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Known Solution but not path?

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  • #45944

    Chad
    Participant

    I have a black belt project I would like to tackle and wanted some forum advice.  It inlvolved PAT in the pharma industry.
    I know the solution to the problem or the outcome, but due to regulatory issues it will take quite a bit of data analysis and alternative methods testing to implement?  Could this be a viable six sigma project?

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    #151103

    6Sigma Newbie
    Participant

    My understanding is..if u know a solution to a problem..just go do it!.

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    #151115

    BTDT
    Participant

    Chad:As I understand PAT, it is centred on the Control phase aspects of the Six Sigma process. The quote I found says, “A desired goal of the PAT framework is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process.”This sounds very much like a DFSS project to me.Sprinkle in a few elements of MSA, risk analysis (FMEA), process modelling and optimization and you should have a decent amount of work to do. You will likely have to design an adequate sampling, audit and control plan to finally sign off on the project.Cheers, BTDT

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    #151120

    Putnam
    Participant

    Depends on what you’re talking about.  There’s a lot of “PAT” stuff out there in pharmaceuticals that really doesn’t fit the overall bill.
    If this is a PAT application where the sensors already exist, the tanks/blenders/lines are modified for them, and the methodology is validated against a standard assay, it might fit within the normal six sigma program.
    If you’re looking at new technology/sensors, the lab’s not seen them before, there’s no in-house analytical expert on the technique, the equipment will have to be significantly modified, or a number of other issues, the overall project is way beyond a normal six sigma scope.  Doesn’t mean you couldn’t break it up and look at the individual parts as several projects.
    If you’re bumping into a regulatory issue, you’ll need QA, management, production, and Regulatory buy-in before you do much of anything.  Good chance to try out those “soft” skills.

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    #151207

    Heebeegeebee BB
    Participant

    The real question is not knowing the solution, but knowing that the solution(s) developed is(are) the right/robust one(s).   I’ve seen many people rush to judgement and implement the “known solution” only to have it backfire with catastrophic results.   Take your time and follow DMAIC and make data-driven decisions that you are able to validate.

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    #151212

    Adam
    Participant

    If you know the solution than just do it.  Don’t call it a Six Sigma project because all data and ideas will be biased towards your solution.  Find a problem that is hurting the organization and appears to have no solution.  That will be your greatest benefit as far as Six Sigma goes.  Otherwise you’re just using statistics to validate your answer.

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    #151218

    Idiotin math.
    Participant

    After defining the  problem,Just take  your  time  to find & measure the  right data,then spend  time  to  analyze correctly the  available  data (statistic will be used  mostly  in  those  2  phases),try  to  reeot-cause  the  problem for  finding  the correct  solution.good  luck

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