Handbook of Investigation and Effective CAPA Systems:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
La Vergne
ASQ Quality Press
2022
|
| Ausgabe: | 3rd ed |
| Online-Zugang: | HWR01 |
| Beschreibung: | Description based on publisher supplied metadata and other sources |
| Beschreibung: | 1 Online-Ressource (257 Seiten) |
| ISBN: | 9781636940397 |
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| 505 | 8 | |a Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Preface to the Third Edition -- Acknowledgments -- Chapter 1. The Quality System and the Investigation and CAPA Element -- 1.1 THE QUALITY SYSTEM AND CAPA -- 1.2 INVESTIGATION AND CAPA RELATIONSHIP WITH OTHER QUALITY SUBSYSTEMS -- 1.3 NCR OR CAPA? INVESTIGATION PHASE VERSUS FIXING CAUSES -- 1.4 CORRECTIVE OR PREVENTIVE? -- 1.5 INVESTIGATION AND CAPA INVESTIGATION RELATIONSHIP WITH QUALITY CULTURE -- Chapter 2. Investigation and CAPA Requirements for the Life Sciences-Regulated Industry -- 2.1 FDA PHARMACEUTICAL CGMP -- 2.2 FDA MEDICAL DEVICES QSR -- 2.3 FDA QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT) -- 2.4 FDA GUIDANCE: INVESTIGATING OUT-OF-SPECIFICATION (OOS) TEST RESULTS FORPHARMACEUTICAL PRODUCTION -- 2.5 FDA GUIDANCE: QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS -- 2.6 EUROPEAN PHARMACEUTICAL GMP (EUDRALEX) VOLUME 4 -- 2.7 HARMONIZATION PROCESSES: ICH AND GHTF/IMDRF -- 2.8 ICH Q10: PHARMACEUTICAL QUALITY SYSTEM -- 2.9 ISO 13485 AND NON-US MEDICAL DEVICE REGULATIONS -- 2.10 GHTF QUALITY MANAGEMENT SYSTEM-MEDICAL DEVICES-GUIDANCE ON CORRECTIVE ACTION AND PREVENTIVE ACTION AND RELATED QMS PROCESSES -- 2.11 COMPLAINT INVESTIGATIONS: REGULATORY EXPECTATIONS AND BEST PRACTICES -- 2.12 CURRENT OBSERVATIONS AND REGULATORY TRENDS FOR INVESTIGATIONS AND CAPA SYSTEMS -- Chapter 3. ISO 9001:2015: Nonconformance and CAPA Requirements -- Chapter 4. Effective Investigation and CAPA Processes: From Problem Detection to Effectiveness Check -- 4.1 PROBLEM DETECTION: DISCOVERING PROBLEMS -- 4.1.1 Sources of Data about Product and Quality Issues -- 4.1.2 Initial Impact Assessment -- 4.1.3 Process Trending -- 4.2 PROBLEM INVESTIGATION: DISCOVERING ROOT CAUSES -- 4.2.1 Symptoms, Causal Factors, and Root Causes | |
| 505 | 8 | |a 4.2.2 Fixing Symptoms: Corrections -- 4.2.3 Problem Description -- 4.2.4 Barrier Analysis -- 4.2.5 Root Cause Identification Processes and Tools -- 4.2.6 Root Cause Categories -- 4.3 CAPA PLAN: CORRECTIVE AND PREVENTIVE ACTIONS TO FIX ROOT CAUSES -- 4.3.1 Establish Effective Corrective and Preventive Actions -- 4.3.2 Validation and Verification Prior to Implementation -- 4.3.3 Implementation of Corrective and Preventive Actions -- 4.4 EFFECTIVENESS EVALUATION -- 4.4.1 Verifying That Solutions Worked -- 4.4.2 Training Effectiveness -- 4.5 MANAGEMENT OF THE INVESTIGATION AND CAPA SYSTEM -- 4.5.1 Investigation and CAPA System Structure -- 4.5.2 Investigation and CAPA Process Metrics and the FDA's Quality Metrics Program -- 4.5.3 Risk Management and the Investigation and CAPA System -- 4.5.4 