Course Name
Process FMEA (PFMEA) for Medical Device Manufacturing – Risk Analysis and Preventive Control
Course Overview
Welcome to the Process FMEA (PFMEA) for Medical Device Manufacturing – Risk Analysis and Preventive Control training course by ARG Academy. This training provides participants with a highly practical understanding of Process Failure Modes and Effects Analysis (PFMEA) and its specific application within medical device manufacturing. The program focuses on team-based analysis, data-driven decision-making, and the seamless integration of PFMEA with existing quality systems, such as risk management and process validation.
Course Objective
The primary objective of this course is to train participants to systematically identify potential process failures, assess risks, determine root causes, and implement preventive controls. By the end of this training, participants will be able to:
● Explain the purpose and importance of PFMEA in medical device manufacturing.
● Develop and interpret Process Flow Diagrams (PFD).
● Conduct a structured PFMEA analysis by identifying failure modes, effects, and causes.
● Assess risks using Severity, Occurrence, and Detection ratings, and calculate Risk Priority Numbers (RPN).
● Apply root cause analysis tools, specifically the Fishbone (Ishikawa) diagram and the 5 Why methodology.
● Develop effective control plans and mitigation actions.
Course Benefits
Participating in this training provides significant professional and organizational advantages:
● Improves overall product quality, safety, and regulatory compliance through proactive risk mitigation.
● Equips cross-functional teams to develop effective control plans and link PFMEA results directly to process controls.
● Teaches effective strategies for risk prioritization, ensuring organizational focus is placed on high Severity risks first.
● Provides the knowledge needed to maintain the PFMEA as a “living document” that is continuously updated after changes, incidents, complaints, or audits.
Who Must Attend
This training is designed for professionals involved in risk management or process validation within manufacturing environments. Target participants include:
● Production and Engineering personnel.
● Quality Assurance staff and Process Engineers.
● Supervisors, Line Leaders, and Technicians.
● Continuous Improvement teams.
Note: A basic understanding of manufacturing processes is required. Prior exposure to quality tools or risk management concepts is beneficial but not mandatory.
Methodology
The course is delivered using an engaging, hands-on methodology designed to ensure the practical application of risk management tools:
● Interactive Learning: Utilizes interactive lectures, group discussions, and case studies featuring medical device recall statistics and lessons learned from real-world failures.
● Hands-on Workshops: Participants will complete four core workshops: Process Flow Diagram Development, PFMEA Practical Application (identifying risks and calculating RPN), Fishbone Analysis, and 5 Why Analysis.
● Comprehensive Materials: Attendees are provided with participant slide decks, PFMEA templates and worksheets, sample Process Flow Diagrams, and example control plans.
● Assessment: Course completion is based on active participation in discussions and workshops, the successful completion of group exercises, and demonstrated understanding during peer presentations.
Course Duration
● The training spans 2 Days.
● The standard schedule consists of 14 Hours of training, typically running from 09:00 to 17:00 each day.
HRD Corp Claimable Course
100% HRD Corp Claimable Training
Stop letting your monthly levy sit idle. Upgrade your workforce with our fully approved corporate training programs under the SBL-Khas Scheme.
Why Choose Us?
● No Out-of-Pocket Cash: Fees are deducted directly from your e-TRiS account.
● Certified Trainers: All programs are led by HRD Corp TTT-approved experts.
● Zero Paperwork Hassle: We assist you with the entire grant application process.
● Flexible Programs: Tailored courses in Leadership, Digital Skills, Sales, and Soft Skills.
Secure Your Training Grant Today
Don’t let your training budget go to waste this year. Slots fill up fast! Click the Enquiry button below!
