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Implementation Of Quality Assurance Principles Into The Manufacturing Environment. Presented by: John M. Cachat Chairman and Founder, IQS, Inc. Implementation Steps. QA vs QC vs QM Quality Management Model ROI – Show Me the Money Why Limit to Manufacturing?. ISO 9000 Definitions.
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Implementation Of Quality Assurance Principles Into The Manufacturing Environment Presented by: John M. Cachat Chairman and Founder, IQS, Inc.
Implementation Steps • QA vs QC vs QM • Quality Management Model • ROI – Show Me the Money • Why Limit to Manufacturing?
ISO 9000 Definitions Quality Control The operational techniques and activities that are used to fulfill requirements for quality Quality Assurance All those planned and systematic activities implemented to provide adequate confidence that an entity will fulfill requirements for quality
According to Dr. Joe Juran • QA Develops Plans To Ensure Quality For The Overall Organizational System • QC Inspects And Reports • The Same As Finance (QA) And Accounting (QC)
QA vs QC vs QM QM – Quality Management FDA Regulated ISO13485 GMP Automotive TS-16949 Aerospace AS9100 General ISO9000
Linking to Other Cool Stuff • Lean – reduce waste • Six Sigma – reduce variation • Operational Excellence • Business Process Improvement • Managing with Metrics • Non-Financial, Non-Inventory
Who Cares? • Poor Communication Results from Poor Definitions • QM is not a departmental responsibility • Top Management needs to understand that QM is a process approach that can solve existing business problems. • QM is not another project – it is a means to reduce cost, reduce risk
Manufacturing Challenges • Multiple Market / Specs • One System Meet All • Entire Product Lifecycle • What Does A Single System Look Like? • How Do You Explain It?
Multiple Markets – Multiple Specs FDA Regulated ISO13485 GMP Automotive TS-16949 Aerospace AS9100 General ISO9000
QM – Quality Management Impacts the Entire Product Lifecycle • Marketing / Sales • Engineering • Purchasing • Quality • Manufacturing • Human Resources • Finance / Accounting “Quality” is Everyone’s Business
Manufacturing Process Flow MANUFACTURING • INPUTS • Employees • Equipment • Gauging • Process Flows • Risk Analysis • Control Plans • Work Instructions • Blueprints / Specs • Raw Material / Parts • Change Requests OUTPUT Product
The Research Has Been Done • 1980s - USAF Research – Design A System That Does Everything Manufacturing Needs, But Do Not Overlap Accounting And Inventory Business Processes • 1990s – American Society of Quality (ASQ) Technical Committee on Quality Management Systems
Reality Check • Make Sense? • Easy To Explain? • Too Busy – Which Ones To Drop? • Impacts Entire Organization • Framework For Solving Problem, Achieving Goal, Satisfy A Need – This Is NOT A Separate Project
The Approach:Pass the Test vs Learn • Pass the Test • We have to calibrate gages for ISO9000 • Learn • We calibrate gages so that we do not reject good material or accept bad material
The Approach:Pass the Test vs Learn • Pass The Test • Document What You Do – Do What You Document • Learn • Documentation Is Used To Improve Communication
ROI – Do The Math • What are your priorities? • Saving time • Reducing cost • Increasing compliance
ROI – Do The Math • Most organizations are surprised to learn that quality initiatives have a huge – and fast – impact on time and cost reduction. • Surprised? Many think that quality costs money, when in reality poor quality increases expenses often caused by errors created in redundant and ad hoc work that is not tied to an overall process. • Reduce Costs by Improving Quality
ROI – Do The Math “ Most people think that quality costs money, well – I will tell you, we’ve learned the hard way – not having quality costs money. Building it right the first time is one of the few ways to save money and actually improve the company.” – Fortune 100 CEO in CIO magazine
Conclusions • Effective Communication Requires Understanding QC vs QA vs QM • Reduce Costs by Improving Quality • Lean Quality Management – Eliminate Waste • Do the Math – ROI Calculator
Conclusions • World Class Quality is a Organizational Challenge, Not a Manufacturing Challenge • Use Best In Class Business Models • Learning Approach Provides Long Term Benefits • Reduce Costs by Improving Quality • This is a framework for deployment, like ERP – not another project