Hello,

We are going to create CP based on PFMEA, but we have a problem with determination of controls that should be transferred from PFMEA to CP. Please help?

Whatever you say you do in the FMEA to prevent or detect a problem should be transferred to the Control Plan as a control method. Typical examples might be 1st piece inspection, routine inspection, SPC, etc.

If I understand your question correctly -
The controls you list on your PFMEA are listed in the Prevention and Detection Controls columns. Decide whether those controls are process or product based. If product based they would be listed in the Product Characteristics column of the Control Plan. If they are process based they would be listed in the Process Characteristics column of the Control Plan.

At a minimum,those controls that have a special characteristic associated with them in the D/PFMEA.

Hi everyone,
I had some concern with regards to FMEA and Control Plan.
I was wondering what could be the frequency of updating the FMEA? Every six months? Every annual? What could be the industry standard in updating FMEA? Please advice.
For Control plan, what does the standard require regarding this. Here's the situation, we have several models of speaker. Do we have to create or generate a control plan for each model? we have less than a 100 models, do we have to create 100 control plan for each model? :mg: How about FMEA, do we have create a 100 FMEA. Please advise. :frust:
Best regards,
Raffy:cool:

For the FMEA-The simplest answer is whenever new information becomes available. This could be practically every day.

NOTE : At this point this does not necessarily mean that you have to release the documents into records . Otherwise you could be potentially be running to records every other day. You have to look at the resources available to you and set a realistic goal of when you want forward to records.

Control Plan - When you have enought changes in place (from the FMEA) to make it practical/worthwhile.

This is where the FMEA/Control Plan Team is really valuable. Get a joint consensus on how many changes it takes to make it worthwhile to submit the FMEA/Control Plan package. This gives you a baseline frequency. Another criteria that would impact this frequency would be the importance/benefit of the change. Here management may want to override your schedule.

I have personally found that planning for every six months is effective as a baseline. From an audit perspective (internal/external) I have had no issues.
I have shown auditors the documented team consensus (which is based on resources) and they were quite happy.:agree1:

Hi everyone,
I had some concern with regards to FMEA and Control Plan.
I was wondering what could be the frequency of updating the FMEA? Every six months? Every annual? What could be the industry standard in updating FMEA? Please advice.
For Control plan, what does the standard require regarding this. Here's the situation, we have several models of speaker. Do we have to create or generate a control plan for each model? we have less than a 100 models, do we have to create 100 control plan for each model? :mg: How about FMEA, do we have create a 100 FMEA. Please advise. :frust:
Best regards,
Raffy:cool:

I seem to recall in the past, there was a clause regarding "families" of products could be covered with just one PFMEA / CP. Please re-read your latest AIAG Manual to find that language if it still exists...:2cents:

I seem to recall in the past, there was a clause regarding "families" of products could be covered with just one PFMEA / CP. Please re-read your latest AIAG Manual to find that language if it still exists...:2cents:

I don't have access to my manual at the moment, but the dispensation you're referring to is certainly there. It says that "family" documents may be used so long as the similarity (or consistency, or something) of the parts and requirements has been reviewed. In general, though, all bets are off if there are special characteristics that apply to one or more parts but not the others in the family.

The FMEA manual doesn't specifically address "family" FMEAs, but TS 16949 itself addresses the concept in Annex A. It says:Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process.
The same concept can be (and is often) applied to FMEAs.

The FMEA manual doesn't specifically address "family" FMEAs, but TS 16949 itself addresses the concept in Annex A. It says:
The same concept can be (and is often) applied to FMEAs.

I was wrong in my previous post, which should teach me not to open my yap if I don't have the book in front of me. :bonk:

It's the 4th Edition PPAP manual (page 5) that says (for D- and PFMEA, flow diagram and control plan),
A single [document] may be applied to a process manufacturing a family of similar parts or materials if reviewed for commonality by the organization.

I didn't check the PPAP manual. I have the others in PDF format, but I'm still waiting for AIAG to publish a PDF version of PPAP...

Hello Covers... here is a question for you. We are a manufacturing company and have been updating some Control Plans. I have the job of ensuring that they are correct. My question is "What exactly should be on a CP?" I know it is derived from the PFMEA and Flowchart but I am unsure if Receiving and Shipping should not be required to be on there. These 2 processes are not on our PFMEA or the Flowchart as these documents deal with Manufacturing processes only. Are we wrong not to have these processes and their controls documented in these? Do we need to go further back and update the PFMEA and Flowcharts to include these 2 processes?
All your help is greatly appreciated...:applause:

Sharon, if you have an APQP Manual from AIAG, there are examples in there with explanations. Basically, list all your specifications and controls for part dimensions and process controls, and list how you are going to measure, control, document and reaction plan if they are nonconforming. There must be some posted here in the Cove, and/or in the free file attachments list.

