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Failure Mode and Effect Analysis (FMEA) – 4th Edition-IATF 16949 requirements

Course outline

2 days
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Duration

2 days

Overview

A Workshop that focus on the Design and Process Risk analysis. The workshop helps the participants to perform the proper procedures on Risk Analysis on any products or processes. Both Corrective and Preventive Actions should be implemented if there are high risk factors or area. It also exploits and disseminates the appropriate and proper tools for Process control Plan and documentation. A general procedure for performing and documenting the FMEA process will be given. The roles and responsibility of various functional groups will be deliberated during the session and established for future references.

Target Audience

All Personnel involve in R & D, Quality, Production and also those in Marketing and Sales.

Objectives

This session enable the participants to :

  • Understand the appropriate Procedures to perform Risk Analysis for a Process or Design.
  • Construct the effective FMEA table.
  • Document the FMEA process and transfer relevant actions to the appropriate Control Plan for Manufacturing.
  • Manage and facilitate cross functional groups in performing FMEA Analysis.
  • Know and appreciate the importance of setting Right Control plan in ensuring product quality and process Capability.
  • Ensure Product and Process quality in Proactive Manner.

Contents

A. General Introduction.

  • 1. The Worldwide Effort of Re-engineering.
  • 2. Global Competition in Business Development.
  • 3. Customer's Requirement, Audit and Quality Improvement.
  • 4. The Quality and Reliability Aspects of Products.
  • 5. Basic Definition of Risks Associated with a Product, Design and Process.
  • 6. Tools for Assessing and Remedying Risks.
  • Fault Tree Analysis.
  • Redundancy Circuit or Flow.
  • FMEA Studies.

B. FMEA Methodology.

  • 1. Development of FMEA.
  • History of FMEA.
  • Requirements of FMEA in today’s quality systems such as TS16949 etc.
  • Gap analysis for FMEA 3rd edition and current 4th edition.
  • 2. Different Types of Approach in Managing a Process.
  • Reactive Methods -- Fire Fighting
  • Proactive Approach.
  • Corrective and Preventive Actions.
  • 3. Risk Analysis of a Process/Design.
  • Critical Failures. -- Assignment of Rating and Examples.
  • Major Failures. -- Assignment of Rating and Examples.
  • Minor Failures. -- Assignment of Rating and Examples.
  • 4. Process Flow Charts.
  • Use of Appropriate Symbols.
  • Construction of Process Flow Charts. (Exercises)
  • 5. Design and Process FMEA.
  • The Differences.
  • Examples of Design and Process FMEAs.
  • FMEA Meetings -- Who, When, How, Why and What needed to exist.
  • Fault Tree Analysis. (FTA) -- Application to determine the various route of failures.

C. Tools that can be applied while doing FMEA Studies.

  • Identifying Root Causes.
  • Problem Solving Techniques.
  • Analyzing and Writing Operating/Manufacturing Procedures.
  • Poka Yoke (Mistake Proof) Methods.

D. Design FMEAs.

  • The Arts of identifying Failure Modes.
  • Risks on Failures of Products.
  • Measures of Severity, Frequency and Detection .
  • Interaction Effects.
  • Design Controls.
  • Examples and Workshop on Design Analysis based on your company's product application and customer's requirement.
  • Roles and Responsibilities of every members in Design FMEAs.
  • Exercises.

E. Process FMEAs.

  • 1. Identifying process failure modes.
  • 2. Assigning Severity, Frequency and Detection Ratings.
  • 3. Process Control Guidelines.
  • 4. Developing Corrective and Preventive actions.
  • Definition of Corrective and Preventive Actions.
  • Developing effective Corrective and Preventive Actions.
  • Tools applicable during development of Corrective and Preventive Actions.
  • Correct method to write Corrective and Preventive Actions in Process FMEAs.
  • 5. Examples on Process FMEAs.
  • 6. Workshop on Real Life Process FMEA Applications.

F. Transferring FMEA results to Control Plan or Design Standards.

  • 1. Example of control plans and Design Standards.
  • 2. Regular Audit Procedures.
  • 3. Exercise and workshop.

G. Linkage between FMEA and QFD.

  • 1. What is QFD?
  • 2. When, Where, Who, How, What and Why of QFD.
  • 3. General Examples.

H. General Discussion.

  • 1. Composition of FMEA Team & Members' roles and responsibility.
  • 2. Managing Team and Maintaining Team morale.
  • 3. Current TS16949 requirements for FMEA usage.
  • 4. General Discussion.

Course Methodology

The course will be conducted in the form of Workshop, Lectures, Case studies, Practically design the FMEA for participant's application and examples.

Programme scope, delivery arrangements and suitability are confirmed during enquiry.