A
Thanks for everyones contribution. I took my time replying becuase i wanted to wade through all the suggested info and cross-refernce it with my copy of the ISO Standard.
Actually i have to be honest and say i am still struggling, i think maybe i am blinded by my usual environment (Automotive Motosport).
4.4.1 I can accept that a design procedure needs to exist blah blah blah
4.4.2 I can accept that some sort of design and development planning needs to exist. Whatever ISO wants, i usually ask for a Project Plan (Although these inevitably turn out to be a design and production time-plan).
4.4.3 Organisational and Technical Interfaces - In my environment this is too variable to define, in the procedure i just list all the interfaces i can think of and put in a get-out clause like 'where necessary'.
4.4.4 Design Input - Seems simple enough, a description of what we are trying to design (Although some cynical colleagues did once define a design input as 'Car should be as fast as possible'. I cant help but sympathise with them sometimes).
4.4.5 Design output - IE a drawing, and it appears that this should be checked. Against normal drawing standards i can accept, against a design input i have a problem, in most of the examples that i have seen the design input is a product of an engineer or marketing managers fantasy, and the design input is difficult to write until after the finished product can be seen (Maybe i am just unlucky with the products that i work with).
4.4.6 Design Review - My experience of design review is that it is taking place on an almost contiuous unofficial level. All the people involved are shocked when they are asked to fix a date and discuss all the necessary components. The best i have ever been able to do is get a Head Engineer to sign-off that design of the final product is complete. If its Christmas i might actually get him to compare it with the design input.
4.4.7 Design Verification - Err i think i have already done this Mr Auditor. What is wanted here.?????????
4.4.8 Design Validation - Err what are we talking about here, could it possibly be testing the prototype. If so i have no problem. (Wouldnt it be nice if it said this more clearly in the standard)
4.4.9 Design Changes - No problem they have to be handled according to a consistent procedure.
Re-reading the above it seems my problem lies somewhere between 4.6, 4.7, 4.8. Fortunately the auditors must have the same problem, otherwise they wouldnt have approved so many of my companies (Or maybe it was that bottle of whisky....)
Marc
I have a couple of suggestions, during recent debates i have referred people to your site and told them to go through one of the threads.
It is a good sort of training. Do you think it is worthwhile to offer some sort of on-line training? ie i tell engineers to log on to a course for design review, they do some interactive training, answer a questionnaire and get an E Mail certificate. I suppose in some way it takes work away from the implementer/consultant, but it may also support him.
Although i suppose i am paid to interprete the standard, i know that i, and many of my customers can only relate to it through real-life examples. Is it worthwhile to set-up on your web-site 4 or 5 real-life examples for each element of ISO 9000? I dont mean the procedures themselves, as very often they are written in the same dry manner as the Standard itself.
Regards
------------------
Andy B
Actually i have to be honest and say i am still struggling, i think maybe i am blinded by my usual environment (Automotive Motosport).
4.4.1 I can accept that a design procedure needs to exist blah blah blah
4.4.2 I can accept that some sort of design and development planning needs to exist. Whatever ISO wants, i usually ask for a Project Plan (Although these inevitably turn out to be a design and production time-plan).
4.4.3 Organisational and Technical Interfaces - In my environment this is too variable to define, in the procedure i just list all the interfaces i can think of and put in a get-out clause like 'where necessary'.
4.4.4 Design Input - Seems simple enough, a description of what we are trying to design (Although some cynical colleagues did once define a design input as 'Car should be as fast as possible'. I cant help but sympathise with them sometimes).
4.4.5 Design output - IE a drawing, and it appears that this should be checked. Against normal drawing standards i can accept, against a design input i have a problem, in most of the examples that i have seen the design input is a product of an engineer or marketing managers fantasy, and the design input is difficult to write until after the finished product can be seen (Maybe i am just unlucky with the products that i work with).
4.4.6 Design Review - My experience of design review is that it is taking place on an almost contiuous unofficial level. All the people involved are shocked when they are asked to fix a date and discuss all the necessary components. The best i have ever been able to do is get a Head Engineer to sign-off that design of the final product is complete. If its Christmas i might actually get him to compare it with the design input.
4.4.7 Design Verification - Err i think i have already done this Mr Auditor. What is wanted here.?????????
4.4.8 Design Validation - Err what are we talking about here, could it possibly be testing the prototype. If so i have no problem. (Wouldnt it be nice if it said this more clearly in the standard)
4.4.9 Design Changes - No problem they have to be handled according to a consistent procedure.
Re-reading the above it seems my problem lies somewhere between 4.6, 4.7, 4.8. Fortunately the auditors must have the same problem, otherwise they wouldnt have approved so many of my companies (Or maybe it was that bottle of whisky....)
Marc
I have a couple of suggestions, during recent debates i have referred people to your site and told them to go through one of the threads.
It is a good sort of training. Do you think it is worthwhile to offer some sort of on-line training? ie i tell engineers to log on to a course for design review, they do some interactive training, answer a questionnaire and get an E Mail certificate. I suppose in some way it takes work away from the implementer/consultant, but it may also support him.
Although i suppose i am paid to interprete the standard, i know that i, and many of my customers can only relate to it through real-life examples. Is it worthwhile to set-up on your web-site 4 or 5 real-life examples for each element of ISO 9000? I dont mean the procedures themselves, as very often they are written in the same dry manner as the Standard itself.
Regards
------------------
Andy B