Flipping CAPA on Its Head with Prevention and Root Cause Analysis
Problems happen and an enormous amount of time, money and energy is spent on reacting to these issues rather than preventing them from happening. In the Life Sciences, the most effective method of ensuring safety and quality management and reducing quality issues is a closed-loop corrective and preventive action system (CAPA).
To illustrate the issue, consider this scenario… reusable medical devices like gowns tear prematurely at around 40 uses, far short of their intended 100 lifecycles. The reason was often attributed to vague reasons like human error or improper repair. The root cause often remained elusive, concealed under surface-level solutions, and lacked comprehensive communication across facilities. Despite multiple closures in CAPA claiming resolution, the genuine culprit was a chemical reaction, a detail overlooked at a high expense.
Unraveling the genuine cause proves intricate, and there is a tendency to blame humans and a challenge in uncovering the true root cause when metrics are the primary focus. The cost of not identifying the real cause outweighs the expenses involved, highlighting the significance of investing time for accurate resolution.
The critical aspect involves adhering to the seven fundamental elements of the CAPA process:
- Identifying the problem
- Evaluating the problem
- Developing and investigating
- Analyzing the problem
- Creating an action plan
- Implementing the action plan
- Analyzing its effectiveness
Underscoring the necessity of prevention, and emphasizing the "plan, do, check, act" methodology is key. Lack of support from pertinent stakeholders hampers progress and complicates the process. Furthermore, avoiding a blame game is crucial; understanding the error's cause, rectifying it, and ensuring the effectiveness of the solution are paramount.
Missteps in CAPA processes can lead to exorbitant consequences. As an example, a product recall represents only a fraction of the fallout from misdiagnosed issues. Research from McKinsey suggests a recall can incur costs up to 600 million dollars, with the medical device industry annually spending about 5 billion dollars on recalls, a figure impossible to disregard given the potential risks to lives.
The payoff from executing CAPA correctly in Life Sciences is immeasurable.
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