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Old 12th January 2008, 05:25 PM
nativeamrc

 
 
Total Posts: 2
Re: Develop Control plan from PFMEA: how to?

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

Here's how I do it. This method has passed 1st, 2nd and 3rd party audits (and I have received compliments on ease of translation).

Start with your process flow diagram, here's a simple example:
1 - Incoming inspection
2 - Assembly
3 - Final Test
4 - Shipping

Notice the numbering!

Create your PFMEA (simplified for space) from the flow diagram (e.g. Process Function/Requirements - Potential Failure Mode - Current Process Controls. I didn't fill in all the columns here for simplicity):
1.1 - Incoming inspection - wrong parts - match parts against Mfg. and Mfg. number
2.1 - Assembly - incorrect assembly - use drawing XYZ
2.2 - Assembly - incorrect torque - note torque values on page 3 of drawing XYZ - mark torqued items with paint pen
3.1 - Final test - outputs out of specification - test per instruction 123.
3.2 - Final test - Key Control Characteristic - Voltage Out - section 1 on 123
3.3 - Final test - KCC - Current Out - Section 2 on 123
4.1 - Shipping - damaged packaging and or product- design and test packaging per requirements - see results in APQP file
4.2 - shipping - incorrect packaging - training to requirements
4.3 - shipping - incorrect packaging - product/dock audits per audit schedule

Create your Control Plan from the PFMEA, matching those items that will be ongoing (note that Items 4.1 and 4.2 were resolved at PFMEA stage and the ongoing requirements are in section 4.3)
Number - Process Name - Control Method - Reaction Plan (columns left out for simplicity)
1.1 - Incoming inspection - Incoming Inspection Procedure - Supply Corrective Action Procedure
2.1 - Assembly - Drawing XYZ - Reject and Rework, Control of Non-Conforming Product Procedure
2.2 - Assembly - Torque values on page 3 of drawing XYZ, mark torqued items with paint pen - Reject and Rework, Control of Non-Conforming Product Procedure
3.1 - Final test - test per instruction 123 - Reject and Rework, Control of Non-Conforming Product Procedure
3.2 - Final test, KCC, Voltage Out - Section 1 on 123 - Reject and Rework, Control of Non-Conforming Product Procedure
3.3 - Final test, KCC, Current Out - Section 2 on 123 - Reject and Rework, Control of Non-Conforming Product Procedure
4.3 - Shipping - Customer packaging requirement E16 & Our Packaging Instruction, product/dock audits per audit schedule - Reject and Rework, Control of Non-Conforming Product Procedure & Improvement Procedure for any audit findings or observations.

I hope that makes sense. The important thing here is to have some way to follow "Process A" from Process Flow to PFMEA to Control Plan. Obviously, this has been incredibly simplified and there is a lot of missing data from both PFMEA and Control Plan that you will need to address.

If this is WAY too simple, PM me and I'll send you a redacted version of a PFMEA -> Control Plan from our latest product.
Hey Icy Mountain:

Your knowledge is admired. Would you please send me a copy of a redacted plan I can look at? Thanks!

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