webinar

Failure Mode Effective Analysis

Aiju Chau — Mon, 19 Apr 2021 14:39:59 +0000

Failure Mode Effective Analysis Aiju Chau Mon, 04/19/2021 - 10:39

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-��ݮ��Ƶ 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

CBB presents: System Level Test and Maturity Grid Risk Management with Abdul Khalfan

Carly Turnbull — Fri, 26 Mar 2021 17:30:01 +0000

CBB presents: System Level Test and Maturity Grid Risk Management with Abdul Khalfan Carly Turnbull Fri, 03/26/2021 - 13:30

QMS Webinar Series: System Level Test and Maturity Grid Risk Management

Speaker: Abdul Khalfan CQE, SSGB

Principal, Quality Assurance & Reliability Engineering Consulting Services

System Level Test – Product Qualification (also is categorized as Product Validation) Test Process

System Level Test is based upon ‘Process Management Methodology’ for establishing and maintaining Reliability and the integrity of a product from the Prototype phase to the end of its development cycle, i.e., ‘Product Qualification’.

System Level Test approach creates a focus on the relationships between internal and simulated external customer environment and suppliers and identifies the attributes of all required information, data, and data analysis for development and manufacture of reliable products.

The synopsis being, qualifying or validating a reliable new product to the market on time, meeting internal and external customers requirements as per the ‘Product Requirement Document (PRD)’ and Technical Specifications. Thereby, the company/organization benefits from its well-deserved reputation, customer satisfaction, and profitability!

Introduction to Product Quality Management Maturity Grid (PQMMG) – Risk Management Tool

PQMMG is a Risk Management Tool that realistically captures, records, and becomes a catalyst for mitigation of the actual Failures. Failures that occur throughout the Product Qualification process stages of Prototype, Design Verification, New Product Introduction (NPI), Manufacturing Process, Product Qualification (includes hardware, software, manufacturing, supply chain, service, packaging, and transportation).

PQMMG concept of ‘Risk Level’ is one of many tools that is available to assess the risk realistically that is involved during the Product Development transition stages. Experience has shown repeatedly that it keeps risk levels into perspective leaving no ambiguities during and after the Product Qualification process.

The salient feature of PQMMG is that the Risks which negatively impact the Reliability, Availability, Serviceability, Usability, and Install-ability (RASUI) are identified and agreed upon by the entire Development and Management Teams for their resolutions.

In conclusion, the ‘Product Quality Management Maturity Grid (PQMMG)’ is a conduit to minimize and mitigate the Product Risks at all levels depicted from the test results during its development stages to conform to the Product Requirements and Technical Specifications in a realistic manner. This will ultimately result in customer satisfaction!

About Abdul Khalfan:

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

Please contact cbb@uwaterloo.ca for the meeting link

CBB presents: Quality Management Systems Webinar Series - Product Life Cycle with Abdul Khalfan

Charlotte Armstrong — Fri, 23 Oct 2020 14:52:26 +0000

CBB presents: Quality Management Systems Webinar Series - Product Life Cycle with Abdul Khalfan Charlotte Armstrong Fri, 10/23/2020 - 10:52

QMS Webinar Series: Product Life Cycle (PLC)

Speaker: Abdul Khalfan CQE, SSGB

Principal, Quality Assurance & Reliability Engineering Consulting Services

Product Life Cycle (PLC) refers to sequential phases from product planning to end of life. Generally, it comprises of six main stages, they are: i) Product Planning, ii) Design and Development, iii) Verification and Validation, iv) Production, v) Product Release/Field Follow/Sustaining Engineering and vi) End of Life of the Product.

i) Product Planning Phase – Product Planning is to identify customer needs, analyze business trends, and market competition, and develop product proposals. The document which describes and details this phase is known as Marketing Requirement Document (MRD).
ii) Design and Development Phase – This phase usually begins with preparation of detailed product requirements. These detailed requirements are documented and defined in a Product Requirement Document (PRD). Based upon the PRD, Technical Specifications are developed to conform to the Product Requirements as defined in the PRD and that truncates upwards to the MRD.
iii) Verification and Validation Phase – This phase consists of two major steps: Design Verification (DV) and Design Validation, also known as (DV). Once the design is completed, there is a design verification process which is paper based, i.e., Engineers and Technical Teams from cross-functional departments provide their input. If there is a consensus that the Design meets the Product Requirements as defined, a small no. of units are built for DV testing. These units are known as Prototypes.
Based upon the successful results of the Prototype units the Design Validation process commences. In this phase a statistical sample size of units are selected and extensively tested in accordance with the product requirements to ensure that the product will comply with the Reliability, Availability, Serviceability, Useability, and Installability better known as RASUI concepts. The intent is to provide a minimum of 80% statistical confidence level that the product is built right, i.e., as per its defined requirements.
iv) Production Phase – In this phase the Manufacturing process must be validated for Production readiness or Mass Production (MP).
v) Product Release Phase – Once the product has been validated for its design and manufacturing processes, and the product is officially released for the market place for sales and service sustaining Engineering or Current Engineering Team takes over from the parent Design Team and provides Technical and Maintenance support to the external customer installations. It is also known as Field Follow phase.
vi) End of Life (EOL) Phase – This is the terminal phase of a Product Life Cycle. The product is discarded, scrapped, or recycled when it is unable to continue or is not cost effective.

