ISPE Good Practice Guide: Asset Management cover image

ISPE Good Practice Guide: Asset Management

Published:November 2019

Pages:116

The ISPE Good Practice Guide: Asset Management provides practical guidance for establishing an asset management system that enables organizations to realize increased value from their assets, both physical and non-physical. This Guide identifies best practices in strategic asset management as outlined in the ISO 55000 series of standards. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach. This Guide provides recommendations, examples, and resources to help organizations in the development or improvement of their asset management system.

  • 1 Introduction
  • 1.1 Background
  • 1.2 Purpose and Objectives
  • 1.3 Scope
  • 1.4 Benefits
  • 1.5 Key Concepts/Terms
  • 2 Asset Management – Determination of Organizational Plans and Objectives
  • 2.1 Introduction
  • 2.2 Understanding the Organization and Its Objectives
  • 2.2.1 Asset-Related Factors that Inform Organizational Objectives
  • 2.2.2 Integrated Management System Approach
  • 2.3 Business Drivers
  • 2.4 Understanding the Stakeholders
  • 2.5 Setting the Scope of the Asset Management System
  • 2.6 Organizational Context
  • 2.6.1 External Stakeholders
  • 2.6.2 Internal Stakeholders
  • 2.6.3 Organization Lifecycle
  • 2.6.4 Asset Lifecycle of Facilities
  • 2.6.5 System and Asset Lifecycle
  • 2.6.6 Product Lifecycle
  • 2.7 Leadership, Behavior, and Change
  • 2.7.1 Organizational Design – Maximizing Asset Value
  • 2.7.2 Roles, Responsibilities, Relationships, and Interfaces
  • 3 Asset Management System – Setting Policy and Strategy
  • 3.1 Introduction
  • 3.2 Asset Strategy
  • 3.3 Asset Management Policy
  • 3.3.1 Asset Management Policy Development
  • 3.3.2 Asset Management Policy Contents
  • 3.4 Strategic Asset Management Objectives
  • 3.4.1 Organizational Context
  • 3.4.2 Asset Management Context
  • 3.4.3 Asset Management Objectives
  • 3.5 Strategic Asset Management Plan (Asset Management Strategy)
  • 3.6 Strategic Financial Planning
  • 3.6.1 Links with the SAMP
  • 3.6.2 Strategic CAPEX and OPEX Considerations
  • 3.7 Determination of Strategic Risk and Opportunities
  • 3.7.1 Demand Analysis
  • 3.7.2 Asset Risk Assessment
  • 3.7.3 Outsourcing
  • 3.8 Performance Evaluation
  • 3.8.1 Asset Performance
  • 3.8.2 Asset Management System Performance
  • 3.8.3 Context, Purpose, and Scope
  • 3.8.4 Lifecycle Value Realization
  • 4 Asset Management Plans – at the Operational Level
  • 4.1 Introduction
  • 4.2 Alignment with Organization Strategy
  • 4.2.1 Determination of Asset Portfolio
  • 4.3 Development of the Operations Asset Management Plan
  • 4.3.1 Site Asset Strategy
  • 4.3.2 Site CAPEX and OPEX Plan and Budget
  • 4.3.3 Investment Prioritization
  • 4.3.4 Asset Lifecycle
  • 4.4 Determination of Resources
  • 4.4.1 Communication and Awareness
  • 4.4.2 Competence Management and Training
  • 4.4.3 Information System and Technology Requirements
  • 4.4.4 Determination of Suppliers
  • 4.5 Asset Operation
  • 4.5.1 Condition Monitoring
  • 4.5.2 Maintenance and Calibration
  • 5 Asset Management Maturity – Journey to Operational Excellence
  • 5.1 Introduction
  • 5.2 Asset Management Maturity Level – Awareness
  • 5.2.1 Risk Management in the Awareness Level
  • 5.2.2 Key Asset Management Fundamentals in the Awareness Level
  • 5.2.3 Value in the Awareness Level
  • 5.3 Asset Management Maturity Level – Developing
  • 5.3.1 Risk Management in the Developing Level
  • 5.3.2 Key Asset Management Fundamentals in the Developing Level
  • 5.3.3 Value in the Developing Level
  • 5.4 Asset Management Maturity Level – Implementing
  • 5.4.1 Risk Management in the Implementing Level
  • 5.4.2 Key Asset Management Fundamentals in the Implementing Level
  • 5.4.3 Value in the Implementing Level
  • 5.5 Asset Management Maturity Level – Optimizing
  • 5.5.1 Risk Management in the Optimizing Level
  • 5.5.2 Key Asset Management Fundamentals in the Optimizing Level
  • 5.5.3 Value in the Optimizing Level
  • 5.6 Performance Evaluation and Improvement
  • 5.6.1 Performance Monitoring and Measuring
  • 5.6.2 Continual Improvement
  • 5.6.3 Examples
  • 6 Appendix 1 – Asset Management Policy: Additional Information
  • 7 Appendix 2 – Strategic Asset Management Plan (SAMP): Additional Information
  • 8 Appendix 3 – Asset Management Plan: Additional Information
  • 9 Appendix 4 – References
  • 10 Appendix 5 – Glossary
  • 10.1 Acronyms and Abbreviations
  • 10.2 Definitions
  • Michael Anderson, CMRP, Life Cycle Engineering, USA
  • Matthew J. Baldwin, Novo Nordisk, USA
  • Steve Bryan, AstraZeneca, United Kingdom
  • Michael S. Cheney, Biogen Idec, USA
  • John S. Hughes, CAI, USA
  • Scott D. Morris (Co-Lead), Sanofi, USA
  • Stephen E. O’Brien, Pfizer Inc., USA
  • Dr. Phillip Richardson, AstraZeneca, United Kingdom
  • Robert Smith (Co-Lead), International Isotopes Inc., USA

The pharmaceutical industry is a heavily regulated, asset-intensive industry with structured quality management systems and supporting business processes. Often it is difficult to determine how to best integrate the business processes and quality management system so that they work together to support the strategic objectives of the organization.

The ISO 55000 series of international standards for asset management (ISO 55000 [1], ISO 55001 [2], and ISO 55002 [3]) was first published in 2014 by the International Organization for Standardization (ISO) [4] and introduced the fundamentals of asset management and the supporting asset management system. These fundamentals, when integrated into the broader governance and risk framework of a pharmaceutical organization, can contribute tangible benefits and leverage opportunities. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach.

Effective control and governance of assets, physical and non-physical, by organizations is essential to realizing value through managing risk and opportunity in order to achieve the desired balance of cost, risk, and performance. The regulatory and legislative environment in which the pharmaceutical industry operates, with a focus on GMP, is increasingly challenging. The inherent risks that many assets present are constantly evolving.

The asset management system helps pharmaceutical operations to align the needs of stakeholders to the business. Whether it is the patients who need the drug products, the manufacturers who produce it, the regulators who ensure the products are safe, or the investors who fund the operations, all stakeholders should have confidence that the operation will support their needs.