Quality Failures and Lean Six Sigma

Six Sigma – iSixSigma Forums Industries Healthcare Quality Failures and Lean Six Sigma

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    I’m working on a paper that involves analyzing examples of quality failures within the pharmaceutical industry and how a Lean Six Sigma program could help to improve these quality failures. I have hit a road block and am having trouble with the topic. I am not concerned with the cost reduction benefits of a LSS program, strictly the quality improvements.

    If anybody could provide a few examples of quality failures in pharma, or even ways Lean Six Sigma improves quality I would greatly appreciate it!

    Thanks again!


    Don Hutchcraft

    The key to Lean is minimizing waste. Create current value stream maps to see how things operate now and find where the wasted time comes from (waiting, overproduction, rework, movement, people, intellect, inventory and transport). This will give you a better idea of where the poor quality comes from.

    An example is waste in movement. For me it came when I performed a 5S analysis on my vehicle. Once I found that I was wasting time making multiple trips too and from, digging for tools and parts and just being disorganized, I was able to improve the quality of the work I was doing because things were easier to find and get too. Plus, everything was is a specific place and returned there for the next time.

    Follow these and you may find how to overcome your road block.



    The quality failures in pharmaceuticals are too many to mention. Is there is a specific part of the pharma process/industry you are interested in? Compound development? Safety and Efficacy testing? Manufacturing?

    I’ve got years of experience in application of LSS in the Safety and Efficacy testing of pharmaceuticals. Failures include things like; miss doses, wrong dose given, timing of dosing incorrect, failure to collect observations according to protocols, failure to document findings, failure to store compound at correct storage conditions (temp), failure to mix compound according to protocol etc…


    Katie Barry

    @schultz33 Did you search our site before asking your question? We have an Industries section with categories on Healthcare and Pharmaceuticals:

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