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Question about Non-conformances during New Product Introduction

Ninja

Looking for Reality
Trusted
#11
I'm seeing good info for handling non-conformance...but little mention of Design Control.
Tracking bugs during development is (should be) separate from NCR or CAPA.
I figure that's why the whole Design Control section is there...so that new things can be developed without drowning them in paperwork.

@qualprod: Is the product in manufacture? Or is it still being developed?
or even useful to open NCR records for every single bug encountered during development.
I'm guessing by this that it is still being developed?
 
#12
I'm seeing good info for handling non-conformance...but little mention of Design Control.
Tracking bugs during development is (should be) separate from NCR or CAPA.
I figure that's why the whole Design Control section is there...so that new things can be developed without drowning them in paperwork.

@qualprod: Is the product in manufacture? Or is it still being developed?

I'm guessing by this that it is still being developed?
Is during the development.
Good point, Is not so easy, sketches, calculations, simulations, cross checking, preliminary drawings, revisions, 3d , 2d ,etc.
 

John Broomfield

Staff member
Super Moderator
#13
Is it usual in some case (school, hospital) to raise NCR s and apply scrap,repair, rework?

No.

Repair is the only option when dispositioning a nonconforming service. And repair is a design change unless the original service design specified the options to compensate the customer for the possible types of service failure.
 

Ninja

Looking for Reality
Trusted
#14
Is during the development.
So a more basic question:
Why would an NCR be written?
Design control is to find out/test/verify/validate the design...the current design not working is a normal part of this. The current process failing is a normal part of this. DC is the sandbox where you can see what breaks and fix it without NCR and CAPA bogging everything down...
Including NCR and CAPA in Design Control is the same as requiring all of your guesses to be correct 100% of the time.
To an extent, the only NCR or CA I would see in Design Control is not following DC procedures.
 

Tyranna

Involved In Discussions
#15
JIRA in my world, is normally utilized for bug software fixes. Issues may be found in the field or at customer sites. Hardware product issues may also be entered into JIRA although I have rarely seen strictly hardware issues in JIRA.

The flaws found in software should be discovered in verification/validation test processes, caught and fixed during design. These might go in JIRA as well depending upon the company.

Non-Conformances found in processes normally are documented within a Corrective Action System (that could be JIRA as well but requires much work to get it to work correctly due to the nature of the inherent fields).

NCRs - reports written for non-conforming materials caught during incoming inspection processes; these may be contained in a central database and assigned to the procurement personnel for discussion and closure with vendors. NCRs may also be written for subsequent material deviations as a means to document flaws and capture the expenses (whether to return or scrap, etc. ).

ECARs - an ecar may be written against a contract or subcontract manufacturer who has been found to not follow prescribed requirements for goods/materials. i.e. suppose a label maker was contracted with to provide laminated labels of a x size. Drawings and specs were provided. First article may be good, but a subsequent order is found to be unlaminated and twice the original size. An ECAR with a subsequent request for an 8D report is sent to the manufacturer so that they can do root cause, corrective action, etc.

At any rate, that is my general take on corrective actions after 30 years of auditing. NCR - non-conforming report is pretty generic term so can encompass many types of issues, most companies I have dealt with break it out into "types" as above - each a separate database for ease of use.
 
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