QUALITY REGULATION SYSTEM
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Safety
- Sterility
- Biocompatibility
- Blood Compatibility
- Mechanical Safety
- Chemical Safety
- Electrical Safety
- Thermal Safety
- Radiation Safety
- Environmental safety
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Effectiveness
- Physical
- Mechanical
- Biological
- Duration of use
- Barrier properties
- Risk vs. benefits (Radiation)
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QUALITY REGULATION SYSTEM
- Quality Philosophy
- Design Control
- Process & Process Control
- Validation
- Personnel
- Building & Environment
- Equipment & Calibration
- Device Master Record
- Device History Record
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QUALITY REGULATION SYSTEM
- Site Master File
- Document & Change Control
- Material Component Management
- Purchasing and Acceptance Activities
- Labeling
- Specification and Standards
- Standard Operating Procedures
- Device Evaluation
- Packaging
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QUALITY REGULATION SYSTEM
- Storage, Distribution and Installation
- Servicing
- Sterilization
- Sampling & Statistics
- Quality Manual
- Quality System Audit
- Complaints & Failure Investigations
- Factory Inspections
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QUALITY
A comprehensive system, so designed,
documented, implemented and controlled, and so furnished with
personnel, equipment and other resources as to provide
assurance that products will be consistently of a quality
appropriate to the intended use.
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QUALITY ASSURANCE PRINCIPLES
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Quality, safety and effective must be
designed and built into the product.
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Quality cannot be inspected or tested
into the finished product
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Each step of the manufacturing process
must be controlled to maximize the probability that the
finished product meets all its quality and design
specifications.
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ACHIEVING QUALITY ASSURANCE
- REVIEW – an in-depth review of all aspects which have
a bearing on quality
- QA MANUAL – describe all parts of organized system by
which quality is assured within & outside the factory
before, during and after manufacture
- RESPONSIBILITY – appoint a person responsible for
establishing quality goals, implementing methods; training
staff and ensuring standards are met
- AUDIT—provide feedback that QA is being attained
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MANUFACTURING VARIABLES
- MAN : Experience, Qualification, Training, Attitude
- MATERIAL : Correct quality
- METHOD : Proven, Consistent, Reliable
- MACHINE : Suitable, Location, Validation, Reliable,
Maintenance
- MONEY :Management response
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QUANTIFICATION OF QUALITY
OBJECTIVE QUANTIFICATION
Product improvement to market a fail safe device By May 31,
2001
Training to conduct 20 hours design
reliability training during the year 2001
Cost Control to hold inspection/testing costs to 3.4 % of
mfg. cost during 2001
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QUALITY COSTS
PREVENTIVE COSTS —>Costs to prevent failures and/or
reduce appraisal costs
APPRAISAL QUALITY COSTS —>Costs of
inspection testing and quality evaluation
INTERNAL FAILURE QUALITY COSTS —>Costs of
non-conformance while under company control
EXTERNAL FAILURE QUALITY COSTS —>Costs of
non-conformance after leaving company control
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PREVENTIVE QUALITY COSTS
- Quality Planning
- Vendor Approval System
- Personnel Training
- Documentation System
- Preventive Maintenance
- Calibration
- Sanitation
- Process Validation
- QA Auditing and Self-inspection
- Data or trend Analysis
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