ISO 9001 4.4.1 "...shall determine the processes needed..."

[Big Jim]

So do I, and we repeatedly attempt to achieve that through our review and comment on the standards themselves. Meanwhile, instead of waiting for ISO/TC176 to adopt our sensible comments we look to other sources to interpret the standards.

For example, our ASQ’s update of Deming’s process diagram:

What is Process View of Work? | ASQ

It’s an excellent summary of our profession’s current understanding of a process view of work that has been evolving since 1986.

Interesting presentation. I decided not to comment further. Many things flew my head while reading it, but I'm not sure if any of it would be of value to the discussion.

 

[Peter Fraser]

John

Thank goodness 9000 has dropped the "transformation" idea from its definition of a process. But ISO9000 doesn't help when it defines an activity as "the smallest identified object of work in a project"...

I have always thought of processes as Russian dolls - what is very complex to one person may be a minor step to someone else. But I would hope that if someone carries out an activity they actually achieve something.

 

[John Broomfield]

Peter,

If the work flows across disciplines, functions, departments or organizations I’m pretty sure we are looking at a process.

If the work is completed by an individual I’m fairly sure it’s an activity and all activities are part of a process.

But I’m not sure how or if this fits with your Russian Doll analogy.

 

[Jim Wynne]

“Unfortunately often it is often the Auditors, CBs, and ABs that are interpreting, and usually without paying attention to the organization's needs, and writing NCRs just because they think they can.”

This behaviour may be caused by auditee uncertainty, especially if the auditor is looking for evidence of nonconformity instead of looking for evidence of effectiveness.

False dichotomy. It's possible for a process to effective and nonconforming. If you disagree, be careful not to create a tautology in doing so.

 

[Ninja]

It's possible for a process to effective and nonconforming.

no truer words...

 

[Kronos147]

One of the benefits of ISO 9001 is that the organization may take a unique approach to their process identification. It need not be a cookie cutter ID, it should be reflective of the organization.

I believe that an ineffective process identification is recognizable in the documented information of the organization. If Production and Purchasing are identified (example, in a Business Manual under section 4.4), but Management Review looks at Shipping and Sales (as a method of monitoring processes)(and nothing else), and Internal Audits focuses on procedures (there is one for assembly, but not shipping, one for supplier manegement, but nothing on actual purchasing for production), there is a disconnect. So, the identification, Management Review, and the Internal Audit are non-conforming (to the requirements of ISO 9001), as they are not effective.

If the organization is issued a non-conformance (internally or externally) that states "the identification of processes is not effective", and the organization revises the identification, Management Review template, and the Internal Audit program, will it make the system more or less effective?

Or is it just a waste of time?

When I consult with an organization, I promote the use of processes and sub processes. So while it's true that "Production" usually encompasses other 'activities' (Machining, Assembly, Welding, Paint, etc...), I would advise considering these as sub processes, to keep things simple.

If there are procedures for Machining, Assembly, Welding, Paint, etc., the Internal Audit need not review each procedure, rather they audit the Production Process. The Internal Audit may lead to a review of several procedures, but only auditing internal procedures is IMO not effective.

IME, to be effective, you really need the system to be clear as to the following for each process:
● Ownership
● Requirements (ISO 9001, customer, statutory, regulatory)
● Procedures (internal requirements)
● Risks and Opportunities specific to the Process
● Key Performance Indicators or Performance Metrics
● Objectives that are relevant to the Process
● Training requirements for personnel performing the process and sub-processes
● Relevant Interested Parties (‘Internal’ and 'External’ Customers apply)
● Internal Audit plan reviews all of the above

 

[John Broomfield]

Effectiveness is “the extent to which planned activities are realized and planned results are achieved.”

How can an organization (that has adopted ISO 9001 as part of its plan to fulfill customer requirements) claim to work effectively as a system and be nonconforming?

A system may have achieved the planned results but unless it does this by realizing its planned activities, including conformity to ISO 9001, it is not effective.

What am I missing? Must we commit the tautology of saying effective and conforming?

 

[mattador78]

“Unfortunately often it is often the Auditors, CBs, and ABs that are interpreting, and usually without paying attention to the organization's needs, and writing NCRs just because they think they can.”

This behaviour may be caused by auditee uncertainty, especially if the auditor is looking for evidence of nonconformity instead of looking for evidence of effectiveness.

What has happened to auditor training and supervision?

Thankfully i was given advice by the QM at a customer of ours who was helping me integrate into my new role that I should be confident in my system and in our processes and its the best advice I've been given. From our historic audits we have been consistently high standard and we only make minor changes where required upon finding issues through our own inspection of our processes or because of a customer requirement. I have been questioned on parts of our system or processes during audits and I have had the confidence to say it works and it complies can we move on.

 

[Jim Wynne]

Effectiveness is “the extent to which planned activities are realized and planned results are achieved.”

How can an organization (that has adopted ISO 9001 as part of its plan to fulfill customer requirements) claim to work effectively as a system and be nonconforming?

A system may have achieved the planned results but unless it does this by realizing its planned activities, including conformity to ISO 9001, it is not effective.

What am I missing? Must we commit the tautology of saying effective and conforming?

A customer receives a product that meets all of their requirements. It meets specifications, the price is right, it's delivered on time, it's in the required packaging--everything needed to satisfy the customer. When that product was being made, there was an activity process work done that had documented requirements, one of which was that step 1 had to be completed before step 2, but it really didn't matter which step was done first, and in this case 2 was done before 1. This is non-fulfillment of a requirement--a nonconformity. Does this mean that the process wasn't effective? Remember that the root of the word "effective" is "effect."

 

[Peter Fraser]

Peter,
If the work flows across disciplines, functions, departments or organizations I’m pretty sure we are looking at a process.
If the work is completed by an individual I’m fairly sure it’s an activity and all activities are part of a process.
But I’m not sure how or if this fits with your Russian Doll analogy.

An activity has all the same properties as a process (trigger / action / resources required / influencing factors / outputs / other outcomes). "Making a decision" may be the responsibility of one person, but it may be as significant / risky as other processes.
Taking Procurement as an example, it will be a single process to some people/organisations, but could just as easily be split into Purchase Ordering + Expediting + Goods Receipt in other situations. And the person raising a requisition may see it all from a totally different perspective than the Finance Director who is accountable for the performance of the overall process.