Management of External CAPA -- Chapter 5. Human Error Investigation and Reduction -- 5.1 ABOUT HUMAN ERROR: SOME STATISTICS -- 5.1.1. Data Integrity and Human Error -- 5.2 HUMAN ERROR AND THE HUMAN FACTOR -- 5.3 PSYCHOLOGY AND CLASSIFICATION OF HUMAN ERROR -- 5.4 HUMAN FACTORS -- 5.4.1 Compliance and Quality Culture -- 5.4.2 Workplace Involvement: Motivation and Attention -- 5.4.3 Adequate Supervision and Staffing -- 5.4.4 Procedures and Task Design -- 5.4.5 Training, Competence, and Performance -- 5.4.6 Examples of Human Factors in Process Operations -- 5.5 HOW ORGANIZATIONS DEAL WITH HUMAN ERRORS -- 5.6 INVESTIGATING HUMAN ERRORS -- 5.7 ROOT CAUSES RELATED TO HUMAN PERFORMANCE: PERSONAL FINDINGS WITHIN THE REGULATED INDUSTRY -- 5.8 HUMAN ERROR AND RETRAINING -- 5.9 WORKING FROM MEMORY -- 5.10 MULTITASKING AND HUMAN ERRORS -- 5.11 HOW TO REDUCE THE PROBABILITY OF HUMAN ERROR -- Chapter 6. Laboratory Investigations -- 6.1 INTRODUCTION TO QC LABORATORY INVESTIGATIONS AND CAPA -- 6.2 ANALYTICAL OOS INVESTIGATIONS -- 6.3 INVALIDATION OF TESTING RESULTS. | |
| 505 | 8 | |a Chapter 7. The Biggest Opportunities of the Investigation/CAPA System and How to Fix Them -- 7.1 LACK OF INVESTIGATION PLAN -- 7.2 TIMELINESS -- 7.3 EVERYTHING IS AN ISOLATED EVENT -- 7.4 ROOT CAUSE NOT IDENTIFIED -- 7.5 ROOT CAUSES IDENTIFIED BUT NOT CORRECTED -- 7.6 CORRECTING THE SYMPTOM INSTEAD OF THE CAUSE -- 7.7 LACK OF INTERIM ACTIONS -- 7.8 LACK OF TRUE PREVENTIVE ACTIONS -- 7.9 LACK OF EFFECTIVENESS VERIFICATION OF THE ACTION TAKEN -- 7.10 MULTIPLE CAPA SYSTEMS WITHOUT CORRELATION -- 7.11 OVERUSE AND ABUSE OF HUMAN ERROR AND RETRAINING -- 7.12 FOCUSING MORE ON THE SOFTWARE THAN ON THE INVESTIGATION AND CAPA SYSTEM -- Chapter 8. Developing an Internal Investigation and CAPA Expert Certification -- 8.1 CONTENT OF THE CERTIFICATION -- 8.2 EVALUATING THE EFFECTIVENESS OF INVESTIGATION AND CAPA TRAINING EFFORTS -- Chapter 9. Documenting Investigation and CAPA: Forms and Examples -- 9.1 CONTENT OF THE INVESTIGATION REPORT -- 9.2 CONTENT OF THE CAPA PLAN -- 9.3 COMPLIANCE WRITING -- 9.4 FORMS -- 9.4.1 Investigation Report -- 9.4.2 Root Cause Analysis Checklist -- 9.4.3 Human Error Investigation -- 9.4.4 CAPA Plan -- 9.4.5 Investigation Report Assessment -- 9.4.6 CAPA Plan Assessment -- 9.5 EXAMPLES OF INVESTIGATION REPORTS -- 9.6 EXAMPLES OF CAPA PLANS -- 9.7 FINAL RECOMMENDATIONS -- Appendix A -- Acronyms -- Glossary -- References -- Index -- About the Author | |
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Datensatz im Suchindex
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| author | Rodriguez-Perez, Jose (Pepe) |
| author_facet | Rodriguez-Perez, Jose (Pepe) |
| author_role | aut |
| author_sort | Rodriguez-Perez, Jose (Pepe) |
| author_variant | j p r p jpr jprp |
| building | Verbundindex |
| bvnumber | BV048831393 |
| collection | ZDB-30-PQE |
