Good Practice Guide: Maintenance
Title:
Good Practice Guide: Maintenance
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Author(s): Calitri, Chaz; Orombelli, Pietro; Adrian, Lawrence; Augen, Alberto; Bradney, Martin; Brodowski, Tom; Cappelle, Thomas; Clark, Dennis; Jackson, W. Michael; Jordan, Mark; Lennon, Robert; Ranieri, Tonino; Rodriguez, Constantino; Rolandi, Claudio; Styles, Andrew; Wessel, Mark; Wittmann, George
The ISPE Good Practice Guide: Maintenance provides practical solutions and tools for ensuring quality and compliance of maintenance operations in a regulated industry. Covering current and established practices, this guide helps achieve technical and regulatory accuracy and cost-effective compliance in a new or an existing maintenance program for effective strategy and efficiency. Offering maximum flexibility, this guide clearly helps define roles and responsibilities across cross-functional areas and recommends a systematic approach aimed at continuous improvement of maintenance operations. The Guide is focused on maintenance in cGMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program. The Guide seeks to enable widespread adaptation and encourage innovation.
Table of Contents
Good Practice Guide: Maintenance
- Preface 24
- Acknowledgements 35
- Table of Contents 57
- 1 Introduction 79
- 2 Philosophy and Key Concepts 1113
- 3 Maintenance Basic Practices, Maintenance Good Practices, and Maintenance Best Practices 1921
- 4 Maintenance Program 2325
- 5 Maintenance Management 3537
- 5.1 Information Requirements 3537
- 5.2 Records for Equipment, Systems, and Facilities 3638
- 5.3 Human Resources 3638
- 5.4 Planned Maintenance 3739
- 5.5 Spare Parts 3840
- 5.6 Paper Based Maintenance Management Systems 4143
- 5.7 Computerized Maintenance Management Systems 4244
- 5.8 Maintenance Documentation 4345
- 6 Work Execution 4547
- 6.1 Work Order Management 4547
- 6.1.1 Work Request 4648
- 6.1.2 Typical Work Request to Work Order Flow Chart 4648
- 6.1.3 Information Requirements for Work Requests 4749
- 6.1.4 Work Order 4850
- 6.1.5 Information Requirements for Work Orders 4850
- 6.1.6 Planning and Scheduling 4951
- 6.1.7 Requirements for Planning and Scheduling 5052
- 6.1.8 Information Requirements for Planning and Scheduling 5153
- 6.1.9 Work Order Completion 5153
- 6.1.10 Information Requirements for Work Order Closure 5254
- 6.1.11 Information Requirements for Work Order Closure 5456
- 6.1.12 Emergency Work Management 5456
- 6.1.13 Typical Features of Emergency Work Processes 5456
- 6.1.14 Performance Measurement – Key Performance Indicators 5557
- 6.2 Self Inspection and Continuous Improvement 5557
- 6.3 Contract Management and Outsourcing 5658
- 6.4 Change Management 5860
- 7 Roles, Responsibilities, and Interfaces 6163
- 8 Training 6567
- 9 Appendix 1 – Regulatory Citations 6971
- 10 Appendix 2 – Environmental, Health, and Safety in a Maintenance Environment 7577
- 11 Appendix 3 – Science-Based Quality Risk Management 8385
- 12 Appendix 4 – Maintenance Templates and Examples 9193
- 13 Appendix 5 – Glossary and Acronyms 9799
- 14 Appendix 6 – References 103105
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