Part of the broader Enterprise Quality Management Software (EQMS) functionality portfolio, Corrective and Preventive Action (CAPA) management is a tool utilized by many organizations to identify, resolve, and avoid nonconformances. Just as it sounds, CAPA has two main elements, corrective and preventive actions, both of which aim to improve the quality of processes.
Although CAPA processes have long been employed by companies, they have evolved correspondingly with new technologies and strategies. It’s common today for the tool to be integrated with many applications in IT architectures and play a central role in global quality management initiatives. Below, I’ll discuss the main elements of CAPA management.
Sources of Nonconformances
Nonconformances can be thought of as undesired deviations that occur during business processes. Because CAPA is used to identify, correct, and prevent adverse events, it’s important to understand where companies find the sources of these nonconformances:
- Internal Audits and managerial review: can be routine, random, or to target a specific issue
- Statistical Process Control: trending analysis used during production to find statistical inconsistencies or anomalies
- Quality Inspection: covers processes across the value chain in supplier activities, design, and production up through distribution and services
- Customer complaints: originates after distribution, typically in service and warranty management
- Other inspections: can include inventory management and equipment maintenance
Corrective Action Process
It’s important to note that there’s a difference between corrective and preventive actions. A corrective action process is initiated in response to a nonconformance. While corrective actions processes vary by organization and also by which software or application is being used, there are generally several steps taken to resolve an undesired event:
- Acknowledge the nonconformance
- Assign personnel to investigate
- Conduct and document a root cause analysis
- Establish and execute a plan for correcting the action
- Establish a plan for preventing its reoccurrence in the future
- Globally communicate the corrective action to groups that may face similar risk
- Investigate related processes or gaps in quality management systems to reduce risk of similar nonconformances
- Analyze the impact of the nonconformance and determine action needed (product recall, scrap, etc.)
- Validate that corrective action has worked and nonconformance hasn’t returned
Preventive Action Process
A misconception commonly noted is that a preventive action is simply the step following a corrective action. However, a preventive action should be viewed separately. It’s a proactive or predictive action taken to avoid a nonconformance in a business process. It can also be used to improve the efficiency or effectiveness or a process. Staples of a preventive action processes include:
- Identify potential nonconformance or area for improvement from trending analysis, internal discussions, or customer recommendation
- Assign personnel to investigate preventive action
- Develop plan and execute preventive action
- Locally test the efficacy of preventive action
- Globally communicate the preventive action to groups that may face similar risk
- Validate that preventive action has worked and nonconformance has been averted or process improvement has been realized
How CAPA Fits into EQMS
Companies have traditionally developed internal CAPA management processes that include a considerable amount of manual processes and spreadsheets. Those that needed stronger CAPA management capabilities may have implemented a point solution that’s typically local to a facility or business unit. Today, though, market leading organizations are leveraging emerging technologies such as EQMS to expedite the process and make it more effective at the global scale.
CAPA management is a common application in most EQMS solutions. The holistic framework helps to standardize, centralize, and automate CAPA processes under a unified information management system. Applications generally deliver the ability to streamline the routing and delivery of CAPA processes such as personnel notifications, escalating issues, approving corrective or preventive actions, and communicating nonconformances and resolutions at an enterprise level.
Making use of Service-oriented architecture (SOA), CAPA applications found in EQMS shadow the effectiveness of traditional CAPA functionalities by integrating data from broader enterprise and point systems across the value chain. Nonconformances identified in SCM, design, manufacturing, and distribution can be managed, documented, resolved, and communicated from the EQMS system.
Integrating CAPA with Risk Management
Traditionally, a first-in-first-out methodology for corrective and preventive actions has been used to reduce nonconformances. However, it's becoming more common today for companies to integrate CAPA and nonconformance reporting modules with risk management capabilities, introducing the ability to assess the impact of and prioritize nonconformances at the global level.
Many EQMS solutions have this capability built in. The centralization of data from throughout the value chain and in disparate facilities can help to uncover global trends that would otherwise be difficult to find. When coupled with the ability to assess nonconformances with risk management criteria, companies can make a significant impact on operational risk.
Have Experience with CAPA Management?
We’re currently recruiting companies for a case study on corrective and preventive action processes. If you have previously or are currently working on project regarding the transition from manual CAPA processes to an automated CAPA management tool, we would like to talk to you. Please contact mike.roberts@lnsresearch.com.
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