John K Taylor

Quality Assurance of Chemical Measurements

• Broschiertes Buch

Produktbeschreibung

This definitive new book should appeal to everyone who produces, uses, or evaluates scientific data. Ensures accuracy and reliability. Dr. Taylor's book provides guidance for the development and implementation of a credible quality assurance program, plus it also provides chemists and clinical chemists, medical and chemical researchers, and all scientists and managers the ideal means to ensure accurate and reliable work. Chapters are presented in a logical progression, starting with the concept of quality assurance, principles of good measurement, principles of quality assurance, and evaluation of measurement quality. Each chapter has a degree of independence so that it may be consulted separately from the others.

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 348
• Erscheinungstermin: 18. Dezember 2020
• Englisch
• Abmessung: 234mm x 156mm x 19mm
• Gewicht: 490g
• ISBN-13: 9780367451417
• ISBN-10: 0367451417
• Artikelnr.: 60022387

Autorenporträt

Taylor, John K.

Inhaltsangabe

Preface
CHAPTER 1. Introduction to Quality Assurance
CHAPTER 2. Precision, Bias, and Accuracy
Axioms
Corollaries
Sources of Error
Errors of Rounding
Influence of Uncertainty on Decision
CHAPTER 3. Statistical Control
CHAPTER 4. Statistical Techniques
Basic Requirements
Distributions
Statistics of Measurements
Estimation of Standard Deviation
Estimation of Standard Deviation from Replicate
Measurements
Estimation of Standard Deviation from Duplicate
Measurements
Estimation of Standard Deviation from the Range
Pooling Estimates of Standard Deviations
The Analysis of Variance
Do Two Estimates of Precision Differ?
What are the Confidence Limits for an Estimate of a
Standard Deviation?
Confidence Interval for a Mean
Does a Measured Value Differ from an Expected
Value?
Do the Means of Two Measured Values Disagree
Significantly?
Statistical Tolerance Intervals
Pooling Means to Obtain a Grand Average
Outliers
Rejection for an Assignable Cause
Rule of the Huge Error
Statistical Tests
Dixon Test for Outlying Observations
Grubbs Test for Outlying Observations
Youden Test for Outlying Laboratories
Cochran Test for Extreme Values of Variance
Statistics of Control Charts
Control Limits
Central Line Considerations
Agreement With Established Value
Has the Central Line Changed?
Use of Random Number Tables
CHAPTER 5. Chemical Analysis as a System
Systematic Approach to Analysis
Effective Problem Solving
CHAPTER 6. The Model
Importance of a Model
Development of a Model
Data Quality Objectives
CHAPTER 7. Planning
General Aspects of Planning
Development of an Experimental Plan
Content of a Measurement Plan
CHAPTER 8. Principles of Sampling
Initial Considerations
Sampling Plan
Peer Review
Training
Sample Management
Problem of Subsampling
Critical Matters Related to Samples
Quality Assurance of Sampling
Sample Uncertainties
Stratification
Holding Time
Statistical Considerations in Sampling
Measurement Situations
Statistical Sampling Plan
Basic Assumptions
Guidance in Sampling
Cost Considerations
Minimum Size of Increments in a Well
Mixed
Sample
Size of Sample in Segregated Materials
Acceptance Testing
Matrix
Related Sampling Problems
Sampling Gases
Sampling Liquids
Sampling Solids
Sampling Multiphases
CHAPTER 9. Principles of Measurement
Terminology
Measurement is a Comparison Process
Principles of Chemical Measurement
Figures of Merit
Precision
Sensitivity
Limit of Detection and Limit of Quantitation
Short
term and Long
term Standard Deviation
Bias
Selectivity
Other Considerations
Importance of an SOP
Ruggedness Testing
Standardization of Methods
Selection of Appropriate Methodology
Guidelines for Selecting Instrumentation
Internal vs External Services
CHAPTER 10. Principles of Calibration
What Needs to be Calibrated
Requirements for Calibration
Frequency of Calibration
Mode of Calibration
Linear Relationships
Tests for Linearity
Calibration Uncertainties
Intercalibration
Additional Remarks
CHAPTER 11. Principles of Quality Assurance
CHAPTER 12. Principles of Quality Control
Competence
Suitable Facilities and Equipment
Good Laboratory and Good Measurement Practices
Standard Operations Procedures
