What should be included in the Design Change Document

J

Jennifer27

#1
Hi!!
Now, I also want to know about the Design Change.

I feel I should include in the Design Change document all the changes in the design that in some way:
a. Affected the intended use of the software
b. Introduced a new risk or hazard

I believe I can skip changes that were made for an aesthetic purpose like changing the color of display box etc.

Any input will be highly appreciated.
Thanks so much
Jennifer
 
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jkuil

Quite Involved in Discussions
#2
A design change request should generated for any change in specifications. That include product (software) changes, labeling (including manuals) changes, changes to distribution and installation procedures, etc.

These changes may be due to a change in the intended use, but the change may also be due to better support current intended use.
The change may introduce new risks or hazards, but may also change already identified risks and hazards. Basically, the change request should initiate a risk analysis activity and identify any risk mitigating activities (e.g. validation and control activities) required to manage the change.
 

yodon

Staff member
Super Moderator
#3
Jan is quite correct. Let me try to further drive home the point.

The real intent of change _control_ is so that someone doesn't just make a change on a whim resulting in unexpected consequences. To control changes, you get input from all stakeholders that the change can be made.

For example, maybe the box color was chosen for a particular reason - maybe even safety.

If you're already in production, then changing the color would need to be communicated in a timely manner to allow for rolling in the change.

In my opinion, once you baseline something, any change should be controlled. Even if you're just fixing typos in a document, the change should go through the control processes to ensure all stakeholders can offer their input and that changes are rolled out in a controlled fashion.

Now if your change control process is so rigid and bureaucratic that it's difficult to get a seemingly trivial change through in a timely fashion, that's a completely different issue.
 
G

gholland

#4
You should be documenting the reason for the change, the specific things being changed, the plan for the change, and the results of the plan. There should be a way to trace the reason behind your changes, the parts involved, the changes made (in detail), evidence that you planned your change including risk analysis, and then a final report (typically the Enginerring Change Order) that demonstrates that the plan was executed and the results reviewed by the appropriate people.

Simple changes shouldn't be a burden but should trigger design change processes. If it is simply cosmetic, we would typically conduct a Technical Review that states such and release it into the DHF. The ECO for the change would then reference that review and then processed... all this should take little time.


:2cents:
 
J

Jennifer27

#5
Thanks Jan "also be due to better support current intended use AND but may also change already identified risks and hazards" very appropriate just didn't think of that.
 
J

Jennifer27

#6
Thanks Yodon, very rightly said and thanks Gholland for explaining how to handle simply cosmetic trivial change.
 
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