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 44
- Acknowledgements 55
- Table of Contents 77
- 1 Introduction 99
- 2 Philosophy and Key Concepts 1313
- 3 Maintenance Basic Practices, Maintenance Good Practices, and Maintenance Best Practices 2121
- 4 Maintenance Program 2525
- 5 Maintenance Management 3737
- 5.1 Information Requirements 3737
- 5.2 Records for Equipment, Systems, and Facilities 3838
- 5.3 Human Resources 3838
- 5.4 Planned Maintenance 3939
- 5.5 Spare Parts 4040
- 5.6 Paper Based Maintenance Management Systems 4343
- 5.7 Computerized Maintenance Management Systems 4444
- 5.8 Maintenance Documentation 4545
- 6 Work Execution 4747
- 6.1 Work Order Management 4747
- 6.1.1 Work Request 4848
- 6.1.2 Typical Work Request to Work Order Flow Chart 4848
- 6.1.3 Information Requirements for Work Requests 4949
- 6.1.4 Work Order 5050
- 6.1.5 Information Requirements for Work Orders 5050
- 6.1.6 Planning and Scheduling 5151
- 6.1.7 Requirements for Planning and Scheduling 5252
- 6.1.8 Information Requirements for Planning and Scheduling 5353
- 6.1.9 Work Order Completion 5353
- 6.1.10 Information Requirements for Work Order Closure 5454
- 6.1.11 Information Requirements for Work Order Closure 5656
- 6.1.12 Emergency Work Management 5656
- 6.1.13 Typical Features of Emergency Work Processes 5656
- 6.1.14 Performance Measurement – Key Performance Indicators 5757
- 6.2 Self Inspection and Continuous Improvement 5757
- 6.3 Contract Management and Outsourcing 5858
- 6.4 Change Management 6060
- 7 Roles, Responsibilities, and Interfaces 6363
- 8 Training 6767
- 9 Appendix 1 – Regulatory Citations 7171
- 10 Appendix 2 – Environmental, Health, and Safety in a Maintenance Environment 7777
- 11 Appendix 3 – Science-Based Quality Risk Management 8585
- 12 Appendix 4 – Maintenance Templates and Examples 9393
- 13 Appendix 5 – Glossary and Acronyms 9999
- 14 Appendix 6 – References 105105
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