Peter Fraser
Trusted Information Resource
I can't open the file: View media item 4580 - I have advised the Cove, but why can John see it and I can't?!!!
I can't open the file: View media item 4580 - I have advised the Cove, but why can John see it and I can't?!!!
I can't open the file: View media item 4580 - I have advised the Cove, but why can John see it and I can't?!!!
Wow, thanks for your very quick and extensive response. Very much appreciated!.
1.
People is a resource. There are procedures to support the People part, but it's not a core process.
Same as plant & equipment. It's a resouce, supported by procedures
The core processes are the ones that make us money. That's our intake on core processes.
All the items to the sides are resources/processes to help achieve our core processes and deliver quality to our customer. they will have (sub) processes attched to them.
2.
Yeah, we have looked into that, but we have chosen to have them separate. We do have 1 CAPA form though.
3.
We have a Opportunity & Risk Management procedure. This is covered in quality planning, management review etc.
Would that have to be mentioned separately or would it be OK as long as you can explain how you manage risks?
4.
We have a separate design procedure. In the core processes, it's part of what we call the Manufacturing Process.
As long as we can show our procedure (and ofc evidence that we do what/how we say we do).
Thanks again for your input.
1. So, have you got Recruiting and Training for Competence covered?
2. As long as your colleagues know that the CA part of CAPA stops recurrence then no problem. I would drop the PA part of CAPA on the form to remove any possibility of confusion.
3. Your colleagues should be prepared to demonstrate their risk based thinking as part of the system which, of course, includes them.
4. Do you mean Manufacturing Services?
Thanks to Eric at the Cove for sending me a copy - it may be 'cos the picture was embedded rather than attached, although I don't recall previous problems. Anyway...I don't know. I'm a newbie with less than 10 posts, so I couldn't add a link. Had to embed the jpg after uploading to the Cove gallery.
Thanks to Eric at the Cove for sending me a copy - it may be 'cos the picture was embedded rather than attached, although I don't recall previous problems. Anyway...
I have two real issues with what folk seem to think they have to do to comply with 9001 - PDCA and a "process map". And, guess what, you have covered both of them in one! First of all, PDCA is mentioned as a method that may be useful - full stop. And drawing a system map to show how your processes interact can't easily be done in two dimensions.
To me, the key test for your management system is "Does it help your people to understand how the business runs, and what they have to do within that?" Does your diagram help your staff? Have you asked them? [Forget about your CB for this]
You say that some of the items in the side boxes are Resources - I agree, but why then call this a Process Map?(!)
I could point out a few other issues, but if your CB accepts it then you have met one objective. Just to give you an idea of what I think is missing... your Support box should list processes / there is hardly any interaction between the boxes (eg data and improvements go in all directions, surely?) / Purchasing must cover more than items for Manufacturing, and should it not come before Manufacturing / |Continual Improvement is an objective / outcome, not a process...
But if your CB is happy(!), I would concentrate on making sure that your actual processes are defined and communicated.