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The QA Pharm

Quality Insider

Resolutions for Pharma Quality Assurance

I will give myself permission to expect more out of management...

Published: Friday, January 13, 2012 - 14:46

Like anyone else, when I plan for the new year, I need to set aside time for reflection and anticipation. I look back and ask, “Have I made a difference in anyone’s life?” I look forward and ask, “What do I want to change that I either have control over or can influence?” For people working in the pharmaceutical industry, these questions are not only personal but also professional.

The quality assurance professional should always have the sense of a high calling. That calling needs to go beyond being the “checker” who culls out the defects to being the applied scientist or engineer who helps to design quality into the product.

This reminds me of the dear soul who proudly showed me the bucket of discarded product that she plucked off the conveyor belt. The occasion was a plant tour to understand how this company saw the role of the quality function. The next stop on the tour was the QC lab that was backed up with samples. Analysts were randomly selecting their favorite tests to squeeze in before their next coffee break. It didn’t take long to determine that the view of the quality function at this client was anchored in… approximately the 1950s.

On the other hand, there are companies on the cutting edge of science and technology with breakthrough products that fulfill the dire need of desperately sick people. Yet, in their evolution, the very bright people who work for these organizations did not pay sufficient attention to FDA compliance.

Looking back

As I look back, I see pharmaceutical companies ranging in their quality assurance evolution from knuckles still dragging the ground to walking upright but tripping over their own feet. So there is still plenty of work to do, and the enlightened—and bold—quality professional is not short of material to make a difference.

I say “bold” for a reason. In my opinion, the single factor holding back the quality professional, and consequently the company, is lack of courage.

The economy is not to blame for everything, but working on the inside of just about any company means doing our work in an environment fraught with fear. Timidity is rampant. It is rare to find someone who has the balance of panache and guts to tell the Emperor that he is butt-naked. It is a game of not making waves, keeping your head low—and for Pete’s sake never pointing out a problem to your manager that makes him have to speak to his director. (Like that's going to happen.)

Looking forward

My prediction is that the winnowing process will continue in our industry, and those with neutered quality assurance departments will either be acquired or rehabbed—or fail. In true Darwinian fashion, the fittest will survive to reproduce.

Regardless of the situation, I would suggest these resolutions for the quality assurance professional:

1. I will make myself more valuable through continuing education that will make me a more enlightened quality professional. This education will include real courses from recognized institutions, not trendy certifications.

2. I will find my voice and speak up when I see unacceptable quality and regulatory compliance risks. I may need personal coaching on how to deliver negative messages, but I will not stop going up the chain of command until I am satisfied that reasonable action has been taken.

3. I will learn how to make the business case when I see an opportunity for improvement. As a professional who has been conditioned not to be influenced by cost, I need to learn how to develop and deliver proposals that speak in the universal language of business: money.

4. I will get out of my cubicle to see what others are doing to broaden my industry perspective. I will resist the notion that my daily working experience is necessarily typical of the industry.

5. I will understand how my role fits into the business process cycle and will hold myself accountable for results, even if the results are bad news. This may mean developing standard cycle times and finding efficiencies to complete my part on time.

6. And my personal favorite: I will no longer prepare a useless slide deck for a management presentation on “what went wrong and recommendations” until management has supported the recommendations from the previous presentation for the same problems that went wrong. I will give myself permission to expect more out of management, especially when it comes to doing my job right.

 

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About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).