quality assurance & quality control: an overview - state water
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Quality Assurance & Quality Control:
An Overview
Karen LarsenEnvironmental Scientist
Region 5, Sacramento
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Quality Assurance & Quality Control (QA/QC)
What is it?Why is it important?24 elements of a Quality Assurance Project Plan (QAPP)SWAMP Requirements & Guidance
PLANNING
PAEP
Monitoring Plan
QAPP
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What is a Quality System?
A management system that ensures quality of work process, products, and services.Quality Management Plan (QMP) documents elements of the quality system.Quality Assurance (QA) is the management activities described in the QMP
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What is a QA Project Plan?
Document describing the technicaland quality activities of a specificproject.Quality Control (QC) is the set of procedures implemented as part of the QA program.
Quality System(QMP)
QA Project
Plan
QC Procedures
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Why is QA/QC Important?
Focuses effortsStandardizes activitiesPrevents wasteInsures a useable product of known quality
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Quality Assurance Project Plan (QAPP)
A written, approved document that describes:A. Project planning & managementB. Data generation & acquisitionC. Assessment & oversightD. Data validation & usability
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A. Project Planning & Management
1. Title & approval sheet2. Table of contents3. Distribution list
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A. Project Planning & Management
1. Title & approval sheet2. Table of contents3. Distribution list4. Project/task organization5. Problem definition &
background6. Project/task description
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A. Project Planning & Management
1. Title & approval sheet2. Table of contents3. Distribution list4. Project/task organization5. Problem definition & background6. Project/task description7. Quality objectives & criteria
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7. Quality Objectives & Criteria
Precision, Bias, & Accuracy
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7. Quality Objectives & Criteria
Representativeness
0
20
40
60
80
100
Cerio
daph
nia
Morta
lity (%
)
1 2
1
122
3
3
4
4
5
5
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7. Quality Objectives & Criteria
Comparability – Performance Based Methods System
(PBMS)
ELISA v. GC/MS Method for Measuring Diazinon Example
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7. Quality Objectives & Criteria
Completeness
How much of the data planned to be collected must be valid to meet the project
objectives?
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7. Quality Objectives & Criteria
Sensitivity
CO
NC
EN
TR
ATIO
N
SAMPLES
MDL
ActionLevel
ActionLevel
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A. Project Planning & Management
1. Title & approval sheet2. Table of contents3. Distribution list4. Project/task organization5. Problem definition & background6. Project/task description7. Quality objectives & criteria8. Special training & certification
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A. Project Planning & Management
1. Title & approval sheet2. Table of contents3. Distribution list4. Project/task organization5. Problem definition & background6. Project/task description7. Quality objectives & criteria8. Special training & certification9. Documentation & records
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B. Data Generation & Acquisition
10. Study design
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B. Data Generation & Acquisition (cont’d)
10. Study design11. Sampling methods12. Sample handling & custody13. Analytical methods
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B. Data Generation & Acquisition (cont’d)
10. Study design11. Sampling methods12. Sample handling & custody13. Analytical methods14. Quality control
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14. Quality Control
Duplicates – intra-laboratory precision
Splits – inter-laboratory precision
Blanks – contamination
Spikes – accuracy & bias
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B. Data Generation & Acquisition (cont’d)
10. Study design11. Sampling methods12. Sample handling & custody13. Analytical methods14. Quality control15. Equipment testing, inspection, &
maintenance16. Equipment calibration & frequency17. Acceptance of supplies &
consumables
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B. Data Generation & Acquisition (cont’d)
10. Study design11. Sampling methods12. Sample handling & custody13. Analytical methods14. Quality control15. Equipment testing, inspection, &
maintenance16. Equipment calibration & frequency17. Acceptance of supplies & consumables18. Non-direct measurements
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B. Data Generation & Acquisition (cont’d)
10. Study design11. Sampling methods12. Sample handling & custody13. Analytical methods14. Quality control15. Equipment testing, inspection, &
maintenance16. Equipment calibration & frequency17. Acceptance of supplies & consumables18. Non-direct measurements19. Data management
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C. Assessment & Oversight
20. Assessments & response actions
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C. Assessment & Oversight
20. Assessments & response actions21. Reports to management
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D. Data Validation & Usability
22. Data review, verification & validation
23. Verification & validation methods
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D. Data Validation & Usability
22. Data review, verification & validation
23. Verification & validation methods24. Reconciliation with user
requirements
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QA Overview Summary
Utilize all project planning documentsUtilize SWAMP toolsUtilize available resourcesRefer to the QAPP throughout the project
