Difficulties with Process Approach - Defining 'Effectiveness'

[eee]

As I know the clause 0.2 "Process approach" in FDIS 9001:2000 again changed. Moreover there is an ISO/TC176' decision to produce special guidance module regarding this problem. Neverthless, how should I start, using cl. 4.1 of ISO 9001:2000?

4.1 a) Identifying processes
I identified
- 6 interested parties (customers,
stuff, owners etc.)
- 8 key production processes ( marketing, design, purchasing, production etc.)
- 7 main management processes (responsibilities,planning,recourses, measurement etc.)
So I have a matrix of 6*8*7=336 processes.OK
4.1 b) Determining the sequense and interaction of these processes. Ha-ha,
Shall I identify input and output for all these processes?
How shall I describe this interaction to stuff and auditors ( a matrix, a lot of flowcharts, in procedures)?
4.1 c) Determining criteria and methods required to ensure that both the operation and control of these processes are effective.
I don't know how to do it, because I understand that my internal and external auditors are not able to estimate: "Are operation and control really effective?".
And what is the noun for the adjective "effective" - effectiveness or efficiency. You know that it is a big difference between them.

Thank you in advance

[Kevin Mader]

"4.1 b) Determining the sequense and interaction of these processes. Ha-ha,
Shall I identify input and output for all these processes?
How shall I describe this interaction to stuff and auditors ( a matrix, a lot of flowcharts, in procedures)?"

Perhaps the best visual way to show interactions between processes is with a Venn Diagram. All will be disproportionaly affected in all probability. You may elect first to do some type of Regression Analysis to determine correlation between processes to help you create the diagram. Inputs/outputs is a good place to start.

Regards,

Kevin

[Marc]

"...4.1 c) Determining criteria and methods required to ensure that both the operation and control of these processes are effective..."

Inspections and tests.

"...I don't know how to do it, because I understand that my internal and external auditors are not able to estimate: "Are operation and control really effective?"

You determine this - not auditors.

"...And what is the noun for the adjective "effective" - effectiveness or efficiency. You know ..."

Effectiveness ~ Does it work and if so how well?

Efficiency is an input/output ratio in units appropriate to what you're looking at. There are natural gas furnaces which are 95% efficient and there are others which are 60% efficient. This is an instance of BTUs lost to entrophy (potential of the gas put in {input} vs the BTUs output to the home). In manufacturing processes things can get much more complex. Try an internet search for Machine Efficiency, for example. See what you get back...

I suggest it is worthwhile flowcharting the Product or service delivery process, at he 'macro level', before embarking on preparation of your Procedure Manual. You might have over 300 sub processes but only one or two product types which the manual should address.

[HFowler]

I am developing a Quality Management System for a small company. I plan to use graphical process models like the one shown in the beginning of the ISO 9001:2000 Standard in place of writing text procedures, (except for the required 6) to describe our processes. Is anyone else taking this approach?

We are using some process models to describe high level functions but we are mostly using flowcharts in place of text procedures. From the registrars and auditors we've talked to, flowcharts seem to be preferred over text procedures as much as possible anyways!

Just an opinion, but I find that the level 2 procedures lend themselves to be written documents that reference the work instructions that are flow-charted.

In reality, very few use the procedures, most use the work instructions and forms.

By flow-charting work instructions it makes it easier for the general work population to understand and perform.

ASD...

[Marc]

-> I find that the level 2 procedures lend themselves to be
-> written documents that reference the work instructions
-> that are flow-charted.

I disagree. I believe level 2's are the first to be flow charted. I haven't had a client use text level 2's since 1995.