Accuracy and Calibration Failures in Science and Engineering

Michael D. Holloway is President of the 5th Order Industry, which provides training, failure analysis, and designed experiments. He has more than 40 years of experience in the industry, holding 16 professional certifications and one patent. He has authored ten books and contributed to several others. His expertise lies in failure analysis, reliability engineering, and designed experiments for science and engineering.

• Preface xix1 Introduction: Today is a Good Day to Fail 12 The Shift in a Calibration Standard 53 Technical Root Causes Behind Calibration Failures 134 Calibration Drift in Action: Industry-Specific Failures 195 New and Notorious Failures: Analytical Failure and Calibration Risk 796 Bad Data Leads to Bad Things Beyond the Lab 1057 M's Put to Use 1248 Universal Reasons for Failure 1319 Building Technical Safeguards 14310 Summation and Systemic Safeguards 15311 Historical Data Normalization Protocol 15912 External Audits and Peer Comparisons 16513 How to Build and Sustain This Culture 17114 Steps for Suggested Safeguards 17915 More Steps for Institutionalizing Retrospective Analysis 19916 Implementation & Culture Change – Embedding Calibration17 When Myth Gets It 22918 Bad Judgment and Being Where You Do Not Belong 24119 Calibration, Culture, and the Courage to Question 259Appendix 263Measurement Integrity Readiness Index (MIRI) 267Terminology 273Templates 277Detailed Checklists by Industry 283Interactive Workbook Section 291Calibration Integrity Maturity Model & Scoring System 295Recalibration Tracking Worksheets 299Error Reporting & CAPA Analysis Templates 301References and Source Documentation 303Index 309