Quick Tip: Focus on quality system processes that most directly impact safety and effectiveness
Quality system audits are costly and time consuming. Make them count by using a risk-based approach to auditing by prioritizing high-risk processes and focus on effectiveness, not compliance.
It sounds completely counter-intuitive!
The main purpose of an “audit”, after all, is to check if we are doing things exactly the way we are supposed to. That is, whether we are following the rules or not. While this is generally true for an external audit or an inspection, it is more useful to focus on effectiveness rather than compliance in an internal audit.
Even the regulatory authorities across the world are recognizing the heavy burden of multiple audits and inspections on medical device manufacturers, which take away resources and time that could otherwise be invested in new product development and continuous improvement activities.
That is why we hear so much about a least burdensome approach1, which, according to the FDA, is the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner the right time.
There is a movement in the regulatory compliance world to adopt a least-burdensome approach for regulatory decision making throughout the device lifecycle. In this context, the auditing practices in the industry are moving from an element-based approach to a risk-based approach.
Simply put, a risk-based approach to auditing Quality Systems focuses on processes that directly impact the safety and effectiveness of a medical device. Processes such as design control, CAPA, risk management, manufacturing, clinical evaluation and post-market surveillance should be given a high priority. In addition, the focus of an audit should be to check for effectiveness using a process-based approach, rather than checking for compliance using a checklist-based approach.
The risk-based approach is a new method, especially in light of MDSAP, which applies a process-based approach to evaluate different processes of a quality system based on their potential impact on product safety and effectiveness. The question is not whether you meet a specific requirement or not, the question is whether your most critical processes are effective in achieving their intended goals. It is more about inputs, outputs, feedback loops and inter-relationships.
It is time to take a new approach to auditing Quality Systems!
