4 views of quality
4 views of quality
1.Transcendental View
2. User-Based View
3. Product-based View
4. Manufacturing - Based View
1. Quality starts with the customer
The user benefits and product features belong to the customer.
acceptable quality level
the maximum percentage of defects allowed in a production process
Quality Assurance System
All the policies and activities implemented in a business operation to ensure that products and services meet all quality standards.
Quality Products
Meet market requirements (customer satisfaction)
Meet Legal requirements (customer safety)
2 Quality working definitions
1. The characteristics of a product or service that bear on its ability to satisfy stated or implied needs.
2. A product or service free of defects
2. Quality is not inspection
You cannot inspect quality into an item. Defect prevention is preferable to quality inspection and correction. Quality at the source.
Good Manufacturing Practices (GMP)
manufacturing guidelines set by the Food and Drug Administration (FDA) that provide the minimum requirements that a medical device manufacturer must meet to ensure that their products are of high quality and do not pose a risk to the consumer or public.
Quality at the source
The concept that quality output is not only controlled at the end of the production line, but at every step in the production process.
Types of Regulations
OSHA
EPA
ASTM
FDA
ISO
2 things quality drivers
1. driving revenue
2. reduces cost
3. Poor quality is costly
every defect represents a cost which is often hidden. These costs include inspection time, rework, wasted material and labor, lost revenue, and the cost of customer dissatisfaction.
Incoming Inspection Procedure (IIP)
A documented procedure of the steps needed to inspect and ensure the quality of received materials or parts.
Regulations
Rules based on and intended to implement a specific piece of legislation. This is accomplished by issuing regulations.
Quality Manufacturing Practice (GMP) Compliance
: Quality management and organization
: Device Design
: Packaging and labeling control
: etc.
The three steps of the quality process
1. Discover from the market the product characteristics that connote quality.
2. Translate these characteristics into identifiable attributes.
3. Organize manufacturing processes to ensure that products are made precisely to these specifications
4. Zero defects is the quality standard
The idea that mistakes are inevitable is rejected out of hand. Aiming at an "acceptable" defect level encourages and causes defects.
Inspection
the examination measurement testing, gauging, and comparison of materials or items to determine if they conform to specified quality requirements.
Specification
A written statement of the required characteristics of a product or process, to define its production, and acceptance.
Zero Defects
No defects. Nada
some reasons for a Zero Defects Quality Policy
and if 99% was good enough...
3 major plane crashes will happen each day
2 million documents will be lost by the IRS this year
Process Control
steps taken to ensure that a process is predictable, stable, and consistently operating at the target level of performance with only normal variation.
Standard
A document that provides rules or guidelines for a product or process, to establish acceptable levels of quality, performance or safety.