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  ISO 9001/4:2000
  How to do with "process approach" at all?

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Author Topic:   How to do with "process approach" at all?
eee
Forum Contributor

Posts: 19
From:Saint-Petersburg, Russia
Registered: Apr 2000

posted 30 August 2000 02:07 AM     Click Here to See the Profile for eee   Click Here to Email eee     Edit/Delete Message   Reply w/Quote
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

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Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 30 August 2000 01:02 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
"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

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 30 August 2000 01:47 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
"...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...

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Alan Cotterell
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Posts: 120
From:Benalla, Victoria, Australia
Registered: Oct 1999

posted 28 September 2000 01:28 PM     Click Here to See the Profile for Alan Cotterell   Click Here to Email Alan Cotterell     Edit/Delete Message   Reply w/Quote
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. My article on Administrative Risk Control and Flowcharting might help: http://www.angelfire.com/nb/hazsub/admincont.html

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