Failure Mode and Effects Analysis (FMEA): 5-Day Professional Training Course

Course Overview

This comprehensive FMEA Training provides systematic methodology for identifying potential failures, assessing risks, and implementing preventive actions. This intensive 5-day program covers FMEA fundamentals, Design FMEA (DFMEA), Process FMEA (PFMEA), FMEA-MSR (Monitoring and System Response), risk priority calculation, corrective action planning, and AIAG-VDA harmonized standards for automotive, manufacturing, aerospace, and healthcare industries.

Who Should Attend This FMEA Course?

• Quality Engineers implementing FMEA programs

• Design Engineers conducting DFMEA studies

• Process Engineers performing PFMEA analysis

• Manufacturing Engineers improving production reliability

• Product Development Teams in new product launches

• Reliability Engineers reducing failure rates

• Six Sigma Professionals using FMEA tools

• Automotive Suppliers meeting IATF 16949 requirements

• Risk Management Professionals assessing product risks

Course Objectives

Participants will master FMEA methodology, failure mode identification, severity/occurrence/detection rating, Risk Priority Number (RPN) calculation, action priority determination, DFMEA and PFMEA execution, AIAG-VDA standards application, corrective action development, and FMEA documentation and maintenance.

Day 1: FMEA Fundamentals and Methodology Overview

Morning Session: Introduction to FMEA

Topics Covered:

• FMEA definition and historical development

• Purpose: risk reduction and failure prevention

• Benefits: cost savings, quality improvement, reliability enhancement

• FMEA in product development lifecycle

• Types of FMEA: Design, Process, System, Equipment, Service

• When to conduct FMEA: timing and triggers

• FMEA team composition and roles

• Integration with other quality tools: QFD, control plans, DVP&R

FMEA Evolution:

• Traditional FMEA approach

• AIAG 4th Edition standards

• VDA methodology differences

• AIAG-VDA harmonized handbook (2019)

• Key changes and improvements

Afternoon Session: FMEA Process and Structure

Topics Covered:

• Seven-step FMEA process overview

• Step 1: Planning and preparation

• Step 2: Structure analysis (5T approach)

• Step 3: Function analysis

• Step 4: Failure analysis

• Step 5: Risk analysis

• Step 6: Optimization

• Step 7: Results documentation

• FMEA forms and templates

• Living document concept and updates

FMEA Foundation:

• Boundary diagrams and scope definition

• System hierarchy and breakdown

• Interface identification (internal and external)

• Requirements cascade from customer to component

• Traceability and linkages

Workshop:
Understanding FMEA structure using product/process examples from participants’ industries.

Day 2: Design FMEA (DFMEA) Methodology

Morning Session: DFMEA Structure and Function Analysis

Topics Covered:

• Design FMEA fundamentals and objectives

• Product structure breakdown (system, subsystem, component)

• Block diagrams and system boundaries

• Function identification and classification

• Functional requirements definition

• Interface analysis between components

• Design intent and customer requirements

• Parameter diagrams (P-Diagram)

5T Analysis Approach:

• Intent: customer requirements and design objectives

• Item: product structure hierarchy

• Function: what the design must accomplish

• Failure: ways functions can fail

• Task: actions to reduce risk

Afternoon Session: DFMEA Failure and Risk Analysis

Topics Covered:

• Failure mode identification techniques

• Potential failure modes for each function

• Failure effects: local, next level, end user

• Severity rating (1-10 scale): safety, compliance, customer impact

• Potential causes of failure

• Occurrence rating (1-10 scale): frequency and probability

• Current design controls: prevention and detection

• Detection rating (1-10 scale): control effectiveness

• Action Priority (AP) determination

• High/Medium/Low risk classification

Risk Assessment:

• Critical characteristics identification

• Special characteristics designation

• Safety and regulatory requirements

• Relationship between severity, occurrence, detection

Hands-On Exercise:
Conducting DFMEA for automotive component or consumer product.

Day 3: Process FMEA (PFMEA) Methodology

Morning Session: PFMEA Structure and Function Analysis

Topics Covered:

• Process FMEA fundamentals and objectives

• Manufacturing process flow diagrams

• Process structure breakdown (workstation/operation level)

• 4M analysis: Man, Machine, Material, Method

• Process function identification

• Process requirements: specifications, standards, regulations

• Relationship between DFMEA and PFMEA

• Input-Process-Output model

Process Analysis:

• Process boundaries and scope

• Process steps and sequence

• Equipment and tooling requirements

• Operator involvement and skills

• Material specifications and characteristics

Afternoon Session: PFMEA Failure and Risk Analysis

Topics Covered:

• Manufacturing failure modes identification

• Process-specific failure modes vs. design failures

• Failure effects on subsequent operations and customer

• Severity rating for process failures

• Potential causes: equipment malfunction, operator error, material variation

• Occurrence rating based on process capability (Cpk)

• Current process controls: prevention (mistake-proofing, procedures)

• Detection controls: inspection, testing, statistical process control

• Detection rating and control effectiveness

• Action Priority using AIAG-VDA approach

• Critical-to-Quality (CTQ) characteristics

Risk Mitigation:

• Poka-yoke (error-proofing) implementation

• Statistical Process Control (SPC) application

• Inspection and testing strategies

• Preventive maintenance programs

Practical Workshop:
Developing PFMEA for assembly or machining process.

