The latest issue of Pharmaceutical Technology features a letter from the editor regarding various quality issues which have plagued the industry over the past year (really the past couple of years). The latest of these came to light after this letter was published – further evidence that whatever is causing these problems seems to be continuing unabated. So, then, what is the cause, or rather, what are the causes?

Ms. Hoffman has asserts that one of the causes, if not the cause, of this apparent crisis is that companies have significantly reduced the numbers of quality personnel employed. This reduction in quality force, is supported by the annual employment survey that they publish. Ms Hoffman’s conclusion is certainly reasonable. We have a significant quality problem in the industry, coupled with a significant reduction in the number of people whose job is quality. In fact, the causal relationship may be valid (I would note that the systematic problems referred to date back before this years employment changes, and in every case reflect problems that were a long time in developing). However, I would propose that its not. I would propose that the reduction in force reflects one of the underlying causes, a cause that is so significant that fixing it represents a major challenge. This is not, I think, the only cause. There is another cause that Ms. Hoffman addressed earlier in the year. I will address these first two causes here. There is, though, one significant cause, that I never hear anyone address. In many ways, it is reminiscent of the Emperor and his new clothes. It is a problem I’ve seen since I first set foot in a quality department over 20 years ago. I will briefly discuss this at the end, but I think it merits an entire blog entry to itself.

Let me briefly discuss one cause that Ms. Hoffman brought up last August, the subject of training. When you have several industry veterans describing the state of training in modern pharma and biotech companies using terms like “abysmal”, and “woefully inadequate”, the situation is dire. There has been a long standing myth in the pharma industry that an ideally written procedure would obviate the need for much training. Following that myth, you would then believe that simply handing the procedure to any random person off the street would enable them to successfully complete their required tasks. However, in practice we know that this doesn’t work. All procedures assume some base level of knowledge. The greater that base, the less detailed the procedure needs to be in order to be effective. Part of this phenomenon is that there are invariably aspects to executing the procedure that will help things go more efficiently, or reduce the amount of difficulties one might encounter down the line – but that shouldn’t be part of the written practice because they are truly optional, or too difficult to describe. This is a complicated way to describe what is best termed as wisdom. The simple collection of insights one develops with experience. So, as is pointed out, the loss of training dollars is bad, but worse is the loss of the experienced “mentors” that could impart the wisdom of experience.

This latter point, the loss of experienced personnel is related to one of the seven deadly diseases of Deming. Although Deming was specifically focused on top management, the loss of experienced people further down in the organization causes not only a break in leadership, but a loss of the accumulated wisdom that is important to any organization. In addition to the deadly disease associated with the loss of experienced personnel (and there is one deadly disease we haven’t touched on yet), this whole attitude toward both training and on the job training violates the 14 principles that Deming felt was so important to the transformation of business.

The training issue, while bad all by itself, reflects a cost cutting mindset that is also leading to the loss of quality personnel (and personnel in other areas). Management in the pharmaceutical industry has become focused almost entirely on short term profits and management by the accounting department. History has shown that such a mindset does not end well for the company that engages in it. This is true whether business makes human medicines, or toy cars. of course, as Ms. Hoffman points out, the consequences for the public are not as deadly in the case of toy cars, but the consequences to the business are similar. Of course, it is interesting to note the somewhat lopsided loss of quality personnel during this current round of corporate purges that seem to be going on. I have to wonder a bit as the cause. Is it entirely that quality costs money? To some degree that is likely the case. Its sad that such a mindset persists to this day. Shortly after the first GMP class I ever attended started, we were told that management in all companies look upon quality as a cost center. I had hoped we would have moved on from their, but obviously we haven’t. I also wonder, however, if the disproportionate laying off of quality personnel reflects a lack of satisfaction on the part of management with their quality groups. As I noted above, many of the problems that companies have been experiencing have roots long before this recent round of downsizings and reorganizations.

Clearly, the one problem that exists is that senior management has generally still not signed on to the belief that they must be the champions and leaders of quality. However, that is not the entire problem with quality in our industry. This leads me to two topics that I will address in subsequent blog entries. The first is a sense, promulgated by our government, that compliance with regulations assures some measure of quality. While it is heretical of me to suggest this, I think all but the most basic of regulations probably serve to interfere with quality. The second is a fundamental question about the skill set of those who engage in quality within the pharmaceutical industry. In general, are the skills of those engaged in quality the skills necessary to improve quality? This, too, I will address in a later entry.