Failure Mode Effective Analysis

QMS Webinar Series: Failure Mode Effective Analysis

Speaker: Abdul Khalfan CQE, SSGB

Principal, Quality Assurance & Reliability Engineering Consulting Services

Failure Mode Effective Analysis

Failure Mode Effective Analysis better known as FMEA. It is an effective tool to provide decision making information to a Team of design, manufacturing, industrial, test, service, quality, and sustaining engineers, supply chain, maintenance personnel, program managers, management, and stakeholders at large to make value-added and pragmatic decisions to address chronic issues and ideas of improvements regarding their products/devices and services based upon objectiveness and not subjectiveness.

The concept of designing FMEA as a tool to address chronic and safety issues initiated in the 1960’s by the Aerospace industry during the Apollo missions, in the 1970’s by US Navy and Automotive industries.

There are four types of FMEA: i) System FMEA, ii) Design FMEA, iii) Process FMEA, and iv) Service FMEA.

The output of FMEA is based upon a ‘Risk Priority Number’ whose acronym is ‘RPN’. ‘RPN’ is calculated by taking into consideration the problem / issue at hand of its Severity multiplied by Occurrence multiplied by Detection or mathematically RPN = Severity X Occurrence X Detection. Typically, higher the ‘RPN’ number, higher the priority to address the issue at hand. However, this may or may not be applicable in each and every case as business decisions need to taken into account also.

The salient feature of FMEA is that it can be put into effect or practiced at any given point in time within the Product Life Cycle (PLC). It is or can be used to address problems/issues and improvement ideas for reliability, availability, serviceability, installability, and cost improvement.

About Abdul Khalfan:

Abdul Khalfan is a Quality Management Systems Professional (QMS) with extensive experience in the high-tech industry. His hands-on style and practical approach to business management makes him a natural catalyst for improvement initiatives. His unique career path and ground up experience has provided him with business and process insights leading to greater profitability, value-add, and efficacy for small, medium, and large companies and organizations such as NCR Corporation, Flextronics, Ingenico, Com Dev, Teledyne-Dalsa, ITT, Bell-Howell, KA Imaging, Curriato Inc., Schock Metal America Inc., Durose Steel, Honda Automotive, Kaparel, to name a few. Currently, he is providing Consulting Services for ISO 9001:2015 and ISO 13485:2016 Standards to Medical Device and non-medical companies in Kitchener-Waterloo area.
Abdul Khalfan consistently focused upon underperforming processes and products to higher levels of excellence and profitability. Using careful statistical analysis and a keen eye for value-add and process improvements he has been able to transform unproductive, wasteful practices into effective and value added process improvements.
Additionally, Abdul Khalfan, has established from ground zero the entire infra structure of QMS resulting in ISO 9001 Certification in the first audit; managed continuous improvement projects which in one case improved the ‘Early Life Performance’ of products by 47% resulting in savings of millions of dollars, significantly reduced the number of process steps and data consolidating North American data in one database saving 10 man days of work and savings of US$ 100,000 annually. Similarly, significantly streamlined and formalized haphazard and broken Engineering Change Request and Engineering Change Notice processes in a formal consolidated and automated process, thereby realizing its effectiveness, efficiency, reduced number of errors, timely execution, and cost savings.

Abdul Khalfan is an ASQ Certified Quality Engineer (CQE), SSGB, an Exemplar Global Certified Lead Auditor for ISO 9001:2015 and ISO 13485:2016 Standards, Certified Process Management and Improvement Trainer, holds Advanced Quality Assurance Diploma with an Electrical Engineering background.

He has been a frequent guest speaker at ASQ Meetings on Quality and Reliability subjects, part time instructor at Conestoga College on the subject of Total Quality Management (TQM), and is currently delivering Quality and Reliability workshops for UW CBB (Centre for Bio-Engineering and Biotechnology).

Abdul’s Consulting Services website address: www.qareconsulting.com.

Please contact cbb@uwaterloo.ca for the meeting link