About Abdul Khalfan:

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

Webinar viewing information will be sent with your registration confirmation email.

CBB presents: Quality Management Systems Webinar Series - Basic Concepts of Quality with Abdul Khalfan

Charlotte Armstrong — Tue, 20 Oct 2020 13:37:44 +0000

CBB presents: Quality Management Systems Webinar Series - Basic Concepts of Quality with Abdul Khalfan Charlotte Armstrong Tue, 10/20/2020 - 09:37

QMS Webinar Series: Basic Concepts of Quality

Speaker: Abdul Khalfan CQE, SSGB

Principal, Quality Assurance & Reliability Engineering Consulting Services

The central theme of ‘Basic Concepts of Quality’ is to imbed the fundamentals of ‘Quality’ concepts in everyday work life and in their interactions with the society at large.

The ‘Basic Concepts of Quality’ focuses on the thought process of Quality is everybody’s business! It is a never-ending journey of Continuous Improvement…… It defines and explains the following:

What is Quality?
What are the four absolutes of Quality?
What is Quality Based upon?
Definition of a Customer
Definition of a Supplier
What is a Process?
Process Management Model
System for Improving Quality
Performance Standard
Measurement of Quality
Price of Non-conformance (PONC)
Calculation of PONC
The Importance of Measurement
Individual’s Commitment
Typical Quality Systems
Closed Loop Corrective Action System ((CLCA)

About Abdul Khalfan:

Abdul Khalfan is a Quality Management Systems (QMS) seasoned professional with over 30 years of experience in Quality Assurance, Product Development and Validation, Reliability Engineering, and Continuous Improvement. He is detailed oriented in Process development, planning, designing, documenting, establishing, training, auditing, and successfully implementing QMS from ground zero that conform to ISO 9001 and ISO 13485 Standards. Abdul has deep Process Management and Improvement knowledge-know-how, and experience in Product Life Cycle, Product Validation, and Business Process Analysis. He has gained technical knowledge, experience, and management skills over the past 37 years through Fortune 500 companies, such as NCR, AT&T, Flextronics, Bell-Howell, ITT, First Data, Teledyne (Dalsa), as well as small, medium, and large high-tech corporations such as Ingenico, Com Dev, Ingenico, KA Imaging, Durose Steel Corporation, B.TE. Automotive, Curiato Inc., and the likes of it.

Abdul Khalfan has won several awards for product development, product validation, and product improvement and quality systems saving companies millions of dollars in cost improvements and minimizing waste!

Abdul’s work experience, knowledge, and know-how are in the high-tech, medical devices, space, automotive, steel, and packaging industries. His experience in Quality Assurance and Reliability Engineering spans from Canada, USA, Europe, China, Australia, New Zealand, Turkey, Middle East, and Pakistan.

Abdul is an American Society for Quality (ASQ) Certified Quality Engineer (CQE). Abdul has Quality Assurance and Advanced Quality Assurance Diplomas with an Electrical Engineering background. He is a Certified Process Management and Improvement (PM&I) Lead/ Facilitator from NCR Corporation and AT&T. He is KPMG and ASQ Certified Lead Auditor. Attained Project Management Certification from University of ��ݮ��Ƶ. Abdul is Certified in Six Sigma Green Belt (SSGB). He has achieved certification in ISO 9001 and ISO 13485 Standards.

Abdul was a part-time Instructor at Conestoga College Institute of Technology and Advanced Learning for teaching ‘Total Quality Management (TQM)’ Systems. Abdul has been a guest speaker at ASQ Kitchener Section, ASQ Quality Conferences, and Society of Manufacturing Engineers meetings on Quality related subjects.

Webinar viewing information will be sent with your registration confirmation email.

Save the date for the next QMS Webinar: Product Life Cycle on November 25!