ASQ Failure Mode and Effects Analysis (FMEA) (ES 211-1)
March 22 @ 8:30 am - 4:30 pm
Instructor: Ray Lotfi, BS in ME, and MS Engineering Management
ASQ RU: 0.8 Prerequisite: None
Risk management (FMEA) is one of the most important components of design, validation, and verification of any product. It starts from concept and ends after product commercialization. Therefore any professional involved in this area will benefit from the knowledge learned.
Professionals attending the course will learn the general FMEA concept and apply to their product in the class.
The ROI for a company is that FMEA is a required body of knowledge in order to comply with ISO 13485:2003 used in the medical device and pharmaceutical industries. It is also part of the ISO 9001 and other international quality standards. A successful FMEA action, once completed, will improve quality; reduce cost, increase safety, and increase confidence in your product or service.
The classroom techniques will include lecture, individual participation, group problem discussion, case studies, and quizzes to test understanding where applicable. Detail FMEA models will presented for discussion and training.
In an instructor-led class, any individual’s weaknesses of the subject matter are worked-on as a group so as to explain, clarify and fix the weakness. In addition, a classroom-based class provides the camaraderie, collaboration, and connections with others in the field of Quality that may provide support and assistance in many other ways.
The class materials are text book, handout, and models of FMEA.
Topics to be covered:
- Definitions and information
- History, development, and correlation with ISO
- Definition, specification and method of generating FMEA
- Relation of FMEA and risk management
- Roll of statistics and probability in FMEA processes
- Including past company data
- Team building and development
- FMEA champion or leader
- Participant from all departmental representing the product or process
- Examples Development
- Discussion and best course of action
- Design FMEA
- Process FMEA
- Other custom application FMEA
- Areas of connection to other Quality/Engineering discipline
- Utilization of other products/processes
- FMEA as a dynamic tool
- FMEA and CAPA – a great place for auditors
- Key success of FMEA (team playing)
About the Instructor – Ray Lotfi: firstname.lastname@example.org
Ray Lotfi is an independent consultant with over 20 years of operation experience with expertise in medical device and consumer product industries on Quality, Regulatory, R&D, Logistic, and Manufacturing issues.
Ray has been the project leader on multiple projects, chaired FMEA teams and served on CAPA panels. He has authored Quality System Manuals, Standard Operation Procedures, and Manufacturing Operation Procedures. He has led commissioning projects -Installation, Operation, and Performance Qualification – for medical devices in aseptic environments.
Ray has Master of Science in Engineering Management for the Milwaukee School of Engineering and Bachelor of Science in Mechanical Engineering from the University of Wisconsin
Attendance, Registration, Refund, and Payment Details:
Textbooks and reference materials are included in the course fee unless otherwise indicated. Some courses use instructor supplied material and these are included in the fee.
Section reserves the right to cancel the course if the minimum enrollment is not met.
Substitutions after Registration are permitted. Inform Education Chairperson and/or Section Treasurer to ensure accurate attendance records.
Email from Eventbrite.com addressed to you will be used for important course information. Please open immediately and take appropriate action.
Refunds provided if class is not held.
Payment for the course is due by the first class session unless prior arrangements are made with the Section Education Chair or Section Treasurer.
PayPal: Follow instructions on Registration page
Pay by Check: Make payable to ASQ Philadelphia Section 0505
Mail to: ASQ Section 0505, Treasurer
ASQ Philadelphia Section 0505 Treasurer
c/o Stewart Roseman
1217 Hartranft Ave, Fort Washington, PA 19403.
Pay by invoice: Send P.O. to Section Treasurer, Stewart Roseman email@example.com. Provide name of contact person to receive Sections’s invoice.
Credit Card/Check/Invoice payments firstname.lastname@example.org
Class information and Emergency Contact: – Ray Lotfi, (610) 308 8495
If the course is held during the day, except where noted, lunch and morning and afternoon breaks are included in the fee. Emergency cancellation notification is to the mobile phone number you provided at registration.
FYI: This course can be held at your company with a minimum of 6 or 8 attendees at a reduction from the classroom based fee. Except for the Certification Exam Preparation courses, this course can be customized to subjects and issues at your company.
The company must take care of breaks and lunch and a suitable training area and projection equipment. The course curriculum, time and date are negotiated directly with the instructor. A proposal will be submitted based on the understanding of your requirements.