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Define vs. Determine vs. Document - Explain

V

Vic de Beer

#1
I know that "document" = written down, as in "documented evidence/procedure etc".:read:
But what about define and determine? could it simply mean: think about it and tell me about it? i.e. no documents are required?:(
Come to think of it, what about identify?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Define, determine, document Explain

Hello Vic, please give us a little background. Are you working to 9001? 14001? 18001? In each Standard the process of defining and determining is undertaken a bit differently, and needs documentation - or not. In the case of 9001, see ISO's guidance on documentation needs.
 
V

Vic de Beer

#3
Re: Define, determine, document Explain

I am refering mostly to ISO 9000 but this can also apply to ISO 14000.
Thanks for the reference, I will look at it.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: Define, determine, document Explain

In 14001, the organization identifies needed processes to control effluents, wastes, resource uses etc. by listing what they are, their severity (by nature of their volatility, chemical nature, amount used/disposed of/produced, and so on. I would expect this to be set down in some sort of document, and be periodically reviewed for current conditions. In this document (or a related document) I would expect to see what activities result in these outputs, and perhaps what federal, state and/or local requirement regulates them. From this I would expect to see process documents that tell people in the operations what they must do to make sure the wastes/effluent/usage remains within limits the organization has set out to achieve (controls).

All of this sounds complicated, but I can imagine an adapted FMEA used to lay most of it out.

This becomes less clear for quality systems, except for TS16949, which wants APQP, FMEAs and such assistance in identifying and determining processes needed to assure customer satisfaction. ISO 9001 doesn't specifically require documentation for determining/identifying processes needed to assure customer satisfaction, but it can be helpful.

Since there aren't firm requirements of what to use, you have some freedom. A large organization will probably need something more elaborate, but small organizations might use a flow chart to show activities involved with identifying processes needed to ensure customer satisfaction. Evidence that you are doing the steps in the flow chart and identifying customer requirements, stakeholder needs, product specifications, needed sourced services like shipping/delivery, and so on could be kept to show you are complying with 4.1a and even using a process approach like ISO is asking for in its introduction. The evidence could be meeting minutes, engineering review notes, requests for quotes, checklists, project management packages, estimates of costs and ROI, etc.
 
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