Ready, Aim, Aim, Aim……….

I had lunch with a couple of colleagues other day and we were comparing notes on some of the challenges we encountered in Quality Management when working in the regulated industry. As it turned out, we share one very common challenge where we’ve been engaged to assist an organization in addressing adverse inspection or audit findings. We’ve all at one point encountered an executive officer from that company say “Just get all the documents done as quickly as possible and get it in the system” or similar words to that effect.

That phrase alone speaks volumes on how misguided some organizations are on what Quality Management is about. In such organizations, many of the executive team mistakenly believes that Quality Management is all about the volume of paper it generates and do not appreciate what the documents represent to their business. They see it as a necessary evil for conducting business in a regulated industry. Those beliefs and values percolates down through the organization and often result in the hiring and appointment of Quality Managers who are powerless to create a quality culture – Paper Tigers. These quality groups often approach deploying Quality Management Systems with a “box checker” mentality. By that I mean they try to embed in their quality programs, each element and tool from a checklist without attempting to understand the philosophy, integrate the systems or facilitate culture change. In these instances, quality is managed in a reactive ‘catch-as-catch-can” mode. Its easy to identify the “WHAT” of these elements, a quick web-search will direct you to any number of websites, literally an alphabet soup of abbreviations! For the regulated industry they include; ICH, FDA, EMEA, HPFB, etc. and for industry standards; ISO, PICs, ASTM, ISPE, etc. It is more challenging to know the “HOW” in implementing these elements with an integrated approach.

A more insidious result of such a dysfunctional approach to Quality Management is a never-ending cycle of quality processes. In this scenario, the Quality Manager is unable to impress on executive management the benefits and importance of embracing a quality culture. The Quality Manager’s role is boxed into a very defined space delineated by the operations directly affecting the production process and the quality processes that are specifically mandated by the applicable regulations. Within the organization, the quality processes are viewed as excessive, generates too much paper, and unnecessarily costly. As a result the quality processes are ineffectively deployed, poorly understood and unsupported. The Quality Unit focuses on the execution of the processes like so many hamsters on their wheels but none of these are linked to the larger objective of increasing efficiency, reducing and eliminating scraps, preventing process drifts, identifying and correcting sources of errors etc. Some common symptoms are; Quality Manual and Policies are not signed or read by executive management, personnel training programs cover only what is mandated for the industry, high rate of product returns and complaints, high rate of reworks or rejects, repeated adverse audit and inspection findings, and an understaffed quality unit. In one particularly egregious instance, where I had alerted the organization that a product did not conform to the manufacturing specifications and that there was no data to support its ability to meet its intended function in the field, I was asked if I’d approve the release of that batch if the Vice President and Director issued a memo indicating that they acknowledged my concerns with regard to that batch! Sadly such organizations do not reap the benefits from the cost of all the effort in implementing a Quality Unit and deploying a Quality Management System. This is akin to; buying a cannon, loading the cannon, aiming the cannon…aiming the cannon…..aiming the cannon… aiming the cannon…

If you build it (RIGHT), they will come

My wife and I were quite excited that one of our favourite restaurants decided to open a location in our neighbourhood. We were a bit disappointed by our experience. Was food was not quite as good as I had hoped? Nope, that wasn’t it, I think it probably was as good but some how it did not measure up because the décor was kind of stark, the tables were so close I could taste the food on the next table! The waiter had too many tables and although we could see that he was busy all the time, it was a long time between his visits to each of his tables From anywhere in the room you could see all 15 or so tables in the roughly square room in a sort of a cafeteria-like way. It was more of an overall experience. I was reflecting on this a little and decided to apply some of my Quality Management thinking to it. Purely from a diner’s perspective, I did sort of an informal Gap Analysis. I needed to contrast that experience with one we’ve had at the opposite end of the spectrum. You know the feeling when you’ve by chance stumbled on to a hidden gem of a restaurant? The food was delightfully well prepared, complex in texture and taste. The wait staff were attentive but not overbearingly so. The music was just loud enough to hear over a quite conversation and the tables spaced sufficiently apart that you know you are not alone but sufficiently separated to create an intimate space. The wine list is long enough to provide a variety of choices but not so large to be intimidating. The timing between courses were just right that you did not feel rushed nor do you remember sitting back and thinking “I wonder what’s taking them so long?”. I could probably make a long list to contrast the two experiences.

It occurred to me that most of us probably have similar experiences either with services and products we’ve purchased and that there’s an underlying concept of Quality Management involved. The menus of restaurants like the hidden gem above do not cover the entire spectrum of what each of us consider tasty and desirable, yet they command a loyal clientele. There are other examples of similar customer loyalty. Owners of Apple Computers and other Apple products like the iPhone, iPod, etc are fiercely loyal to Apple. The Disney Corporation captured our hearts as children and continues to enjoy our patronage as adults!

Given the diversity of society and desires, regardless of whether it’s a restaurant, resort, or an electronic device the company cannot predict nor hope to anticipate our every need. Its an imperfect world we live in and my favourite restaurant, Disney and Apple will and do make mistakes and on occasion, fumble a pass. We not only forgive them, we come back for more. Is there a secret ingredient? I’m sure the marketing experts will have lots to say, throwing in phrases like selling to the need, selling the sizzle not the stake, managing the expectation etc. Some or probably all true. What is also true is that they understand their product and in that understanding are able to identify the key parameters that help them provide a consistent quality. I believe that this not by accident but by design. Indeed in Quality Management parlance, it called Quality by Design (QbD). QbD was first introduced by Joseph Juran and has been adopted by a number of industries notably the automotive industry and more recently by the pharmaceutical industry. Indeed in the past few years the United States Food and Drug Administration (USFDA) in collaboration with and their European (EMEA) and Japanese counter parts issues a guidance on QbD through the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The concept is simple, define and understand the product and the processes needed to deliver the product, identify and develop the processes needed to be in place to meet the objective and identify the risks involved in the process and how best to mitigate those risks.