Change vs Consistency
The tension between maintaining consistency and enabling change within Quality Assurance (QA) is a complex interplay and is the essence of what a Pharmaceutical Quality System should manage.
On the one hand, consistency is foundational to pharmaceutical clinical development and commercial delivery.
Your drug is safe and will work because it is fundamentally the same drug as what passed through a clinical trials program. Consistency ensures that products or services reliably meet clinical and patient expectations. Therefore, unwavering consistency is fundamental to trust among consumers or end-users, as they know what to expect every time. A mentor introduced GMP to me as "Say what you are going to do, write it down, and do it again, and again and again".
On the contrary, change allows for adopting better technologies, processes, or methodologies. It's the path to innovation and continuous improvement and organisations must change to remain competitive. More importantly from an assurance perspective change will be forced upon us. Both well-intentioned and quality "enhancing" change such as new regulations, and technologies, along with unwanted change from deviations, defective inputs, and bankrupt suppliers. Machine parts will wear and brain cells will forget instructions.
To navigate the change / consitency tension, there are only a few principles that I have found any consistency in always helping:
Simplify:
The fewer moving parts in any system, the fewer things that can change and the fewer things that will interact with the change, causing a propagation of further change, wanted or not. Relentlessly pairing down on system bloat is a necessary obsession.
Phased Implementation: Introducing changes in phases, allowing for gradual adaptation and feedback loops to form before you commit fully.
Stakeholder Engagement: Involving all stakeholders in the change process, addressing their concerns, using their experience for a smoother transition and understanding where and how the "rubber meets the road".
These will never be included as regulatory advice but remain essential principles to navigate what we do in Quality Assurance.