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 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.
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