Non-conformances whilst in the Design and Development stage of a project

[neash83]

Hello,

I am looking to get some thoughts and opinions on how people manage nonconforming product whilst in the Design and Development stage of a project.

At a design review stage if there is a problem with the design would you raise an NCR? Say it is decided the dimensions on the drawings need to be amended as two parts don?t quite fit together correctly (from prototypes or samples produced), how do people go about managing this change? Via an NCR? Separate actions from the design review? As the product isn?t technically ?live? does it constitute a non-conformance as the specification/drawing is yet to be released?

Thanks

 

[PaulJSmith]

Re: Non-conformance's whilst in Design and Development

Absolutely not ... unless you have a bunch of unaccounted-for time you wish to spend on excessive and unnecessary paperwork.

Note it in the review as action needed, and move on to more important things.

 

[somashekar]

Re: Non-conformance's whilst in Design and Development

Hello,

I am looking to get some thoughts and opinions on how people manage nonconforming product whilst in the Design and Development stage of a project.

At a design review stage if there is a problem with the design would you raise an NCR? Say it is decided the dimensions on the drawings need to be amended as two parts don?t quite fit together correctly (from prototypes or samples produced), how do people go about managing this change? Via an NCR? Separate actions from the design review? As the product isn?t technically ?live? does it constitute a non-conformance as the specification/drawing is yet to be released?

Thanks

The intent of the review (at various stages of design and development) is to correct any errors and confirm that it works as intended at that stage.
So correction does happen at several stages, including inputs. However if you have set out to design a Camel and you are seeing Elephant, then more than a corrective action, you must see if competent persons are involved in the design and development phases.

 

[NikkiQSM]

Re: Non-conformance's whilst in Design and Development

No NCR is needed. Design & Development is the process where adjustments, and failures can be expected. It is the process used to ensure there will be no failures / adjustments needed when the project does go live.

I would make a note of the changes / adjustments needed and proceed.

 

[Vthouta]

Re: Non-conformance's whilst in the Design and Development stage of a project

Hi,

During the design and development stage there is no need for issuing NCR officially as the product is not been completely qualified for production.

But, I do notice that the review should be documented for future purposes. I would suggest to use a action register on simple spread sheet that captures Date, Issue found, who found, Action item status -open/closed.

This log could be useful while making the validation plans in future.

Vikram

 

[kreid]

If the drawings are formally controlled (have been issued / have a configuration ident) then I would say that some sort of formal change process is needed.

But as there other replies say, it does not constitute a non-conforming product as the product does not formally exist yet.

 

[AndyN]

Hello,

I am looking to get some thoughts and opinions on how people manage nonconforming product whilst in the Design and Development stage of a project.

At a design review stage if there is a problem with the design would you raise an NCR? Say it is decided the dimensions on the drawings need to be amended as two parts don?t quite fit together correctly (from prototypes or samples produced), how do people go about managing this change? Via an NCR? Separate actions from the design review? As the product isn?t technically ?live? does it constitute a non-conformance as the specification/drawing is yet to be released?

Thanks

Testing in a lab - prototype builds etc usually have some type of "build log" and even a a non-conformance report. It's going to depend on how many people are involved etc how "formal" this becomes. In my book, which was written by Xerox btw, errors are kept track of because it all erodes the development budget and time/materials are booked against that budget.

 

[QA_Newbie2000]

I agree with the consensus that a NCR is not required. As the name indicates a design review is just that, a review of the design to determine if it is correct. What we do, assuming the drawing/design is controlled /released is raise an Action Request (AR) that details what the problem is. The AR is evaluated and eventually becomes an Engineering Change Order (ECO). The intent of the ECO is to resolve the problem identified by the AR

 

[AndyN]

I agree with the consensus that a NCR is not required. As the name indicates a design review is just that, a review of the design to determine if it is correct. What we do, assuming the drawing/design is controlled /released is raise an Action Request (AR) that details what the problem is. The AR is evaluated and eventually becomes an Engineering Change Order (ECO). The intent of the ECO is to resolve the problem identified by the AR

If the details of the failure are recorded the same way, for input into the design function for them to take action, then what it's called is just a name. It's the principles of reporting failures etc. In fact, if we get into details, testing - which is likely to reveal such failures - plus any actions taken should become inputs to the design reviews. Rarely are people that sophisticated, so Engineering often make the same mistakes over and again.

AR/NCR doesn't matter what it's called, as long as you follow the right process.