| contents | Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Preface to the Third Edition -- Acknowledgments -- Chapter 1. The Quality System and the Investigation and CAPA Element -- 1.1 THE QUALITY SYSTEM AND CAPA -- 1.2 INVESTIGATION AND CAPA RELATIONSHIP WITH OTHER QUALITY SUBSYSTEMS -- 1.3 NCR OR CAPA? INVESTIGATION PHASE VERSUS FIXING CAUSES -- 1.4 CORRECTIVE OR PREVENTIVE? -- 1.5 INVESTIGATION AND CAPA INVESTIGATION RELATIONSHIP WITH QUALITY CULTURE -- Chapter 2. Investigation and CAPA Requirements for the Life Sciences-Regulated Industry -- 2.1 FDA PHARMACEUTICAL CGMP -- 2.2 FDA MEDICAL DEVICES QSR -- 2.3 FDA QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT) -- 2.4 FDA GUIDANCE: INVESTIGATING OUT-OF-SPECIFICATION (OOS) TEST RESULTS FORPHARMACEUTICAL PRODUCTION -- 2.5 FDA GUIDANCE: QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS -- 2.6 EUROPEAN PHARMACEUTICAL GMP (EUDRALEX) VOLUME 4 -- 2.7 HARMONIZATION PROCESSES: ICH AND GHTF/IMDRF -- 2.8 ICH Q10: PHARMACEUTICAL QUALITY SYSTEM -- 2.9 ISO 13485 AND NON-US MEDICAL DEVICE REGULATIONS -- 2.10 GHTF QUALITY MANAGEMENT SYSTEM-MEDICAL DEVICES-GUIDANCE ON CORRECTIVE ACTION AND PREVENTIVE ACTION AND RELATED QMS PROCESSES -- 2.11 COMPLAINT INVESTIGATIONS: REGULATORY EXPECTATIONS AND BEST PRACTICES -- 2.12 CURRENT OBSERVATIONS AND REGULATORY TRENDS FOR INVESTIGATIONS AND CAPA SYSTEMS -- Chapter 3. ISO 9001:2015: Nonconformance and CAPA Requirements -- Chapter 4. Effective Investigation and CAPA Processes: From Problem Detection to Effectiveness Check -- 4.1 PROBLEM DETECTION: DISCOVERING PROBLEMS -- 4.1.1 Sources of Data about Product and Quality Issues -- 4.1.2 Initial Impact Assessment -- 4.1.3 Process Trending -- 4.2 PROBLEM INVESTIGATION: DISCOVERING ROOT CAUSES -- 4.2.1 Symptoms, Causal Factors, and Root Causes 4.2.2 Fixing Symptoms: Corrections -- 4.2.3 Problem Description -- 4.2.4 Barrier Analysis -- 4.2.5 Root Cause Identification Processes and Tools -- 4.2.6 Root Cause Categories -- 4.3 CAPA PLAN: CORRECTIVE AND PREVENTIVE ACTIONS TO FIX ROOT CAUSES -- 4.3.1 Establish Effective Corrective and Preventive Actions -- 4.3.2 Validation and Verification Prior to Implementation -- 4.3.3 Implementation of Corrective and Preventive Actions -- 4.4 EFFECTIVENESS EVALUATION -- 4.4.1 Verifying That Solutions Worked -- 4.4.2 Training Effectiveness -- 4.5 MANAGEMENT OF THE INVESTIGATION AND CAPA SYSTEM -- 4.5.1 Investigation and CAPA System Structure -- 4.5.2 Investigation and CAPA Process Metrics and the FDA's Quality Metrics Program -- 4.5.3 Risk Management and the Investigation and CAPA System -- 4.5.4 Management of External CAPA -- Chapter 5. Human Error Investigation and Reduction -- 5.1 ABOUT HUMAN ERROR: SOME STATISTICS -- 5.1.1. Data Integrity and Human Error -- 5.2 HUMAN ERROR AND THE HUMAN FACTOR -- 5.3 PSYCHOLOGY AND CLASSIFICATION OF HUMAN ERROR -- 5.4 HUMAN FACTORS -- 5.4.1 Compliance and Quality Culture -- 5.4.2 Workplace Involvement: Motivation and Attention -- 5.4.3 Adequate Supervision and Staffing -- 5.4.4 Procedures and Task Design -- 5.4.5 Training, Competence, and Performance -- 5.4.6 Examples of Human Factors in Process Operations -- 5.5 HOW ORGANIZATIONS