FMEA 4th Edition – Risk Assessment w/Control Plan-Core Tools - Omnex Europe

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FMEA 4th Edition – Risk Assessment w/Control Plan

FMEA 4th Edition – Risk Assessment w/Control Plan



  • Program Managers
  • Product Mangers
  • Quality Managers 
  • Project Managers
  • Design Engineers
  • APQP Team Members
  • Development Coordinators
  • Process Engineers
  • Quality Professionals
  • PPAP Coordinators


Participants should possess a working knowledge of quality systems and methodologies, and have some experience in ISO-based quality management systems.


content icon  SEMINAR CONTENT

This first day overview addresses the use of Design Failure Mode and Effects Analysis and Design Verification Planning in new product to ensure a successful launch of new products/processes and capable serial production.

This second day overview offers insight into, and hands-on experience with, the linkages between various aspects of the APQP process. Specifically, the development and linkage of Process Flows, PFMEAs and Control Plans are addressed. It shows how Process Flows, PFMEAs, Control Plans and shop floor documentation can be used to achieve process standardization and improvement.

The approaches discussed and employed in this course are consistent with the intent and guidelines in the APQP 2nd Edition, FMEA 4th Edition, and PPAP 4th Edition manuals issued by GM, Ford and FCA through the AIAG



After this training, the participants will have knowledge and understanding of:

tick How to develop and use DFMEA and DVP&R to identify and address design risk during the product development process and in support of the manufacturing process development process

tick Process Flow

tick Links between Process Flow, PFMEA, Control Plan and Work Instructions

tick The FMEA as analytical process

tick Process FMEA and Control Plan


outline icon SEMINAR OUTLINE

Day 1

  • APQP Phases: Key Phase Deliverables (Outputs)
  • DFMEA Introduction
      - DFMEA Purpose
      - DFMEA Objectives
      - New Products
      - Linkages
  • DFMEA Preparation
      - Define the Customer
      - Identify Specific Functions and Requirements
      - Robust Designs
      - Breakout Exercise 1: Boundary (Block) Diagram
      - Breakout Exercise 2: Parameter (P) Diagram
      - Other Inputs to DFMEA
  • Developing the DFMEA
      - Starting the DFMEA Form
      - Design Failure Modes
      - Potential Design Causes
      - Potential Controls & Prevention
      - Potential Effect & Severity
      - Action Planning
      - Evaluating and Maintaining DFMEAs
      - Breakout Exercises 3-8: Developing the DFMEA
  • Design Verification Plan & Report (DVP&R)
      - Objectives of DVP&R
      - DVP Format & Flow
      - Management Responsibility for DVP
      - Challenges to Development

 DAY 2

  • APQP and PFMEA Introduction
      - APQP Phases
      - PFMEA Defined
      - PFMEA as a Living Document
  • APQP Inputs to PFMEA and Process Flow Diagram
      - Phase II Inputs/Deliverables
      - Phase III Deliverables
      - Process Flow Diagram
      - Breakout Exercise 1: Developing a Process Flow Diagram
      - Print Preparation
      - Special Characteristics
      - Phase III Inputs/Deliverables
      - PFMEA Analytical Sequence
  • Developing a Process FMEA
      - Preparing the PFMEA
      - Failure Mode and Effects
      - Controls Prevent / Detect
      - Risk Priority Number
      - Classification Column
      - Breakout Exercises 3-5: Developing a PFMEA
  • Developing a Control Plan
      - What is a Control Plan?
      - Control Plan Header Information
      - Control Plan Fields
      - Breakout Exercise 6: Creating a Control Plan


Each participant will receive a seminar manual, including a complete package of problem solving worksheets and checklists for each step of the process, as well as all team exercise materials.


CONTACT US: +49 30 61285700

Event Properties

Event Date 04-06-2019 9:00 am
Event End Date 05-06-2019 5:00 pm
Capacity 15
Individual Price €800.00
Location Albrechtstrasse 58, 12103 Berlin, Germany
We are no longer accepting registration for this event

All OMNEX open courses are delivered in english language

Training Series (english)

Harmonized AIAG - VDA D-FMEA, P-FMEA

For agile APQP teams looking for a flawless launch and PPAP


Here you find our IATF 16949:2016 Series Courses

Here you find our NEW ISO 26262:2018 Series Courses

Here you find our Problem Solving Series Courses

Here you find our ISO/IEC 27001:2013 Series Courses

Here you find our ISO 9001:2015 Series Courses

Here you find our IMS (ISO 9001 and/or IATF 16949, ISO 14001 and ISO 45001) Series Courses

Here you find our ISO/IEC 17025:2017 Series Courses

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