Every regulated organization understands the need to implement a quality system. In fact, it’s a “shall” clause for all Life Science companies to ensure they are compliant with industry regulations. From there, as the organization matures, its people, processes and technology evolve from a compliance, to a correction, to a prevention mindset, eventually resulting in increased quality brand recognition and shareholder value.
Consider a scenario in which a manufacturer maximizes the capabilities of its quality system. If that company really “did it right the first time;” if every motion, thought, and investment — from the product development, through market approval, through manufacturing at all production sites, through supplier outputs, and along the value chain — was spent “right the first time” — the outcome would be “right.” Right for the consumer/patient and for the manufacturer.
In the real world, it is a struggle to realize this scenario without executive buy-in. It is incumbent on the Quality function to solicit and secure support from the boardroom. This Insight Brief examines an effective approach to building the case for a Quality Management System (QMS) by establishing enterprise-wide consensus, including executive leadership.
Executive sponsorship drives Quality Maturity
Every organization strives to become the leader in its industry. They are not born leaders but can strive to take the position by venturing out on the path to quality maturity. As organizations advance on the quality journey, they can more effectively address regulatory challenges, better manage risk, and bring quality systems into alignment. The diagram below depicts the stages of that journey.