Quality Manager Owning Design Controls Process

Hi FRA 2 FDA,
Some great advice above. As you mentioned your company is small, but consider this. If you author a document, who in the company provides the review pertaining to Quality? I'm in a similar position, but our Quality team is four people. Once person from Quality may author, with support from SMEs, but there will be two people from quality reviewing: the author and another Quality team member. I working on the culture change here, also a startup, and it takes time. For now The SMEs own the related SOPs, while I own the "Qualtiy" SOPs: Quality Manual, CAPA, Supplier controls, etc. I working on the other documents for SME ownership! Keep up the fantastic work!

Quinn-
You are lucky to have other quality buddies! Usually if I author a document (or revise one under my ownership), I have our ops manager be my reviewer because she is the only person I trust to go through the document and give it a thoughtful and complete review. And luckily, she also has the most knowledge about any of it out of anyone else here as she and I were employee #1 and #2. We have been here since the beginning and have invented and implemented everything that happens here. I did bring this issue (of the design controls content) up with her and she was completely on board with authoring her process stuff and me reviewing it because that works well so I know I don't have to worry about it from that stand point. You also keep up your good work and best of luck!

Can you demonstrate competency? This can be via qualifications and/or experience . If not you cannot be responsible for technical decisions. Would you let a welder rewire your home?
You can review and question but a technically competent individual is required to design and assess the technical aspects of the process/product

Well since this has been unearthed, I thought I'd provide an update. I took the job and received the full raise I asked for and have had no problems as of yet. We lost one engineer shortly after this thread left off and engineering slowed down. Next month, we are adding two more engineers to the mix. I have the feeling I will be able to be involved with directing them and being the quality voice in a way that makes sense based on my knowledge. I am not anticipating any issues. We shall see...

Thanks for the update FRA 2 FDA