LEADER 08676nam 2200469 450 001 9910768478603321 005 20230407014342.0 010 $a9783031117244$b(electronic bk.) 010 $z9783031117237 035 $a(MiAaPQ)EBC7144528 035 $a(Au-PeEL)EBL7144528 035 $a(CKB)25456658100041 035 $a(PPN)266350194 035 $a(EXLCZ)9925456658100041 100 $a20230407d2023 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aGuidelines for laboratory quality managers /$fSaverio Mannino 210 1$aCham, Switzerland :$cSpringer,$d[2023] 210 4$d©2023 215 $a1 online resource (170 pages) 225 1 $aIntegrating food science and engineering knowledge into the food chain ;$v14 300 $aIncludes index. 311 08$aPrint version: Mannino, Saverio Guidelines for Laboratory Quality Managers Cham : Springer International Publishing AG,c2022 9783031117237 327 $aIntro -- 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. 327 $a2.4 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. 327 $a4.13 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. 327 $a6.4 Quality Control Samples -- 6.5 Guidelines on Interpretation of Control Charts -- 6.6 Practical Points in Using a Control Chart -- 6.7 Process Capability -- 6.8 Capability Indices Cp and Cpk -- 6.9 How to Conduct a Functionality Study -- 6.10 Process Capability Analysis: An Example -- 6.11 Six Sigma and Process Capability -- 6.12 Process Capability Index Cpk and Six-Sigma Metric -- 6.13 Conclusions -- Chapter 7: Risk Management -- 7.1 Risk Management Requirements in the New Laboratory Standard ISO17025 -- 7.2 Addressing Risks -- 7.3 Addressing Opportunities -- 7.4 Integrating and Implementing Actions -- 7.5 Risk Management -- 7.6 Risk Identification -- 7.7 Failure Modes and Effects Analysis (FMEA) for Laboratory -- 7.8 Probability of Occurrence -- 7.9 Probability of Occurrence with Standard Linear Scaling -- 7.10 Severity -- 7.11 Risk Mitigation -- 7.11.1 Table Form for Risk Mitigation -- 7.12 Detection Level -- 7.12.1 Detection Level Table -- 7.13 RPN Calculation -- 7.14 Examples -- 7.14.1 Medical Example: Prostate Specific Antigen (PSA) Test -- 7.14.2 Example 2: HUMIDITY for Rice and Mill Analysis -- 7.15 Sampling Frequency -- 7.15.1 Quantitative Overall Risk Assessment (Simplified) -- 7.16 Frequency of Sampling/Analysis -- 7.16.1 Quantitative Risk Assessment (Simplified) Incorporating Example Exponential Weighting Function (Notional) -- 7.17 Useful Reading -- 7.18 Example of Risk Assessment for an Analytical Method from sampling Collection to Test Results -- Index. 410 0$aISEKI-Food series ;$v14. 606 $aFood$xQuality 615 0$aFood$xQuality. 676 $a664 700 $aMannino$b Saverio$0293939 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 912 $a9910768478603321 996 $aGuidelines for laboratory quality managers$93657924 997 $aUNINA