Failure Mode and Effects Analysis
Duration: 60 Minutes
Failure Mode Effects Analysis (FMEA) is a closed loop continuous improvement activity that begins by planning for quality. It identifies what can go wrong with a product or process, the severity and probability of the undesirable event, and existing controls (if any) to prevent or mitigate the problem. It is however not a once-and-done activity because it is updated to reflect actions taken to remove or mitigate failure modes. An FMEA is therefore a living document and continual improvement activity that supports other elements of the quality management system.
Objectives of the Presentation
Why Should you Attend
- Know the role of FMEA in advanced quality planning (AQP)
- Know how FMEA helps to plan, rather than inspect or even build, quality into a product or service
- Know the definition of critical and significant product characteristics (or in general, critical to quality characteristics)
- Know the meaning and assessment of a failure mode's Severity (S), chance of occurrence (O), and likelihood of detection (D), and how to obtain from them the Risk Priority Number (RPN). Also know, however, that high severity failure modes require attention regardless of the RPN
- Know the role of the FMEA as a living document rather than a once and done activity
- Know how FMEA supports ISO 9001:2015's requirements for actions to address risks and opportunities
FMEA is a basic element of advanced quality planning (AQP) or Advanced Product Quality Planning (APQP). It therefore plays a central role in planning for quality, continuous improvement, and definition of the control plan. It supports risk based thinking (as required by ISO 9001:2015), and is sufficiently important in the automotive industry that the Automotive Industry Action Group (AIAG) publishes a manual for it.
Who can Benefit
- Role of FMEA in Advanced Quality Planning
- Role of FMEA in ISO 9001:2015, Actions to Address Risks and Opportunities
- Types of FMEAs: Design and Process
- Terminology: Critical and significant characteristics, failure mechanisms and failure modes
- Preparation of the FMEA: Severity, occurrence, and detection ratings, and the Risk Priority Number (RPN). Identification of existing controls, development of new ones, and corresponding adjustment of the ratings and RPN
- Role of the FMEA in the quality management system as a quality record and living document
- Awareness of the Army's Risk Management Process as a simpler alternative
Quality management professionals, including design and manufacturing engineers, and people with responsibility for ISO 9001 and/or ISO/TS 16949.
FMEA is a standard quality management process to identify, assess, and then eliminate or mitigate potential failure modes in products and services. This closed loop approach makes it part of a continuous improvement cycle rather than a once-and-done activity. Deliverables include identification of processes for which controls are needed, which means it helps define the control plan in Advanced Quality Planning.