Standard for process control level depending on gravity (severity)?

Dear friends,
I am preparing for an assessment audit from a supplier. One of customer requirement it’s related to: “Standard for process control level depending on gravity(severity)”. I am very honest to say that I didn’t work before with this kind of standard. All severities from FMEA have been deployed (related also with IPR) as controls in Control Plan based on our common sense, history; but not based on a formal rule related to severity ?
How I choose the criteria for doing actions based on severity?
Is somebody using this type of rule ? How look a document for this ? Could be QA Matrix?

Thank you very much and God bless you.

luciano said:

Dear friends,
I am preparing for an assessment audit from a supplier. One of customer requirement it’s related to: “Standard for process control level depending on gravity(severity)”. I am very honest to say that I didn’t work before with this kind of standard. All severities from FMEA have been deployed (related also with IPR) as controls in Control Plan based on our common sense, history; but not based on a formal rule related to severity ?
How I choose the criteria for doing actions based on severity?
Is somebody using this type of rule ? How look a document for this ? Could be QA Matrix?

Thank you very much and God bless you.

Click to expand...

It seems to me that if you've taken severity ratings from the PFMEA into account in establishing process controls you've done what the customer probably wants. Am I missing something?

Jim Wynne said:

It seems to me that if you've taken severity ratings from the PFMEA into account in establishing process controls you've done what the customer probably wants. Am I missing something?

Click to expand...

Not, that’s not the problem.
We have an internal system based on AIAG manuals for ranking and we have taken in to account all risks; for all of them have been addressed specific rankings and every item from FMEA has been deployed in Control Plan. What they want its something else. They want to see some “family of actions” addressed to specific severity score.
For example what kind of action are required if severity is 9? But if severity is 6?
The below example are taken form an audit report from one of our plants
Is this more clear now?


Phenomenon: Control characteristics are seted on the experience of people in charge to build control plan.
There is no manual to make up control plan and there is no guide to control methods according
to gravity.
Problem: It is possible to forget some risks and so, outflow bad parts.
Requirement: It is necessary to:
- Create a guide to define control methods according of gravity (related to level of process assurance)- Standardize rules to decide important characteristics to control (CSR, level 1,2; process important ones...)
- Standardize methods to decide sample method and frequency for taking samples


Thank you very much

luciano said:

Not, that’s not the problem.
We have an internal system based on AIAG manuals for ranking and we have taken in to account all risks; for all of them have been addressed specific rankings and every item from FMEA has been deployed in Control Plan. What they want its something else. They want to see some “family of actions” addressed to specific severity score.
For example what kind of action are required if severity is 9? But if severity is 6?
The below example are taken form an audit report from one of our plants
Is this more clear now?


Phenomenon: Control characteristics are seted on the experience of people in charge to build control plan.
There is no manual to make up control plan and there is no guide to control methods according
to gravity.
Problem: It is possible to forget some risks and so, outflow bad parts.
Requirement: It is necessary to:
- Create a guide to define control methods according of gravity (related to level of process assurance)- Standardize rules to decide important characteristics to control (CSR, level 1,2; process important ones...)
- Standardize methods to decide sample method and frequency for taking samples


Thank you very much

Click to expand...

Unfortunately, and as you're finding out, customers don't always make sense in their requirements. If you have demonstrated that your method consistently accounts for mitigation of risk with regard to PFMEA severity factors and they're not buying it, there isn't much you can do except adopt the new philosophy. (Apologies to the spirit of Dr. Deming)

Jim Wynne said:

Unfortunately, and as you're finding out, customers don't always make sense in their requirements. If you have demonstrated that your method consistently accounts for mitigation of risk with regard to PFMEA severity factors and they're not buying it, there isn't much you can do except adopt the new philosophy. (Apologies to the spirit of Dr. Deming)

Click to expand...

The purpose of this audit is to introduce us in their supplier panel. It’s an assessment audit to become their suppliers.
Until now we do not have yet their specific production line in place, and this audit will be performed on similar processes of other customers.
Their expectations are ridiculous for me because they expect to find our QMS setup on their requirements even we are not yet their suppliers
To put in place their expectations means to change the documents (CP, FMEA method) which have been agreed by actual customers. (of course we will do this for them)
but they told us that they don’t find in place a system in place according to their specific requirements (many of them are not congruent with TS) they will penalty us. This is stupid because they expect that all our customers to play according to their rules. (I am talking here by final car producers. We are firs tire supplier for some customers).
I understood that I have to fulfill ther requirements but to change also the other forms, methodology which imply other customers this is stupid.
To come with expectations to find in place a system according to your specific requirement even that system was agreed by all our customers and certification TS board for me is stupid.

Dear all,
Does any one of you heard about this requirement, and have some ideas and suggestions?

Thank you very much.

Luciano,

Your outburst is understandable.
Here is a way of looking at the requirement.
Imagine you are in the process of making control plan. You have two charateristics in place, 'A' highly severe say severity '8', the other 'B' less severe say '2'. Now consider that both these characteristics are controllable through Visual Inspection only. Ofcourse this is decided through your PFMEA. Hope you agree this practical scenario.
Now try answering my Questions...
Which one of the options you would consider for 'A' -
Highly Skilled Inspector or Semi-Skilled Inspector?
A Visual Instruction with Photographs or the one with texture?
Maintain Limit Samples/Master Samples or Do not Maintain any Sample?
Record the Inspection results or Do not record?
Use some control like 'marking' to ensure it is checked or no such control?

Remember 'a Visual Inspection is a Visual Inspection' and hence carries same detection rating. But these are some special controls that stands tall at the end of the day.
Does it help?
Thanks

ganeshsundaresan said:

Luciano,

Your outburst is understandable.
Here is a way of looking at the requirement.
Imagine you are in the process of making control plan. You have two charateristics in place, 'A' highly severe say severity '8', the other 'B' less severe say '2'. Now consider that both these characteristics are controllable through Visual Inspection only. Ofcourse this is decided through your PFMEA. Hope you agree this practical scenario.
Now try answering my Questions...
Which one of the options you would consider for 'A' -
Highly Skilled Inspector or Semi-Skilled Inspector?
A Visual Instruction with Photographs or the one with texture?
Maintain Limit Samples/Master Samples or Do not Maintain any Sample?
Record the Inspection results or Do not record?
Use some control like 'marking' to ensure it is checked or no such control?

Remember 'a Visual Inspection is a Visual Inspection' and hence carries same detection rating. But these are some special controls that stands tall at the end of the day.
Does it help?
Thanks

Click to expand...

Thank you very much for your input.
It make sense.