Corrective Action (CAPA) Systems at Innovative Companies

Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process. Regulatory compliance requires organizations to capture all corrective action issues and track their corrective action process to completion. About 30% to 50% of all 483 citations in FDA regulated industries are related to problems with Corrective Action & Preventive Action (CAPA) processes. The corrective action process also forms the core of various quality management disciplines such as Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) or TOPS-8D (see the table below) or ISO 9000.

In a manufacturing organization, when Deviations, Nonconformance, Out of Specifications, Incidents or Complaints occur, Corrective and Preventive Actions need to be initiated to remedy the problem. Once a CAPA has been initiated, it follows its assigned workflow process. For instance, the first step may be to initiate an investigation and to properly identify the root cause of the nonconformance. Once the root cause has been identified, CAPA items can be created and routed for approval. Once the corrective actions have been approved, appropriate changes are implemented in the environment and then the CAPA is closed out.

A software solution can be very helpful in managing and tracking a CAPA process. According to AMR Research, a leading industry analyst firm, the core functionalities resident in a CAPA system should include the following:

• Web-based change management, audit trails, and tracking
• Visualization, reporting, and quality performance analytics
• Configurable workflows and standard template-based best practice workflows
• Roles-based information view
• Trigger and event management and integration to back-end systems
• A Modular product, capable of being incrementally deployed.

The adoption of CAPA systems will become widespread because of their enabling role in mitigating significant business risks and driving quality as an integrated part of the manufacturing process. As a result, companies are no longer buying a stand alone CAPA system; they want their CAPA solution to be an integrated part of a compliance and quality solution.

Team-Oriented Problem Solving, 8 Disciplines (TOPS-8D)
Step 1	Form an appropriate cross-functional team The team should include a champion who has the resources and authority to implement the team's solution.
Step 2	Define the problem.
Step 3	Contain the problem. Protect the customer from the problem. This step can be omitted when 8D is used for a proactive improvement because there is no "problem" (like defective parts).
Step 4	Identify the root cause.
Step 5	Select a permanent correction.
Step 6	Implement the corrective action and verify its effectiveness
Step 7	Make the change permanent (standardization). Also share the solution with similar operations. This is best practice deployment.
Step 8	Recognize the team's achievement

Please send feedback on this paper or ideas for additional research topics to the author at agupta@metricstream.com