iSixSigma

How do FMEA and Control Plan fit together?

Six Sigma – iSixSigma Forums Old Forums General How do FMEA and Control Plan fit together?

Viewing 25 posts - 1 through 25 (of 25 total)
  • Author
    Posts
  • #27498

    Cannizzo
    Participant

    Hi everyone,
    I love this forum! I hope that someone will be able to help me with my small dilemma on FMEA and control plans. Here is my question: How does an FMEA and control plan fit together on a project?
    I understand that the FMEA helps identify what can go wrong with the process that I’ve improved and leads you through to mitigants. I also understand the control plan to do the same!? What’s the difference, or is the FMEA part of your control plan (but they’re used in different phases, argghhh!). I’m confused. Any help would be appreciated.
    Thanks, Carol

    0
    #67491

    Murray
    Participant

    A control plan should be a direct reflection of your FMEA plus any customer mandated controls (they should be using data but sometimes don’t)
    The distinction is the detail of the control plan. They could easily be one document if we put sufficient detail in the FMEA

    0
    #67494

    “Ken”
    Participant

    Carol,A control plan is constructed at the conclusion of a Process FMEA. It’s not used in a product or application. When looking at the Process FMEA, causes are flagged which have either preventative or inspection controls. Any high risk causes that do not have controls are potential process failure points. A control plan are all of the actions that will be done to minimize and/or mitigate the potential process failures. These actions appear sequentially in the controls section of the FMEA. They could include such activities as set-up checks and tests, mistake proofing activities, or online inspections with pertinent criteria. Good Luck,Ken

    0
    #67495

    Hartshorn
    Participant

    You state in your message that your using the FMEA do identify what could go wrong with your process AFTER you have improved it.  This may be where you are getting confused.  The FMEA should be used before improvements are made.  It is a tool to actually help you identify what needs to be improved and guide you through root causing.  It is at that point that you put together your control plan, as the others have stated, after the improvements are made.  The FMEA is a working document that should be maintained throughout the improvement process.

    0
    #67535

    M.K.Ramanujam
    Participant

    Carol/ Allen,
    Thought I’d pen my thoughts on this.
    FMEA tell you, what can go wrong, how severe the effect, how frequent the defect/cause occurs and current controls available. This is a parent document to feed into your control plan which is more of How to do the current controls effectively. eg
    For a FMEA on Tea preparation, failure mode may be too sweet, cause could be more sugar , current controls could be taste before serving to spouse / sugar quantity control.
    The control plan now details the frequency of taste checks, the ‘gage’, the acceptable standards of sweetness and what to do if the tea is less sweet or more sweet. (THIS is EFFECTS ‘Monitoring-Control’)
    The cause is the one which really needs to be controlled. The cause is the sugar quantity, so Control plan tells you the correct quantity in grams, the actual way of weighing the sugar, frequency of checking the weight etc.
    So the real ‘difference’ between FMEA and Control plan is in the deploymewnt level of quality control.
    In some operations of Auto companies, they have ‘married’ the features of both FMEA and Control plan and called this DCP (Dynamic Control plans).
    Hope this helped…
    Ram

    1
    #67537

    Praneet
    Participant

    Hi Carol
    FMEA, as everyone has mentioned so far will tell you which pain areas to tackle first. FMEA is essentially a tool for prioritising areas to initiate Preventive and Corrective actions.
    Having done this exercise, you now need to define the norms for the prioritised variables identified and establish Control plans to ensure that these variables stay within the norms decided upon.
    Cheers
     

    0
    #67538

    andy_c
    Participant

    Carol
    Correct, but you need to distinguish the fact that there are 2 types of FMEA. One is for design and the other is for process.

    0
    #67539

    Ananth
    Participant

    Hello,
    In my experience and knowledge, the control plan follows the FMEA.
    Through FMEA, you will understand and estimate the way and the probability of occurence of mode of failure. Combining the severity of failure on functioning of the system, the risk priority number is worked out.The risk priority determines the controls one establishes to prevent reduce the severity. These controls on the system is reflected in the control plan.
    While drawing up the control plan, carry out the FMEA to decide on the control points required.
    This is how the control plan and FMEA are worked out together.

