Identifying Processes in a Company

S

SybilleH

#1
I have recently completed the Internal Auditing course and am not sure how to handle this one. Our registrar's auditor and the Lead Auditor who conducted the training were MILES apart on what should be identified as a process. Our auditor has "strongly recommended" we have no more than 8 or 9. The course instructor suggested 20 to 25 minimum!! They are so FAR apart - one is also telling me Management Review is a process, the other is not. My head is spinning and I would appreciate your feedback.
Thanks!
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Indentifying Processes

I have recently completed the Internal Auditing course and am not sure how to handle this one. Our registrar's auditor and the Lead Auditor who conducted the training were MILES apart on what should be identified as a process. Our auditor has "strongly recommended" we have no more than 8 or 9. The course instructor suggested 20 to 25 minimum!! They are so FAR apart - one is also telling me Management Review is a process, the other is not. My head is spinning and I would appreciate your feedback.
Thanks!
Hi SybilleH - welcome to the cove...

One can say "all work is a process". The question becomes what processes need to be documented in order to meet the requirements of a standard, or the needs of a business.
Looks like your auditor is saying he needs to see 8 or 9 documented processes to meet the requirements of a standard, where the instructor is looking for more (and probably being more realistic).
Do what meets he needs of your business.
ISO9001 only REQUIRES 6 documented procedures - but you will surely need more unless you are a one or two person shop.
I'm in a medium size medical device company and we easily have 100 controlled procedures and work instructions to satisfy ISO9001, ISO13485, FDA QSR, and customer expectations.

And Management Review is most definately a process - and a requirement of ISO even though it doesn't require a separate procedure, you have to cover the process inputs and outputs somewhere. In a minimalist system that might be in the Quality Manual, but more companies will have a separate procedure.
 

Big Jim

Super Moderator
#3
Re: Indentifying Processes

Hi SybilleH - welcome to the cove...

One can say "all work is a process". The question becomes what processes need to be documented in order to meet the requirements of a standard, or the needs of a business.
Looks like your auditor is saying he needs to see 8 or 9 documented processes to meet the requirements of a standard, where the instructor is looking for more (and probably being more realistic).
Do what meets he needs of your business.
ISO9001 only REQUIRES 6 documented procedures - but you will surely need more unless you are a one or two person shop.
I'm in a medium size medical device company and we easily have 100 controlled procedures and work instructions to satisfy ISO9001, ISO13485, FDA QSR, and customer expectations.

And Management Review is most definately a process - and a requirement of ISO even though it doesn't require a separate procedure, you have to cover the process inputs and outputs somewhere. In a minimalist system that might be in the Quality Manual, but more companies will have a separate procedure.
Be careful. Procedures do not equal processes.
 

Big Jim

Super Moderator
#4
Re: Indentifying Processes in a Company

I have recently completed the Internal Auditing course and am not sure how to handle this one. Our registrar's auditor and the Lead Auditor who conducted the training were MILES apart on what should be identified as a process. Our auditor has "strongly recommended" we have no more than 8 or 9. The course instructor suggested 20 to 25 minimum!! They are so FAR apart - one is also telling me Management Review is a process, the other is not. My head is spinning and I would appreciate your feedback.
Thanks!
The root of the problem here is that the term has never been well defined within the ISO scheme. ISO 9000 defines a process simply as activities that have inputs and outputs. That simple of a definition doesn't seem to meet what they are talking about in ISO 9001:2008 element 4.1.

Until ISO (or perhaps the committee that is responsible for ISO 9001) comes up with a better explanation, there will always be debate on this topic, or as I have said before, this ship will remain adrift.

It would seem that processes could be divided into two main categories, business processes and manufacturing processes. Element 4.1 seems to be talking about business processes, and I have started to hear that term quite a bit recently. Element 7.5.2 seems to be talking about manufacturing processes.

I would tend to agree with your auditor, that most companies can or have divided themselves into around eight or nine core business processes. It depends on how the company has structured themselves. There may be many additional activities (or sub processes) contained within the core processes.

