Establishing Key Process Characteristics (KPC's)

[DWPOZE]

Does anyone have any information about establishing key process characterisics?

 

[somashekar]

Re: Establishing Key Process Characteristics

Does anyone have any information about establishing key process characterisics?

If you are talking about manufacturing process, then your process validation will identify and establish the key process characteristics.

 

[DrM2u]

Re: Establishing Key Process Characteristics

Here are a few tips:
- PFMEA: identify not only the product characteristics, but also the processes and the process characteristics that can affect the most the product characteristics
- DOE: can help you do the same, in conjunction with PFMEA
- your experienced operators and process SME (Subject Matter Exprests) are also a good resource to identify key process characteristics
- forums like this and blogs are also a good resource if you don't have the internal resources
- there is also the hard way: you conduct blind experiments, trying to identify the parameters that have the most impact on product quality

Hope this helps a little.

 

[qusys]

Does anyone have any information about establishing key process characterisics?

Probably you can divide into MOP ( management oriented process), COP ( Customer oriented process) and SOP ( support oriented process).
They shall have an owner, stewards, performers roles, indicators and metrics set, procedures.
Each process hall be characterized by inputs and output and be a portion of interralated processes of your QMS.

 

[Stijloor]

Probably you can divide into MOP ( management oriented process), COP ( Customer oriented process) and SOP ( support oriented process).
They shall have an owner, stewards, performers roles, indicators and metrics set, procedures.
Each process hall be characterized by inputs and output and be a portion of interralated processes of your QMS.

These are not "shall's", but are included in the Plexus auditor training.
They are often misinterpreted as requirements.

Stijloor.

 

[qusys]

These are not "shall's", but are included in the Plexus auditor training.
They are often misinterpreted as requirements.

Stijloor.

Yes, Stijloor.
It was only a suggestion to give a sort of criteria that I wanted to share.
No "shall".
thks for feedback

 

[TrishDish]

We are seeing more orders from our customers with KPC type requirements. Customers want to see evidence of our variation management of key characteristics. We currently don't have any process or associated procedures that address these requirements and honestly don't know where to start.
My apologies for not inserting this question into the right forum but I couldn't readily find what I am looking for.