Design Control Issues - Toolroom says the system is too complicated

K

kapoor

#11
Design control format

Hi
I have gone through ur design data sheet. But i could not understand whether this sheet is used to review ur product design in case of any abnormality is observed on shop floor or its regular design review format.

Please let me know in details what problem ur facing and how actual user want to change the system. Being QMS professional our motive is to make user friendly system and a system which looks very good but not friendly to actual user.

If u send me more details and process flow for this system i will try to resolve ur problem.
Kapoor
 
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D

David Hartman

#12
Fire Girl,

Perhaps I'm reading into your Tool makers concerns, but let me ask a few questions.

If I understand correctly your tool maker probably receives a request for a new tool (Through what media? - email, a paper doc, phone call, etc.). If that is true, then that is your record of the "initial design review" and input definition.

If the tool maker initiates further discussions with the requestor (once again via email, phone, etc.) then that is your design input review (obviously a record of the phone calls would have to be documented somehow), but some designs are going to be simplistic enough that a formal review is not necessary (and your process should state that).

Create design should be easy, if the tool maker has the design documented somewhere (which I would hope occurs, else all that info is lost and has to be regenerated every time). To meet the requirement all that is necessary is to ensure that the media used for documenting the design is somehow dated (maybe electronic timestamp for e-media).

Output review and verification are accomplished in a single step by the toolmaker looking at the design document and ensuring that he has captured what was required. For audit purposes how is this proven: Did he continue to manufacture the tool? (If yes, reveiw/verification were acceptable; If no, then he must have made changes to the document.)

Why would he have to add a step in each of these cases to document all of this activity on a separate document, other than for the ISO auditor's benefit? If there is no other reason, then your system should somehow recognize what is being done without that separate step. Your NOT in business to please the ISO auditor!
 
M

mitsu11

#14
In my last position, I had a similar "issue". He was an old school engineer who couldn't shake the thought that ISO was the flavor of the month. I couldn't convince him, but eventually I gave up. I realized that he was ALREADY doing all of the necessary steps; he just wasn't documenting them very well.

Instead of teaching this old dog a new trick, I used his current practice to show him what all of those ISO terms meant. "Inputs" are those details you write down in your ragged wire notebook while you are on the phone with a customer. "Outputs" (for our case) are the drawings, BOMs, and any instructions written when you are done (which could be identified as goals up-front). "Reviews" were done pretty much every day when this engineer and the production manager had lunch together. "Verification" was when he hobbled out to the production floor and checked to be sure that the assembler built it right. "Validation" was (for our case) when the customer called back and said Yea or Nay.

All of this could happen in a day, or 6 years, depending on the project. So, in order to harness the minor ISO stuff required, I gave him this attached (?) form to complete as a plan, which acted as a project folder cover page, too. He could pull out a folder, no matter what stage it was in, and identify important dates and information.

Of course, the critical part was the discussion.
Old school engineer = at least a year of discussions
Toolroom guy = Good bloody luck!
 

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Z

ZeeMan

#15
Verification vs. Validation: My 2 Cents

Fire Girl said:
David

Can you guys give me your definition of the difference between verificaiton and validation? That seems to be a real bone of contention.

FG
Verification = Determining whether the design meets what the customer asked for (requirements).

Validation = Determining whether the design meets what the customer wanted (needs).

The difference resulting from performing these two actions is the stuff the customer forgot to / didn't know to ask for, most often from a user's perspective and not from a performance standpoint.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#16
The best example I have/use for the design control processes is baking a cake:
Plan - the recipe
Inputs - the ingredients
Outputs - the cake
Design review - checking the stages of the consistency etc.
Verification - added all the ingredients, oven and correct temperature.
Validation- eating -the real test.
 
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