DEAL WITH HUMAN ERRORS -- 5.6 INVESTIGATING HUMAN ERRORS -- 5.7 ROOT CAUSES RELATED TO HUMAN PERFORMANCE: PERSONAL FINDINGS WITHIN THE REGULATED INDUSTRY -- 5.8 HUMAN ERROR AND RETRAINING -- 5.9 WORKING FROM MEMORY -- 5.10 MULTITASKING AND HUMAN ERRORS -- 5.11 HOW TO REDUCE THE PROBABILITY OF HUMAN ERROR -- Chapter 6. Laboratory Investigations -- 6.1 INTRODUCTION TO QC LABORATORY INVESTIGATIONS AND CAPA -- 6.2 ANALYTICAL OOS INVESTIGATIONS -- 6.3 INVALIDATION OF TESTING RESULTS. Chapter 7. The Biggest Opportunities of the Investigation/CAPA System and How to Fix Them -- 7.1 LACK OF INVESTIGATION PLAN -- 7.2 TIMELINESS -- 7.3 EVERYTHING IS AN ISOLATED EVENT -- 7.4 ROOT CAUSE NOT IDENTIFIED -- 7.5 ROOT CAUSES IDENTIFIED BUT NOT CORRECTED -- 7.6 CORRECTING THE SYMPTOM INSTEAD OF THE CAUSE -- 7.7 LACK OF INTERIM ACTIONS -- 7.8 LACK OF TRUE PREVENTIVE ACTIONS -- 7.9 LACK OF EFFECTIVENESS VERIFICATION OF THE ACTION TAKEN -- 7.10 MULTIPLE CAPA SYSTEMS WITHOUT CORRELATION -- 7.11 OVERUSE AND ABUSE OF HUMAN ERROR AND RETRAINING -- 7.12 FOCUSING MORE ON THE SOFTWARE THAN ON THE INVESTIGATION AND CAPA SYSTEM -- Chapter 8. Developing an Internal Investigation and CAPA Expert Certification -- 8.1 CONTENT OF THE CERTIFICATION -- 8.2 EVALUATING THE EFFECTIVENESS OF INVESTIGATION AND CAPA TRAINING EFFORTS -- Chapter 9. Documenting Investigation and CAPA: Forms and Examples -- 9.1 CONTENT OF THE INVESTIGATION REPORT -- 9.2 CONTENT OF THE CAPA PLAN -- 9.3 COMPLIANCE WRITING -- 9.4 FORMS -- 9.4.1 Investigation Report -- 9.4.2 Root Cause Analysis Checklist -- 9.4.3 Human Error Investigation -- 9.4.4 CAPA Plan -- 9.4.5 Investigation Report Assessment -- 9.4.6 CAPA Plan Assessment -- 9.5 EXAMPLES OF INVESTIGATION REPORTS -- 9.6 EXAMPLES OF CAPA PLANS -- 9.7 FINAL RECOMMENDATIONS -- Appendix A -- Acronyms -- Glossary -- References -- Index -- About the Author |
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| dewey-full | 615.1068/1-DC23 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-search | 615.1068/1-dc23 |
| dewey-sort | 3615.1068 11 DC 223 |
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| discipline | Medizin |
| discipline_str_mv | Medizin |
| edition | 3rd ed |
| format | Electronic eBook |
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Human Error Investigation and Reduction -- 5.1 ABOUT HUMAN ERROR: SOME STATISTICS -- 5.1.1. Data Integrity and Human Error -- 5.2 HUMAN ERROR AND THE HUMAN FACTOR -- 5.3 PSYCHOLOGY AND CLASSIFICATION OF HUMAN ERROR -- 5.4 HUMAN FACTORS -- 5.4.1 Compliance and Quality Culture -- 5.4.2 Workplace Involvement: Motivation and Attention -- 5.4.3 Adequate Supervision and Staffing -- 5.4.4 Procedures and Task Design -- 5.4.5 Training, Competence, and Performance -- 5.4.6 Examples of Human Factors in Process Operations -- 5.5 HOW ORGANIZATIONS DEAL WITH HUMAN ERRORS -- 5.6 INVESTIGATING HUMAN ERRORS -- 5.7 ROOT CAUSES RELATED TO HUMAN PERFORMANCE: PERSONAL FINDINGS WITHIN THE REGULATED INDUSTRY -- 5.8 HUMAN ERROR AND RETRAINING -- 5.9 WORKING FROM MEMORY -- 5.10 MULTITASKING AND HUMAN ERRORS -- 5.11 HOW TO REDUCE THE PROBABILITY OF HUMAN ERROR -- Chapter 6. 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| id | DE-604.BV048831393 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T21:35:29Z |
