Guidelines for Laboratory Quality Managers

Preface
Acknowledgments
Contents
Chapter 1: Introduction and ISO17025:2017
	1.1 Clause 1: Scope
	1.2 Clause 2: Normative References
	1.3 Clause 3: Terms and Definitions
	1.4 Clause 4: General Requirements
		1.4.1 Impartiality
		1.4.2 Confidentiality
	1.5 Clause 5.0: Structural Requirements
	1.6 Clause 6.0: Resources Requirements
		1.6.1 General
		1.6.2 Personnel
		1.6.3 Facilities and Environmental Conditions
		1.6.4 Equipment
		1.6.5 Metrological Traceability
		1.6.6 Externally Provided Products and Services
	1.7 Clause 7.0: Process Requirements
		1.7.1 Review of Requests, Tenders and Contracts
		1.7.2 Selection, Verification, and Validation of the Methods
		1.7.3 Sampling
		1.7.4 Handling of Test or Calibration Items
		1.7.5 Technical Records
		1.7.6 Evaluation of Measurements Uncertainty
		1.7.7 Ensuring the Validity of Results
		1.7.8 Reporting Results
		1.7.9 Complaints
		1.7.10 Nonconforming Work
		1.7.11 Control of Data – Information Management
	1.8 Clause 8.0: Management System Requirements
		1.8.1 Management System Documentation (Option A)
		1.8.2 Control of Management System Documents (Option A)
		1.8.3 Control of Records (Option A)
		1.8.4 Actions to Address Risks and Opportunities (Option A)
		1.8.5 Improvement (Option A)
		1.8.6 Corrective Actions (Option A)
		1.8.7 Internal Audits (Option A)
		1.8.8 Management Reviews (Option A)
Chapter 2: Essentials for Quality Management in a Chemical Testing Laboratory
	2.1 Managing the Quality of Laboratory Testing Processes
	2.2 Developing a Quality Management System (QMS)
		2.2.1 PLAN
		2.2.2 DO
		2.2.3 CHECK
		2.2.4 ACT
	2.3 Six Sigma Quality Management System
		2.3.1 Define, Measure, Analyze, Improve Stages
			2.3.1.1 Define Stage
			2.3.1.2 Measure Stage
			2.3.1.3 Analyze Stage
			2.3.1.4 Improve Stage
	2.4 Quality Systems
		2.4.1 Quality System, Assurance, Assessment and Control
		2.4.2 Principles of Quality Control
		2.4.3 Principles of Quality Assessment
		2.4.4 System Planning
		2.4.5 Investigation Phase
		2.4.6 Quality Manager Responsibilities
		2.4.7 Steering Team Responsibilities
		2.4.8 Task Team Responsibility
		2.4.9 Timeline
		2.4.10 Implementation Phase
		2.4.11 Consolidating the Program
		2.4.12 Monitoring and Evaluating the Program
		2.4.13 Management Review
		2.4.14 Communication and Motivation
	2.5 Tips
		2.5.1 Tip: 1 – Human Resources
		2.5.2 Tip: 2 – Scheduling and Conducting the Gap Analysis
		2.5.3 Tip: 3 – Quality Manual
		2.5.4 Tip: 4 – Example of Task Assignments
		2.5.5 Tip: 5 – Example of Project Gantt Chart
Chapter 3: Preparing for Analysis: The Analytical Method
	3.1 Sources of Methods
	3.2 Evaluation of Published Methods
	3.3 AOAC International (AOACI)
	3.4 The Codex Alimentarius Commission
	3.5 The European Union
	3.6 The European Committee for Standardization (CEN)
	3.7 ISO
Chapter 4: Statistics for the Quality Control Laboratory
	4.1 Data Presentation
	4.2 Measure of the Central Tendency (Mean, Median, Mode)
		4.2.1 Median
		4.2.2 Mode
	4.3 Measures of Spread (Range, Variance, Standard Deviation)
		4.3.1 Range
		4.3.2 Variance
		4.3.3 Standard Deviation
	4.4 Normal Distribution
	4.5 Using Samples to Estimate Population Values
	4.6 Standard Error of the Mean
	4.7 Shapiro-Wilks for Testing Normality
		4.7.1 Sulphur Dioxide SO2 in White Wine
	4.8 Confidence Intervals
	4.9 Steps in the Process of Hypothesis Testing
