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How to develop a Control Plan from a PFMEA (Process FMEA)
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How to develop a Control Plan from a PFMEA (Process FMEA)
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  Post Number #9  
Old 19th January 2008, 01:26 PM
Icy Mountain's Avatar
Icy Mountain

 
 
Total Posts: 902
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

In my experience, an auditor digging down to this level has not found anything significant in my quality system and is now desperately trying to find something, anything, to save him from and empty finding list. Quite simply, this system meets the shalls and I have enough evidence in low scrap, low rework, and low warranty to prove the system effective (YMMV). I even have a few instances where the correct and feedback system generated a trend that ended up in our Continual Improvement system for correction. We don't need to generate a corrective action and an 8D for every single non-conformance: such a requirement would be extremely wasteful and inefficient given our company's operating philosophy.

The "correct and feedback" system is built into our company culture. Since we are a high mix, low volume manufacturer with very little automated assembly and test equipment, we rely on 100% testing and each subsequent operation depending on the correctness of the previous operation. For example, if you do not install a part correctly, the next station cannot install their part. If a product fails voltage output, the rest of the batch is not "suspect" because you are testing the voltage output of every unit. This correct and feedback is recorded but the "quality" group does not get involved unless the rework times or incidents rise to a significant level. Usually, returning the rejected piece to the station where the problem was introduced (for rework) is enough to stop it. We may have a couple more pieces in the pipeline but it is vanishingly rare for us to have a large pile of product, all with the same defect.
Thanks to Icy Mountain for your informative Post and/or Attachment!

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  Post Number #10  
Old 19th January 2008, 01:37 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

Quote:
In Reply to Parent Post by Icy Mountain View Post

In my experience, an auditor digging down to this level has not found anything significant in my quality system and is now desperately trying to find something, anything, to save him from and empty finding list. Quite simply, this system meets the shalls and I have enough evidence in low scrap, low rework, and low warranty to prove the system effective (YMMV). I even have a few instances where the correct and feedback system generated a trend that ended up in our Continual Improvement system for correction. We don't need to generate a corrective action and an 8D for every single non-conformance: such a requirement would be extremely wasteful and inefficient given our company's operating philosophy.

The "correct and feedback" system is built into our company culture. Since we are a high mix, low volume manufacturer with very little automated assembly and test equipment, we rely on 100% testing and each subsequent operation depending on the correctness of the previous operation. For example, if you do not install a part correctly, the next station cannot install their part. If a product fails voltage output, the rest of the batch is not "suspect" because you are testing the voltage output of every unit. This correct and feedback is recorded but the "quality" group does not get involved unless the rework times or incidents rise to a significant level. Usually, returning the rejected piece to the station where the problem was introduced (for rework) is enough to stop it. We may have a couple more pieces in the pipeline but it is vanishingly rare for us to have a large pile of product, all with the same defect.
Icy,

Congratulations! This is an excellent description of an effective quality system. Nothing "high-tech", straightforward timely internal customer feedback and immediate response. It works. In my opinion, some quality systems are unnecessarily complex; either to make an impression on someone or to create job-saving busy work. It seems that you have covered all the bases. I looked at the previous posts. Again, great work.

Stijloor.
  Post Number #11  
Old 19th January 2008, 03:34 PM
David DeLong's Avatar
David DeLong

 
 
Total Posts: 461
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

I have always found it interesting developing a Control Plan directly from the PFMEA. It does certainly make sense developing a Control Plan from the Process Flow Diagram but directly from the PFMEA?

When one is involved in a small team developing a Process FMEA, there is a complete section called "Current Process Controls Detection" or "Current Process Controls Preventive". I wonder where the team would obtain the information so that these columns could be completed. Maybe a Control Plan? If there was no control plan developed or even roughly developed, would not the Process FMEA die right there?

Please let me know where one would obtain the information on a new product so that we could complete the controls section of the Process FMEA without a somewhat developed Control Plan?
  Post Number #12  
Old 19th January 2008, 04:02 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

Quote:
In Reply to Parent Post by David DeLong View Post

I have always found it interesting developing a Control Plan directly from the PFMEA. It does certainly make sense developing a Control Plan from the Process Flow Diagram but directly from the PFMEA?

When one is involved in a small team developing a Process FMEA, there is a complete section called "Current Process Controls Detection" or "Current Process Controls Preventive". I wonder where the team would obtain the information so that these columns could be completed. Maybe a Control Plan? If there was no control plan developed or even roughly developed, would not the Process FMEA die right there?

Please let me know where one would obtain the information on a new product so that we could complete the controls section of the Process FMEA without a somewhat developed Control Plan?
Hello David,

Even though you may be working on a "new" product or "new" process, it may have a number of characteristics that are pretty similar to a product that has been designed/manufactured before. As you know, the DFMEA and PFMEA process is an assessment of the "current state of affairs", in other words: what controls do we currently have that are either of a preventative or detection type that could be utilized? Historical records combined with "engineering judgment" is the key here. And if there's absolutely nothing in place, then we leave the columns blank which means we've got work to do.