| indexdate | 2024-07-10T09:47:12Z |
| institution | BVB |
| isbn | 9781636940397 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-034096971 |
| oclc_num | 1356006318 |
| open_access_boolean | |
| owner | DE-2070s |
| owner_facet | DE-2070s |
| physical | 1 Online-Ressource (257 Seiten) |
| psigel | ZDB-30-PQE ZDB-30-PQE HWR_PDA_PQE |
| publishDate | 2022 |
| publishDateSearch | 2022 |
| publishDateSort | 2022 |
| publisher | ASQ Quality Press |
| record_format | marc |
| spelling | Rodriguez-Perez, Jose (Pepe) Verfasser aut Handbook of Investigation and Effective CAPA Systems 3rd ed La Vergne ASQ Quality Press 2022 ©2022 1 Online-Ressource (257 Seiten) txt rdacontent c rdamedia cr rdacarrier Description based on publisher supplied metadata and other sources Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Preface to the Third Edition -- Acknowledgments -- Chapter 1. The Quality System and the Investigation and CAPA Element -- 1.1 THE QUALITY SYSTEM AND CAPA -- 1.2 INVESTIGATION AND CAPA RELATIONSHIP WITH OTHER QUALITY SUBSYSTEMS -- 1.3 NCR OR CAPA? INVESTIGATION PHASE VERSUS FIXING CAUSES -- 1.4 CORRECTIVE OR PREVENTIVE? -- 1.5 INVESTIGATION AND CAPA INVESTIGATION RELATIONSHIP WITH QUALITY CULTURE -- Chapter 2. Investigation and CAPA Requirements for the Life Sciences-Regulated Industry -- 2.1 FDA PHARMACEUTICAL CGMP -- 2.2 FDA MEDICAL DEVICES QSR -- 2.3 FDA QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT) -- 2.4 FDA GUIDANCE: INVESTIGATING OUT-OF-SPECIFICATION (OOS) TEST RESULTS FORPHARMACEUTICAL PRODUCTION -- 2.5 FDA GUIDANCE: QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS -- 2.6 EUROPEAN PHARMACEUTICAL GMP (EUDRALEX) VOLUME 4 -- 2.7 HARMONIZATION PROCESSES: ICH AND GHTF/IMDRF -- 2.8 ICH Q10: PHARMACEUTICAL QUALITY SYSTEM -- 2.9 ISO 13485 AND NON-US MEDICAL DEVICE REGULATIONS -- 2.10 GHTF QUALITY MANAGEMENT SYSTEM-MEDICAL DEVICES-GUIDANCE ON CORRECTIVE ACTION AND PREVENTIVE ACTION AND RELATED QMS PROCESSES -- 2.11 COMPLAINT INVESTIGATIONS: REGULATORY EXPECTATIONS AND BEST PRACTICES -- 2.12 CURRENT OBSERVATIONS AND REGULATORY TRENDS FOR INVESTIGATIONS AND CAPA SYSTEMS -- Chapter 3. ISO 9001:2015: Nonconformance and CAPA Requirements -- Chapter 4. Effective Investigation and CAPA Processes: From Problem Detection to Effectiveness Check -- 4.1 PROBLEM DETECTION: DISCOVERING PROBLEMS -- 4.1.1 Sources of Data about Product and Quality Issues -- 4.1.2 Initial Impact Assessment -- 4.1.3 Process Trending -- 4.2 PROBLEM INVESTIGATION: DISCOVERING ROOT CAUSES -- 4.2.1 Symptoms, Causal Factors, and Root Causes 4.2.2 Fixing Symptoms: Corrections -- 4.2.3 Problem Description -- 4.2.4 Barrier Analysis -- 4.2.5 Root Cause Identification Processes and Tools -- 4.2.6 Root Cause Categories -- 4.3 CAPA PLAN: CORRECTIVE AND