CRE CRE Corrective Action and Continuous Improvement

Question 1

The primary purpose of a Corrective Action and Preventive Action (CAPA) system is to:

Accepted Answer

Eliminate root causes and prevent recurrence of nonconformances

Answer

Document all failures for regulatory audit compliance

Answer

Assign responsibility and accountability for failures

Answer

Reduce maintenance labor costs only

Question 2

The 8D (Eight Disciplines) problem-solving process begins with which discipline?

Accepted Answer

Forming a cross-functional team

Answer

Identifying and verifying the root cause

Answer

Implementing immediate containment actions

Answer

Formally defining the problem statement

Question 3

In the PDCA (Plan-Do-Check-Act) improvement cycle, the 'Check' phase involves:

Accepted Answer

Monitoring and evaluating results against planned objectives

Answer

Developing the improvement plan

Answer

Implementing the planned solution

Answer

Standardizing and institutionalizing successful changes

Question 4

Six Sigma's DMAIC improvement roadmap stands for:

Accepted Answer

Define, Measure, Analyze, Improve, Control

Answer

Design, Measure, Analyze, Improve, Control

Answer

Define, Monitor, Analyze, Implement, Control

Answer

Design, Monitor, Assess, Implement, Check

Question 5

Poka-yoke is a quality and reliability technique that refers to:

Accepted Answer

Error-proofing devices or methods that prevent mistakes from occurring

Answer

Statistical process control using control charts

Answer

Structured root cause analysis using cause-and-effect diagrams

Answer

Formal corrective action documentation systems

Question 6

A fishbone (Ishikawa) cause-and-effect diagram is primarily used to:

Accepted Answer

Identify and organize potential root causes of a specific problem

Answer

Map the sequential steps of a manufacturing process

Answer

Document customer requirements and design inputs

Answer

Track cost of quality metrics over time