Priorities in first month as a new QA Manager

[Jonathanlai928]

Hi all,

I'm starting a job in a new manufacturer with 13485. This is my first role as a QA Manager having previously been a QA/RA Specialist for another 13485 company.

My game plan in brief is this:
- learn processes and go through with all process owners. Identify weaknesses and strengths.
- identify low hanging fruit i.e. fix/clear up quarantine area and establish quarantine procedure (current area is not being used)
- set a 30-60-90 day plan
- review NCs and complete full system internal Audit (not done this year and NB audit is in a few months)
- implement weekly or bi-monthly quality meetings (we had this at my old place) or piggyback off of weekly production meeting

Long term (after NB audit) I am hoping to revamp the procedures and convert into a process map dominant QMS and map the processes with each process owner.

Anything else that's crucial? Any tips?

 

[Johnny Quality]

Congratulations on your new position!

Depending on the size of the organization, I'd try to go out and meet everyone - especially your internal customers and suppliers.

I wouldn't have a focus on adding much, unless there are gaps in the system that need to be filled. I start with observing the full system and seeing what waste can be removed.

What would the quality meetings be for? Who would attend? How would you get their buy in? What are the expected outputs?

Do the procedures need revamping?

 

[Jean_B]

1. Get to know who has the information that isn't in the systems. Build relations and report with them and everyone they have relations and report with. (Points 1, 2 and 3 tbh).
2. Get to know which information isn't flowing, and where redundant and conflicting information may reside.
3. Verify who has access to which information sets, and who actually accesses these, and in how far they can understand the structure of it (especially when it comes to the status of information).
4. Then first move everything which has been lagging in getting into compliance with the EU MDR, which would mostly mean focussing on Post-Market Surveillance, complaints and clinical evaluation, and then R&D with RA. This because you've probably been hired more to manage certification than quality.

Only then start with your list, and actually improve quality because you know the musicians, and not the instruments, and you can be more like a conductor than a person who maintains the hobo, drum and world's tiniest violin.

 

[yodon]

If your company is the legal manufacturer (your name on the label) then I would highly recommend looking at the feedback, complaints, and any adverse events reported. Make sure all that is buttoned up and has the appropriate feedback loops in risk management.

 

[Ed Panek]

I suggest becoming an ISO 13485 lead auditor using online classes. That helped me prioritize our problems and create a real-world list of priorities. Do you have an instance failure or a systemic failure?

 

[Sidney Vianna]

Anything else that's crucial? Any tips?

In my experience, the MOST CRITICAL aspect is the level of understanding and engagement by the organization top management. Something that rarely can be assessed during the hiring process. Your ability to succeed in the job is immensely affected by top management being aware, involved and interested in doing the right things right, I repeat, the right things right.

So, engaging with them is paramount.

 

[Jonathanlai928]

Thank you for all your points. The quality meetings are more of a catch up. This is to keep me in the loop so I can feed back to CCO. We can talk about any reportable incidences, quality issues, PMS etc

 

[Jonathanlai928]

In my experience, the MOST CRITICAL aspect is the level of understanding and engagement by the organization top management. Something that rarely can be assessed during the hiring process. Your ability to succeed in the job is immensely affected by top management being aware, involved and interested in doing the right things right, I repeat, the right things right.

So, engaging with them is paramount.

I agree. I will report to CCO and I will try to really get him on my side as he is the main decision maker.

 

[Jonathanlai928]

I suggest becoming an ISO 13485 lead auditor using online classes. That helped me prioritize our problems and create a real-world list of priorities. Do you have an instance failure or a systemic failure?

They have mentioned and I will follow up. They plan to put me on a lead auditor course.