GXP TRAINING TIPS

GXP—Quality, Responsibility, Integrity, and Accountability

David Markovitz

“GXP Training Tips” provides ideas and suggestions associated with the plan- ning, management, and execution of training programs for regulated industries. Reader comments, questions, and suggestions are requested. Case stud- ies illustrating training applications submitted by readers are most welcome. Please send your comments, questions, and suggestions to column coordinator David Markovitz at [email protected] or to coordinating editor Susan Haigney at [email protected].

INTRODUCTION Consider the following four words: • Quality—distinguishing attributes of products and services that customers desire and for which they are willing to pay for • Responsibility—moral and legal liability, reliability, trustworthiness MARCUS MORESBY/GETTY IMAGES MORESBY/GETTY MARCUS • Integrity—firm adherence to a code of moral and ethical values • Accountability—to assume the sole and primary obligation for the performance of a product or service rendered.

These four concepts are interminably linked. It is literally impos- sible to speak about one without referring to the others. Just check the dictionary definitions for quality, responsibility, integrity, and account- ability and you will often find each referenced in the other’s definition. Quality, responsibility, integrity, and accountability are fundamental to GXP compliance. GXP includes the regulations for the manufacture of pharmaceuticals, medical devices, blood products, biologics, dietary supplements, and food. GXP can be viewed as the foundation for a quality system. GXP compliance is impossible without quality, respon- sibility, integrity, and accountability. The following are examples of where organizations have drifted away from these important concepts.

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THE COST OF A RECALL Deming also warned us about sub-optimization, A large recall of the iconic brand product Tylenol or what he called tampering (2). Tampering with occurred in early 2010. The recall was due to an odor a stable system always makes things worse. Global traced to a chemical used on wooden pallets used economic crises cause organizations to rethink and in the distribution of the final product. The manu- reevaluate how they do business. Too often people facturer of Tylenol, McNeil Consumer Healthcare, a implement changes without proper testing or evalu- Johnson & Johnson company, was accountable and ation on how the change may impact stages of the took responsibility by initiating a recall, at a signifi- process downstream. The change may have a posi- cant cost to the company. tive effect at the immediate stage, yet have an over- Outside our industry, in 2010 Toyota, another all negative effect to the final product or service. iconic brand, recalled millions of cars for a sticky Although it’s an old cliché, it’s one that is timely accelerator pedal and stopped selling certain models during an economic crisis—“Work smarter, not until a permanent fix was found and implemented, harder.” Working smarter means we should strive also at a huge cost to the company. to optimize systems and processes and avoid the Dr. W. Edwards Deming, one of the 20th century’s knee-jerk reactions, the quick fixes, and the band- leading quality gurus, often said that the true costs aid approaches. The following are four ways to associated with quality problems were unknown and approach problems: unknowable (1) . Consider the cost to the reputation • Absolve yourself of the problem—“It’s not my of both Johnson & Johnson and Toyota. Consider problem.” This is denial, ignorance, or “passing the cost of lost sales of their other products now and the buck.” in the future. Consider the cost to the pride of the • Solve the problem—identify and implement workforce of both companies. And in the case of the quick fix and apply it McNeil Consumer Healthcare, the cost of respond- • Resolve the problem—identify and implement ing to the US Food and Drug Administration 483 a permanent solution observation report and warning letter the company • Dissolve the problem—resolve the problem received in January 2010. It can take years, even and optimize the process or system to prevent decades, to develop a reputation for quality—and a its reoccurrence. weekend to lose that reputation. Now consider that in both examples these prob- Of course, the most effective approach is to dis- lems could and should have been avoided. GXP solve the problem. However, it is also the approach compliance, quality, responsibility, integrity, and applied least frequently. Dissolving problems requires accountability are not just necessary at the end of the resources and the discipline to stick with it. The co- product trail. They need to be paramount in every- nundrum is that so much time is spent on solving the thing we do at every step of the process. problem by applying the quick fix that there is no time left to devote to dissolving the problem. COST REDUCTION OR OPTIMIZATION? Solving the problem is the CA in CAPA (correc- There is immense pressure due to the economic tive action and preventive action), and dissolving downturn to reduce costs. However, we need to the problem is the PA in CAPA. Too often people in evaluate the impact of any cost savings on the quality organizations get caught up in CA with no time left of the product or service. for the PA. They may say they have a CAPA system, A good way to approach cost reduction is by work- and even a policy or standard operating procedure ing to optimize systems and processes. Deming de- describing their CAPA system, but in practice they fined optimization as “a process of orchestrating the have a CA-CA-CA system. A review of FDA warn- efforts of all components towards the achievement of ing letters provides examples. the stated aim whereby everyone gains” (1).

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GXP TIPS Stress that whenever you affix your signature or In GXP training sessions, take time to discuss qual- initials on a company document, you are taking on ity, responsibility, integrity, and accountability. Go legal liability. You are responsible and accountable into depth with trainees into what these words really for your actions. mean in our industry and at your company. A general This is a good time to reinforce these concepts observation I have made in over three decades in with existing employees as well. This is especially FDA-regulated industries is that when companies find critical now when companies are under immense themselves in violation of one of the GXP require- pressure to improve performance. Compromising ments, it almost always comes down to “Somebody quality by cutting corners and taking shortcuts will didn’t do what they were supposed to do.” They either always lead to increased costs. didn’t consider quality to be all that important, or they shirked their responsibility to do their job properly, or REFERENCES they didn’t understand that integrity is critical in our 1. Deming, W. Edwards, The New Economics for Industry, Gov- industry, or they weren’t being held accountable. ernment, Education, Massachusetts Institute of Technology; In training new employees, stress that it is a privi- 2nd edition, 1994. lege to work in an industry where the aim is improving 2. Deming, W. Edwards, Out of the Crisis, MIT-CAES, 1986. the quality of life and, in many cases, sustaining life GXP itself—And along with that privilege comes a respon- sibility. It is their responsibility to know the job well, ABOUT THE AUTHOR always do their job properly (which in most cases in David Markovitz is the founder and president of GMP Training our industry means following procedures), and they Systems, Inc., (www.GMPTrainingSystems.com) a provider of should stop and ask for help when they are not sure GXP training products and services. David can be reached at how to proceed. [email protected] and at 714.289.1233.

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