CRE Corrective Action and Continuous Improvement Flashcards
6 cards from real CRE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRE Corrective Action and Continuous Improvement flashcards as text
The primary purpose of a Corrective Action and Preventive Action (CAPA) system is to:
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.
The 8D (Eight Disciplines) problem-solving process begins with which discipline?
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.
In the PDCA (Plan-Do-Check-Act) improvement cycle, the 'Check' phase involves:
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.
Six Sigma's DMAIC improvement roadmap stands for:
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.
Poka-yoke is a quality and reliability technique that refers to:
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.
A fishbone (Ishikawa) cause-and-effect diagram is primarily used to:
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.