New Interaction of Processes ISO 9001:2015 - Please Review

[Swagman]

Hi All,

I'm new to Quality Management Systems, and like a lot of you, I suspect I am (as a newbie) wrestling with the task at hand and specifically 9001:2015

But then I found this wonderfully informative forum, which seems to be well represented with experienced people willing to lend a hand to impart some knowledge and good advice to those amongst us who are new to the world of ISO..

We are a company who is already certified to 9001:2008, so I'm hoping that all the main building blocks are in place, and the transition 'may' only take some tinkering around the edges, (clause 4 for example), as all of our main Supplier Management, Corrective Actions, Management Review etc are in place and have been working fine.. but famous last words eh!

Anyway, sorry for the long introduction, better get to my question.. I have started with our IOP as I feel this will then allow me to set up a process based Audit schedule, and map out which clauses of the standard we have fulfilled against each process, to look for any gaps.

But looking at other examples of IOP's I can't help but think I've missed a whole load of processes in the 'service realisation' stage.

We have as you might expect an awful lot of processes and procedures that would fall below what I have tried to keep as a 'high level' IOP as I realise that for each one I show on the IOP I will have to create a Turtle Diagram of sorts with all of the associated ins, outs, who, when, why, how, risks, owner etc... so wanted to minimise that, but perhaps I have gone too far!

So for 'Business Sales and Development', we already have processes/procedures under that heading that would relate to 'Formal Procurement and Bid Management' and 'Contract Initiation', basically our company wins most of it's work from Invitations to tender, once that work has been sucessfully negotiated and won, we move to deliver the service the customer has stipluated in the tendering process, so we move in my IOP to 'Service Delivery'. The processes/procedures we have in place for each of our service delivery contracts, show things like where the work comes from, how it is tracked through it's lifecycle (while in our posession), to our digitisation of the work into an electronic form, our QA of that work to see it matches the clients requirements and then final handoff to the client.

So the question really is, if our current processes/procedures show all of those steps within one or a series of flows, do I need to break out items like 'Work Receipt', Work Tracking', 'Digitisation', 'QA', 'Handoff', on the actual IOP or I can I keep it very high level as 'Service Delivery' and use the customer specific SLA and KPI's to track that all of the sub processes I've mentioned are performing as expected?

Also, As we have say 6 clients, who we perform 'Service Delivery' for, do I somehow need to distinguish the different clients requirements, and say have multiple 'Service Delivery' Icons on my IOP, one for each client, as the information on each associated Turtle Diagram may be slightly different dependant of the clients requirements... or instead of using computers to generate the output, we may use paper etc?... we are obviously a service related business performing data manipulation in various forms, but I could see the same problem if you made different types of widgets etc, how do you genericise the turtle diagram and IOP steps for multiple different products..

Thanks for any and all advise to what has been a confusing first few months

 

[Coury Ferguson]

Just a quick bump on this post. Any feedback from anyone?

 

[Eredhel]

Are you looking at 4.4 for this?

 

[howste]

But looking at other examples of IOP's I can't help but think I've missed a whole load of processes in the 'service realisation' stage.

I thought the same thing when I looked at it. The center section seems pretty sparse. It seems like all you do is give a bid, win the order, then provide the service. Can you tell us what kind of service is being provided? That might help us to understand the context a little better. Based on the terms you're using I'm guessing maybe IT services?

What I don't see in your diagram is how you design and validate the services you provide. Also, if there is any equipment, software, or outsourced services involved in your services, how do you purchase them? It looks like you jump from clauses 8.2 to 8.5 in the standard and skip over the requirements in 8.3 and 8.4 in your diagram.

So the question really is, if our current processes/procedures show all of those steps within one or a series of flows, do I need to break out items like 'Work Receipt', Work Tracking', 'Digitisation', 'QA', 'Handoff', on the actual IOP or I can I keep it very high level as 'Service Delivery' and use the customer specific SLA and KPI's to track that all of the sub processes I've mentioned are performing as expected?

Also, As we have say 6 clients, who we perform 'Service Delivery' for, do I somehow need to distinguish the different clients requirements, and say have multiple 'Service Delivery' Icons on my IOP, one for each client, as the information on each associated Turtle Diagram may be slightly different dependant of the clients requirements... or instead of using computers to generate the output, we may use paper etc?... we are obviously a service related business performing data manipulation in various forms, but I could see the same problem if you made different types of widgets etc, how do you genericise the turtle diagram and IOP steps for multiple different products..

I don't think you need to get too detailed at this level with the Work Receipt and other steps that you mentioned. I also wouldn't customize the processes for each of your clients. That's probably already done in your SLA and other agreements.

 

[ousgg]

Two questions I always ask when we are establishing basic processes and their interactions:

1) Do each of these processes have a clearly-defined owner?
2) Do each of these processes have a clearly-defined KPI?

If the answer to either of these is 'no', then it's time to review.

Your IOP does not have to be an all-encompassing statement of how you comply to the spec. Do you really want to try and formulate a nonsense KPI for Management Review or Document Control? Do you want to assign a process owner for Continual Improvement when your basic expectation is that ALL process owners enact some Continual Improvement? Do you really need to put your MD on the stand as 'Process Owner for Management Review' when he has already assumed responsibility for most of Section 5?

Your IOP should be a representation of how your company works: how it actually gets goods/services out the door. There's no wrong way to do it, as long as your processes have clearly defined outputs and ways to measure those outputs. And you certainly don't have to use it to demonstrate over-riding compliance to the standard.

 

[Document Dame]

I notice you mentioned the need for more detail. While preparing for our AS9100D Transition Audit I"ve been receiving varying views on how detailed our Sequence and Interaction of Process should be.

I created a draft Core and Support Processes Document to give a visual representation (emphasis on DRAFT) per 4.4.2.

It’s not as detailed as others that I’ve seen, but I already have a Quality Document Matrix listing the Processes and the supporting Forms, Work Instruction, QAPs, etc. for each.

Note: I also have a QMS Library Matrix which adds REV Levels, Control Methods, and Responsibilities.

I need to know if putting the Core and Support Processes Document in the Quality Manual and having the Quality Document Matrix to provide additional detail is enough to fulfill the clause 4.4.2.

I attached 2 of my Rev. C documents for review.

I would appreciate additional input.
Thanks!