Design/Change Control Procedure - How to cope with Changes during Development?

T

todayssunny

#21
Hi Aphel,

I'm not sure if this thread is still active.
However in such a case as described by you,
our procedure requires to complete a design change form (during development / pre design transfer).
A part of this form is to assess the change impact...in your case the assessed impact would be to go back and do the change and repeat design verification afterwards.

bes regards
 
Elsmar Forum Sponsor
#22
Hello everybody,

Thank you for all the answeres and guesses...

The problem i have, is not to control changes in single documents (e.g. drawings), therefor we have a nice procedure (document controls).

But what are your solutions (procedures) if you have for example the following change during development:

Imagine, you just went through the milestone design freeze, you have already startet design verification. And now - during design verification you realise, that you are not able to pass a certain requirement and you are forced to make a change to a functional design input requirement.

What are your design change procedures saying in such cases?
How do you organise, manage and document such necessary changes?


Best regards,
Aphel
I also have the same question.

I don't know how to properly control the design change before design transfer, and don't know how to compile the Design History File (DHF) after the design change has been finished.
 

yodon

Staff member
Super Moderator
#23
I don't know how to properly control the design change before design transfer, and don't know how to compile the Design History File (DHF) after the design change has been finished.
At some point, the design artifacts go under design controls. Any change after that must follow the Design Changes procedures (820.30(i)). Presumably, you already have procedures for this. Typically, a "change request" is opened then that is reviewed to determine scope and impact (especially on the Risk Analysis). The proposed changes are approved and then implemented. Some method to verify or validate the changes is defined. If you have already done any system V&V then the impact of the change on those efforts needs to be evaluated and likely some additional V&V work is warranted. The change record providing traceability to what all changed / what was done as well as the updated design artifacts become part of the DHF.

Hope that makes sense.

In the future, it might be best if you open a new thread rather than jumping on an old one.
 

QAengineer13

Quite Involved in Discussions
#24
After reading this page, I need some clarity related to the concept of Pre-Production change control and Post-production change control

In a design and development project, say they have an alpha build, beta build and then their Pre-production unit (PPU) build.

Before PPU build process start is when the design freeze happens and the Design verification starts.....

Is the term Pre-production change control means anything and everything related to the change control before the DESIGN TRANSFER is my understanding, correct? and Post-production is after the sucessful transfer and the Production units are built, is this correct?

:thanx:
 

Marcelo

Inactive Registered Visitor
#25
Is the term Pre-production change control means anything and everything related to the change control before the DESIGN TRANSFER is my understanding, correct? and Post-production is after the sucessful transfer and the Production units are built, is this correct?
Nope, pre-production should in fact be before design input (because after that, the design process "goes into" design control).
 

QAengineer13

Quite Involved in Discussions
#26
Nope, pre-production should in fact be before design input (because after that, the design process "goes into" design control).
Thanks Marcelo, but sometimes I find these FDA terminology used are tricky for interpretation.

For conversation sake,
In this case if the pre-producttion is before Design Input because the Design Control process kicks in, I agree then the FDA should used a simple plain language as "Pre-design control change process" or "Pre-input freeze change control process" why would they use a term " production" when the production of the NPI/NPD happens only after successful design transfer?

Please let me know whether my interpretation makes any sense? thanks:cfingers:
 
Last edited:

QAengineer13

Quite Involved in Discussions
#27
Thanks Marcelo, but sometimes I find these FDA terminology used are tricky for interpretation.

For conversation sake,
In this case if the pre-producttion is before Design Input because the Design Control process kicks in, I agree then the FDA should used a simple plain language as "Pre-design control change process" or "Pre-input freeze change control process" why would they use a term " production" when the production of the NPI/NPD happens only after successful design transfer?

Please let me know whether my interpretation makes any sense? thanks:cfingers:
Nope, pre-production should in fact be before design input (because after that, the design process "goes into" design control).

Also could you or anyone in the group share with me an example of what would be the Pre-production change control checklist/ form/ procedure would look like? :thanx:
 
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