CAPA stands for Corrective Action and Preventive Action. It's a systematic way companies use to fix problems (corrective action) and prevent them from happening again (preventive action). Think of it like a detailed action plan that quality professionals use when something goes wrong in a process or product. It's especially important in regulated industries like manufacturing, pharmaceuticals, and medical devices. When you see CAPA on a resume, it means the person has experience in problem-solving and improving quality systems.
Led CAPA investigations resulting in 40% reduction in product defects
Managed CAPA system implementation across 3 manufacturing sites
Developed and executed Corrective and Preventive Action programs for FDA compliance
Typical job title: "Quality Assurance Specialists"
Also try searching for:
Q: How would you implement a CAPA system in a company that has never had one?
Expected Answer: A senior candidate should explain the steps: assessing current quality systems, creating documentation procedures, training staff, establishing review processes, and ensuring regulatory compliance. They should mention involving stakeholders and creating measurable success criteria.
Q: Describe a complex CAPA you managed and its outcome.
Expected Answer: Look for answers that show leadership in problem investigation, root cause analysis, solution implementation, and verification of effectiveness. They should mention team coordination and documentation practices.
Q: What's the difference between corrective and preventive actions?
Expected Answer: They should explain that corrective actions fix existing problems, while preventive actions stop potential problems before they happen. Should provide simple examples of each.
Q: How do you determine if a CAPA is effective?
Expected Answer: Should discuss monitoring results, measuring outcomes, collecting data, and verifying that the solution actually fixed the problem and prevented recurrence.
Q: What documentation is needed for a CAPA?
Expected Answer: Should mention basic documentation requirements: problem description, investigation findings, action plan, implementation steps, and effectiveness check results.
Q: What triggers a CAPA?
Expected Answer: Should list common triggers like customer complaints, audit findings, product defects, or process deviations.