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ASQ Philadelphia – Failure Mode and Effects Analysis “FMEA”, ES 211-1 (Thursdays Apr 6 & 13)

April 6 @ 5:30 pm - April 13 @ 9:00 pm

Free - $575.00

ASQ Philadelphia – Failure Mode and Effects Analysis “FMEA”,   ES 211-1.

This course meets on two consecutive Thursdays, April 6 and April 13.

Instructor: Ray Lotfi, BS in ME, and MS Engineering Management

ASQ RU:  0.6         Prerequisite: None 

Proposed Benefits:

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. 

Class Details

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 InstructorRay Lotfi: raylotfi@gmail.net

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.

Payment Options:

PayPal: Follow instructions on Registration page

Pay by Check: Make payable to ASQ Philadelphia Section 0505

Mail to:            ASQ Section 0505, Treasurer

c/o Dr. Chris Connors

811 Williansburg Blvd

Downingtown, PA 19335                                  

Pay by Invoice: Send P.O. to Section Treasurer, Chriss Connors, chrisconnors811@gmail.com. Provide name of contact person to receive Section’s invoice.


Class information & Emergency Contact: – Ray Lotfi, (610) 308 8495


Credit Card/Check/Invoice payments: – Section Treasurer, Chriss Connors , (610) 864-8637, chrisconnors811@gmail.com

General information

   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.


If interested, contact the Ray Lotfi, at (610) 308 8495 raylotfi@gmail.com.


April 6 @ 5:30 pm
April 13 @ 9:00 pm
Free - $575.00
Event Category:


Philadelphia Section – American Society for Quality


Montgomery County Community College
340 Dekalb Pike
Blue Bell, PA 19422
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