PREVENTIVE ACTIONS TO FIX ROOT CAUSES -- 4.3.1 Establish Effective Corrective and Preventive Actions -- 4.3.2 Validation and Verification Prior to Implementation -- 4.3.3 Implementation of Corrective and Preventive Actions -- 4.4 EFFECTIVENESS EVALUATION -- 4.4.1 Verifying That Solutions Worked -- 4.4.2 Training Effectiveness -- 4.5 MANAGEMENT OF THE INVESTIGATION AND CAPA SYSTEM -- 4.5.1 Investigation and CAPA System Structure -- 4.5.2 Investigation and CAPA Process Metrics and the FDA's Quality Metrics Program -- 4.5.3 Risk Management and the Investigation and CAPA System -- 4.5.4 Management of External CAPA -- Chapter 5. Human Error Investigation and Reduction -- 5.1 ABOUT HUMAN ERROR: SOME STATISTICS -- 5.1.1. Data Integrity and Human Error -- 5.2 HUMAN ERROR AND THE HUMAN FACTOR -- 5.3 PSYCHOLOGY AND CLASSIFICATION OF HUMAN ERROR -- 5.4 HUMAN FACTORS -- 5.4.1 Compliance and Quality Culture -- 5.4.2 Workplace Involvement: Motivation and Attention -- 5.4.3 Adequate Supervision and Staffing -- 5.4.4 Procedures and Task Design -- 5.4.5 Training, Competence, and Performance -- 5.4.6 Examples of Human Factors in Process Operations -- 5.5 HOW ORGANIZATIONS DEAL WITH HUMAN ERRORS -- 5.6 INVESTIGATING HUMAN ERRORS -- 5.7 ROOT CAUSES RELATED TO HUMAN PERFORMANCE: PERSONAL FINDINGS WITHIN THE REGULATED INDUSTRY -- 5.8 HUMAN ERROR AND RETRAINING -- 5.9 WORKING FROM MEMORY -- 5.10 MULTITASKING AND HUMAN ERRORS -- 5.11 HOW TO REDUCE THE PROBABILITY OF HUMAN ERROR -- Chapter 6. Laboratory Investigations -- 6.1 INTRODUCTION TO QC LABORATORY INVESTIGATIONS AND CAPA -- 6.2 ANALYTICAL OOS INVESTIGATIONS -- 6.3 INVALIDATION OF TESTING RESULTS. Chapter 7. The Biggest Opportunities of the Investigation/CAPA System and How to Fix Them -- 7.1 LACK OF INVESTIGATION PLAN -- 7.2 TIMELINESS -- 7.3 EVERYTHING IS AN ISOLATED EVENT -- 7.4 ROOT CAUSE NOT IDENTIFIED -- 7.5 ROOT CAUSES IDENTIFIED BUT NOT CORRECTED -- 7.6 CORRECTING THE SYMPTOM INSTEAD OF THE CAUSE -- 7.7 LACK OF INTERIM ACTIONS -- 7.8 LACK OF TRUE PREVENTIVE ACTIONS -- 7.9 LACK OF EFFECTIVENESS VERIFICATION OF THE ACTION TAKEN -- 7.10 MULTIPLE CAPA SYSTEMS WITHOUT CORRELATION -- 7.11 OVERUSE AND ABUSE OF HUMAN ERROR AND RETRAINING -- 7.12 FOCUSING MORE ON THE SOFTWARE THAN ON THE INVESTIGATION AND CAPA SYSTEM -- Chapter 8. Developing an Internal Investigation and CAPA Expert Certification -- 8.1 CONTENT OF THE CERTIFICATION -- 8.2 EVALUATING THE EFFECTIVENESS OF INVESTIGATION AND CAPA TRAINING EFFORTS -- Chapter 9. Documenting Investigation and CAPA: Forms and Examples -- 9.1 CONTENT OF THE INVESTIGATION REPORT -- 9.2 CONTENT OF THE CAPA PLAN -- 9.3 COMPLIANCE WRITING -- 9.4 FORMS -- 9.4.1 Investigation Report -- 9.4.2 Root Cause Analysis Checklist -- 9.4.3 Human Error Investigation -- 9.4.4 CAPA Plan -- 9.4.5 Investigation Report Assessment -- 9.4.6 CAPA Plan Assessment -- 9.5 EXAMPLES OF INVESTIGATION REPORTS -- 9.6 EXAMPLES OF CAPA PLANS -- 9.7 FINAL RECOMMENDATIONS -- Appendix A -- Acronyms -- Glossary -- References -- Index -- About the Author Erscheint auch als Druck-Ausgabe Rodriguez-Perez, Jose (Pepe) Handbook of Investigation and Effective CAPA Systems La Vergne : ASQ Quality Press,c2022 9781636940113 |
