Informational ISO9001:2015 Process Interactions
- Thread starter Solitude
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AMIT BALLAL
Super Moderator
I am resurrecting this topic only because I would like to reduce the number of Processes down to an appropriate level and rename the rest to "Support Process"? or ???
Just what is the typical number of processes and what are they?
We have a list of SOP's and a Flow Diagram and a Matrix at the end of our Quality Manual. I'd like to ditch the Flow Diagram 100%. Don't need it.
Don't need the list of SOP's either but it helps with the correlation for the Matrix. Right? (Oh, I hate ISO 9001:2015)
Any input or criticism is appreciated!
LOL!
1, 2, 3, ...GO!
There is no standard specifying how many processes there should be and which processes it should include. But the processes you have defined seems more like activities to me rather than process.
Eg. You can combine processes such as Management Review, Internal auditing, Record/Document control, Continuous improvement under one process i.e. QMS
Measurement & calibration, control of non conforming product, Inspection can be clubbed under one process i.e. Quality assurance & control.
TBMK, I would suggest to have processes less than 10. This will best help to manage processes easily. Again this will depend on how your organization works, do what make sense to your organization.
Amit I don't think this is appropriate at all. Pushing things like control of nc outputs with calibration etc isn't going to work. I agree that some of Crusader's processes are activities and not processes, however.
Crusader: Anything inspection and test isn't a process in my experience. They are part of a process, just like review is for document control, for example.
Take a look at your stuff and ask yourself what is the input being changed. Inspection and test doesn't "change" anything. As far as the interaction of processes, I'd simply take a look at the core processes and pack everything around them. For example, does design come before customer inquiry or after? In other words do customer contracts include line items which say "Please design me something to do X, Y and Z"? Or do you design things and then put them for sale, so the customer's order says "I'd like to buy NN"...
AMIT BALLAL
Super Moderator
Andy, sorry for bad explanation in earlier post. This suggestion was based on what we do at our organization. In our organization, Control of NC products, calibration etc. processes are considered as sub-processes and included under one process i.e. Quality control and assurance. This is because quality control & assurance process owner is process owner of this sub-processes as well. I agree control of NC products and calibration are different processes and will need to work differently due to its input-output and interaction with other processes.
If my interpretation is incorrect, please let me know, I am open to learn.
Last edited:
Project Man
Involved In Discussions
It looks good. We added Purchasing to the Production Planning because purchasing is a focal point for auditors. They like that we call it out specifically as part of the core process.
Side note: SOP-006 is great but I've seen some auditors want a separate preventive action SOP. Personally, I initially fought back on that (and won) but the longer I do this the more value I see in having it as a separate SOP. It makes you more intentional in actually dealing with issues.
Side note: SOP-006 is great but I've seen some auditors want a separate preventive action SOP. Personally, I initially fought back on that (and won) but the longer I do this the more value I see in having it as a separate SOP. It makes you more intentional in actually dealing with issues.
Crusader
Trusted Information Resource
Thank you. I am hoping this is approved by our CB.
FYI: I have been advised more than once that "Purchasing" here/most businesses is a sub-process. I am in total agreement on that. Everybody's different huh?
And SOP-006 is only Corrective Action because our CAR Form does have a step for permanent preventive measures, when possible, though. No auditor can tell anyone to have a separate PAR document/procedure/process. A step on the CAR form is enough.
Project Man
Involved In Discussions
I agree with you 100%. Just wanted to you know about some of the curve balls that get thrown. Good Luck!
Tagin
Trusted Information Resource
Thank you. I am hoping this is approved by our CB.
FYI: I have been advised more than once that "Purchasing" here/most businesses is a sub-process. I am in total agreement on that. Everybody's different huh?
And SOP-006 is only Corrective Action because our CAR Form does have a step for permanent preventive measures, when possible, though. No auditor can tell anyone to have a separate PAR document/procedure/process. A step on the CAR form is enough.
Some thoughts:
Shipping does not output to customer satisfaction per se; it outputs to the customer. Customer sat is then a result of what they receive (and how they recvd it, etc.), via some means of feedback and measurement. I see the intent in how you have shown it, but it is rather....abstracted. It may suffice, or it may raise a flag.
Where are 4,5,6 addressed? E.g., do you have a risk management SOP to address 6.1, or have you woven risk mgmt into the rest of your system somehow? Where are quality objectives defined and communicated? How is context of the organization handled? etc.
It is not required to list the exact SOPs, and it may make maintaining the doc more tedious as your SOPs get added/removed/changed over time, requiring the process-interaction doc to be updated to reflect those changes. On the other hand, if there is actual usefulness that people get out of including the SOPs by name, then it may be worth it.
Attached is the diagram we use, and it has passed audits with no issue.
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