Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market?

in case of purchasing controls, should requirements be met such that

  • pre-requisites in above example, to be in place before purchase order

    Votes: 1 100.0%
  • before batch release, all the above points to be in place before batch-initiation or batch-release.

    Votes: 0 0.0%
  • Others!!!

    Votes: 0 0.0%

  • Total voters
    1
  • Poll closed .

v9991

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#1
Subpart E--Purchasing Controls
Sec. 820.50 Purchasing controls.
above requirement translates to "evaluation of supplier" - specification - quality agreement - and 'type&controls"

in order to comply with the requirement(s), for that matter any one.,
should we

option 1:- all the above mentioned relates are pre-requisites for purchase requisition.
option 2 :- all the above points to be in place before batch-initiation and batch-release.


in my earlier post, I could not really focus this aspect of the subject ..
https://elsmar.com/Forums/showthread.php?t=69475
 
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shimonv

Trusted Information Resource
#2
Re: is the 'compliance' an pre-requisite or is it ok before batch release to market

I think it depends on where you are at in the product life cycle phase.
If you are in a early research phase it is not necessary, but your procedures needs to back it up.

If you are in the development phase the purchasing controls have to be in place because you want your product V&V to be valid and representing the final product for release.

During limited or mass production purchasing controls must be in place to insure product quality.


-Shimon
 

v9991

Trusted Information Resource
#3
Re: is the 'compliance' an pre-requisite or is it ok before batch release to market

I think it depends on where you are at in the product life cycle phase.
If you are in a early research phase it is not necessary, but your procedures needs to back it up.

If you are in the development phase the purchasing controls have to be in place because you want your product V&V to be valid and representing the final product for release.

During limited or mass production purchasing controls must be in place to insure product quality.

-Shimon
Agree, and it makes sense wrt purchasing controls.

how does the same logic pan out when we talk about design controls!
i.e.,
represent the design control documentation before design-transfer/verification
vs
monitoring/tracking the progress of various aspects of design (inputs - outputs - verification - review - validation)

in short, is it ok to summarize the 'design control components' at a significant milestone, viz., design-transfer/validation stages of product development?
 

shimonv

Trusted Information Resource
#4
Re: Is the 'compliance' an pre-requisite or is it ok before batch release to market

Sorry... it is not clear to me what you are asking.
Perhaps you can rephrase or someone else could address the question.


Best,
Shimon
 

v9991

Trusted Information Resource
#5
Re: Is the 'compliance' an pre-requisite or is it ok before batch release to market

:eek:
Sorry... it is not clear to me what you are asking.
Perhaps you can rephrase or someone else could address the question.
Best,
Shimon
:eek:

Sorry for not being not so clear:eek:... thank you for guiding me towards being more explicit and elaborative.

Product development has milestones of poc-pilot-pivotal. each representing respective deliverables and visibility.

On the other hand the 'design controls' include various elements ( plan - inputs - outputs - review - verification - validation )

and the query from my side, is that, at what stage the design elements would be updated/formalized;
  • * is it ok to update those elements before submission batches.(pivotal studies)
  • * is it expectations that, these elements be updated on a periodic and ongoing basis.

once again thank you.

here is another attempt of crisper version of query... ...
is it ok to summarize the development data into design control elements at some milestone VS doing it online as the development progresses!
 
Last edited:

shimonv

Trusted Information Resource
#6
Re: Is the 'compliance' an pre-requisite or is it ok before batch release to market

Hן V9991,
My prospective is that proof-of-concept is like 'playing' in a sand box. It is not necessary to force design controls on these.
As you move forward with the development of a pilot product you ought to have design controls. It will make it much easier to gear up towards pivotal V&V and external tests.

It's okay to update the elements of design controls and related files, but it has to be within the framework of your design and development procedure with its milestones and constranits.

My answer is a bit too general, I think. but I hope you will find it helpful.

Cheers,
Shimon
 
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