    0
    #67540

    Alf Wang
    Participant

    Carol
    To my understanding, FMEA is a tool to study the failure mode and freqeuency for happening, how to detect the failure, to identify the most Risk-taking process or material inputs. Therefore, it is different from the control plan.
    First, FMEA is used when the process is new or something wrong happen for my process.
    Secondly, FMEA is in Measure/measure stage,
    Finally, Control plan is to fix the good result by SPC…..If anything special, the operator can easily see and correct.
    I don’t the above explaination can satisfy you or not? If you would like to discuss with me, email.

    0
    #67542

    Cannizzo
    Participant

    Thank you everyone! Is it any reason why I love this forum and site so much? I had a question and everyone stepped forward to help provide the answer — it really helped. Thank you. It is much more clear in my mind now.
    Carol

    0
    #67544

    Carlos R. Coutinho
    Participant

    In fact the Control Plan is a result of a previous FMEA. The team encharged of a project uses the FMEA as a tool to identify the potential failures that must be addressed and the controls that will keep it under control. These results in a Control Plan that must be available at the shop floor and for everyone responsible to run the process. The FMEA must not be available for everyone.
    In a regular basis the FMEA must be revised and all changes are updated on the Control Plans. Therefore there is a dynamic link between the two documents. 

    0
    #67546

    Arash Shahin
    Participant

    To answer this question, first we need to answer the following questions:

    What is Control and what is FMEA ?
    Does control consist FMEA, or does FMEA consist control ?
    If FMEA feeds a control plan, what are the outputs of FMEA, or What are the inputs for a control plan?
    Does FMEA involve all the inputs for the control plan ?
    If FMEA only consists of the defects information, which kind of control plans can be useful for controlling those defects (like n and np control charts in SQC, or ppm in Six Sigma) ?
    If FMEA is a special advanced quality technique, which special specifications of other advanced quality control plans could act as a linkage between FMEA and those control plans ?
    However, I think by answering those questions in a complete technical way, not only your own question is answered, but also you will be able to write a very good technical paper. For any more idea please contact me again, or if your paper is now ready to be published, please don’t forget to write my name behind yours on our paper!!

    0
    #67551

    Dunne
    Member

    With the FMEA you and your team narrow in on the numerous failures/problems, prioritize their importance (RPN) and begin with solutions to resolve the failures/problems.
    The Control Plan is basically your working document guiding you and your team through making those recommended solutions to resolve your problems/failures.  You decide which issues to resolve, who will do it, how often etc.  The control phase is your time to gradually let go of the project and turn the Control back to the process owner.  The control plan also has tests in it to prove your savings after the changes have been made.

    0
    #67555

    Chuck Anger
    Participant

    Great comment.  Here is my take on the relationship between the FMRA and your Control Plan.
     
    They are absolutely linked.  Your control plan begins as soon as you start identifying all of your critical X’s.  That means it starts even before your FMEA.  The FMEA starts to formalize your actions that will be taken to “control” your process.  In discussions with many others the DMAIC roadmap is interpreted to have solids walls between each phase.  This is not true!  As you learn through each phase you are often taken back to a previous step.  There is continuous movement back and forth.  DMAIC helps you to resolve questiones, etc in a consistent way to ensure that you are complete before you call things done.  In fact we teach that the Process Map, C&E , and FMEA are living breathing documents.  They are revisited often through the first year or so after a project is completed. 

    0
    #67564

    m romero
    Participant

    I’m an engineer with ten years of experience in the manufacturing field, and have been part of a APQP team in my company.
    Here is my theory of FMEA- Failure mode Effect Analysis  1) Design a FMEA that best fits your process, begin with a Flow chart diagram which draws up your process being studied.
    2) Start by using your part print to highlight all the dimensions of the part to be produced, than start with 1st operation and subsequent process and all the potential defects and thier causes and controls.
    3) Develop RPN, BASE OFF SEVERITY,OCCURRENCE AND DETECTION.
    After a FMEA has been developed, looking at your Control Plan, this will be your Production Process Control Driver or INspection plan.
    Let me know if this sums up most of it.
     

