Root Cause Analysis and CAPA|company

Read the ebenfits of an in-company course.

All errors indicate some form of quality deficiency in your organisation’s quality system, such as deviations, complaints, or recalls. Regulatory authorities expect companies to identify, investigate, and correct these quality deficiencies as part of daily operations in a regulated environment.

With Root Cause Analysis (RCA), your employees gain a structured understanding of the underlying causes of a problem, which is essential for defining and implementing effective Corrective and Preventive Actions (CAPA).

In this course, your organisation’s employees will work with a structured approach to problem-solving, learning how to clearly identify, describe, and document problems. This may include incidents, deviations, or quality issues that require formal investigation.
When employees participate together, the course creates a shared foundation for investigations, problem-solving, and decision-making across the organisation.

Once the problem is defined, an RCA is performed to identify the root causes. The aim is to understand why the problem occurred to prevent recurrence within your organisation.

The employees are introduced to systematic RCA tools and methods that can be applied directly in a regulated working environment. The training can incorporate your organisation’s own cases and challenges, making the learning directly relevant to daily practice.

Based on the RCA outcomes, a CAPA plan is developed and used as a structured tool to manage corrective and preventive actions within your quality system.
 
The CAPA plan defines actions to correct the existing issue (Corrective Actions) and actions to prevent recurrence (Preventive Actions). Implementation may involve process changes, procedure updates, employee training, or system adjustments across your organisation.

After implementation, it is essential to monitor and evaluate the effectiveness of CAPA actions to ensure the issue has been resolved and does not reoccur. This typically includes ongoing monitoring, internal audits, and process reviews within your organisation.

The course combines theoretical presentations, case studies, and knowledge sharing with a strong focus on practical application in your organisation’s quality environment.

This provides a common methodology for handling deviations, root cause investigations, and CAPA activities across functions and departments.

Your benefits

• You get tools to identify root causes of problems using RCA.
• You understand the difference between corrective and preventive actions.
• You can contribute to continuous quality improvements by identifying relevant CAPAs.

Your company's benefits

• Your employee works systematically to resolve problems.
• Your employee is adept at avoiding repeated errors and ensuring compliance.
• Your employee contributes to improved efficiency and productivity.