This QA team seems to be largely about administering SOPs that other people write and asking those same other people to review CAPAs. They have limited to no regulatory knowledge about pharma packaging, systems, or transport. They almost never interact with clients. They are not able to manage or deliver projects. They constantly say “we aren’t SMEs, we can’t do this.”

Some examples:
- My old QA teams would never have let me manage change notification since I’m a commercial person. This QA team has no product change management process in place, and don’t regard it as their jobs to track change or notify clients of major change. They weren’t aware this is a GxP obligation. No kidding. So I’ve now started to triage change and introduce an impact analysis and notification process. (This scares the heck out of me as I don’t think I know enough to do this.)
- When clients have regulatory questions about packaging, transport, etc. these get punted to me. QA have no idea, and there seems to be no concept of a regulatory function or education within the company. (Again, this terrifies me because who am I to answer these questions.)
- There is no understanding of GmP. I had to explain that certain kinds of tests had to be conducted at least in triplicate to be valid, and when they didn’t believe me, to prove this by showing the team documents from other supplier tests.

So - is this a logistics thing? Like, they’re just a totally different calibre compared with my previous colleagues? Or are Quality departments supposed to be like this and I’m the problem? This is not a small start-up by the way. It’s a business unit within an S&P 500 company.

Sorry about the rant. I would just love to hear what y’all think.

 

[Ronen E]

Companies are different. There is no golden standard. Be thankful that you have good experience(s?) in your history to learn from; rise to the challenge or move on, if you feel it's FUBAR.

Note - It makes sense to bundle up QA and reg together, but it's not a law of physics. Again, companies are different. You will see all kinds of structures, and accordingly strengths and weaknesses in great variation. Sometimes it all comes down to the personal tendency of a key individual. Not kidding.

 

[Bev D]

QA departments that hide behind their walls are not uncommon. Usually they arise from inside and are a function of the old saying about those who can’t do it are those that judge it

 

[Ed Panek]

Companies are different. There is no golden standard. Be thankful that you have good experience(s?) in your history to learn from; rise to the challenge or move on, if you feel it's FUBAR.

Note - It makes sense to bundle up QA and reg together, but it's not a law of physics. Again, companies are different. You will see all kinds of structures, and accordingly strengths and weaknesses in great variation. Sometimes it all comes down to the personal tendency of a key individual. Not kidding.

This 109%

I grew up career wise in 2 companies that used fear to motivate. When something went wrong you went to their boss to complain.

My years in the military told me that. Or so I thought.

How I now get results is in developing personal relationships with my coworkers. I need to work with the shipping manager. Walk around his work area. Talk to him. get to know him or her personally

Thinking back that’s how the military worked too. You spoke to them as Joe A friend who knows about shipping related things. Not the person to point fingers at when they screw up. Yes it may come to that but that’s a horrible first perspective.

Your company culture will tell you how you should approach any problem.

 

[Randy]

My years in the military told me that.

Flitter, I was in the military, you were in something else...

 

[Jen Kirley]

Welcome millychantilly!

I agree with my fellow Covers that organizations can be organized and operate very differently from each other. I am curious about the difference in size and age of your past and present employers. Larger companies with older QMS tend to specialize more; in my 30 years of QA I have never had to learn regulatory aspects pharma packaging, systems, or transport of pharma or otherwise. Not getting answers might only mean those specific people don't know, but someone else does.

For example, I don't see how QA needs to be managing product changes. In my experience, product changes are manages by Product Development Engineering with QA as an assist; my site's Product Quality team does not interface directly with customers, we have people in specific high level roles for that.

My concern is that you are being asked for things that may be outside your intended role. That can happen in large organizations too, when knowledgeable people leave and the newcomers don't know who to ask to get a specific thing done. Since you are being asked you will need to ask others from whichever group has established what is being done; if regulated things are being done at all correctly, someone has executed their responsibility to do so at some point, probably during the initial product development phases. There would have been a project for that along with all the other activities needed to make/deliver/service a thing from the beginning.

Do you know who those people are in your current organization? If not, I would try asking the Engineering Manager/Director.

Moving to new organization can be bewildering, and yes terrifying for those with levels of responsibility who are surrounded by people who ask you for odd things and don't have the answers you need.