Failure Mode and Effect Analyses Training for Medical Device Injection Molding Processes

Failure Mode and Effect Analyses Training for Medical Device Injection Molding Processes

What will You Learn:

Gain a clear grasp of Process FMEA (pFMEA) and its role in medical device injection molding with this hands-on course. You’ll navigate ISO 14971 and ISO 24971 standards, master risk analysis with Severity, Occurrence, Detection ratings, and RPN, and integrate pFMEA into validation phases (IQ, OQ, PQ). Through practical case studies, real-world scenarios, and AI tools, you’ll build compliant, audit-ready skills—leaving confident to execute effective pFMEAs independently.

Target Audience

Quality Engineers, Process Engineers, Project Managers, Automation Engineers ready to excel in risk analysis.

Key Learning Objectives:

Understand pFMEA’s purpose and application in medical molding.
Conduct step-by-step risk analysis with practical mitigation strategies.
Integrate pFMEA into validation and maintain audit-ready documentation.
Apply real-world skills using case studies and AI tools.

Course Details

Duration: 1 Day Onsite, 8 Hours.
Format: In-Person, Hands-On, Small Group (Max 12).
Prerequisites: Basic Excel and MS Word knowledge.
Certification Note: Part of the Process Validation Specialist program.

Agenda:

08:30 – 09:00 | Welcome & Introduction
- Course objectives & quick participant intros.
- Overview of the day’s hands-on program.
09:00 – 10:15 | Module 1: pFMEA Essentials
- What is pFMEA and why do we use it?
- Understanding Severity (S), Occurrence (O), Detection (D), and RPN calculations—hands-on intro exercise.
- Industry standards overview (ISO 14971, AIAG-VDA).
- (10:15 – 10:30 | Coffee Break)
10:30 – 12:00 | Module 2: Step-by-Step pFMEA Execution
- Defining the scope, process boundaries, and forming teams.
- Identifying failure modes and causes (interactive group exercise).
- Assigning Severity, Occurrence, Detection ratings, and calculating RPNs—hands-on practice.
- (12:00 – 12:45 | Lunch Break)
12:45 – 14:15 | Module 3: Risk Mitigation & Validation Integration
- Developing actionable mitigation plans (hands-on planning session).
- Linking mitigation actions to validation phases (IQ, OQ, PQ).
- Verifying mitigation effectiveness and updating pFMEA documents—practical walkthrough.
- (14:15 – 14:30 | Afternoon Coffee Break)
14:30 – 16:30 | Module 4: Practical Group Workshop
- Extended hands-on workshop: Participants create a pFMEA on a provided case example (injection molding scenario).
- Group discussion and in-depth feedback session to refine your work.
16:30 – 17:00 | Wrap-up & Q&A
- Key takeaways from hands-on learning, lessons learned, and open questions.
- Course evaluation and feedback

What You’ll Gain

Confidently execute a pFMEA process from scope to mitigation for medical molding.
Apply Severity, Occurrence, Detection ratings, and RPN to prioritize risks hands-on.
Link pFMEA to validation phases (IQ, OQ, PQ) with practical know-how.
Build audit-ready documentation using real-world injection molding scenarios.

Join the course

Max 12 participants—ideally multidisciplinary for a richer learning experience
Price: €1,800
Scheduling: On Request – Contact Us to Book

Explore More Training Courses

Process Validation for Injection Molded Medical Devices – Expert

Take your validation skills to the next level with advanced techniques and strategies.

Medical Device Process Validation Effective Protocol Writing

Master the art of crafting detailed validation protocols that stand up to scrutiny.