Developing Effective Procedures

By Jeff Hall & Lisa Hawkins

Creating or updating procedures requires a foundational understanding of their purpose, rather than simply addressing regulatory requirements. A Quality Management System (QMS) should focus on maintaining control to ensure patient safety, rather than being a mere collection of procedures. Effective documentation is achieved through a structured approach that prioritizes Change Management, Risk Management, and Knowledge Management.

Before drafting procedures, organizations should assess their product lifecycle, the nature of their products, and available resources. For smaller companies, this may differ significantly from larger, multi-site organizations, but the principles remain consistent. A successful documentation system integrates these three key processes, allowing for efficient product realization and continuous improvement.

Quality Risk Management (QRM) is crucial for establishing a solid documentation foundation. Companies should incorporate risk management principles into all QMS aspects, ensuring comprehensive oversight of potential issues, especially regarding critical processes like change management and deviation handling.

Change Management must be robust, evaluating the impact of changes on overall product quality and adhering to regulations. Preapproval of changes is essential to maintain control and accountability.

This white paper examines how Knowledge Management plays a vital role throughout the product lifecycle by systematically managing information related to processes and compliance. This integrated approach supports informed decision-making, ultimately leading to a streamlined and effective documentation system.

By shifting focus from merely creating procedures to understanding their role within a broader quality framework, organizations can foster a more effective and adaptive quality culture.