Altering the genetic code of management review.

Abstract

When you mention the words “Management Review,” do people shudder at the thought of spending hours discussing past issues they are already aware of and have discussed ad nauseam? Is there a fear of even bringing issues to the management forefront? Although the whole idea of management review makes good business sense and has been done informally in business as long as anyone can remember, the formal mechanisms and detailed requirements in the Quality System regulation and various Quality System standards are causing many corporations to re-evaluate how they address Management Review. It seems that sometimes, due to the nature of a highly regulated industry, we spend an inordinate amount of time and resources complying with regulations without seeking to add value to the process. Otherwise stated, better quality translates into a better product and meeting our customer’s needs. So if we are meeting regulations without adding value to the process, then a re-evaluation of how we are meeting these regulations is warranted. The industry’s “genetic code” is such that we believe that if we comply with the regulations, our process has been inherently optimized, when in fact there are a number of ways to meet and exceed regulations. The goal of this article is to take a step back from the management review process and address two key issues—metrics and global analysis. I want to examine where we can create additional value within management review and ultimately attempt to alter the genetic coding of how we accomplish complying with management review regulations. Regulation 21 CFR Part 820.20(c) delineates that management with executive responsibility must periodically evaluate the suitability and effectiveness of the quality system. From a compliance standpoint, the function of this requirement is to inform management of significant issues within their respective areas, so they are able to adequately evaluate the health of the quality system. As mentioned, these types of reviews are done everyday across different industries because it makes good business sense. This is now simply a formalized mechanism to ensure management reviews and subsequent evaluations occur. The difficulty arises in determining what exactly must be analyzed and discussed to make these meetings more meaningful and more productive in an environment where management does not have the time to spend on meetings that don’t add value to the management of the business.