1 Process Control: Introduction to Quality Control

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Published 2026-06-01 · 10 slides · 0 views

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1 Process Control: Introduction to Quality Control Introduction to Quality Control-Module 6 2 Learning Objectives At the end of this module, participants should be able to: Define quality control and describe its relationship to the overall

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1 Process Control:Introduction to Quality Control

Introduction to Quality Control-Module 6 2 Learning Objectives At the end of this module, participants should be able to:
Define quality control and describe its relationship to the overall quality management system.
Describe differences in quantitative, qualitative, and semi-quantitative examinations.

Introduction to Quality Control-Module 6 3 The Quality Management System

Introduction to Quality Control-Module 6 4 Definition Quality Control (QC) is part of quality management focused on fulfilling quality requirements ISO 9000:2000 (3.4.10)
QC is examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete examination (analytic) process.

Introduction to Quality Control-Module 6 5 Purpose The goal of QC is to detect errors and correct them before patients’ results are reported

Introduction to Quality Control-Module 6 6 Quantitative Examinations Measure the quantity of a particular substance in a sample Measurements should be both accurate and precise

Introduction to Quality Control-Module 6 7 Qualitative Examination Methods Examinations that do not have numerical results:
growth or no growth
positive or negative
reactive or non-reactive
color change

Introduction to Quality Control-Module 6 8 Semi-quantitative Examination Methods Results are expressed as an estimate of the measured substance:
“trace amount”, “moderate amount,” or “1+, 2+, or 3+”
number of cells per microscopic field
titers and dilutions in serologic tests

Introduction to Quality Control-Module 6 9 QC Program Steps include corrective actions

Introduction to Quality Control-Module 6 10 QC Summary important part of quality management system
goal is to identify errors and eliminate them before reporting patient results
different methods applied for quantitative, qualitative, and semi-quantitative results

1 Process Control: Introduction to Quality Control

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