Distinction Between GLPs, GMPs, and SOPs
Protocols for Specific Purposes
Contents of a PSP
Other Quality Control Techniques
Inspection
Documentation
Training
The Quality Control System
CHAPTER 13. Blank Correction
Sources of Blanks
Control of Blanks
Evaluation of Blanks
Statistical Treatment of the Blank
Significance
CHAPTER 14. Control Charts
Format
Control Limits
Evaluating Control Limits
Control Samples
Frequency of Control Measurements
Identification of Population
Strategy of Use
Assignment of Uncertainty
Range Control Charts
Approach
Use of Range Control Charts
Sub span Range Control Charts
Range Performance Charts
Range Ratio Control Charts
Collateral Control Charts
Critical Collateral Measurement Control Charts
Recovery Control Charts
Other Useful Control Charts
Additional Remarks
Blinds vs Double Blinds
CHAPTER 15. Principles of Quality Assessment
Internal Techniques
External Techniques
Qualitative Identification
Other Techniques
CHAPTER 16. Evaluation Samples
Prime Requirements
Types of Evaluation Samples
Liquid Samples
Solid Samples
Gas Samples
Stability of Mixtures
Subsampling
Integrity of Evaluation Samples
CHAPTER 17. Reference Materials
Role of Reference Materials
Uses of Reference Materials
Certification of Reference Materials
CHAPTER 18. Traceability
Chemical Traceability
Standards Prepared by the Analyst
Standards Prepared by Others
Physical Standards
Reference Materials Produced by NBS
Reference Materials Produced by Others
Traceability of Analytical Results
Concept of the National Measurement System
CHAPTER 19. Quality Audits
Internal Audits
Internal Systems Audits
Internal Performance Audits
Mechanism
Corrective Actions
External Audits
Independent Audits
Forms
Personal Quality Assurance Profile
Laboratory Quality Assurance Profile
Quality Assurance Survey
Quality Assurance Practices Check List
Quality Assurance Training Profile
CHAPTER 20. Quality Circles
Organization
Objectives
Operation
Reporting
Agenda
CHAPTER 21. Validation
Validation of Samples
Validation of Methodology
Validation of Data
CHAPTER 22. Reporting Analytical Data
Minimum Requirements
Data Limitations
Numerical Values
Limits of Uncertainty for Data
Significant Figures
Guidelines for Reporting Results of Measurements
Guidelines for Combining Data Sets
Arbitrary Reporting Procedures
Reporting Low
Level Data
Report Format
CHAPTER 23. An Improved Approach to Performance
Testing
Premises
Advance Estimation of Precision
Performance Testing Plan
Diagnosis
Feedback
Consensus Values
Statistical Treatment of Data
CHAPTER 24. Correction of Errors and/or Improving
Accuracy
Identification of Problems
Improvement of Performance
Editing Data
CHAPTER 25. Laboratory Evaluation
Generic Guidelines for Evaluation
Accreditation
Self
Evaluation
CHAPTER 26. The Quality Assurance Program
Approaches to Quality Assurance
Quality Assurance Policy
Planning for Quality Assurance
Development of a QA Program
Quality Assurance Manual
Federally Mandated Quality Assurance Programs
Public Health Service
Food & Drug Administration
Environmental Protection Agency
Non federally Mandated Quality Assurance Programs
Quality Assurance for Measurement Programs
Relating Personnel to Quality Assurance
Appendix A. Terminology Used in Quality Assurance
Appendix B. Quality Assurance Program Documentation
B. l Example Quality Assurance Program Document
B.2 Outline for Use in Preparing an SOP for a
Measurement Method
B.3 Outline for Use in Preparing an SOP for
Calibration
B.4 Outline for Use in Preparing a GLP or GMP
Appendix C. Statistical Tables
C.l Use of Range to Estimate Standard Deviation
C.2 Z
Factors for Two
Sided Confidence Intervals
for the Normal Distribution
C.3 Student t Distribution
C.4 Factors for Computing Two
Sided Confidence
Intervals for E.
C.5 Factors for Computing Two
Sided Confidence
Intervals for a Normal Distribution
C.6 Critical Values for the F Test
C. 7 Values for Use in the Dixon Test for Outliers
C.8 Values for Use in the Grubbs Test for Outliers
C.9 Values for Use in the Youden Test for Outliers
C.10 Values for Use in the Cochran Test for Extreme
Variance
C.11 Short Table of Random Numbers
Appendix D. Study Aids
D. l Seventy
Five Terms Commonly Used in
Discussing Quality Assurance
D.2 Seventy
Five Top