quality management systems chris p. james its elementary
TRANSCRIPT
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Quality Management Systems
Chris P. James
Its Elementary
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Agenda
• Elements of a Quality Management System
• Product Realization
• Continual Improvement
• Resource Management
• Affects on a FUS Standard
• Questions
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Quality Challenge
Baldwin Corp.
Scott Co.
Colby Inc.
McArdle Services
Wehr LLC.
Not Everything Is Always As It Appears
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Elements of a Quality Management System
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” - William A. Foster
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Elements of a Quality Management System
• Organizational structure and Responsibilities• Process Controls and Methods• Data Management• Resources - including materials as well as human resources• Customer Satisfaction• Continuous Improvement (corrective/preventative action)• Product Quality (validation/verification)• Equipment Maintenance and Calibration• Sustainability - including efficient use of resources and responsible environmental operations• Monitoring by continual assessment (internal or external)
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What Can a Quality System Manage
• Production System
• Packaging & Labeling System
• Facilities & Equipment System
• Laboratory Controls System
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Which Path is Acceptable?
ACME Quality
Manufacturer’s Quality
Program
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Product Realization
“Quality is not an act, it is a habit.” - Aristotle
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What should a quality system manage
Product Realization is the combination of all processes (step by step) - from initial design to actual delivery of final product/service - that deliver an output meeting defined requirements (specifications).
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Continual Improvement
“Quality means doing it right when no one is looking.” – Henry Ford
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Continual Improvement
1. Containment
2. Root Cause Analysis
3. Corrective Action
4. Preventative Action
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Continual Improvement
Containment: Immediate actions to reduce the severity of the identified problem (slow production line, provide for temporary fix/repair, etc.)
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Continual Improvement
Root Cause Analysis: A detailed review of the issue to determine the true cause for the problem. Utilizing various methods such as 5 why’s, Ishikawa (fishbone/cause-effect) chart, etc.
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Continual Improvement
Corrective Action: Once the true cause of the problem is identified, action take to resolve/reduce the likely of same problem from reoccurring.
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Continual Improvement
Preventative Action: Analysis of processes/operations to mistake proof them so as to eliminate problems from happening (prevention)
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Resource Management
“The quality of an organization can never exceed the quality of the minds that make it up.” - Anonymous
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Personnel Competency and Development
Personnel competency can be broken down into the following areas:
• Determine the necessary competence (skills)
• Provide training and evaluate the effectiveness
• Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
• Maintain appropriate records of education, training, skills and experience.
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Elements That Can Be Overlooked
The working environment should also be managed to help achieve a conforming product, such as:
• Human factors:• safety rules and guidance• ergonomics
• Physical factors:• hygiene, cleanliness• noise, vibration• heat, light, air-flow• security
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Affects on a FUS Standard
“It is easier to do a job right than to explain why you didn't” - Martin Van Buren
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