ASQ Updated CQE Exam Questions and Answers by lillian

In Failure Mode and Effects Analysis (FMEA), the focus should be on implementing corrective actions on items that have high Risk Priority Numbers (RPN) or high severity values. The RPN is calculated by multiplying the severity, occurrence, and detection ratings, and it helps prioritize which failure modes need immediate attention.

When an auditor finds a major discrepancy during a pre-award audit of a new supplier, the appropriate action is to include the discrepancy in the final report. This documentation is essential for transparency and for the organization to make informed decisions regarding the supplier. While other actions like verifying corrective actions and investigating the cause are important, they are typically follow-up steps after the discrepancy has been officially recorded.

Design Failure Mode and Effects Analysis (DFMEA) is a systematic method for evaluating a design to identify potential failure modes, their causes, and effects, and to prioritize the actions to mitigate these failures.

Identify Personnel Responsible for Implementation:

While important for action plans, it is not the primary focus of DFMEA.

Predict Failure Frequencies:

DFMEA does consider failure frequencies, but the primary goal is to address and mitigate failures.

Minimize Measurement Variation:

This is more relevant to process control and not the primary focus of DFMEA.

Mitigate Failure Modes:

The main objective of DFMEA is to identify potential failure modes and implement actions to reduce or eliminate the risks associated with these failures.

This involves analyzing the design to foresee where it might fail and taking preventive measures to improve reliability and safety.

References: Quality engineering and risk management texts, specifically those discussing the principles and objectives of DFMEA.