Is this what you were looking for to answer your question?

Sharon - The short answer is "Yes you are wrong" not to include the Receiving and Shipping processing steps on all 3 documents. There can be/are Failure Modes associated with each of those steps. Even if you do not come up with Failure Modes, each step in your process flow needs to be on your Process Flow Diagram and subsequently listed in the PFMEA and CP (with or without any Modes or Controls).

I have the APQP book and the only part that I see about receiving is in the A-8 Control Plan Checklist # 6 "Does the control plan address incoming (material/components) through processing/assembly including packaging?" My question is maybe too simple...? Do we need to have the Receiving (incoming material inspection) and Containerizing / Shipping processes listed on our CP if they are not listed on the PFMEA or Mfg Flowchart. Should they be listed on the PFMEA and Flowchart to begin with?

Bill posted just as I was typing my last reply....thanks Bill. Here is my next question...
Can we have a generic PFMEA, Flowchart, and CP for all Mfg processes and non-Mfg processes like recieving, containerizing, and shipping...Then have a Product Specific CP as required by our customers showing only the specific processes for that Mfg Part? Our flowcharts as they stand now start at Kitting (allocation of raw material from inventory) and end with packaging. Shipping area does all containerizing and order preparation...

Bill posted just as I was typing my last reply....thanks Bill. Here is my next question...
Can we have a generic PFMEA, Flowchart, and CP for all Mfg processes and non-Mfg processes like recieving, containerizing, and shipping...Then have a Product Specific CP as required by our customers showing only the specific processes for that Mfg Part? Our flowcharts as they stand now start at Kitting (allocation of raw material from inventory) and end with packaging. Shipping area does all containerizing and order preparation...

First - please excuse me. I have just contracted a major head cold and the thought process isn't clicking as it should.

Yes you can have generic PFD, PFMEA, and CP. Let me try to illustrate with our die casting processing:
1) We receive aluminum sows and alloying elements.
2) They are placed in a WIP area.
3) We receive "insertable" components.
4) They are placed in a WIp area.
5) We alloy the aluminum and elements
6) We inspect the aluminum alloy
7) We deliver the aluminum to the holding furnace(s)
8) We inspect the aluminum in the furnace
9) We cast the part(s)
10) We extract the part
11) We quench the part
12) We trim the part
13) We inspect the part
14) We load the part into WIP containers
...............
48) We pack finished parts into shipping containers
49) We truck finished containers/skids to shipping
50) Shipping prepares container/skid for transportation per BOL
51) Shipping loads truck

These are very generic steps in our processing of all parts and would show up in each part specific PFD, PFMEA, and CP. If some steps aren't necessary in the production sequence of a part, it wouldn't show up there. The Modes and Controls are pretty basic to whatever part we make. The differences between parts show up in the Control Plan at the inspection steps where the blueprint specifications would differ for various features on the part.

Does that help or add more to any confusion?

Well I'm just getting over the flu so maybe I didn't explain my problem accurately....:notme:
Now before I reccomend that our PFMEAs, Flowcharts, and CP be revised to include Receiving and Shipping... is there anywhere that this is stated as a requirment (either Customer specific or ISO/TS)?

I don't have copies of most of the "blue books" or the ISO/TS document(they've been "borrowed") so I can't state for certain that it's a requirement. The A-8 Control Plan Checklist does ask in question 6 "Does the Control Plan address incoming (material/components) through processing/assembly including packaging?" While not necessarily a requirement, it does make sense (to me anyway) that the steps are included. Since the documents are tied together and are actually built upon one another, it would follow that the Receiving and Packaging (shipping from your description) would be line items on the PFD then carried over to the PFMEA and then carried over to the CP. (I know we've had another thread or two discussing this, but I haven't found it yet.)

Added in edit: Sharon, please look at the first and third threads listed at the bottom of this page. Maybe they'll help a little.

I agree with Bill.
When I do a Process Flow Chart and PFMEA it covers "door to door". This results in recieving and shipping being included in the control plan.

Thanks All
I did check the APQP book and on page 33 it states:
" In effect, the Control Plan describes the actions that are required at each phase of the process including receiving, in-process, out-going, and periodic requirements to assure that all process outputs will be in a state of control." This was the statement I was looking for.... we have now put receiving into the PFMEA with ANSI/ASQC 1.4 - Sampling Procedures based on Supplier Rating as a control for incoming inspection, and Dock Audits as a control for our Packaging / Shipping process. I just needed something "written in black and white" to back up my agruement.