Robin Hewitt Email & Phone Number

While my understanding of quality assurance and regulatory affairs has evolved a great deal over the years, there are a few principles I have integrated along the way that have helped me run a successful program.The first is that procedures must be consistent with the reality of operations. Of course, SOPs must follow regulatory guidelines and best practices, but non-compliance may be indicative of deficiencies in training, staff, supplies, equipment, operations management, or the SOP itself. My preferred approach is to involve personnel in the design of the SOPs that govern their specific role within the company. This is helpful for cultivating personal accountability and leads me to the next point.The second principle is to know your processes and the staff who run them. When I was promoted to Team Lead at Nature's Formula, the scope my duties expanded from informal supervisor of two employees in a single department to direct supervisor of twenty-three employees in six departments, five of which I had no prior experience. I approached this by shadowing the experienced staff in each department, and helping out with equipment configuration, documentation, and other duties wherever possible. This was tremendously helpful for scheduling, but it also provided an understanding of whether an employee worked quickly because they were efficient, or they cut every corner likely to go unnoticed.The third principle I want to share is best represented by the quote: "We don't have a problem. We need a plan." This is not so much about putting a positive spin on problems as it is about having a resolution-focused mentality. I have seen the detrimental impact that "blame-culture" can have on a workplace, where an enormous amount of energy gets spent trying to determine who should bare the responsibility of a particular mistake. My approach sticks to basics of CAPA, how to correct the issue and prevent it from occurring again. Understanding why it happened and who was responsible may be part of the investigation, but this process is only concerned with the facts.