    0
    #67571

    Abraham Guillen
    Participant

    according with my knowledge this  two documents have different objectives:    The fmea is a tool that helps you to identify the possible flaws in your process, the possible cause  of this flaws and at same  time establish corrections  that will  be carried out in a certain  time and establish the person responsible to do this acction (Supervisor, engineers, technician…..), when all the activities mentioned in the FMEA are completed the document can be closed.    2) once completed your FMEA (the corrective action and controls has already been implemented in your process) you use the CONTROL PLAN  to keep under control all of correctives action  (you control of the preceso) and not get a momentary correctives action on the process.

    0
    #67573

    Anonymous
    Participant

    FMEA is a living document in which potential failures are analysed and failure modes, their causes and their effects are prioritised for reducing the risk. The next document is Control Plan for controlling prototype / pre-launch / production parts. These are two separate documents and both are required.

    0
    #67575

    K S Varadhan
    Participant

    FMEA is proactive to weed out likely modes of failure. Control plan is reactive in the sense that during manufacture/conversion adequete care is taken to conform. This is to ensure that what was visualized during FMEA is tranlated in to product/service preventing occrrence of failure modes. We can compare FMEA and Control Plan to Quality of Design amd Quality of Conformance in the classical Quality control concept. 

    0
    #67592

    Anonymous
    Participant

    FMEA is a tool that is used in the Analyze phase to help the project team identify all the factors that can influenec the
    Project Y,assess the consequences of the effect,list current
    detection methods,and identify possible action itens to mitigate the overall RPN rating.
     
     
    The Control Plan is a summary of the items that must be accomplished by the Process Owner to sustain the project gain.
    Identification of the critical Xs,operating setpoints,SOPs,
    action items to take when the process drifts using control
    charts,and a response plan would be included in a good control plan.

    0
    #67612

    PATIL BHUPESH
    Participant

    Please refer to QS 9000 reference book for detals.

    0
    #99507

    narayanan
    Member

    In some operations of Auto companies, they have ‘married’ the features of both FMEA and Control plan and called this DCP (Dynamic Control plans).
    Hope this helped…
    Ram
    FMEA AND CP IN SAME FORMATE OR SEPARATE FORMATE?

    0
    #99511

    Rodrigo Regatieri
    Member

    The FMEA is a document where everything which could be wrong must to be analysed. What you will put in your Control Plan, depends wich standard your company is certificated. For ISO/TS 16949: 2002, for example, everything that you have in your control plan must be in the PFMEA. If you have Inspection plans and other kinds of control in your process to prevents products scraps, like machine timely maintenance, regulations and calibration of pressure controls, this controls must be included in PFMEA. But every control that you put in the Control Plan must have a capability study and MSA study (R&R).

    0
    #99512

    Rodrigo Regatieri
    Member

    The FMEA is a document where everything which could be wrong must to be analysed. What you will put in your Control Plan, depends wich standard your company is certificated. For ISO/TS 16949: 2002, for example, everything that you have in your control plan must be in the PFMEA. If you have Inspection plans and other kinds of control in your process to prevents products scraps, like machine timely maintenance, regulations and calibration of pressure controls, this controls must be included in PFMEA. But every control that you put in the Control Plan must have a capability study and MSA study (R&R).

    0
    #99615

    Ram
    Participant

    The FMEA / Control is integrated into a single format called Dynamic control plan. Current controls portion of FMEA is expanded into the ‘control plan’.
    Advantage is that FMEA and control plan are synchronous, the disadvantage being complexity of the info presentation…
    But it works!!!
    Ram

    0
    #186503

    CHITNIS
    Participant

    FMEA, as name say, is a brainstorming process in which we all chance of product/process going wrong is thought, their effect analysed with level of severity, occurence and difficult level in detection of error.
    where as control plan is reverse of this, its base plan which when followed will lead to controlled process in manufacturing and finally a good controlled product.
    FMEA is what can go wrong and Control Plan is what is to be checked / controlled for good product.
    For Eg. if you have to go to college in morning, you decide what are all factors like missing connecting bus, high traffic etc, may lead to late for college class. This comes under FMEA and actions like keep enough time margin, start early are part of control plan.
    FMEA is concept/brainstorming/thought process for happening of defect while control plan is action/process spec control method details.
    Hope, I am able to clear some doubts.
     

    0
Viewing 25 posts - 1 through 25 (of 25 total)

The forum ‘General’ is closed to new topics and replies.