mlthompson said:
I'm finding that debating the process approach vs elemental approach is futile. It is being enforced despite what each of us may personally feel.
So I quess, rather than debate further, I would like to ask the forum on how you apply the process approach to your organization. Please include issues raised by your auditor to meet their personal expectations/interpretations and also those items you do that makes the process approach work for you.
I'm asking this because the ISO standard refers to the process approach but doesn't explicitly define what is required to pass certification/surveillance audits.
I'm surprised this thread went dead. I think you asked a good question. I'm an auditor and consultant, so I'll share some of what I commonly see.
Most companies are defining two types of processes, sometimes three. The two most common types are:
customer oriented processes (the key, critical path processes that affect the product and the customer). Common examples are Sales, Design,
APQP or Engineering, Purchasing, Manufacturing, Storage and Shipping. There can be other versions as well, of course.
support processes (the administrative, supporting processes). Common examples are Training, Management, Calibration, Maintenance, Quality, Internal Auditing, Corrective Action, Controlling Docs & Records. I also see processes like IT Support, Continual Improvement, HR with some regularity. There are others, but these are frequent ones.
Some few companies define a third type as management oriented processes, which is just a subset of support processes, with a particular link to management activities. Only a few of my clients define this as a group. Most simply lump them into their support processes group.
Most clients develop a high level map to show how these core processes sequence, and describe the interactions of the supporting processes. Most clients also use some sort of a flow chart, process map or turtle diagram to describe each process, and how it breaks out.
Lastly, most also have a procedure for each process, which further describes the things they need to communicate about each process that has not already been covered in the charts. Then, where needed additional work instructions and forms exist, pretty much the same ones they had under the previous version of ISO.
It is also becoming more common to see ISO 14001 and maybe Safety integrated with their ISO 9001 or TS systems.