Quality Manager Owning Design Controls Process

[FRA 2 FDA]

I have been the sole member of the quality department at a start up med dev company for the last 2+ years. During this time, I have learned a ton (so much of which has come from here), gotten my feel under me, and gradually taken on more and more. Prior to this my only experience in this arena was as a lowly tech at a global biotech company, followed by a couple non-quality roles at manufacturing companies. We were without an engineer from September to March so during that time, I started getting more hands on with the DHF and some of the product development activities. We now have two engineers and for the last month or so I've been directing the design review meetings and all the preparation for them, and in the process, directing the engineers to a degree. I recently demanded a big raise which the powers that be are willing to give me (their official offer is coming tomorrow so I don't know exactly what they have in mind yet) and part of this, it has been stated, is me officially owning the design controls aspect. Fine, I already do anyway. But the COO mentioned that eventually I would be the author of rationales that pertain to V&Vs and other requirements that currently the engineers write for the design stuff and the production manager writes for the process stuff. This seems off to me. My intuition says that the process owners/SMEs are the ones who should author such documents and that I would be a quality reviewer/approver. But I have no idea if I'm right. Can you wonderful people with broader knowledge and experience tell me if I should accept this responsibility or not?

 

[Ed Panek]

Assuming this is FDA QSMR and ISO 13485 regulated.

The major risk with a non-expert drafting and signing memos is that during an audit the non-expert is called to task to defend that memo which will cause problems. Do you know enough about the engineering and production work to justify rationales in those areas?

I strongly suggest that SME are tasked with those responsibilities

 

[yodon]

It would be interesting to understand the COO's motivation. Does the COO feel this would unburden engineering from 'quality red tape' work? Or is it just, 'well, we have to justify the raise so here's more responsibility'? Accept the responsibility with the caveat that they send you to training to develop the necessary competencies.

 

[Bev D]

In my experience, the V&V protocols are best developed in a team effort with design engineering input and leadership/input from someone who is an expert at study designs. The engineers by themselves will typically under power adn omit study designs that should be challenging their design instead of merely confirming them. And confirmation is occassionally accomplished by the engineer believing they have done the right thing so a real world study isn’t executed. The study design expert balances this out. In some cases the study design expert is a degrees statistician in others it’s someone who has deep knowledge and experience in study designs. Who they report to can vary depending on the organization. I haven’t seen successful placement of the study design expert in engineering - the conflict of interest is too great and teh study design expert gets over ruled too often.

 

[FRA 2 FDA]

Thanks to all so far. As to the motivation, I believe it's a little of the justifying the raise mentality and also a little of unburdening himself mentality. Currently he has been responsible for "writing" such documents however, he almost never delivers anything and what ends up happening is he pawns it off on one of us anyway then signs. In all honesty, I'd rather be the one to do it because I know it would get done and get done on time, I'm just not sure I'm the right person with the right knowledge to do it.

 

[yodon]

No reason, then, that you can't LEAD the effort, drawing on team members with expertise like @Bev D mentioned as needed.

 

[Enternationalist]

Owning the process isn't quite the same as owning the decisions. In any engineering process, there will be decisions any one person isn't qualified to make. An experienced mechanical engineer can't sign off for an experienced electrical engineer, right?

To me, owning the design control process is about making the right people see the right information and make the relevant decisions. I would push back on the idea that you are the key person for drafting v&v rationales. Honestly, it feels a little belittling to the effort required in managing a design control process to think that drafting the whole company's V&V rationales is a task that could reasonably fit in that workload. You're quality staff, not a personal secretary and note-writer for all the SMEs - they should be thinking about it and writing it down if they're the ones doing it.

Perhaps frame it as a willingness to pull together the final "formal" versions of documents and tell people what sort of documentation is required, but not a direct assumption of the responsibility to draft initial rationales.

 

[Sidney Vianna]

Can you wonderful people with broader knowledge and experience tell me if I should accept this responsibility or not?

Your posts show you are both a very educated and intelligent person. If you feel comfortable with the responsibilities, confident you can access resources to lead the effort and believe your (new) compensation is commensurate with the headaches that sure will happen, go for it. It will definitely enhance your professional experience and expose you to interesting challenges. Good luck.

 

[Tidge]

I already do anyway. But the COO mentioned that eventually I would be the author of rationales that pertain to V&Vs and other requirements that currently the engineers write for the design stuff and the production manager writes for the process stuff. This seems off to me. My intuition says that the process owners/SMEs are the ones who should author such documents and that I would be a quality reviewer/approver. But I have no idea if I'm right. Can you wonderful people with broader knowledge and experience tell me if I should accept this responsibility or not?

I can understand the hesitancy to be the author, but the job as described sounds to me as one where there is an elevated level of expertise required/expected. I'm thinking "co-author" more than "reviewer/approver". It is possible that the company simply wants you to be able to discuss all rationales with authority and phrased this request somewhat clumsily.(*1)

If the company really is "small", the COO is possibly trying to self-justify the investment the company wants to make in you. What is the quality level of current rationales? Are writing these taking huge amounts of other folks' time that it makes sense that the new job requirements are commensurate with the new pay level? If the company is small, it is possible that you can eventually develop complete subject mastery over all of the sorts of things that require expertise!

(*1) There certainly will be rationales required in areas where any one person has zero base knowledge. As a word of caution: I have seen (more times than I care to admit) plenty of plans, deviations, reports, fishcakes, whatever where the quality reviewer flat out said something along the lines of "I don't know what it means but it looks like they followed procedure; I approve." If I was the COO I would NEVER want an approver to even THINK such a thing. As @Sidney Vianna wrote above: You've demonstrated the ability to intellectually engage with the written word in this forum, I would try to communicate with the that you are committed to do the same for her and the company.

 

[FRA 2 FDA]

Wow, thank you guys so much. I posted this seeking a little grounding in reality and actually got so much more. I'm honored that you think of me as such and have to extend some credit to you guys- as I said, this forum has been a huge part of my education and I'm contributing as I can in return. That said, I do think I'll approach it as a collaborative effort between myself and the SMEs.

The company IS small and justifying the investment was exactly the thought a trusted friend and colleague (and one who went through her own "promotion" experience last summer) suggested. I think the only case where these are currently taking up anyone's time is the COO's. So I think if I take it off his plate, work together with engineering/production to co-author then eventually we will either be big/busy enough that these will be farmed out to people in the proper departments or we will stay small and I will end up gaining the expertise and I can take the responsibility if it makes sense for me to. I do always look back and feel grateful when I've taken an opportunity to expand my knowledge and involvement. I just always want to make sure it's done cautiously.