iSixSigma

RD QFD

Viewing 6 posts - 1 through 6 (of 6 total)
  • Author
    Posts
  • #39714

    PharmBB
    Participant

    Hello All,
    I am looking for some examples/case studies to introduce QFD tool in Pharmaceutical R&D to develop new products. Could someone please guide me on how to use this tool and what kind of benefits we can see.
    Thanks for your help in advance.
    PharmBB
     

    0
    #121401

    Schuette
    Participant

    Hmmm, the BB in your name must stand for something besides Black Belt.
    To start – who are your customers?  Identify all internal/external customers first.

    0
    #121402

    PharmBB
    Participant

    Hi Jim,
    Thanks for the reply, you got it right, I am a BB, I have experience in manufacturing Industry and I am new to Pharmaceutical Industry. Right now I am in R&D working on many process improvement project using LeanSigma methodology.
    Often, I find that the internal customer requirments are not well defined resulting in miscommunication, lack of communication or not complete information. This results in delays/wait time in the New product development process. I have used QFD once in one of my project in manufacturing industry, I am trying to introduce QFD in NPD process to gather customer requirments etc..
    If you have a example on Pharmaceutical Product development QFD , could you please share it with me.
    Thanks
    PharmBB

    0
    #121430

    Dayton
    Member

    When I think about the improvement opportunities in pharmaceutical R & D, I think of scale-up issues, stability protocols, clinical trials, molecule development and selection, and a whole host of other things.  Some of which have variance at their core and might make good DMAIC or DFSS projects and some issues that might make for the appropriate use of Lean tools.
     
    But your posting confuses me, it appears that you want to use a specific process tool/approach (QFD) and are looking for an opportunity to use it.  That’s pretty backwards don’t you think?   Find your most nagging R & D process problem and determine the best approach and tools to use in resolving your problem and making your process more robust and fix it.   From what little you have said I don’t believe that you will be long lived in pharmaceutical R&D.
     
    Vinny
     

    0
    #121451

    PharmBB
    Participant

    Hello Vinny,
    Thanks for your reply to my post, I understand what you mean. From my point of view, I don’t think we have to have a DMAIC or DFSS project to introduce QFD in Pharmaceutical R&D. Please read my second msg that may give you little more clarification on what exactly I am looking for.
    Also, could you please explain this to me “From what little you have said I don’t believe that you will be long lived in pharmaceutical R&D” in your last post message..
    Thanks
     

    0
    #121456

    Dayton
    Member

    PharmBB,
     
    My thought in regard to QFD was one of why are you starting there?   It looks that you walked in and decided QFD would give you betterment and now will spend x-number of days and man hours creating and installing a QFD program when it might well be more advantageous to step back and look at the entire process and determine which points in the process need optimization and drive those to project resolution.  
     
    QFD could be a longer-term ongoing background activity put in place incrementally as you worked your big hitter projects.  
     
     I don’t know whether you are in biologics, generics, or innovator drug development but time to market is your primary big hitter and there will be a number of things that get you there.   In biologics the large molecule guys are using Cray computers and bio-boutiques run through millions of potential molecular combinations and there are certainly ways to optimize that interface and the bench work that takes place to bet a potential biological drug, but biologics or drug you still have the issue with API (active pharmaceutical ingredient) sourcing and finding a cost effective supplier with a Drug Master File on record with FDA.   My only point is you have many, many opportunities for drug development process improvement to assure earlier and first pass FDA approval and earlier time to market and to center your activities on QFD deployment seems to me anyway to be a situation where you are draining a swamp teaming with surface level alligators – kill some of them off first and it will even make the swamp recovery process go faster and less prone to nasty bites.
     
    My comment about longevity in pharmaceutical R&D was a tired end of day comment about a BB’s going into a complex scientific and highly regulated environment like the one you are in already knowing the answer and not stepping back and assessing your organization’s specific processes, strengths, weaknesses, and opportunities for substantial process improvement.   But I don’t know you or what you have done and are going to do I just read a couple of sentences that concern me.   
     
    Having done what you are doing I know first hand what you are facing.  There is an inherent belief in the scientific community that the scientist knows what they are doing and any attempt to require them to document their actions, processes and results only slows them down and how can you ask them to change their processes because after all they are the experts?   It’s an interesting road to drive and my answer was always to look at R & D as two separate activities, research needs free flowing creativity and should only be documented to the point of being able to track back to what was done and what the results were, the scientist’s lab notes.   But when you enter the development phase you are in a highly regulated and rigidly documented series of stepwise activities and anything that can be done to smooth and simplify the procedural and administrative path for the scientist assures them a better documented and quicker achieved path which makes plant stability runs, regulatory filings and other things go better and smoother facilitating getting to market quicker and staying on the market.
     
    Just trying to get you comfortable with going into your new job not already having the answer.   You have a lot of work ahead of you, probably limited resources that are not already tied up on drug development and need to take a good look at where you will get the best bang for the buck.  
     
    Best of luck with this because it’s a high stakes game – first to market can mean billions of dollars for a company.   It gets no funner.
     Vinny

    0
Viewing 6 posts - 1 through 6 (of 6 total)

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