Control Plan Content Requirements - Level of Detail

triathlonx13

Starting to get Involved
#11
I'm at a company that is a contract manufacturer for a variety of industries. I accepted a position as Quality Engineer (six month contract) to help out with a class 3 medical device assembly project. The culture here is non-medical (my back ground = 20 years in the Medical Device industry). Part of my task is to review the customers and in-house top level documents prior to final PQ's and production launch. Documents include; Control Plan, Material Specification, pFMEA, Work Instructions and various other connected documents.

The Control Plan was for lack of better words.... crap. I have redlined the documents - but I'm getting push back from my employer... as they do not want to "rock the boat". Specifically I would like to get input on content requirements. These are the guidelines how I understand them to be...see attached guideline.

Your input is appreciated! Thanks
 

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bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#12
I think that is a nice boiled down overview for the basis of the control plan. :applause:

I feel your pain - I have had similar frustrations in my experiences in the medical industry. One of my favorites was the comment I received when trying to implement SPC: "Why do we have to do this? What did we do wrong?" Classic.
 

Jim Wynne

Staff member
Admin
#13
I'm at a company that is a contract manufacturer for a variety of industries. I accepted a position as Quality Engineer (six month contract) to help out with a class 3 medical device assembly project. The culture here is non-medical (my back ground = 20 years in the Medical Device industry). Part of my task is to review the customers and in-house top level documents prior to final PQ's and production launch. Documents include; Control Plan, Material Specification, pFMEA, Work Instructions and various other connected documents.

The Control Plan was for lack of better words.... crap. I have redlined the documents - but I'm getting push back from my employer... as they do not want to "rock the boat". Specifically I would like to get input on content requirements. These are the guidelines how I understand them to be...see attached guideline.

Your input is appreciated! Thanks
Welcome to the Cove, and good job on the PCP instructions--they should be useful to a lot of people.
 
D

dianel

#14
I call out that i only do FMEA & Control Plans in the production phase. I put this statement in my quality manual. We have been certified for about 10 years. First QS, now ISO 9001:2000. We do have inspection processes in receiving and shipping but do not have the FMEA or CP there. Hope this helps.
 
Q

QM Mary

#15
A control plan is dock to dock. It is exactly what it's name states that it is a control plan. Which means how you control the production process. Your flow chart shows the flow of the process, the control plan shows the control of the process and the fema mates with the control plan showing the failure and effects of the process. I work 2nd teir automotive and have had a number of PPAPs rejected because I didn't get enough information on them. Remember to cover every step of the process and every dimension on the print when doing the control plan and pfema. :bigwave: I hope this helps.
 
N

ntrprizxile

#16
Willie, my company has extremely complicated manufacturing process flows (>1200 steps). The control plans are best described as "summary" plans that have all critical process steps (involving measurements and decisions) plus all process steps defined as special characteristics (internal, customer, other) from the PFMEA's. We have used this approach with registrars and have not had any issues for more than 3 years. If asked we can show the entire process flow but are rarely asked to do so.

-Xile


a Control Plan should describe all actions necessary including receiving, in-process,out going and periodic requirements to ensure that all process outputs will be in a state of control.
According to myself all controls necessary to ensure the successfull execution of a Process Function or Operation should be included in Control Plans.

A Colleague tends to differ from me...according to him you only need to identify key product characteristics and their related key process issues in a Control Plan and forget about all other issues such as incoming inspection of material, storage, packaging or movement of product. This implicate that a process with no final product characteristics will for example not need any control actions in the Control Plan.
According to him the incoming inspection system will for example take care of incoming inspection requirements and the 10 other systems will take care of the other aspects.....it is therefore not necessary to incude these in the Control Plan.

I do not agree with his approach.

Question ...will his approach be acceptable and be regarded as compliant to the requirements of QS 9000 or not ????.
 
Q

QM Mary

#17
I am not speaking of what is or is not acceptable to be registared. I am speaking of submitting and getting a Level 3 or greater PPAP package approved by a Tier 1 Automotive company. If you are not automotive and are less than Tier 2 than your documents do not need to be as complicated.
 

Jim Wynne

Staff member
Admin
#18
A control plan is dock to dock. It is exactly what it's name states that it is a control plan. Which means how you control the production process. Your flow chart shows the flow of the process, the control plan shows the control of the process and the fema mates with the control plan showing the failure and effects of the process. I work 2nd teir automotive and have had a number of PPAPs rejected because I didn't get enough information on them. Remember to cover every step of the process and every dimension on the print when doing the control plan and pfema. :bigwave: I hope this helps.
It might be a good idea, with a relatively simple drawing, to include "every dimension on the print" in the PFMEA and PCP, but with complex drawings with hundreds of dimensions and callouts it would be wasteful. The idea of the PFMEA process is to identify the requirements that represent significant risk, and those are the ones that should end up on the control plan. Of course, if you have an unreasonable robot reviewing a PPAP submission, all bets are off.
 

Jim Wynne

Staff member
Admin
#20
I have submitted PPAPs to Honda, Delphi. Ford and UTA they all want the same thing Doc to Doc every dimension accounted for.
I have submitted PPAPs to GM (tier one) Delphi, Visteon, and other big ones and have never seen an instance where every dimension on a print (other than on a dimensional report) was expected to be accounted for. I was also responsible for reviewing PPAP submissions for a vehicle OEM for eight years and wrote their PPAP requirements, and never expected every dimension to be accounted for, with the exception of very simple prints with few dimensions.
 
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