| spellingShingle | Rodriguez-Perez, Jose (Pepe) Handbook of Investigation and Effective CAPA Systems Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Preface to the Third Edition -- Acknowledgments -- Chapter 1. The Quality System and the Investigation and CAPA Element -- 1.1 THE QUALITY SYSTEM AND CAPA -- 1.2 INVESTIGATION AND CAPA RELATIONSHIP WITH OTHER QUALITY SUBSYSTEMS -- 1.3 NCR OR CAPA? INVESTIGATION PHASE VERSUS FIXING CAUSES -- 1.4 CORRECTIVE OR PREVENTIVE? -- 1.5 INVESTIGATION AND CAPA INVESTIGATION RELATIONSHIP WITH QUALITY CULTURE -- Chapter 2. Investigation and CAPA Requirements for the Life Sciences-Regulated Industry -- 2.1 FDA PHARMACEUTICAL CGMP -- 2.2 FDA MEDICAL DEVICES QSR -- 2.3 FDA QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT) -- 2.4 FDA GUIDANCE: INVESTIGATING OUT-OF-SPECIFICATION (OOS) TEST RESULTS FORPHARMACEUTICAL PRODUCTION -- 2.5 FDA GUIDANCE: QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS -- 2.6 EUROPEAN PHARMACEUTICAL GMP (EUDRALEX) VOLUME 4 -- 2.7 HARMONIZATION PROCESSES: ICH AND GHTF/IMDRF -- 2.8 ICH Q10: PHARMACEUTICAL QUALITY SYSTEM -- 2.9 ISO 13485 AND NON-US MEDICAL DEVICE REGULATIONS -- 2.10 GHTF QUALITY MANAGEMENT SYSTEM-MEDICAL DEVICES-GUIDANCE ON CORRECTIVE ACTION AND PREVENTIVE ACTION AND RELATED QMS PROCESSES -- 2.11 COMPLAINT INVESTIGATIONS: REGULATORY EXPECTATIONS AND BEST PRACTICES -- 2.12 CURRENT OBSERVATIONS AND REGULATORY TRENDS FOR INVESTIGATIONS AND CAPA SYSTEMS -- Chapter 3. ISO 9001:2015: Nonconformance and CAPA Requirements -- Chapter 4. Effective Investigation and CAPA Processes: From Problem Detection to Effectiveness Check -- 4.1 PROBLEM DETECTION: DISCOVERING PROBLEMS -- 4.1.1 Sources of Data about Product and Quality Issues -- 4.1.2 Initial Impact Assessment -- 4.1.3 Process Trending -- 4.2 PROBLEM INVESTIGATION: DISCOVERING ROOT CAUSES -- 4.2.1 Symptoms, Causal Factors, and Root Causes 4.2.2 Fixing Symptoms: Corrections -- 4.2.3 Problem Description -- 4.2.4 Barrier Analysis -- 4.2.5 Root Cause Identification Processes and Tools -- 4.2.6 Root Cause Categories -- 4.3 CAPA PLAN: CORRECTIVE AND PREVENTIVE ACTIONS TO FIX ROOT CAUSES -- 4.3.1 Establish Effective Corrective and Preventive Actions -- 4.3.2 Validation and Verification Prior to Implementation -- 4.3.3 Implementation of Corrective and Preventive Actions -- 4.4 EFFECTIVENESS EVALUATION -- 4.4.1 Verifying That Solutions Worked -- 4.4.2 Training Effectiveness -- 4.5 MANAGEMENT OF THE INVESTIGATION AND CAPA SYSTEM -- 4.5.1 Investigation and CAPA System Structure -- 4.5.2 Investigation and CAPA Process Metrics and the FDA's Quality Metrics Program -- 4.5.3 Risk Management and the Investigation and CAPA System -- 4.5.4 Management of External CAPA -- Chapter 5. Human Error Investigation and Reduction -- 5.1 ABOUT HUMAN ERROR: SOME STATISTICS -- 5.1.1. Data Integrity and Human Error -- 