Understanding and Implementing Process FMEA and Control Plans

Course Outline

Module 1: Introduction to Risk Management in Manufacturing

• Importance of risk management
• Overview of FMEA and Control Plans in Quality Management Systems (IATF 16949, ISO 9001)
• Link between FMEA, Control Plans, and Continuous Improvement

Module 2: Fundamentals of Process Failure Mode and Effects Analysis (PFMEA)

• Definition and Purpose of PFMEA
• Key Terminology: Failure Modes, Effects, Causes, Severity, Occurrence, and Detection
• The Role of PFMEA in Process Design and Quality Control
• Differences Between Design FMEA (DFMEA) and Process FMEA (PFMEA)

Module 3: Step-by-Step PFMEA Implementation

• Team Composition and Cross-functional Collaboration
• Identifying Process Steps and Potential Failure Modes
• Assigning Severity, Occurrence, and Detection Ratings
• Calculating Risk Priority Number (RPN) and Action Prioritization
• Recommended Actions and Risk Mitigation Strategies
• Reassessing and Updating the PFMEA

Module 4: Understanding Control Plans

• Purpose and Types of Control Plans (Prototype, Pre-launch, and Production)
• Key Elements of a Control Plan
• Linking PFMEA with the Control Plan
• Developing a Control Plan Based on PFMEA Findings

Module 5: Implementing and Sustaining PFMEA and Control Plans

• Integration into the Production Process
• Monitoring and Updating the PFMEA and Control Plan
• Auditing and Continuous Improvement
• Case Studies and Best Practices

Module 6: Practical Workshop and Case Studies

• Hands-on PFMEA Development
• Creating a Control Plan from PFMEA Data
• Group Exercises and Real-world Scenarios
• Troubleshooting Common Pitfalls

Course Objectives

By the end of the course, participants will:

1. Understand the principles and purpose of Process FMEA and Control Plans.
2. Learn how to systematically analyze process risks using PFMEA.
3. Develop effective Control Plans to mitigate risks and improve quality.
4. Gain practical experience in implementing and maintaining these tools.
5. Enhance their ability to integrate risk management into daily operations.

Learning Outcomes

Participants will be able to:

• Identify and assess potential failure modes in a manufacturing process.
• Assign and interpret severity, occurrence, and detection rankings.
• Develop and update a PFMEA document.
• Create and implement a Control Plan based on PFMEA findings.
• Utilize PFMEA and Control Plans to drive continuous improvement and defect prevention.

Training Methodology

The course will use a combination of:

• Interactive Lectures – Concept explanations with real-world examples.
• Case Studies – Analysis of industry-specific scenarios.
• Workshops & Hands-on Exercises – Participants develop PFMEAs and Control Plans in teams.
• Group Discussions – Peer learning and brainstorming sessions.
• Q&A Sessions – Addressing specific participant challenges.
• Assessment & Feedback – Knowledge checks and personalized feedback.