In-Process Non-Conformance Report Contents

M

madannc

#1
What would you want to see on a non-conformance report template, specifically for an in-process NC?

thx
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Non-Conformance Reports

What type of process(es) and parts? Manufacturing, I assume (as opposed to a service).

I assume we're talking a medical device, correct?
 
M

madannc

#4
Polymer Injection Moulding

currently putting together a URS for an electronic NC system and want some feedback for the fields that others feel would be useful

thx
 
K

KenQE

#7
My experience has taught me to keep these type of forms as simple as possible.

1) Identify the material. Lot/batch/serial numbers. Quantity with/without defect. Exactly where in-process is the material, physically, inventory-tracking, process step.

2) Specifically what is the nonconformance/defect.

3) What needs to be know to make a disposition?

4) Approval for the disposition.

5) Information you want to trend. Defect, Root cause, etc.

I hope this helps,

KenQE
 

Jim Wynne

Staff member
Admin
#8
My experience has taught me to keep these type of forms as simple as possible.

1) Identify the material. Lot/batch/serial numbers. Quantity with/without defect. Exactly where in-process is the material, physically, inventory-tracking, process step.

2) Specifically what is the nonconformance/defect.

3) What needs to be know to make a disposition?

4) Approval for the disposition.

5) Information you want to trend. Defect, Root cause, etc.

I hope this helps,

KenQE
Excellent advice, imo. :agree1: I'd expand on it only to say that in #2, the exact specification should be cited, and specifically how the material failed to meet the specification. I also like to see the measurement method recorded (caliper, micrometer, visual, etc.).
 
H

hitesh

#9
Additionally, it is a requirement to notify responsible party or person of the concern to avoid the concern in future.
Impact of the non-conformance on the previously manufactured lots shall be evaluated and recorded.
Similarly, justification for USE AS disposition is necessary.
 
K

KenQE

#10
A couple of more thoughts...

A REWORK disposition requires rework instructions and re-inspect/re-test instructions.
A Use-As-Is disposition requires justification.

...all of these items can best be handled with the "Add Attached Pages" trick, especially if these dispositions are not often used.



You said specifically an In-Process NCR. I'm sure you realize a Receiving NCR requires different information even though many people use the same form.
 
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