Process Approach Litmus Test - Procedure Titles

[ISO 9001 Guy]

Yes or no, does your system documentation include QMS procedures bearing titles like, "Customer Property?" "Product Identification?" "Inspection and Test Status?" "Preservation of Product?" Procedure titles indicate QMS structure. A QMS is a system of processes. Procedures describe these processes. So procedures indicate processes that have been identified as being necessary to the QMS.

 

[Stijloor]

Re: Process Approach Litmus Test

Yes or no, does your system documentation include QMS procedures bearing titles like, "Customer Property?" "Product Identification?" "Inspection and Test Status?" "Preservation of Product?"

And then?

Stijloor.

 

[Jen Kirley]

Re: Process Approach Litmus Test

Yes or no, does your system documentation include QMS procedures bearing titles like, "Customer Property?" "Product Identification?" "Inspection and Test Status?" "Preservation of Product?"

I may be missing something. What does the title have to do with it? I don't care what they are called, I want them to sensibly describe the plans and controls necessary to ensure both internal and external customers enjoy positive results.

 

[Colin]

Re: Process Approach Litmus Test

Speaking as a consultant, no. There are times when the title of the procedure happens to coincide with the title of a clause e.g. document control, audits, etc, and I sometimes would write a procedure for purchasing if the company want it as a separate entity. On the other hand, I am just starting a project where we have a procedure called 'materials management', which includes planning, purchasing, goods in and receipt and handling of customer property.

 

[AndyN]

Re: Process Approach Litmus Test

Yes or no, does your system documentation include QMS procedures bearing titles like, "Customer Property?" "Product Identification?" "Inspection and Test Status?" "Preservation of Product?"

Titles are somewhat meaningless without context of the business. What are you looking to discuss?

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

Speaking as a consultant, no. There are times when the title of the procedure happens to coincide with the title of a clause e.g. document control, audits, etc, and I sometimes would write a procedure for purchasing if the company want it as a separate entity. On the other hand, I am just starting a project where we have a procedure called 'materials management', which includes planning, purchasing, goods in and receipt and handling of customer property.

Yes, Colin, I agree that in some cases an organization's processes happen to align with the requirements, as you indicated, in the case of support processes. The clauses cited are specifically related to realization processes (from section seven). To treat realization requirements as if they are processes (by dedicating QMS procedures to them) is to employ an elemental approach--contrary to the process approach.

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

I may be missing something. What does the title have to do with it? I don't care what they are called, I want them to sensibly describe the plans and controls necessary to ensure both internal and external customers enjoy positive results.

Since a procedure describes how a process is carried out, a QMS procedure describes how a QMS process is carried out. If you have a procedure, it describes a process. (Per definitions in ISO 9000:2005.)
A QMS is a system of processes. Documents designed to answer a standard's requirements, rather than to describe processes, exemplify an elemental approach--which is not the process approach demanded of the standard.

 

[somashekar]

Re: Process Approach Litmus Test

Since a procedure describes how a process is carried out, a QMS procedure describes how a QMS process is carried out. If you have a procedure, it describes a process. (Per definitions in ISO 9000:2005.)
A QMS is a system of processes. Documents designed to answer a standard's requirements, rather than to describe processes, exemplify an elemental approach--which is not the process approach demanded of the standard.

Just some procedures with titles as mentioned in the opening post does not say much about lack of a process approach ... unless otherwise an assessment shows that these procedures are operating in isolation aka elemental without links and takeovers.

 

[Stijloor]

Re: Process Approach Litmus Test

<snip>A QMS is a system of processes. Documents designed to answer a standard's requirements, rather than to describe processes, exemplify an elemental approach--which is not the process approach demanded of the standard.

While I am all in favor of the process approach, it is not required by ISO 9001:2008.

Stijloor.

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

That's why it's only a litmus test--but it's very accurate if you think about it. Organizations using all of these procedures are very likely to be employing an elemental approach. A brief investigation during stage 1 auditing should confirm that the process structure suggested by the documentation has not been effectively determined. Such procedures demonstrate a confusion between requirements and processes, thus procedurally confusing processes with property, activities, methods, etc.
Although an organization might process customer property, customer property is not ordinarily an organizational process. (Rather, it's a clause or sub-clause of the standard.) If customer property is a QMS process, for sake of argument, and is properly documented as such, then how does an organization measure and improve this process?



Here's some official guidance relevant to this discussion:
From ISO/IAF ISO 9001 Auditing Practices Group Guidance on: Identification of Processes, June 5, 2009. (http://isotc.iso.org/):
". . . 2. A process has defined objective(s), input(s), output(s), activities, and resources
If the auditee does not understand that a process must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you explain to me your operations here? What are the basic jobs carried out in your department? What information do you need to start your work? Where does it come from? Who receives the result of your work? How do you know if you’ve done your job correctly? etc..
This should help the auditor to establish whether the processes (as per ISO 9001) are already defined, have clear inputs, outputs, objectives and so on. . .

". . . 4. The auditee/auditor considers that each clause or sub-clause of ISO 9001
must be defined as a separate process. If the auditor considers this as the right approach, he should refer to relevant ISO documents, (notably the ISO/TC 176/SC 2 document N544 ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach) which clearly indicates the contrary.
If the auditee considers this as the right approach, it is recommended that the techniques outlined in section 2 (above) should be used."

From ISO/TC 176/SC 2/N525R2, Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008, October, 2008 (http://www.iso.org/iso/iso_catalogue/management_standards)

“An organization that has not used a process approach in the past will need to pay particular attention to the definition of its processes, their sequence and interaction.”
“It is stressed that ISO 9001 requires (and always has required) a ‘Documented quality management system’, and not a ‘system of documents’.”
From —ISO/TC 176/SC 2/N544R3, ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach for management systems, October, 2008 (http://www.iso.org/iso/iso_catalogue/management_standards):
“All processes should be aligned with the objectives, scope and complexity of the organization, and should be designed to add value to the organization.”
“. . . each organization should define the number and type of processes needed to fulfill its business objectives. It is permissible for a process that is required by ISO 9001:2008 to be part of a process (or processes) that is already established by the organization, or to be defined by the organization in terms that are different to those in ISO 9001.”