Mapping QMS+business processes in a medical device with class I and IIa+b

Hi

I am in a project where the QMS and all related processes, roles, departments, requirements, and legal together with a mapping of all projects and processes also have to be mapped and visualized. Many of the projects besides are consistence with hardware and software in many projects.
It is a larger company with many projects and SOPs.

My first plan is to due to the analysis of QMS and then on each project with standard GAP +ISO and regulatory?

My first idea is to use Excel and Visio.

What would be the best mapping to use?
My first idea is VSM and SIPOC?
RACI for stakeholders.

Is this a good start or do I have to be aware of issues now?
And would there be a better solution for mapping to use?


Kind Regards

What do you have just now in terms of documentation? I guess that you must have a lot of documentation already if you have many projects etc.
And where do your requirements ("...a mapping of all projects and processes also have to be mapped and visualized") come from?
Personally I would avoid Excel and Visio because you really need to have a common source for your roles, documents etc. Yes for RACI for definig your processes - but I have never been a fan of SIPOC(!)

When it comes to selecting the most appropriate tool to use, be it a software program or something from the quality toolbox, I'd offer that answering the following questions might offer some guidance:

• Why are you doing this exercise?
• What is the expected outcome of this exercise?
• How will the results of this exercise be utilized?
• Who will use the results of this exercise?
• Is this a one-time exercise or something that will become routine?

Without knowing the answers to @RoxaneB questions, it is difficult to offer much in the way of concrete suggestions.

With nothing to go on but the OP, for process mapping... my first tool would be a piece of paper to draw a flow diagram of what I think the process looks like from the established procedure (assuming one exists), and then turn that into something like a Visio drawing. I have found that Visio workflows typically force people to think about the "obvious" flow and draw immediate attention to problematic paths in the flow. (I am assuming that who ever wants this exercise is at least looking for this)

When I've done this sort of exercise, I have found it critical to interview the people using the process after my own mapping of the workflow. I have found the following common outcomes:

• The users can clarify parts of the process that I didn't understand (typically due to ignorance or preconceptions on my part)
• Users sometimes don't follow the flow (for ad hoc reasons)
• Users sometimes can't follow the flow (process has a defect)

Interviewing users first will simply muddy the waters, as individuals will almost certainly be focusing on discrete elements of any given process and not the entire process.

The first bullet point above is something to be VERY cognizant of... I have seen some VERY complicated processed that look as if they could be "streamlined" (by some outside expert) yet teams of trained and qualified individuals have demonstrated that they follow such processes unerringly. This is a reason to know the purpose of the exercise and how it will be used... there may be no return-on-investment for trying to streamline a smooth-running but complicated process.