Corrective and Preventive Action (CAPA)systems provide a wealth of information regarding thequalityof a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.
For instance, it is not uncommon for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole.
So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process?
有什么风险？
First, while it must be noted that there is no standard definition forriskthat can be applied across organizations, the common goal is to mitigate risk, and for those that cannot be eliminated, to reduce them to a level as low as reasonably practicable.
Many companies spend plenty of time and money putting risk metrics in place that are at best subjective based on their level of tolerance.
This leads to inconsistency in the response to negative events. By quantifying risk, companies can more quickly realize a return on investment for their preliminary data gathering and work during the CAPA process.
Building a Risk-based CAPA Matrix
Risk assessment (or impact assessment) is required for any CAPA process and involves the identification, analysis, and prioritization of risks, and the subsequent application of effort to minimize, monitor, and control the probability and/or impact of a negative outcome.
您可以通过以下三个步骤构建简单的CAPA风险矩阵来进行评估：
- 查看历史数据以确定风险属性，频率和影响。从此信息中，公司可以清楚地确定其基线风险敞口以及对风险的需求（风险承受能力）。
- 使用商定的方法来量化风险和影响。
- Plot a 2 x 2 matrix (probability versus severity) to focus on the high-risk and high-impact category.
This CAPA risk matrix becomes a tool that allows you to determine the corresponding actions to events based on those criteria, including no action if it falls within the acceptable risk category.
此外，对于基于矩阵定义的风险等级需要采取行动的事件，由于新的严重性（根据采用的缓解策略）和频率可以测量以产生后续排名，因此有效性审查变得更加分析。
基于风险的CAPA驱动创新
在最重要的患者安全性的生命科学中，必须迅速，系统地解决与质量有关的风险。
因此，使用矩阵方法可以允许根据风险自动触发某些活动，从而可以得到充分保护产品的质量，同时可以将资源归还创新和帮助患者的业务。
By quantifying risk, companies can more quickly realize a return on investment for their preliminary data gathering and work during the CAPA process.