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?
DS – As Dr. Deming said, companies need to manage people in order to manage quality. Companies around the world have a lot of expertise and knowledge but if they’re not managing people well, things can go astray. These problems usually reflect a management issue.
PhM – Can you recommend any best practices?
DS – One way is to commit to learning more about quality and managing people within the umbrella of quality, and making this learning a long-term commitment. If you make a long-term commitment and realize that it will take some time to get there, it will help the industry and our communities as a whole. ASQ offers quality management certification to train people in all industries on management. It also allows them to network with peers from companies in all industries, including those who might be considered role models, who have been extremely successful at this.
We’ve networked, for example, in Japan, with electronics and automotive companies and learned their best practices. We need to bring this expertise into our own shops and learn from each other.
PhM – Which industries provide the most realistic Quality Management benchmarks for the drug industry?
DS – Food and chemical processing are very close in terms of primary drivers. When it comes to drug delivery and combination drug-devices, we can learn a lot from discrete manufacturing and “widget” makers. But we can also learn from automotive, aviation and aerospace, because they’re very innovative and go to extreme details to minimize variation to the Six Sigma level. A lot of industries today still have trouble reaching Four Sigma, but some are reaching Six Sigma through innovation.
The pharmaceutical industry is [already] highly innovative. If we can learn to be innovative and consistent at the same time, then we can develop very useful drugs
that people can use and trust all the time, without any of these little blips on the map that give a black mark to theentire industry around the world.
PhM – Varying raw materials quality seems to plague drug manufacturers. Excipients, for example, are commodity materials and grades can meet USP standards yet vary
highly in terms of material properties. The automotive industry banded together and has standardized and reduced variation in the products its vendors supply. What must
the drug industry do?
DS – The automotive industry has gone out of its way to work with suppliers, to identify key suppliers and put capital into them and work with them to reduce variation
and waste. The pharmaceutical industry could do the same thing with some of its suppliers. There’s a lot of room for improvement in this area, although there are also some loose ends — for example, with suppliers that have a larger market share in other industries, such as food. Such suppliers don’t have a need to be able to reduce variation or waste to a Six Sigma level if we are purchasing less than 5% of their materials.
But for a critical material, pharmaceutical manufacturers could leverage the need and try to influence them by showing commitment, resources, and possibly capital to
demonstrate how important consistent product quality is to us. It’s possible and is being done, but hasn’t been approached on a global level yet.
PhM – What’s impeding more drug companies from embracing QbD, as defined by FDA?
DS – QbD is very important. Everyone has picked up on this, but one thing that impedes acceptance is that it requires a culture change. Culture change within the
pharmaceutical industry, as in any other industry, takes a while. It’s not just a matter of waiting for generations of people within the industry to change, but changing
paradigms within companies.
Some companies are very research-oriented, others are very manufacturing-oriented. When you have an industry that depends on research and faces very high costs on the research end, when it comes to QbD you’re trying to nail down a specific design of a product as early as possible. Sometimes that’s not possible… you can spend a lot of money trying to design something early on, then learn in clinical studies that it’s not efficacious. The industry has to deal with this all the time. This experience can slow
acceptance of the concept. But also, a lot of intelligent and innovative pharmaceutical
scientists have documented the way they are approaching design and risk analysis, and developing evaluations that can be applied at different stages of the development process, so that a decision is not based just on cost but on science as well, and whether a given drug will be useful and efficacious. The industry may have been
slow to adjust, but more companies are embracing this approach. As people learn how to use these tools, they are discovering how much they can learn from them.
PhM – You’ve been working on the ICH group. How do you see global regulatory harmonization progressing?
DS – There already is some harmonization globally. Even though parts of harmonization are imperfect (ICH is, after all, really more of a standards than a scientific organization), the major intent is being achieved, that is, the intent of having standards for quality, development and raw materials specification and determining whether and what tests to perform. On that higher level, ICH has
developed documentation. We have already harmonized to some point, and we’re approaching [greater harmony] at a very good pace.