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 ????.

Dock to Dock PCP's were recommended by our registrar (when I worked for a large company), but I don't think its that cut and dry. Most receiving Inspection controls just referred to the appropriate receiving procedures. When you start looking at failure modes (PFMEA) that can happen in transit from dock to assembly line, etc, in some cases you may prevent defects from getting through your process.
We definately included more than KPC's, however, I do think the APQP manual is vague in this regard. Others?

Typically a control plan contains customer defined Key Product Characteristics as a minimum, plus any characteristics you decide are important or critical to your process(es) or the product.

The question becomes how far do you go. Your customer may specify 4 Key (or Critical or Special - different companies call them different things) Characteristics. Typically these are defined on the print. Ford uses the infamous 'inverted delta', for example, to identify 'critical' characteristics.

Now it's your turn. You look at areas such as receiving, etc. through delivery. What do you think is critical? You should have input from an FMEA to help you determine your critical characteristics. As is always the case, you're looking at risk factors with your FMEA.

'Legally', your colleague is right saying: "...you only need to identify key product characteristics and their related key process issues in a Control Plan..." However, related key process characteristics may include aspects of everything from receiving to delivery.

"...This implicate that a process with no final product characteristics will for example not need any control actions in the Control Plan..." True - but try to convince an auditor that there are no key characteristics at all. I have seen plenty of products with no customer defined Key Characteristics at all (less so now than 5 years ago because of QS). I have not (in some years) seen a product with no control plan entries.

What receiving does is, in fact, a result of a determination of your identified key characteristics. You may not be thinking of it in the sense of a control plan, but you have receiving requirements for materials and such (including items which go into the product as well as items used to process the product) which have the same basic elements. Sample size, reaction plan, etc. For all intents and purposes receiving does have a control plan. Even in the case of 'ship to stock'.

Your colleague is focusing only on his part of the pie, maybe?

A good question to ask here is: Do you have a Receiving FMEA?

"...and the 10 other systems will take care of the other aspects..." What are the 10 other systems?

Please replace the wording "Key Product Characteristics" in my posting of 22/5 with "Customer defined Key Product Characteristics"

I will appreciate more comments.
Thanks to Marc and Laura

Willie

The appendix on page 79 of the APQP blue book has a reference checklist that indicates control plans and the need to address incoming through packaging. Are there any harder requirements in the blue books / ISOTS 16949 that cite having a the control plan address incoming materials through packaging directly.

I already realize the logic in having them, but the point is that an auditee is challenging me to cite the specific requirement.

I am new to auditing FMEAs and Control plans, yes I have already had training...

Hi everyone,
Is the control plan attached in the 2nd edition APQP Manual was changed? What are the changes? Please advice. A revised control plan attachment is highly appreciated.
Thank you very much in advance for the usual prompt attention you will give in this request.
P.S.
I already requested to purchase the said Reference Manual, but i haven't heard any approvals yet... :( I am currently updating our control plans in preparation for our TS16949 Surveillance Audit probably by June 2009. - Thanks in advance...
Best regards,
Raffy

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 ????.

I agree with you. The control plan should be....well, the control plan. Every characteristic you check, how you check it, with what gage, how often and what do you do if you do not meet the specification should be in this plan for everything you expect to check. Why have a separate system for incoming receiving inspection? Now, if the incoming part is a sublevel BOM with its own part number, then, yes, it should have its own control plan AS the incoming inspection plan. The assembly control plan just brings in the part, maybe with a label verification.

So many people keep trying to reinvent a pretty darn round wheel...:rolleyes:

I agree with you. The control plan should be....well, the control plan. Every characteristic you check, how you check it, with what gage, how often and what do you do if you do not meet the specification should be in this plan for everything you expect to check. Why have a separate system for incoming receiving inspection? Now, if the incoming part is a sublevel BOM with its own part number, then, yes, it should have its own control plan AS the incoming inspection plan. The assembly control plan just brings in the part, maybe with a label verification.

So many people keep trying to reinvent a pretty darn round wheel...:rolleyes:




I too agree.

My experience in a precision components manufacturing (TS) company for Bosch customer (For Hydraulic gear pump covers)

We had control plans with all the process from Receiving inspection of castings,CNC,VMC etc..vibro deburing,Surface treatment, to Final Packing .
The Receiving inspection has important features of casting/Metallurgical properties.

The final Packing also has specific customer requirements as how many components in a Box, and how many rows it should be placed and in anti-corrosive sheets or bags etc(The parts are shipped by sea)

So all the important features or dimensions affecting the final product must be controlled.
The control plan tells us the control methods for all the non-conformances.

Some folks thought that the washes could be skipped over in the control plan - because no dimensions were changing. But a lot of nonconformances came from not controlling the cleanliness of the wash fluid, or the concentration of the solvent or detergent. Finally convinced them that every step needs to be on there!:read:

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

I only have an old copy of the APQP manual but things haven't changed in respect of goods receiving inspection. To quote from the Control Plan Methodology Overview, "In effect, the Control Plan describes the actions that are required at each phase of the process, including receiving, in-process, outgoing and periodic requirements to assure that all process outputs will be in a state of control."

Unless you include all stages of the process inspection, including goods receiving, in the Control Plan, you will not be compliant with the requirements of QS9000.

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

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.

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.

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.

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.

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 ????.

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.

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.

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 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.

So, what you are saying is, that a small failure in the field, even if it can lead to a larger problem is no big deal Tsubaki doesn't think so. Look where GM is now. I'm sorry, I'm just saying that UTA, Tsubaki, and some of the front runners in the industry now have a different outlook. It used to be 1 Pfema changed around here and there would work for all. But not any more. Things are getting where they want more and more detail on every document presented to them.

So, what you are saying is, that a small failure in the field, even if it can lead to a larger problem is no big deal...Where did I say, or even suggest this? :confused: You ultimately have to do what the customer wants, but just because a customer wants something doesn't mean it makes sense, or that you should accept it without at least trying to reason with them.

have you had any six sigma training?

have you had any six sigma training?

Yes, I have.

Some of the manufacturing have thousands of product, they found some difficulty to create thousand of CP in details. In this case, i suggest to make a general CP on your procedure, then the individual CP can just list down all those critical characteristic. However, CP shall include incoming, inprocess and outgoing

You complete your control plans the way you feel you must. However, I just sat through a PPAP meeting with GM/Tsubaki. I ask them if I had to list every dimension from the print, or would they want just the critical dimensions. Their answer to me was, "How do we know you if or how you are going to control all the dimensions or if you are just controling the criticals? So yes, you need to put all dimensions." If you list only your criticals and your PPAP is approved, then you did your job per your customer requirements. CUSTOMER SATISFACTION IS JOB ONE!!!!!