Day 4: FMEA-MSR and Advanced Risk Analysis

Morning Session: FMEA-MSR (Monitoring and System Response)

Topics Covered:

• FMEA-MSR methodology for safety-related failures

• ISO 26262 functional safety integration

• Safety mechanisms and monitoring systems

• Fault detection and diagnostic coverage

• Failure mode classification: Safe Fault, Single Point Fault, Latent Fault

• System response to detected failures

• Severity classification for safety failures

• Controllability assessment

• Automotive Safety Integrity Level (ASIL) determination

Advanced Topics:

• Failure rates and reliability data

• Diagnostic coverage calculation

• Redundancy and fail-safe design

• Hardware and software interactions

Afternoon Session: Action Priority and Optimization

Topics Covered:

• Action Priority (AP) methodology in AIAG-VDA

• AP table usage replacing RPN calculations

• High/Medium/Low priority determination

• Focus on high severity failures first

• Recommended actions development

• Prevention actions vs. detection improvements

• Responsibility assignment and target dates

• Tracking action implementation

• Recalculation after corrective actions

• Validation and verification of actions

Corrective Action Hierarchy:

• Design/process elimination of failure mode

• Design/process modification to reduce occurrence

• Detection improvement through controls

• Documentation and procedure updates

Case Study:
Analyzing high-risk failure modes and developing comprehensive action plans.

Day 5: FMEA Documentation, Integration, and Best Practices

Morning Session: Control Plans and Integration

Topics Covered:

• Control plan development from FMEA

• Linking FMEA outputs to control plans

• Special characteristics transfer

• Process controls specification: methods, frequency, reaction plans

• Control plan types: prototype, pre-launch, production

• FMEA integration with APQP (Advanced Product Quality Planning)

• Design Verification Plan and Report (DVP&R) linkage

• Testing and validation requirements from FMEA

• Measurement System Analysis (MSA) requirements

Quality System Integration:

• IATF 16949 FMEA requirements

• ISO 9001 risk-based thinking

• AS9100 aerospace requirements

• FDA medical device regulations

• FMEA in supplier quality management

Afternoon Session: FMEA Management and Best Practices

Topics Covered:

• FMEA facilitation skills and team leadership

• Cross-functional team management

• Brainstorming techniques for failure identification

• Avoiding common FMEA pitfalls

• FMEA software tools: Relyence, IQS, Byteworx, APIS

• Database management and historical data

• FMEA templates and standardization

• Living FMEA: updates and maintenance triggers

• Lessons learned incorporation

• FMEA metrics and performance indicators

FMEA Success Factors:

• Management support and resources

• Training and competency development

• Timing: early in design/process development

• Honest and thorough risk assessment

• Focus on prevention, not just detection

• Follow-through on corrective actions

• Knowledge capture and reuse

Industry-Specific Applications:

Automotive:

• IATF 16949 compliance requirements

• Customer-specific FMEA requirements (GM, Ford, FCA)

• Warranty reduction programs

Aerospace:

• AS9100 quality requirements

• Flight safety critical analysis

• Reliability predictions

Medical Devices:

• FDA 21 CFR Part 820 design controls

• Risk management per ISO 14971

• Clinical risk assessment

Electronics:

• Component failure modes and mechanisms

• Reliability prediction (MIL-HDBK-217)

• Accelerated life testing

Final Project and Assessment

Comprehensive FMEA Project:
Complete FMEA study including:

• Scope definition and boundary diagram

• Structure analysis and breakdown

• Function identification with requirements

• Failure mode, effects, and causes analysis

• Severity, occurrence, detection ratings

• Action Priority determination

• Recommended actions with assignments

• Follow-up and verification plan

• Control plan linkage

• Professional FMEA documentation

Assessment Activities:

• Written examination on FMEA methodology and standards

• Practical FMEA facilitation exercise

• Rating calibration workshop

• DFMEA or PFMEA completion for real product/process

• Group presentation with peer review

• Action planning and optimization exercise

• Certificate of Professional Training in FMEA

Course Benefits and Learning Outcomes

Participants will understand FMEA principles and standards, conduct Design and Process FMEAs, identify failure modes systematically, assess risks accurately, calculate Action Priority, develop effective corrective actions, create control plans, facilitate FMEA teams, and maintain living FMEA documents.

Training Methodology

Instructor-led sessions with extensive hands-on FMEA workshops, real product/process examples, team facilitation practice, rating calibration exercises, software demonstrations, industry case studies, and project-based learning.

Course Materials

Comprehensive FMEA handbook, AIAG-VDA standards summary, DFMEA and PFMEA templates, rating scales and guidelines, action priority tables, control plan templates, facilitation guides, and professional certificate.

Software and Tools

Introduction to FMEA software platforms (demos), Microsoft Excel FMEA templates, process mapping tools, and collaborative platforms for team FMEAs.

Prerequisites

Basic understanding of product design or manufacturing processes, quality management system knowledge helpful, experience with cross-functional teams beneficial, analytical thinking skills, and no prior FMEA training required.

Keywords: FMEA training, Failure Mode and Effects Analysis, DFMEA Design FMEA, PFMEA Process FMEA, Risk Priority Number RPN, AIAG-VDA FMEA, Action Priority, FMEA methodology, failure analysis, risk assessment, quality engineering, IATF 16949 FMEA, automotive FMEA, FMEA software, preventive action, severity occurrence detection, control plan, APQP, reliability engineering, FMEA facilitation