Module 7 Flashcards
What are the QSE categories?
Documents and records
Organization
Personnel
Equipment
Purchasing and inventory
Process control
Info management
Occurrence management- problems that causes harm or had potential to cause harm
Assessments- internal and external
Process improvement
Customer service and satisfaction
Facilities and safety
What are examples of external assessments?
Accreditation assessments
Proficiency testing
External/interlab QC programs
What are examples of internal assessments?
Quality indicator metrics
TAT
What is the cost of quality?
Processes used to show the financial impact of quality activities
What is the cost of conformance?
Cost due to lab meeting customer expectations and requirements
Prevention costs- activities designed to prevent poor quality
Appraisal costs- associated with measuring, evaluating and auditing lab operations
What is the cost of nonconformance?
Cost of not meeting customer expectations and requirements
Internal failure costs- occur prior to delivery of result to customer
External failure costs- occur after results delivery to customer
What are quality system essentials?
Areas in which clinical labs are inspected, accredited and/or licensed
Align with ISO15189 (international standards document)
