Informational ISO9001:2015 Process Interactions

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#11
Thanks for your feedback Jen. I have seen some systems from companies I have visited and I think that the process interaction element is always done with the minimum amount of processes.

With more records becoming electronic and stored in ERP/MRP systems, IT is very important and every 3rd party audit I have been involved with in the UK looks at some element of IT and data back-ups, etc.

Having just started with a new company who are looking to get ISO9001:2015 certification, clause 4.4.1 and the performance indicator requirement has made me think a little differently about what we are doing. Interesting the comments that your CB made on all processes and performance indicators.

I have started to revise this and will take on board you comments. Thanks again.
I have often asked: "Where is IT in this? Your network is your QMS nervous system, yes?" So I absolutely agree it is important to include the support processes. I have seen what happens when they are not included, left metaphorically speaking outside the streetlight's visibility of the QMS focus. I occasionally find that with maintenance too... :2cents:
 
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Solitude

Starting to get Involved
#12
It will depend on your scope and size of the organization, but to me an org with less than about 600 ppl should not have more than 7 or 8 processes. Obviously you will have smaller sub-processes, but those should align within the others. With each process should also come 1-2 measureables/metrics.
We are sub 600 people and are a fairly standard manufacturing organization. I would be interested in what you would see the 7 or 8 processes as?
 

charanjit singh

Involved In Discussions
#13
I think there have been some very valuable suggestions/comments on the process map posted by Solitude. Besides simplifying by combining some of the related clauses/sub-clauses, you also add clause nos. in each box. In this way you can review whether you have missed any important requirement.
 
#15
Hi,
Bear in mind why you are required to define "process interaction"...
Not for the benefit of you certification auditors...or a quality practitioner...
It is a requirement initially to ensure staff understand how the organisation operates in terms of throughput of typical workflow.
I think the processes defined in the Operational Control section would achieve this...maybe reference the actual individual process references, or provide a link from them for the users to follow the processes through, i.e initial enquiry, followed by quotation (sales), may lead to purchase/design, them manufacture etc...
I would personally remove the other references which may be superfluous.
Hope this helps...
 
#16
Hi MichelleMcR
Your processes are yours...! and it isn't for your CB to dictate this .. it dependes on how you wish to present your processes, work-flow, interactions to your staff, so they can use the QMS as it is intended..to help them work within your own process controls...whatever they may, or need to be..!
 

howste

Thaumaturge
Super Moderator
#18
Food for thought maybe this may help........
Hi Eddie - I know you weren't asking for a critique of your flow chart, but I have a few comments you might consider in the interest of improvement:

1) The middle column in your flow chart is labeled Process Activity but none of the headers in the column include activities. It looks like the process activities have been put under the Input header. Inputs and process activities are different things. You might consider adding another Process Activities header to list the activities for each process to avoid confusion, then the Inputs header will only have inputs in it.
ISO 9000:2015 said:
3.4.1
process

set of interrelated or interacting activities that use inputs to deliver an intended result
2) In my opinion the real interactions between processes deal with the outputs and inputs. The outputs of each process should be inputs to other processes or to the customer. Similarly, the inputs to each process should be outputs of other processes or the customer. As I look at your flow chart I don't see very many inputs/outputs that line up with each other. For example, (in my opinion) the main output of the Purchasing process is purchased product. Purchased product is one of the main inputs to the Production process.
ISO 9000:2015 said:
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.
3) There seems to be a disconnect in some cases with the Measurement and the Reported in MR as metrics. For example the Production Measurement is "Process Performance and Product Conformity, RGA" but it's reported in MR as "On Time Shipments Average Days Late."
 
#19
Hi howste, Thanks for your comments. I will take all opportunities for improvement into consideration. This Process Lay Out has "survived" numerous API and ISO audits.
Current program is API Q1 and ISO 9001:2015. There is always room for improvement. Thanks for taking the time review and comment.
Eddie74
 

Crusader

Trusted Information Resource
#20
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! :thanks:

1, 2, 3, ...GO!
 

Attachments

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