CAPA Practice Exam
CAPA Practice Exam
About CAPA Exam
The CAPA (Corrective and Preventive Action) certification proves your ability to identify, correct, and prevent problems in business processes. It is key for jobs in quality assurance, compliance, and manufacturing. This certification shows that you can handle risks, find root causes, and stop issues from happening again. It boosts your career by making you a valuable part of quality and safety teams. CAPA-certified professionals are in demand in pharma, healthcare, food, IT, automotive, and more. Companies look for experts who can maintain standards, pass audits, and improve systems. This certification increases job chances and builds long-term growth.
Who should take the Exam?
This exam is ideal for:
- Quality Assurance Professionals
- Quality Control Technicians
- Compliance Officers
- Manufacturing Engineers
- Process Improvement Specialists
- Regulatory Affairs Staff
- Operations and Plant Managers
- Healthcare and Pharma Quality Staff
- Auditors and Inspection Leads
- Risk and Safety Professionals
Skills Required
- Problem identification and definition
- Root cause analysis techniques (e.g., 5 Whys, Fishbone)
- Risk assessment and impact evaluation
- Developing effective corrective actions
- Designing preventive actions
- Documentation and reporting for CAPA
- Implementing changes and controls
- Monitoring and follow-up of actions taken
- Regulatory compliance understanding (e.g., ISO, FDA)
- Communication and coordination across teams
Knowledge Gained
- Understanding of CAPA methodology
- Identifying, analyzing, and solving recurring issues
- Using tools for root cause analysis and corrective planning
- Preventing non-compliance and avoiding repeat problems
- Writing effective CAPA reports
- Tracking actions to ensure effectiveness
- Meeting compliance needs for audits and inspections
- Applying CAPA across industries (pharma, manufacturing, etc.)
- Linking CAPA to quality systems and continuous improvement
- Enhancing product and process reliability
Course Outline
The CAPA Exam covers the following topics -
Domain 1 - Introduction to CAPA
- Definition and importance
- CAPA lifecycle overview
- Regulatory requirements (FDA, ISO, etc.)
Domain 2 - Problem Identification and Documentation
- Incident reporting
- Issue classification
- Documentation standards
Domain 3 - Root Cause Analysis (RCA)
- 5 - Whys, Fishbone diagram
- Process mapping
- Human error analysis
Domain 4 - Corrective Actions
- Action planning
- Implementation steps
- Validation of corrections
Domain 5 - Preventive Actions
- Risk identification
- Mitigation strategies
- Process controls
Domain 6 - Monitoring and Effectiveness Checks
- Tracking corrective actions
- Auditing and follow-up
- Success metrics
Domain 7 - CAPA Documentation and Records
- Report writing
- Evidence collection
- Maintaining audit trails
Domain 8 - Integration with Quality Systems
- Link with QMS, GMP, ISO
- Continuous improvement
- Change management
