Background and Objective To answer the question ‘Do I assist or supervise? Achievements of quality management implementation’ I illustrate how a Quality Management System used by a blood establishment can be derived based on simple common sense and is essentially there to control peoples actions to work consistently and safely.
Materials and Methods I briefly review the key principles in EU GMP to illustrate the importance of quality and people management and draw from events in my experience which have provided significant learning opportunities for my organisation.
Results The learning opportunities illustrate the importance of having real time data on which to base actions allowing you to work with suppliers to improve their products and your systems. That corrective and preventative action must be confirmed as effective. The systems you use need to be simple and effective and adhere to the principle of GMP. External inspectors are a valuable source of bench marking data which you can use to improve.
Conclusion If a quality management system is working effectively then as a Quality profession I would assist, however if the effectiveness of the system drifts or individuals/departments fail to play their part I reserve the right to supervise.