OK, the title is a little provocative, but it’s true. A common means of providing guidance to staff and resolving issues with internal and external audits has been to create and modify SOPs to provide a robust and fairly restrictive set of guidelines for processes. This approach leads to a multitude of problems AND more importantly, it doesn’t satisfy what auditor and regulators are looking for.
According to the presentation on E6 R2 available on ICH.org, ” ICH E6 gave sponsors flexibility to implement innovative approaches – but has been misinterpreted and implemented in ways that impede innovation.” To address this and align regulatory guidance with the changing landscape of clinical research, Section 5 of the E6 R2 guidance is focused on risk identification and management, for conducting clinical studies, managing validated systems and addressing issues as they are discovered.
A good, practical strategy for balancing risk and risk management with innovation is to create a Quality Management System that is focused on identifying issues as they arise and addressing them based on seriousness and potential safety issues. To do this, organizations should focus on practical guidelines and training for quality output, rather than lengthy SOPs that are cumbersome to read and understand, but even more cumbersome to manage and keep updated.
Here are some thoughts on shifting from trying to control processes with documentation to moving to a risk-based approach to quality outcomes:
- Define risks within functions (vendor management, site management, data management, etc.), each function has it’s own responsibilities and measures of outcomes and potential risks and improvement potential
- Review SOPs and other documentation to honestly assess if the documented processes and tools are really focused on those risks and quality outputs
- Reconsider detail in SOPs, which should describe the general process and pushing detail into more practical guidance and tools for staff, which can be more easily followed and adjusted with learning
- Make a serious effort to change the perception that Quality Control and Quality Assurance departments are partners of research functional teams to help them become world-class and push best practices, not police or disciplinarians.
- Reward, even incentivize staff for identifying issues with process and quality and recommending adjustments that improve results
- Tap into competitive opportunities and reward teams based on improvement in quality and risk management – each function has it’s own ways to improve