Process FMEA –Risk Management
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Upon completion of this program, participants will be able to:
- Understand the need to perform Process FMEA.
- Understand the concept & benefits of doing Process FMEA.
- Understand the 12 Basic Steps in performing Process FMEA.
- To identify and prevent potential problems from occurring in a product, service or process design.
- Make a necessary risk assessment and decision of the process based on the outputs from the Process FMEA in order to mitigate or avoid process risks.
- Ultimately, select solutions that will permanently eliminate potential process defect(s) or problem(s).
FMEA (Failure Mode and Effects Analysis) and Control Plan are proactive tools, techniques and quality methods that enable the identification and prevention and monitoring of process or product errors before they occur. The main goal is to avoid adverse events that could potentially cause harm to human, equipment and product.
FMEA can help identify and eliminate concerns early in the development of a process. It is a systematic way to examine a process prospectively for possible ways in which failure can occur, and then to redesign the processes to eliminate the possibility of failure. Properly executed, FMEA can assist in improving overall satisfaction and safety levels.
This program will cover how to do a process map to properly document the process and use this information to identify how the process can fail. It will also cover the skills needed to do the scoring for these potential problems so they can be prioritized and that actions can be taken in the high risk areas.
This program is focusing on people who are involved in New Product Introduction, Manufacturing, Services, Quality, Component Technology, Supplier Quality, and various other sourcing roles.
The program content & concepts are explained using every day analogies and real world examples. The learner will get hands-on experience with a fun game and step-by-step examples in workshop environment.
- What Is FMEA?
- Origin & History Of FMEA
- Why FMEA?
- Why FMEA?
- Benefits Of Using Systematic FMEA Methodology
- What Isn’t FMEA
- FMEA Vs. FA
- Types Of FMEA
- QFD & FMEA & Control Plan
- Manufacturing Quality System
- When Is A FMEA Started?
- Forming A Team
- Roles Of A Team Leader
- Typical Meeting Schedule
- Identifying The FMEA Scope
- Process Mapping Methods
- Top Down Chart
- Class Exercise #1: Create A Top Down Chart
- SIPOC Chart
- Class Exercise #2: Create A SIPOC Diagram
- Class Exercise #3: Create A P-Diagram
- Failure Modes: 6 Major Categories
- Top Down Chart
- FMEA 12 Steps Process
- What Is Functionality?
- Severity Ranking
- Relationship Between Failure Modes, Causes
- Class Exercise #4: Create A 5 Why’s On A Common Failure
- Cause & Effect Diagram
- Class Exercise #5: Initiating FMEA –Failure Modes, Effects & Severity Rating
- Occurrence Rating
- Current Controls
- Detection Rating
- Special Characteristic Matrix
- Identify Quick Wins
- Robustness Rating
- Mistake Proofing
- Class Exercise #6: Final Exercise - Complete The FMEA Template
- Process FMEA’S Potential Road Blocks
- FMEA Signoff
- FMEA Updates
- Checklist For Quality FMEA
- Keys To A Successful FMEA Process
- Summary Of Process FMEA
- What Is A Control Plan?
- How Control Plans Support Quality
- Steps To Develop And Maintain A Control Plan