Course Description
FMEAs were first established in the late 1940’s by the United States military to reduce sources of variation and corresponding potential of failures in the production of munitions – and it proved a highly effective tool. The use of FMEAs spread across industries and around the world over the next 70 years and they have become a cornerstone of quality and productivity improvement.
Today, FMEA is commonly used when a process, product, or service is being designed or redesigned, after quality function deployment (QFD), or when an existing process, product, or service is being applied in a new way.
Failure Mode and Effects Analysis (FMEA) is a powerful technique for avoiding process problems and preventing defects in products and services. The use of FMEA helps to anticipate and guide action to prevent failures in both design and process performance. Ideally, organizations should begin using FMEA during the earliest conceptual design stages of a process or product, and then through the design or redesign process. FMEA can also be used effectively before developing control plans for a new or modified process, and for control before and during ongoing processes.
In this intensive two-day workshop, you will learn to estimate the probability of failures and their causes in your product and process. Each participant will have the opportunity to develop all the elements of a Design and Process FMEA, including use of robustness tools, Process Flow Charts and Control Plans. All activities will include industry-specific examples and terminology.
Benefits of FMEA
The following are benefits realized and reported by companies following the effective application and Design and Process FMEA:
- Addresses critical failure modes early in the design cycle
- Makes verification and validation plans more robust
- Fewer ECOs (engineering change orders)
- Faster time to market by reducing product development cycle time
- Reduced scrap and rework
- Fewer customer complaints
- Reduced warranty failures and costs
- Increased productivity
- Increased market share
- Reduction of product recalls
Who Should Attend
This course is designed for engineers and managers from R&D, design, manufacturing, materials, safety, environmental, and quality. Marketing, maintenance, and field service personnel will also benefit from this training. Participants are encouraged to bring their own designs and process maps to get the most out of the hands-on workshops and applications.
Learning Objectives
Through training, participants will learn to:
- Perform Product and Process FMEAs
- Link FMEA to Product Development Process and Advanced Product Quality Planning (APQP)
- Define risk and determine levels of risk requiring mitigation
- Set up an effective Cross Functional Team (CFT) required for FMEA Development
- Efficiently select Severity, Occurrence and Detection rankings
- Implement a Risk Priority Number (RPN) reduction process
- Determine design and process special characteristics
- Understand and demonstrate the links between Design FMEA and Process FMEA
- Create and manage action plans derived from FMEA
- Understand links between FMEA and problem-solving methods, such as:
- Eight Disciplines of Problem Solving (8D)
- 5 Why
- Root Cause Analysis (RCA)
- Plan Do Check Act (PDCA)
- Define, Measure, Analyze, Improve, and Control (DMAIC)
- Understand links to Control Plan Methodology
Course Outline
FMEA Process Overview
- Introductions and course objectives
- The history and purpose of FMEA
FMEA Methodology
- FMEA in Product Development Process
- System / subsystem / component FMEA
- Team structure and rules for efficiency
FMEA Linkage and Collaboration
- The link between Design and Process FMEA
- Special Characteristics (Critical and Significant)
- Special Characteristics as inputs to PFMEA
- What is Risk?
- Criticality (Severity X Occurrence)
- Risk Priority Number (RPN) and its use
- When to act and develop action plans
Practical application of the Design FMEA technique
- Interface analysis / Boundary Diagram
- Parameter Diagram
FMEA Analysis – The Critical Paths
- Path 1
- Item / Functions Requirements / Failure Modes / Effects of Failure / Severity
- Severity ranking guidelines reviewed with best practices
- Actions for High Severity (9 / 10)
- Path 2
- Causes / Prevention Controls / Occurrence
- Occurrence ranking Guidelines with Best Practices
- Actions to eliminate and/or reduce cause probability
- Special Characteristics definition (Key Dimensions / Features)
- Error Proofing and Mistake Proofing (Poke Yoke)
- Path 3
- Test and verification methods
- Detection ranking guidelines
- Actions to improve tests and verification techniques
- RPN reduction
Practical Application of PFMEA
Control Plan Relationships
- Pre-Launch Control Plan
- Production Control Plan
Managing FMEAs
- Family or Baseline FMEA / Legacy
- FMEA and 8D/RCA Relationship
Prerequisites
None
Course Format
16 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
Process FMEA Worksheet
Design FMEA Worksheet
Course instructors
Angelo Scangas – President and CEO
James F. Leonard – Senior Consultant, Process Improvement and Statistical Methods
Laura Halleck – Senior Consultant, Quality Systems Auditing (Automotive, Aerospace)
Ed McFayden – Consultant, Quality Systems, Lean Six Sigma, Auditing
Saleha Yusof-Mullenix – Consultant, Lean Six Sigma
8:30am-4:30pm (EST) each day
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