Setting the bar for quality and compliance

August 5th, 2014 by

There appears to be a continual debate as to where we need to set the bar for quality and compliance in the Pharma industry.  There are a number of strategies I have seen over the years but they all fall into the following in reality;

  1. We will meet what the regulations tell us – no more, no less – it’s what is required.
  2. We will exceed what the regulations say – they are minimum requirements – it will give us a business advantage over our competitors.
  3. We will not meet the requirements to save money and if we get caught we will pay the price.  It is the cost of doing business.

You can probably guess  which your company fits into.  If not, it might be worth thinking this through because, if they have a different strategy than the one you are comfortable with, it might be a frustrating place to work.

The logic, I believe, these strategies use is the following:

The higher we raise the bar, the more cost it is to operate!

But is that hypothesis true? Does it cost more to operate higher on the curve?  I contend – not necessarily so.

This came out when I was teaching a course on the cost of quality recently and one of the attendees was arguing that in their business, margins were small so everything they spent on quality was directly from the bottom line.  Spend more and profits go down.

While this appears logical on the surface, I do not believe it tells the whole story.  It assumes that money spent on quality to raise the bar is simply an overhead and does not impact anything else.  In other word, spend money on quality and it has no impact on efficiency or losses etc.

Rather, I believe that if you spend money on quality systems, it will result in decrease cost of operation, higher throughput in the plant and will lead to a more efficient operation.  One example might be to improve the way investigations are performed.  This should result in more efficient and effective investigations.  This results in true root causes being identified and hence more effective CAPAs which lead to less repeat deviations.  The improved investigation system would require less resources to operate, be done quicker and hence cost less.  And if the investigation actually got to the root cause the CAPA has a higher probability to prevent repeat observations. That is to name just one system.  You could construct scenarios for complaints, change control, lot disposition and validation with similar conclusions.  I believe investing in quality improvements (raising the bar), should be viewed as an investment rather than an overhead.

It took  about three days in the class before the proverbial light bulb went off in his head.  I don’t know if he will take that message back to the plant and even if he does, will they believe and introduce some of this thought process into their operations.  Time will tell.

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