I have seen companies that fall in line with you instructor, and have become tangled in the morass they have created. One defined over five hundred processes. They also had job descriptions with several hundred competencies listed for each position. I even saw a company that had a consultant that told him that his interaction process description had to be flow charted to the point that someone from the outside could walk in and function in any position. After four months of trying to create such a flow chart they dismissed the consultant. The results were page after page of detailed flow charting that took extreme concentration to follow.

Some people seem to read complications that don't exist into ISO 9001:2008, and the resulting boondoggle is nearly impossible to administer.

Some typical core business processes might be: Sales, Engineering, Purchasing, Quality Assurance, Production, Shipping/Receiving/Inventory, and Management Support. All of the other processes can be fitted into a framework of this nature.

In short, I side with the group that thinks your trainer is nuts!
 

qusys

Trusted Information Resource
#5
Re: Indentifying Processes in a Company

I have recently completed the Internal Auditing course and am not sure how to handle this one. Our registrar's auditor and the Lead Auditor who conducted the training were MILES apart on what should be identified as a process. Our auditor has "strongly recommended" we have no more than 8 or 9. The course instructor suggested 20 to 25 minimum!! They are so FAR apart - one is also telling me Management Review is a process, the other is not. My head is spinning and I would appreciate your feedback.
Thanks!
Try to search the word "process" in the ISO 9001 standard and verify where it is reported the requirement to have it.
Jim well explained the fact that some processes are also formed of sub processes and it is up to the organization to set up ( identification with relationships among them) the processes needed for its own QMS. Sometimes to be more attractive for the organization , QMS processes can be seen as "business" processes. As to Management review , I think it is reductive to talk only about it. Par.5 of ISO9001 is extended to all responsibility of the Top mgmt for the organization's QMS and also the activities the mgmt carries out are finalised to gain solid results for the organization ( revenue) and continual improvement of QMS processes to better serve customers. Management review in itself is only of many activities that top mgmt shall do to meet ISO requirement. If you want to call it "process" it is ok the same, but do not complicate the system too much. Look at its effectiveness ( and efficiency) overall without stopping at formalism.
 
Last edited:

Kales Veggie

People: The Vital Few
#6
Re: Indentifying Processes in a Company

I have recently completed the Internal Auditing course and am not sure how to handle this one. Our registrar's auditor and the Lead Auditor who conducted the training were MILES apart on what should be identified as a process. Our auditor has "strongly recommended" we have no more than 8 or 9. The course instructor suggested 20 to 25 minimum!! They are so FAR apart - one is also telling me Management Review is a process, the other is not. My head is spinning and I would appreciate your feedback.
Thanks!
8 or 9 could be too much. Both are wrong ! It should more like "activities" or task then processes.

The standard does not say anywhere how many you should have, you should identity them.

I am working with a 15,000 people organization and we have 6 standard processes. For one of the location (testing and validation) we have a few more identified.

Keep it Simple.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#7
Re: Indentifying Processes

Be careful. Procedures do not equal processes.
This is true. Procedures and work instructions document processes that an organization needs to keep consistent.
There are a nearly infinite number of processes that occur during a business day and we can't document them all.
One might call many of them sub processes or sub-sub processes, but a sub process in the big picture is still a process to the person responsible for it.
Thus the reason I have so many documented *processes*. I consider each one distict to keep it understandable to the guy on the floor manning a press brake. To me what he does is a sub-sub-sub-sub process of product realization. To him the work cycle of bending a part is THE process.

I won't disagree that a company can have a minimal number of major process broken down in to sub, sub-sub, sub-sub-sub processes but I think the OP is more concerned with what needs to be documented.
 
S

SybilleH

#8
Re: Indentifying Processes

Thank you all for your comments. As I orient myself in "the Cove" I am seeing many posts dedicated to this subject. I appreciate all the feedback as well as the wealth of knowledge that is available here. The common theme is to understand what works for us and to ensure we are fulfilling the requirements of the standard. I honestly believe that a huge issue is some of the inherent ambiguity that exists when a document is written with such a diverse, multi-national audience. And I knew that - guess I was hoping for a simple answer.
Sybille
 
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