Understanding and Implementing Process FMEA and Control Plans - 4th Edition

This course is designed to establish the use of 4th Edition Process FMEAs and to help you learn the skills needed to practice risk reduction and defect prevention.

The course covers the linkage between Process Flows, Process FMEAs, Control Plans, and the relation with APQP. This course also provides insight and hands-on experience with how to develop and implement Control Plans for your manufacturing processes.

Course Details

Length

2 Days


Prerequisites

Participants should have experience working in quality assurance


Recommended

Some experience in ISO-based quality management systems is recommended

Learning Objectives

  • Explain the benefits and general framework of FMEA as a risk analysis tool
  • Relate Process FMEAs to APQP and IATF 16949:2016
  • Define FMEA customers
  • Identify functions, potential failure modes and effects
  • Determine potential causes
  • Identify current prevention and detection process controls
  • Identify improvement opportunities to reduce the risk of failure
  • Utilize information gathered from performing an FMEA and construct a Control Plan
  • Connect the Process Flow, Process FMEAs, Control Plans and Work Instructions
  • Relate Control Plans and risk-based thinking
  • Describe the type of information that should be entered in each control plan column
  • Use the dominant factor analysis of each manufacturing process to determine the most appropriate process control methodology
  • Ensure Control Plans consistency with other quality planning methodologies
  • Review and update Control Plans as living documents
  • Develop Control Plans for your manufacturing processes

Who Should Attend

Recommended for Development Coordinators, APQP Team Members, Process Engineers, Quality Professionals, PPAP Coordinators, Project Managers, and other manufacturing roles related to quality assurance.

Agenda

Day 1

  • Process Flow Charts
  • Product and Process Characteristics
  • Special Characteristics
  • Developing and Implementing Process FMEAs
    • Failure Modes
    • Effects
    • Occurrence
    • Detection
    • Process Controls
    • Risk
    • Managing Improvement Actions – Actions to reduce Severity, Occurrence and Detection ratings in the PFMEA
  • Process FMEAs and Control Plan Linkages
  • Integrating APQP Quality Plans: Process Flow, Process FMEAs, Control Plans and Work Instructions
  • Process FMEA Application

Day 2

  • Control Plan Foundations: Y=F(X) and Cause-Effect Diagram
  • Developing and Implementing Control Plans
    • Process step description
    • Product and Process characteristics description
    • Special characteristic symbol
    • Control method: specification tolerance, measurement technique, sampling determination, control methods
    • Reaction plan development
  • Control Plan linkages
  • Control Plan robustness based on most common sources of variation or the dominant factors in determining the quality of the product
  • Key points for Control Plan review – Control Plans as living documents
  • Control Plan Application