In-Process Non-Conformance Report Contents

[madannc]

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

thx

 

[Boscoeee]

Re: Non-Conformance Reports

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

thx

What business sector are you in?

 

[Marc]

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?

 

[madannc]

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

 

[Marc]

Polymer Injection Moulding - Medical devices, correct?

 

[madannc]

correct yes

 

[KenQE]

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]

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. 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.).

 

[hitesh]

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.

 

[KenQE]

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.