Become an expert in handling problems and improve quality
Gain insight into the techniques behind Root Cause Analysis (RCA) and learn how to plan and implement effective Corrective and Preventive Actions (CAPA) to ensure continuous quality improvement.
About the course
Many errors may indicate a quality deficiency in the quality system, such as deviations, complaints, or recalls.
Authorities expect companies to identify and address quality deficiencies that occur in a busy work environment.
With RCA, you gain an understanding of the root causes of a problem, which is crucial for determining and implementing effective corrective and preventive actions (CAPA).
In this course, we apply a structured approach where you learn to clearly identify and describe the problem. This may involve documenting incidents, deviations, or quality issues that require investigation.
Once the problem is identified, an RCA is conducted to determine the root causes. The goal is to understand why the problem occurred in order to prevent recurrence. The course provides examples of how to conduct an RCA using systematic tools.
Based on the RCA results, a CAPA plan is developed. We will explore how such a plan can be structured and why it is important for managing and following up on the different actions.
A CAPA plan outlines the actions needed to correct the current problem and prevent it from occurring again. Implementing the identified actions may involve changes to processes, procedures, employee training, system adjustments, and other relevant areas.
After implementing CAPAs, it is important to monitor and evaluate the effectiveness of the actions to ensure that the problem has been resolved and does not recur. This may include ongoing monitoring, audits, and process reviews.
The course combines theoretical presentations, case studies, and knowledge sharing.
Authorities expect companies to identify and address quality deficiencies that occur in a busy work environment.
With RCA, you gain an understanding of the root causes of a problem, which is crucial for determining and implementing effective corrective and preventive actions (CAPA).
In this course, we apply a structured approach where you learn to clearly identify and describe the problem. This may involve documenting incidents, deviations, or quality issues that require investigation.
Once the problem is identified, an RCA is conducted to determine the root causes. The goal is to understand why the problem occurred in order to prevent recurrence. The course provides examples of how to conduct an RCA using systematic tools.
Based on the RCA results, a CAPA plan is developed. We will explore how such a plan can be structured and why it is important for managing and following up on the different actions.
A CAPA plan outlines the actions needed to correct the current problem and prevent it from occurring again. Implementing the identified actions may involve changes to processes, procedures, employee training, system adjustments, and other relevant areas.
After implementing CAPAs, it is important to monitor and evaluate the effectiveness of the actions to ensure that the problem has been resolved and does not recur. This may include ongoing monitoring, audits, and process reviews.
The course combines theoretical presentations, case studies, and knowledge sharing.
Target group
This course is designed for those working in quality management, production, and process improvement related to deviations, aiming to enhance their skills in effectively identifying and solving problems.
Why choose this course
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.
Course programme
Day 1: 09:00 – 16:00
Day 2: 09:00 – 16:00
The course is based on theory and exercises.
Course Objective: The participant gains insight into relevant regulatory requirements for deviation handling and understands the importance of a systematic root cause analysis to ensure an efficient process and identification of the correct root cause.
The participant understands the value of CAPA and can contribute to the establishment, implementation, and evaluation of CAPA as a natural part of a continuous improvement process.
- Purpose and Authorities’ Expectations
- Overview of the Problem
- Root Cause Analysis
- Documentation of Root Cause Analysis
Day 2: 09:00 – 16:00
- Determine CAPA
- Risk Management
- Implement CAPA
- Evaluate CAPA
The course is based on theory and exercises.
Course Objective: The participant gains insight into relevant regulatory requirements for deviation handling and understands the importance of a systematic root cause analysis to ensure an efficient process and identification of the correct root cause.
The participant understands the value of CAPA and can contribute to the establishment, implementation, and evaluation of CAPA as a natural part of a continuous improvement process.
Instructors
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Helle Bøg, uddannelseskonsulent, Pharmakon
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Julie Dersch, uddannelseskonsulent, Pharmakon
Register for the course
Course Root Cause Analysis and CAPA
Format 2 days, overnight stay not included
Price next year 11.950 kr. excl. VAT
Choose a date and sign up
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