Solitude

Starting to get Involved
#1
We have been giving some thought to process interaction for ISO9001:2015 and we have produced the attached. We are not currently certified and have just started on the road to certification.

I would appreciate any feedback that people may have. I am a little concerned that there is a lot here and when we start to apply section 4.4.1 to this, there is a lot to do in the way of performance indicators, etc.

Thanks in anticipation.
 

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howste

Thaumaturge
Moderator
#2
I does look like you have a lot of processes. Some of them may just be parts of other processes, or could be combined with related processes.

Again, here is the definition of a process in ISO 9001:2105:
ISO 9000:2015 said:
set of interrelated or interacting activities that use inputs to deliver an intended result
You should look at each process and decide if it really is a process, or maybe an activity that is part of another process. For example, Identification and Traceability seems like it is an activity that is done as part of Assembly and other processes. Resources are probably allocated as part of the Management Review and Planning processes. Organizational Knowledge needs to be defined and maintained, but it probably happens as an output of other processes.

You may also combine some of the related processes that are similar or repetitious. For example, you have Planning and Production Planning as two separate processes that may be combined (unless Planning is part of Management Review?). You have Document and Data Control and Control of Records as separate processes that may be combined.

Obviously I'm not saying that you need to do what I suggested, but I'm trying to point out some options to simplify. Ultimately you and your organization will determine the right processes for your system.
 

pondo

Registered Visitor
#3
I think you did an excellent job of laying out exactly what happens in your organization. I also believe, as the replier above, you should consider simplifying for the sake of capturing your performance indicators.

All I did was use the turtle process diagram approach and identify the individual major process that constitute the overall company process. I.e. Sales, Estimating/Pricing, Order Entry, Launch.........through Delivery to the customer. Then I capture the support processes such as maintenance, internal audit, corrective action, etc.. Each separate process has performance measurables. Outputs of previous process are typically the input to the next process.
 

Solitude

Starting to get Involved
#4
Thanks for your feedback. I am looking at rationalising what we have with the team here. A number of these interaction maps I have seen on line look very light and have omissions like Document Control (old ISO) and no Internal Audit process. How does that paint a complete picture of the processes required for the QMS? I understand that they may not be "operational processes" but surely they are necessary??
 

Solitude

Starting to get Involved
#5
I would be interested in what people have as their top level processes as most manufacturing organisations would be similar I would imagine.

Any help would be appreciated. Thanks.
 

Project Man

Involved In Discussions
#6
It is very painful for those of us "eyeball deep" in in the intricacies of day-to-day operations to boil down what we do into very macro terms but that is exactly what is being asked of you.
I would encourage you to read the definition that Howste gave from 9000:2015.
After looking at your chart I believe you have 4 processes:
Customer Focus (all interactions with the customer on the front end and the back end i.e. RFQ, Quote, Contract Review, Customer Feedback, etc)
Design
Purchasing (includes supplier management)
Production Planning/Production (this is everything it takes to get raw mat'l/goods through getting parts to the customer)
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Some of the processes shown in the bottom box could be sub-processes.

I tried to list only the major (production-related) processes in my 2015 audit report, and was told I must list all the processes I audited, as well as (warning!) KPIs for all those processes. Clearly the requirements differ among CBs... :nope:

Anyway, I was happy to see you include IT because your data system is very important! And they support your record retention through backups, yes? IT people are very important sources for risk-based thinking in so many ways. Ask Sony, whose recovery following their hack took almost a year. An interviewee described such details as people were being asked "How much do we pay you?" and having to talk with each other instead of using email.

But I digress. My point is the QMS is for the system, not just the production-related processes, and the system should be represented in the interaction... which, by the way does not have to be a map though yours looks very nice except the support processes I would keep in the bottom (IT, control of documentation, knowledge management etc.) also support the management processes so I would have considered their being in an overall box, in which the diagram can show those subjects touch all the others.
:2cents:
 

Solitude

Starting to get Involved
#9
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.
 

Kronos147

Trusted Information Resource
Trusted
#10
Some of the processes shown in the bottom box could be sub-processes.

I tried to list only the major (production-related) processes in my 2015 audit report, and was told I must list all the processes I audited, as well as (warning!) KPIs for all those processes. Clearly the requirements differ among CBs... :nope:
I would imagine that I would steer the auditor back to my COTO and emphasize why the organization has defined these as sub-processes, and as such, based on the availability of resources, not all sub-processes have KPI's. Rather, the process KPI not being achieved, would trigger a Root Cause Investigation that may in fact point to the sub-process.
 

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