The Quality Police

            A few years ago I was in the process of resigning from my job as Director of Quality from ConforMIS. My boss at that time paid me a kind complement that provided me with a perspective that I had not had prior to that moment. I don’t remember the exact wording, but his basic message was: Quality Managers that work cooperatively with operations are rare and highly sought after. He described my approach to Quality as modern and progressive. Over time I have learned to articulate this as the difference between Quality Control (QC) and Quality Assurance (QA). The word “control” is the key difference between these two responsibilities. QC is responsible for verifying that product is “good.” Often this creates friction between manufacturing personnel and inspectors. It doesn’t help that the people often have the same title as our favorite FDA employees—the Inspectors.

            We might as well give the QC folks a uniform, a badge and a gun. They act like they are the Quality Police. Progressive companies have changed their organizational structure and integrated the Inspectors into the production lines. Now we have U-shaped cells instead of lines. Operators are now referred to as “team members,” and everyone takes a turn at inspection as a normal part of job rotations. This modern and progressive approach is difficult for “old school” Quality Managers to accept. They feel uncomfortable with this approach, because they remember when manufacturing didn’t care about Quality and would just “ship it.” Some of these managers are quite young. Unfortunately, these Quality Managers were taught methods for achieving quality that are thousands of years old.

            The 21^st century is not “out of control.” We merely upgraded our risk controls. Once we relied upon the Inspectors. Now we rely on process validation, automation, and statistical analysis of process variable that are Critical to Quality (CTQ). Many people use rules of thumb to estimate the effectiveness of visual inspection. At best visual inspection is capable of catching 98% of the problems. Validation, automation and statistical analysis each have the capability of exceeding 98% effectiveness by themselves. When we combine each of these methods together, we improve the certainty of making good product to Sigma Quality levels of 5 and 6-sigma. At this level of quality, the importance of visual inspection begins to evaporate. It is in the context of a highly automated and robust process that modern Quality Managers are implementing “radical” changes. We don’t need the Inspectors. We need Quality Engineers that can help us implement the new risk controls.

            When I first started at ConforMIS, I was interviewing candidates for a new QA Associate. I used this title to differentiate it from QC Inspectors. One of the design engineers argued that we needed to hire an inspector that was more qualified at performing measurement of implants. I argued that we needed good suppliers to do this for us. We also needed to have strong supplier controls such as process validations, supplier audits, process risk management, and a physical presence on-site at the supplier. Being the hiring manager, I got my way (I’m also 6’6”).

            During the interview process, I asked each person to describe their role in their current position. One candidate actually described himself as the “Quality Police.” I stopped the interview immediately and showed him the door. Coincidentally, the design engineer thought this candidate was great. When I finally hired someone for the job, I made a point of telling him this story. The person I hired had no experience in the medical device industry and he knew little about measurement techniques. He was also the oldest candidate that interviewed for the job. What won him that job was that his mindset was the most modern and progressive of the people we interviewed. He may also be the first QA person in history to have the customer service department rave about him. I miss working with him, but I know a company in Massachusetts that is very lucky to have him.

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