The value of our work in quality and compliance

It is probably obvious from previous posts that I work in the pharmaceutical industry in the areas of quality and compliance.  Today’s edition of The Porch talks about the value of our work producing high-quality and compliant pharmaceutical products.  What is the payback for all our work?  How do we make a difference in the lives of our patients?  This is an attempt to describe the fruits of our labors.

Most of us are functions that involve compliance to GMP’s, DEA regulations, OSHA requirements, and all their associated global regulations and laws.  These regulations are often ambiguous and can seem to be onerous and drive rigamarole (see previous post on Rigamarology).  I have often heard individuals question the value of correcting documentation errors with “a single line through with the new value recorded and initialed/dated.”  Others ask, “What is the value of doing three process validation lots to prove the process is in control?”  We have probably all wondered whether we go too far with redundant steps, double-checks, % verification, inspection schemes, risk assessments, report re-writes, etc., etc.  Individuals not as close to this want to understand, “What is the value in all this extra work we call quality or compliance?”

Value is one of those popular terms used in business circles these days.  Everyone wants to know the value of our latest acquisition, the value provided by a consulting arrangement, the value we expect from a significant Capital investment, the value drivers for a particular initiative… Understanding “value” is important for us to ensure that our direction is correct and that our priorities are properly placed.  Value is synonymous with “return on investment” or “payback”.  When someone asks about value, they are really asking, “When and what will be the payback for this?”  So, it follows that many want to know, “What is the payback for all of these GMP activities?  When will our extra effort to qualify that equipment, document that activity, repeat that step, or marry the science-with-the-regulations in a way that allows us to release that batch?”

Well, I would like today to share my thoughts on “when we’ll see payback for all our efforts in quality and compliance”:

  • We get a payback during an FDA inspection when the investigator asks to review 10,000 documents and we have confidence that every page of every document will be done right, documented well, and properly tell our story of quality and compliance
  • We get a payback every week when our complaint reports, representing literally millions of doses of products distributed, show only minor issues with product shipped to patients – it is gratifying knowing that the products our patients receive are right, safe, and will fulfill the mission and life-changing impact intended
  • We get a payback every month when we see double-digit improvement in those critical quality metrics that define how we’re doing
  • We get a payback when someone asks where we work and we can tell them proudly – more often than not, the individual will tell of a relative or friend that works or has worked for us or their own story of using our products
  • We get a payback every night when we walk to our car knowing that we did our very best work to make a difference in the lives of others
  • We get a payback when we encounter someone like Sammy, a little 5-year old boy I know that has struggled with cancer for the last three years – he is now in remission, but must get a scan a few times a year to ensure that the cancer has not returned – knowing that we might play a small role in Sammy’s life makes a difference to me

If you will take the time to consider all we do and why we do it, you’ll easily see that quality and compliance have a payback.  Thank you to everyone in our industry for making our compliance and value story a positive one!

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