Occasionally, even the best quality management systems will experience deviations and nonconformances. While it is virtually impossible for a company to eliminate adverse events entirely, it is possible to minimize the impact of a deviation or nonconformance, and to prevent it from recurring. This is accomplished by having a solid corrective action and preventive action (CAPA) process in place. Ideally, the process should include the use of robust automated CAPA tools that are part of a comprehensive, close-looped CAPA solution.
CAPA solutions are essential in regulated environments where unresolved quality events often lead to 483 warning letters, ISO audits, and FDA investigations, all of which can ultimately result in serious disciplinary action. The right corrective action tools can help regulated organizations more easily identify the root cause of a quality event, and take action to resolve the event with speed and accuracy.
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As the FDA, EMA, and other global regulatory agencies continue to tighten their oversight, developing a successful CAPA program is more important than ever, especially for organizations operating in the life sciences and manufacturing industries. In fact, one could argue that the very survival of these highly regulated companies depends upon the efficiency and efficacy of their corrective action processes, and the CAPA tools they use to facilitate those processes.
In order to be successful, a CAPA process must include a consistent method for identifying and investigating nonconformances, which are defined as an action (or result of any action) that does not meet specified regulatory requirements. While there is no denying that nonconformances must be controlled, it is important to remember that not all of them will be serious enough to require a CAPA, or the utilization of corrective action tools. In fact, employees that flood their respective companies with an overabundance of CAPA entries, often referred to as "Death by CAPA", may be doing more harm than good. CAPA investigations can take a significant economic toll on an organization's bottom line. Think of all of the time, money, and energy that life sciences and other regulated companies devote to resolving CAPA issues. Wouldn't these resources be better spent on research and development, marketing, and other efforts that help gain market share and profits? Using risk as a filter, the right CAPA tools can help regulated organizations streamline their CAPA process to avoid the "Death by CAPA" dilemma, improve their cost reduction and process improvement efforts, and remain competitive.
Without robust automated CAPA tools, ensuring effective CAPA oversight can be challenging, particularly in today's fledgling economy where companies are struggling to do more with fewer resources. Once the CAPA process is initiated, the company is obligated to see it through to resolution, which means it must research and determine the root cause of the issue, as well as identify the appropriate corrective action (and corrective action tools) needed to remedy it. CAPA event resolution can be overwhelming, especially when a company is investigating numerous open CAPAs simultaneously. Automated CAPA systems are designed to automate the manual processes regularly used to resolve CAPA issues. Not only does this save significant time and money, it also reduces the risk of human error.
According to the FDA, "the level of study should be commensurate with the risk involved." However, far too many companies continue to deploy their already scarce resources to work on quality events that carry minimal risk for the company. Corrective action tools - like MasterControl CAPA™ - help overburdened companies deploy and automate good risk management processes as a way to filter or classify CAPAs based on severity.
The most common risk filter should consist of a matrix that evaluates impact (e.g., critical, important, minor, and negligible) and frequency (e.g., continually, frequently, occasionally, and rarely); this simple matrix is an essential CAPA tool. Using it, a company can determine whether the issue or event requires corrective action, mitigation/containment, or simple observation. This type of risk filter should precede the organization's SOPs and work-forms, which dictate the data entry and analysis of complaints, deviations, and audit findings. The faster a company can implement these types of automated CAPA tools, the faster it can reduce its number of open CAPAs and achieve corrective action and preventive action compliance success.
MasterControl's electronic corrective action tools are designed to comply with 21 CFR Part 11 and meet FDA GMP, GLP, GCP, and other stringent quality requirements around the globe. MasterControl automates and streamlines not only all CAPA-related documentation and activities, such as routing, follow-up, escalation, and approval, but also the documents and tasks of other quality processes - including risk assessment and management - which are critical to effective CAPA management. This integration helps companies improve their overall compliance efforts. MasterControl CAPA offers:
For more information about MasterControl's CAPA tools, please feel free to contact a contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.