Stijloor.
  Post Number #13  
Old 19th January 2008, 04:34 PM
David DeLong's Avatar
David DeLong

 
 
Total Posts: 461
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

Quote:
In Reply to Parent Post by Stijloor View Post

Hello David,

Even though you may be working on a "new" product or "new" process, it may have a number of characteristics that are pretty similar to a product that has been designed/manufactured before. As you know, the DFMEA and PFMEA process is an assessment of the "current state of affairs", in other words: what controls do we currently have that are either of a preventative or detection type that could be utilized? Historical records combined with "engineering judgment" is the key here. And if there's absolutely nothing in place, then we leave the columns blank which means we've got work to do.

Stijloor.
Thanks Stijloor

So one would bring Control Plans of a similar products into the meeting and sort of develop it during the Process FMEA. I certainly would not want to be the person representing the Quality group without some sort of preparation.

I have always suggested having a "rough" or "not set in concrete" Control Plan prior to the actual Process FMEA. One should be ready for the meeting and certainly could develop a Control Plan from the Process Flow Diagram prior to the meeting. There may be apparent weakness reflected during the meeting in the prepared Control Plan and, of course, it should be made more robust.

Coming into a meeting without a plan seems unprepared.
  Post Number #14  
Old 19th January 2008, 05:01 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

Quote:
In Reply to Parent Post by David DeLong View Post

Thanks Stijloor

So one would bring Control Plans of a similar products into the meeting and sort of develop it during the Process FMEA. I certainly would not want to be the person representing the Quality group without some sort of preparation.

I have always suggested having a "rough" or "not set in concrete" Control Plan prior to the actual Process FMEA. One should be ready for the meeting and certainly could develop a Control Plan from the Process Flow Diagram prior to the meeting. There may be apparent weakness reflected during the meeting in the prepared Control Plan and, of course, it should be made more robust.

Coming into a meeting without a plan seems unprepared.
David,

You're absolutely correct. Obviously, the expectation is that FMEA Team Members would come to the meeting prepared. It also depends on how formal/structured the FMEA Team conducts its business. If the Team has access to the records database on the company's network, they could explore this source of information. Page 23 (Current Design Controls) and page 49 (Current Process Controls) in the AIAG FMEA Manual suggest possible methods.

Stijloor.
  Post Number #15  
Old 19th January 2008, 05:52 PM
David DeLong's Avatar
David DeLong

 
 
Total Posts: 461
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

Quote:
In Reply to Parent Post by Stijloor View Post

David,

You're absolutely correct. Obviously, the expectation is that FMEA Team Members would come to the meeting prepared. It also depends on how formal/structured the FMEA Team conducts its business. If the Team has access to the records database on the company's network, they could explore this source of information. Page 23 (Current Design Controls) and page 49 (Current Process Controls) in the AIAG FMEA Manual suggest possible methods.

Stijloor.
Page 49 of the AIAG manual only describes both the detection and preventive process controls to consider and does not get into how they are derived.

I guess the point that I am trying to make is this.

Going into a Process FMEA from a Quality department and not having any kind of Control Plan developed is not, what I would consider, being prepared. I am pretty sure that the Process Engineer would not come into the meeting without planning the process either.

The AIAG standard does not state that one should come into the meeting without a Control Plan. It does not state that a Control Plan should be developed through the Process FMEA (at least I can't find it). If one developed some type of Control Plan for new the part, would it be considered reflecting "current process controls"? Again, the AIAG standard is fuzzy.
  Post Number #16  
Old 19th January 2008, 06:08 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: How to develop a Control Plan from a PFMEA (Process FMEA)

Quote:
In Reply to Parent Post by David DeLong View Post

Page 49 of the AIAG manual only describes both the detection and preventive process controls to consider and does not get into how they are derived.

I guess the point that I am trying to make is this.

Going into a Process FMEA from a Quality department and not having any kind of Control Plan developed is not, what I would consider, being prepared. I am pretty sure that the Process Engineer would not come into the meeting without planning the process either.

The AIAG standard does not state that one should come into the meeting without a Control Plan. It does not state that a Control Plan should be developed through the Process FMEA (at least I can't find it). If one developed some type of Control Plan for new the part, would it be considered reflecting "current process controls"? Again, the AIAG standard is fuzzy.
David,

The "normal" flow of events is that the control plan is developed as a result of the FMEA process as well as other assessment activities. "Old" control plans related to similar products/processes can certainly be used during this process.

I am curious about our other Fellow Covers' views. Interesting topic.

David, you mentioned "AIAG Standards." Please note that AIAG manuals are all guidelines and not standards, with the exception of PPAP, which contains "shalls."

Stijloor.
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