Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo Especially for content not in the forum
Such as files in the Cove "Members" Directory
Social Distancing - It's not just YOUR life - It's ALL of OUR lives!
Me <——————— 6 Feet ———————-> You

What defines the need for the ISO9001 Design & Development process?

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
By that I mean - can you draw a division between what needs to follow all the ISO steps and what can be done in the Chief Engineer's office at 7:00 at night on a piece of graph paper?

This is killing us. We just don't have the resources to make project out of every modification.

Can I define when the system needs to be used?

For example:
1) a distributor calls and asks to get a valve with SAE threads rather than the standard NPT. All we are changing is the threads - the working parts and all the materials remain exactly the same.
2) A customer calls and says - here's our idea, design us a valve that will do it.

Clearly case 2 would require a whole soup to nuts process... but what of case 1? If we follow the extended process it'll take days, where if we handle it more sensibly, the parts can be made and shipped in a day and we will still end up with the stuff needed in the QMS (drawings, specs, etc).

Can someone give me an example of how to draw the line that will pass and ISO auditor's muster?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: What defines the need for the ISO9001 D&D process?

What you describe in example 1 is a design change. Subject of a sub-paragraph in clause 7.3 of ISO 9001.
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Re: What defines the need for the ISO9001 D&D process?

What you describe in example 1 is a design change. Subject of a sub-paragraph in clause 7.3 of ISO 9001.
So even if a new part number results it can still be considered a design change?
 
M

Mustang

#4
Re: What defines the need for the ISO9001 D&D process?

If it's a new item, then it needs to follow all of 7.0, Product Realization.

There is no easy way out... bottom line, changing threads changes functionality/appicability of that item. What if you shipped the new valve by mistake as the old one? Would it fit?

However, you don't have to reinvent the wheel from scratch, use what you have to start with.

If you have a system, it needs to be followed. That's the point of having one in the first place. You can't "draw the line" on when to use it, and when not to.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
Re: What defines the need for the ISO9001 D&D process?

If you have a system, it needs to be followed. That's the point of having one in the first place. You can't "draw the line" on when to use it, and when not to.

But I can change the system.
 
B

Bob Bonville

#6
Re: What defines the need for the ISO9001 D&D process?

Scott, when I first read your post it occured to me that you were talking pre eBOM. In other words before the design is locked into the Engineered Bill of Materials (aka "as designed").

I believe you are talking about design changes to an already designed and configured part. In this case you have to bite the bullet and process the change through your internal CCB.

Bob
 

Jim Wynne

Staff member
Admin
#7
Re: What defines the need for the ISO9001 D&D process?

What you describe in example 1 is a design change. Subject of a sub-paragraph in clause 7.3 of ISO 9001.
I think a reasonable argument could be made that this is a configuration change, and not a design change. Scott is looking for a bright line, and if there is one the dividing line is drawn in terms of function, I think.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: What defines the need for the ISO9001 D&D process?

I think a reasonable argument could be made that this is a configuration change, and not a design change. Scott is looking for a bright line, and if there is one the dividing line is drawn in terms of function, I think.
As usual, you dissected the issue at hand in a paragraph, or less. In my opinion, a configuration change should be treated as a design change in the context of ISO 9001. The typical protocol of CCB's (Configuration Change Board) follows pretty much the requirements of ISO 9001 7.3.7.

Actually, a suggestion for the ISO 9001:2015 revision should be to revise that sub-paragraph of the Standard to state Design and Configuration changes.
 
Last edited:
J

JaneB

#9
Re: What defines the need for the ISO9001 D&D process?

But I can change the system.
Yes. You most definitely can.

And should when necessary.

The real question then becomes: how can we meet the requirements without tying ourselves in knots and making things far too difficult (and therefore perhaps uneconomic)?
 
#10
Re: What defines the need for the ISO9001 D&D process?

Putting a different thread on a valve is a change, and doesn't need a whole other interation of the design process.

I've also seen where an organization states that anything less than (for example) 10 hours of an engineer's work doesn't require the whole 9 yards of D & D planning etc.
 
Top Bottom