5.2 HUMAN ERROR AND THE HUMAN FACTOR -- 5.3 PSYCHOLOGY AND CLASSIFICATION OF HUMAN ERROR -- 5.4 HUMAN FACTORS -- 5.4.1 Compliance and Quality Culture -- 5.4.2 Workplace Involvement: Motivation and Attention -- 5.4.3 Adequate Supervision and Staffing -- 5.4.4 Procedures and Task Design -- 5.4.5 Training, Competence, and Performance -- 5.4.6 Examples of Human Factors in Process Operations -- 5.5 HOW ORGANIZATIONS DEAL WITH HUMAN ERRORS -- 5.6 INVESTIGATING HUMAN ERRORS -- 5.7 ROOT CAUSES RELATED TO HUMAN PERFORMANCE: PERSONAL FINDINGS WITHIN THE REGULATED INDUSTRY -- 5.8 HUMAN ERROR AND RETRAINING -- 5.9 WORKING FROM MEMORY -- 5.10 MULTITASKING AND HUMAN ERRORS -- 5.11 HOW TO REDUCE THE PROBABILITY OF HUMAN ERROR -- Chapter 6. Laboratory Investigations -- 6.1 INTRODUCTION TO QC LABORATORY INVESTIGATIONS AND CAPA -- 6.2 ANALYTICAL OOS INVESTIGATIONS -- 6.3 INVALIDATION OF TESTING RESULTS. Chapter 7. The Biggest Opportunities of the Investigation/CAPA System and How to Fix Them -- 7.1 LACK OF INVESTIGATION PLAN -- 7.2 TIMELINESS -- 7.3 EVERYTHING IS AN ISOLATED EVENT -- 7.4 ROOT CAUSE NOT IDENTIFIED -- 7.5 ROOT CAUSES IDENTIFIED BUT NOT CORRECTED -- 7.6 CORRECTING THE SYMPTOM INSTEAD OF THE CAUSE -- 7.7 LACK OF INTERIM ACTIONS -- 7.8 LACK OF TRUE PREVENTIVE ACTIONS -- 7.9 LACK OF EFFECTIVENESS VERIFICATION OF THE ACTION TAKEN -- 7.10 MULTIPLE CAPA SYSTEMS WITHOUT CORRELATION -- 7.11 OVERUSE AND ABUSE OF HUMAN ERROR AND RETRAINING -- 7.12 FOCUSING MORE ON THE SOFTWARE THAN ON THE INVESTIGATION AND CAPA SYSTEM -- Chapter 8. Developing an Internal Investigation and CAPA Expert Certification -- 8.1 CONTENT OF THE CERTIFICATION -- 8.2 EVALUATING THE EFFECTIVENESS OF INVESTIGATION AND CAPA TRAINING EFFORTS -- Chapter 9. Documenting Investigation and CAPA: Forms and Examples -- 9.1 CONTENT OF THE INVESTIGATION REPORT -- 9.2 CONTENT OF THE CAPA PLAN -- 9.3 COMPLIANCE WRITING -- 9.4 FORMS -- 9.4.1 Investigation Report -- 9.4.2 Root Cause Analysis Checklist -- 9.4.3 Human Error Investigation -- 9.4.4 CAPA Plan -- 9.4.5 Investigation Report Assessment -- 9.4.6 CAPA Plan Assessment -- 9.5 EXAMPLES OF INVESTIGATION REPORTS -- 9.6 EXAMPLES OF CAPA PLANS -- 9.7 FINAL RECOMMENDATIONS -- Appendix A -- Acronyms -- Glossary -- References -- Index -- About the Author |
| title | Handbook of Investigation and Effective CAPA Systems |
| title_auth | Handbook of Investigation and Effective CAPA Systems |
| title_exact_search | Handbook of Investigation and Effective CAPA Systems |
| title_exact_search_txtP | Handbook of Investigation and Effective CAPA Systems |
| title_full | Handbook of Investigation and Effective CAPA Systems |
| title_fullStr | Handbook of Investigation and Effective CAPA Systems |
| title_full_unstemmed | Handbook of Investigation and Effective CAPA Systems |
| title_short | Handbook of Investigation and Effective CAPA Systems |
| title_sort | handbook of investigation and effective capa systems |
| work_keys_str_mv | AT rodriguezperezjosepepe handbookofinvestigationandeffectivecapasystems |