by Kamaal Anas, Vice President Regulatory Affairs, Wright Medical TechnologyAll too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.
There are three proverbs/curses, attributed to the Chinese, that are applicable to many regulated companies, (1.) May You Live in Interesting Times, (2.) May You Find What You Are Looking For, and (3.) May You Come to the Attention of Those in Authority.