More than half of all Form 483 observations and FDA warning letters cite problems with Corrective Action/Preventative Action plans, or CAPA.
Many of these deficiencies arise when internal investigations fail to find and resolve the root causes of these problems. Whether it’s cost, time, or lack of manpower on staff, it can be easy to settle for treating the symptoms of compliance issues rather than investing the resources needed to dig deeper.
Unfortunately, short term solutions only mean bigger problems down the road when unresolved quality issues return—usually causing more harm than they did before.
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To ensure regulatory compliance and effectiveness while staying efficient, a CAPA system must resolve the core issues plaguing your organization with a strategy to stop these problems from recurring.
To help you get off on the right foot, here are the three key elements at the heart of every successful CAPA system:
1. A sound development process
All pharmaceutical and medical device companies with truly functional quality systems make the effort to develop a robust CAPA. This must consist of nine key components and actions:
- Documented procedures defining how you track your records
- An investigation to determine the root cause once a nonconformance has been identified
- Identifying the corrective and/or preventative actions after the root cause has been determined
- Establishing an approved action plan
- Implementing that action plan properly
- Actively supporting continuous CAPA improvement
- Putting mechanisms in place to monitor and analyze your CAPA system
- Completing all documentation and proper notifications
- Evaluating the effectiveness of the actions performed after implementation
Each of these steps are crucial to CAPA success. From a content perspective, simply addressing nonconformity is not enough. You must document and record each action you’re taking to resolve the issues, as well as a process to monitor and track your actions for root causes.
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Always keep the primary goal of CAPA in mind when designing your system: continuously improving the process that guide the operations of your organization.
2. Tracking, monitoring and analyzing
CAPA systems must have a monitoring process in place to ensure CAPA is both compliant and performing appropriately.
Monitoring your process effectively means selecting the proper metrics that show your actions are actually addressing the root causes of the problems at hand.
Developing Key Performance Indicators (KPIs)
KPIs are crucial to communicating the effectiveness of your CAPA system to decision makers throughout your organization. Running these numbers can be either a continuous or periodic process depending on the sources and availability of data.
Analyzing KPIs allows manufacturers to find nonconformity, and reveal particular areas that require in-depth investigation. This is the key to preventative action. While there are various analytical tools available to run these numbers, a human expert or process owner in charge of this analysis usually improves accuracy and diligence.
3. Ongoing improvement
Successful CAPA systems are constantly scrutinized and revised as new threats to quality emerge. Many observations issued by the FDA cite a failure on the manufacturer’s part to establish a process for verifying their CAPA systems are adequate.
With this in mind, it’s important to design and implement CAPAs that begin by addressing nonconformity, while describing a solid investigation process build around root cause analysis.
Interested in learning how to design a remediation project to address those root causes? Grab our free whitepaper: The Complete Guide to Compliance Remediation Projects to see the process step-by-step.