	4.10 Example of Statistical Tests Routinely Applied in the Analytical Laboratory
	4.11 F-Test
		4.11.1 Comparison of Two Standard Deviations: The F-Test
	4.12 Outliers
		4.12.1 Outliers-Dixon Test
		4.12.2 Grubbs Test
	4.13 Cochran Test for Extreme Value of Variance (Outlier Variance)
	4.14 Combining (Pooling) Estimates of Standard Deviations
	4.15 Precision Calculations
	4.16 Averages
		4.16.1 Comparison of Means: The T-Test
	4.17 Comparing Two Averages by Using the T-Test
	4.18 The Repeatability Limit (r)
	4.19 The Calibration Process: Regression Line
	4.20 Weighted Regression Line
		4.20.1 TIP
			4.20.1.1 The Correlation Coefficient
	4.21 Method of Standard Addition (MOSA)
	4.22 Errors, Linear Regression Analysis and Method of Standard Additions
		4.22.1 Some Definitions
		4.22.2 Errors in Chemical Analysis
		4.22.3 Constant Error
		4.22.4 Proportional Errors
	4.23 The Youden Approach to Constant and Proportional Errors
	4.24 ANOVA- Analysis of Variance
		4.24.1 The ANOVA Summary Table: General Format
	4.25 Two-Way ANOVA
		4.25.1 The Two-Way ANOVA Summary Table
	4.26 Meaning of p-Value
	Appendix
		Shapiro-Wilk Test
		Grubb Statistic Values
Chapter 5: Uncertainty Measurements
	5.1 Approaches to Estimate Measurement Uncertainty
		5.1.1 The Bottom Up Approach
			5.1.1.1 How to Calculate the Standard Uncertainty for a Type A Evaluation
			5.1.1.2 How to Calculate the Standard Uncertainty for a Type B Evaluation
		5.1.2 Top Down Approach
			5.1.2.1 Top-Down’ Requirements
	5.2 Case Study – Determination of Cholesterol in Animal and Vegetable Fats and Oils
	5.3 Example 2
		5.3.1 Estimation of Measurement Uncertainty
		5.3.2 Estimation of Bias and the Uncertainty of Bias
		5.3.3 Result Corrected for Bias
		5.3.4 Result Not Corrected for Bias
	5.4 Other Approaches to Estimate MU: The Horwitz Equation
	5.5 HORRAT Value
Chapter 6: Control Charts and Process Capability
	6.1 Control Charts
	6.2 Construction of a Control Chart
	6.3 Type of Control Charts: Average, Range and Standard Deviation Control Charts
	6.4 Quality Control Samples
	6.5 Guidelines on Interpretation of Control Charts
	6.6 Practical Points in Using a Control Chart
	6.7 Process Capability
	6.8 Capability Indices Cp and Cpk
	6.9 How to Conduct a Functionality Study
	6.10 Process Capability Analysis: An Example
	6.11 Six Sigma and Process Capability
	6.12 Process Capability Index Cpk and Six-Sigma Metric
	6.13 Conclusions
Chapter 7: Risk Management
	7.1 Risk Management Requirements in the New Laboratory Standard ISO17025
	7.2 Addressing Risks
	7.3 Addressing Opportunities
	7.4 Integrating and Implementing Actions
	7.5 Risk Management
	7.6 Risk Identification
	7.7 Failure Modes and Effects Analysis (FMEA) for Laboratory
	7.8 Probability of Occurrence
	7.9 Probability of Occurrence with Standard Linear Scaling
	7.10 Severity
	7.11 Risk Mitigation
		7.11.1 Table Form for Risk Mitigation
	7.12 Detection Level
		7.12.1 Detection Level Table
	7.13 RPN Calculation
	7.14 Examples
		7.14.1 Medical Example: Prostate Specific Antigen (PSA) Test
		7.14.2 Example 2: HUMIDITY for Rice and Mill Analysis
	7.15 Sampling Frequency
		7.15.1 Quantitative Overall Risk Assessment (Simplified)
	7.16 Frequency of Sampling/Analysis
		7.16.1 Quantitative Risk Assessment (Simplified) Incorporating Example Exponential Weighting Function (Notional)
	7.17 Useful Reading
	7.18 Example of Risk Assessment for an Analytical Method from sampling Collection to Test Results
Index