What's the meaning of 'methods' in 4.1(c) ISO 9001?

[howste]

I typically recommend that people not pay much attention to the following sections of ISO 9001 - 4.1, 5.1, 6.1 & 8.1. These are general introductions to the various sections of the standard. If you meet the specific requirements that follow these sections you are unlikely to have any problems meeting these general sections. If they were removed from the standard there would really be no significant change in requirements.

I can probably agree with 5.1, 6.1, and 8.1, but I believe clause 4.1 has been ignored far too much! I agree that it's a very general section, but it provides the big picture thought behind the entire standard. It's the master plan for the entire QMS that provides the framework and linkage between the different requirements of the standard. The 1994 version of ISO 9001 didn't have this key section, and many implementers went out and set up systems with 20 disjointed "buckets" of requirements with no master plan.

It's interesting that 7.1 wasn't included in your list. I suspect it's because it's a planning section for all of the "product realization" requirements. If you compare 4.1 and 7.1 they're actually very similar. In fact, I look at clause 7.1 as a mini version of clause 4.1. I see clause 4.1 as the planning section for the entire QMS.

 

[samsung]

Some wise men at some time devised these with a lot of thought and depth, and I presume the people in the Govt agency now have neither the thought or depth to digest and explain to user now. You could give as much or as little details as you feel depending upon what you expect further to happen from the questionnaire seeking information on 'Quality Excellence' ...

I'm pretty sure what he told (after referring to the rule book) was quite correct & logical. It's obvious from 2.1 that 'method' is a resource and there is nothing in 2.2 except 'method' that can include power and fuel.

 

[samsung]

Upon reconcilation of what has been discussed so far, there are 3 questions:

a) Are 'methods' and 'procedures' synonymous in the context of 4.1 (c)?
b) What's the intent of the clause -

• Does it mean effective 'methods' of operation and effective methods of control? or
• Methods of ensuring (or methods of evaluation) that the operation and controls of the processes are effective?

c) Can it be interpreted to mean 'inputs'?

 

[klraj]

Methods --> modes operandi

 

[somashekar]

a) Are 'methods' and 'procedures' synonymous in the context of 4.1 (c)?

I do not think they are synonymous

Does it mean effective 'methods' of operation and effective methods of control?

Decide what are the required criteria and what methods are needed, so as to ensure that operation and control of processes effectively meet the criteria.

c) Can it be interpreted to mean 'inputs'?

Forms a part of the inputs

 

[samsung]

I do not think they are synonymous.

Decide what are the required criteria and what methods are needed, so as to ensure that operation and control of processes effectively meet the criteria.

Forms a part of the inputs

Yes I too come to conclude that they aren't synonymous. Effective application of the method may require a procedure.

Criteria is understandable. For a work process, it can be the acceptance level w.r.t. quality/ quantity/ env. performance/ scrap etc. or the process specifications /target.

I agree to 'modus operandi' or the manner in which a process is required to be operated and controlled is what the standard defines as a method but I really stuck around when it comes to ensuring effective operation and control of the processes that fall outside the scope of 'core processes/ manufacturing processes', e.g communication, competence evaluation, management review etc.

What can be the possible methods for ensuring effective operation and control of, say the management review or the communication process?

 

[kgott]

clause 4.1 has been ignored far too much! I agree that it's a very general section, but it provides the big picture thought behind the entire standard. It's the master plan for the entire QMS

I know this thread is little old but right now its relevant to me. I agree that this requirement is a key requirement because its integral to the planning the management system.

In terms of “determining criteria and methods needed to ensure that both the operation and control of these processes are effective”, I think:


Internal and external audits would be one method, or, at least a component of the method
Data collected to measure progress towards objectives set, for at least, each key process might be another
Measures of the effectiveness of the corrective action and prevention action process might be another but there must also be others
??
??

 

[howste]

In terms of “determining criteria and methods needed to ensure that both the operation and control of these processes are effective”, I think:

After you've determined what the processes are, you should look at the intended outputs of each process, and determine what methods are needed to achieve them. Determine what methods will be used to measure effectiveness and establish targets.

 

[kgott]

Yes Howste; thats right, I did a bit more work on this and I came up with these means by which it can be done:

Audits
Data generated to measure effectiveness and efficiency of the process
Data generated to measure progress towards objectives for the process
Data generated to measure effectiveness and efficiency of C&P Action
Process review requirements
Comparison of the product to the specifications for the product.
Scrap rate
Non-conformances with the process requirements
stated objectives
Documented Instructions
Documented procedures

 

[howste]

Also remember to define the competencies necessary to achieve the planned results. Who works within the processes? What skills do they need? Define the education, training, skills, and experience.