CRE CRE Corrective Action and Continuous Improvement 1 — Questions and Answers
Question 1: The primary purpose of a Corrective Action and Preventive Action (CAPA) system is to:
- Document all failures for regulatory audit compliance
- Eliminate root causes and prevent recurrence of nonconformances (Correct answer)
- Assign responsibility and accountability for failures
- Reduce maintenance labor costs only
Correct answer: Eliminate root causes and prevent recurrence of nonconformances
CAPA systems are designed to identify root causes of problems and implement actions that prevent their recurrence.
Question 2: The 8D (Eight Disciplines) problem-solving process begins with which discipline?
- Identifying and verifying the root cause
- Forming a cross-functional team (Correct answer)
- Implementing immediate containment actions
- Formally defining the problem statement
Correct answer: Forming a cross-functional team
D1 of the 8D process is forming a cross-functional team with the knowledge and skills to solve the problem.
Question 3: In the PDCA (Plan-Do-Check-Act) improvement cycle, the 'Check' phase involves:
- Developing the improvement plan
- Implementing the planned solution
- Monitoring and evaluating results against planned objectives (Correct answer)
- Standardizing and institutionalizing successful changes
Correct answer: Monitoring and evaluating results against planned objectives
The Check phase involves measuring and analyzing results to determine whether the implemented solution achieved the desired objectives.
Question 4: Six Sigma's DMAIC improvement roadmap stands for:
- Design, Measure, Analyze, Improve, Control
- Define, Measure, Analyze, Improve, Control (Correct answer)
- Define, Monitor, Analyze, Implement, Control
- Design, Monitor, Assess, Implement, Check
Correct answer: Define, Measure, Analyze, Improve, Control
DMAIC is the structured Six Sigma methodology: Define the problem, Measure current performance, Analyze root causes, Improve the process, and Control the gains.
Question 5: Poka-yoke is a quality and reliability technique that refers to:
- Statistical process control using control charts
- Error-proofing devices or methods that prevent mistakes from occurring (Correct answer)
- Structured root cause analysis using cause-and-effect diagrams
- Formal corrective action documentation systems
Correct answer: Error-proofing devices or methods that prevent mistakes from occurring
Poka-yoke, a Japanese term meaning 'mistake-proofing,' uses physical or procedural safeguards to prevent errors before they occur.
Question 6: A fishbone (Ishikawa) cause-and-effect diagram is primarily used to:
- Map the sequential steps of a manufacturing process
- Identify and organize potential root causes of a specific problem (Correct answer)
- Document customer requirements and design inputs
- Track cost of quality metrics over time
Correct answer: Identify and organize potential root causes of a specific problem
The fishbone diagram visually organizes potential causes into categories (such as the 6 Ms) to facilitate root cause analysis.
CRE CRE Corrective Action and Continuous Improvement 1
The primary purpose of a Corrective Action and Preventive Action (CAPA) system is to: