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  Post Number #9  
Old 3rd October 1999, 07:29 PM
barb butrym

Total Posts: 786
I Say...

I like to keep design simple and give the engineers a little controlled freedom. They review the input and agree on a plan based on complexity, and similarity to other previous designs...publish using MS project....project manager keeps a 'project book' with copies of the stuff you did according to the plan and all communications...MS project is on line and available for review only. YA keep project on "track changes" (provides a history of changes and updates..then print one after changes) Reviews are done according to the plan...always prior to purchase of tooling and pre well as what ever else the PM decides. Copies of print outs and drafts become part of the book, drafts have rev control by mark up sign/date between reviews, and rev # after each review.

Reviews show verification of design status/output to the input, as well as the quality plan. Validation when applicable is done either as part of the release, prototypes or after by the customer..again planned in the project time line.

Your procedure states what is minimum in the book and the plan. State soptions that may be used.... And of course assigns responsibilities very clearly. Templates are a plus.

I find the engineers buy into this easily as they don't feel that someone is telling them how to design.

[This message has been edited by barb butrym (edited 03 October 1999).]

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  Post Number #10  
Old 4th October 1999, 01:31 AM
Marc's Avatar

Total Posts: 26,558

Design Control

Approved: __________________________________________________
title Name
Approved: ___________________________________________________
title Name
Approved: __________________________________________________
title Name
Approved: __________________________________________________
title Name
Approved: __________________________________________________
title Name

Change Record
Responsible Person
Description of Change

Initial Release

Distribution List
(list the departments that receive controlled copies)

1. Purpose
To control the design and development of new products.
To define the checks and balances applied to the design and development activity.
To control and verify the design of the products, assign design function responsibilities, define technical interfaces, ensure that the product meets the specified requirements, and verify that the design output meets the design input requirements.
To expose the product design to persons with viewpoints and opinions other than those of product design and development engineers.
To re-evaluate distributed products.
To maximize protection against oversight that might adversely affect product quality, safety, and efficacy.
2. Scope
This procedure applies to the development of all new products from the initial design to the release for manufacturing.

3. Responsibilities
***Job title*** approves the product specification for major new products, product revisions, and accessories.
***Department*** evaluates performance, durability, safety, reliability, and maintainability of the design under expected storage and operational conditions; verifies that all design features are as intended and that all authorized design changes have been accomplished and recorded; validates computer systems and software.
***Department*** provides initial product requirements, performance target values, and market utility assessments.
***Department*** ensures the availability of products and services required for the manufacturing and testing of the product.
***Department*** advises and reviews necessary testing and inspection requirements.
***Department*** ensures that sufficient personnel are available and suitable for the production of the product, and that an appropriate training program is instituted.
***Department*** ensures that the facilities, instrumentation, machinery, equipment, and services are available for the efficient production of the product.
***Department*** tracks revision levels and changes to preliminary drawings. ***Job title*** approves revisions to preliminary drawings.
***Job title*** coordinates:
the design and production of sketches, drawings, and layouts
the building and testing of models, prototypes, and pilots, including the acquisition of materials
the collection and recording of test data
any modifications to the product specification, if necessary
At all stages of development, ***team*** representing ***departments*** may determine whether to modify the product specification or change the design of the product based on test results.

4. Procedure

4.1 Review Team
See Contract Review xxx.
***Job title*** translates the customer's needs into technical specifications.
***Team*** composed of ***job titles*** reviews the specification and ensures it is producible, verifiable, and controllable.
***Team*** generates a design plan identifying activities and assigning responsibility to the activities. Those assigned to perform design activities meet company qualifications. ***Records of qualification*** are stored as Quality Records at ***location***.
***Team*** meets ***activities***.
***Records*** of ***team*** meetings are maintained as Quality Records. ***Job title*** maintains the records for ***length of time*** in ***location***.

4.2 Market Review
***Job title*** can initiate a concept for a new product. Features of a new product are based upon ***information***.

4.3 Product Definition
See Document and Data Control xxx.
***Job title*** develops preliminary drawings. ***Job title*** approves the preliminary drawings.
Customer requirements are incorporated into the design. ***Department*** communicates the requirements to the design team through ***activity***.
Design of product includes the applicable statutory and regulatory requirements to which ***Company*** adheres.
***Job title*** generates ***document*** to support the design. The documents are controlled and maintained by ***department***.

4.4 Qualify and Verify
See Quality Records xxx.
***Job title*** is responsible for testing the new design and records test results on ***name of form***. The ***name of form*** is maintained by ***department*** for ***length of time***.
***Job title*** reviews the test results and if required the preliminary design drawings are revised.
The preliminary drawings are released for a pilot run. ***Job title*** evaluates the pilot run.
The test procedures specify the following ***criteria*** and include: ***types of analysis***.
***Job title*** records the test results onto ***name of form***. The ***name of form*** is maintained by ***department*** for ***length of time***.

4.5 Final Review
A final review to determine if the product meets the requirements of the product specification is held by ***team***.
***Job title*** qualifies the pilot run determining if the product meets the requirements of the product specification.
Subcontracted, suitably qualified facilities are used for specialized testing.
The review includes ***criteria***.
The ***name of form*** releases the design to production. ***Job title*** approves the ***name of form***. The ***name of form*** is maintained by ***department*** for ***length of time***.

4.6 Requalification
Periodically the product is re-evaluated to ensure that the design is still valid with respect to all specified requirements. The review includes: ***criteria***.
Records of the re qualification are maintained on the ***name of form***. ***Job title*** approves the ***name of form***. The ***name of form*** is maintained by ***department*** for ***length of time***.

4.7 Revision Control
Design changes are given the same review as the initial design. ***Job title*** reviews changes and modifications to the design of the product. ***Job title*** revises the documentation.

5. Related Documentation
***record of meetings***
***design plan***
***form for qualification***
***test procedure***
***training records***

Contract Review
Document and Data Control
Corrective and Preventive Action
Quality Records

***list of work instructions***
  Post Number #11  
Old 14th October 1999, 01:02 PM
Andy Bassett

Total Posts: 278
Yin Yang

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....)

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.

Andy B
  Post Number #12  
Old 15th October 1999, 10:09 AM
Marc's Avatar

Total Posts: 26,558

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 am more than willing to 'publish' some if someone wants to provide the material. There have been conversations here about on-line training and such. I'm not 'ready' to spend the time to put something like this together alone, but will collaborate if anyone is interested. If someone want to really get into it we could put something up here as a fee based 'course'. hey - I'm open to ideas.

Does anyone remember the somewhat recent thread where we were discussing on-line training?

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