Pharma’s Evolving Quality Systems: Views from ASQ’s National Director, Donald C. Singer

The Malcolm Baldrige National Quality Award Examiner, certified specialist microbiologist and Six Sigma Green Belt recently shared his views on where the industry is heading and what it needs to improve.

By Agnes Shanley, Editor in Chief

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PhM – How long have you been a Baldrige examiner? What kind of background is required for that?

DS – I’ve been in the program for the past two years and have applied again for this year, because you have to apply each year to become an examiner. From what I understand, and I’m not sure about the exact selection criteria, but they require a lot of experience within the quality field — in some cases, experience that’s focused within a particular industry, but also general quality expertise. It took me quite a while, because I’d worked in a number of different industries, to be able to feel comfortable saying that I was very familiar with quality in pharma. I also have a quality background in industries that are somewhat similar to pharma, such as food and cosmetics.

PhM – Will a drug company ever win the Baldrige award? Is a change in mindset needed?

DS – The industry has always been on a slightly different track than a lot of other big-time manufacturing industries. It’s a highly regulated track and pharma’s products have a direct impact on customer health and safety. For that reason, the drug industry has been very particular about not jumping into what might seem to be a fad, or onto a side or parallel track to meeting global regulatory standards and ensuring product safety.

I don’t think it’s far from possibility that a pharma company will win this award in the future. But winning the award is not the question. The program invites anyone to participate and apply for the award just to go through the process because there is a great deal of learning to be gained. Participants learn how everything is interconnected within quality standards and get a better understanding of how to use quality tools and how to get a focus on the customer at the primary point when developing strategies.

Because it’s a confidential process, I can’t tell you who has applied for the award. It’s possible that a number of drug companies have applied over the past 10 years,
and that they have gone through the process just to learn everything that they can — not with the intent of winning, but just to improve the way they approach quality.

PhM – How are Lean and Six Sigma being used beyond the factory floor in the drug industry today? How can these principles be made more relevant?

DS – I take a holistic view. A lot of Lean Six Sigma is based on starting from the beginning, with the idea of quality in mind, and developing the best processes that
will work most effectively and efficiently. That approach works, whether you make product, design or test it. The R&D side of pharma is made of scientists who deal
with statistics, not just on whether products pass or fail, but on how drugs show efficacy in clinical studies. There are already a lot of statistics going on in R&D that some people aren’t aware of.

Some pharma research professionals may still view Six Sigma as a fad, because there are a lot of people who aren’t familiar with the concepts behind it. They are probably more familiar with the Lean aspects of quality, which can be applied to everyone’s life. You want to improve processes, whether they’re as simple as the way you handle vendor invoices. Making sure that they’re paid on time, for instance, helps maintain a good relationship that can later allow leveraging to improve on costs and help the bottom line.

Lean concepts can also be applied in the lab, for example, with samples coming into the lab — how you handle them, how soon they get tested, how you track them, how testing will be performed, who determines which tests are performed, and who performs the tests. Often, large pharmaceutical companies have their own labs in house, and many are discovering that they can learn lessons in efficiency from contract labs that have numerous external customers. Lean means you remove waste in your processes, and remove excess materials and supplies.

Six Sigma has come into fruition and useability in dealing with suppliers. In pharma, we’re designing drugs and delivery mechanisms and devices. In determining variation, you can measure variation on widgets coming out of any factory. With a drug, you must measure effectiveness in patients. This requires different methods… but you can still take concepts such as statistical process control and other tools and push them
back to suppliers.

Having control over supplier materials and having them develop their own processes so that they are more finely tuned and so that incoming raw materials are of consistent quality will save everyone in the long run. Itnot only saves waste on the supplier’s side, but prevents batches of finished product from being thrown out.

PhM – Recent cases involving Chinese APIs suggest that there might be some weaknesses in pharmaceutical Quality Systems, particularly in dealing with overseas suppliers. What are your views?

DS – I have a focused point of view because I’m a microbiologist, so I cannot answer from the analytical viewpoint. One area that needs to improve is the way we deal with different cultures. Western hemisphere-based businesses need to learn [about different] cultures and about how to speak and communicate and be on the same
understanding level around quality and consistency and reducing variation. ASQ has been getting into a “global transformation” from being primarily a Western hemisphere-oriented organization to a global group, an outlet and a single resource for other parts of the world as well. It’s catching on and we’re moving into Brazil, Mexico,
China and India — all areas that are becoming increasingly important to the pharmaceutical industry.

PhM – We’ve seen recent dramatic cases involving sterility assurance, where internal pharma quality systems failed. What is needed, what are companies missing?

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