Breakout Session A. Asset Management Best Practices and What Trends You Should Know (ISO 55000: Asset Management)

Transcription

1 Breakout Session A Asset Management Best Practices and What Trends You Should Know (ISO 55000: Asset Management)

2 Life Science Leader magazine February 2014

3 Where is the time/energy of FDA? Inspections increasing: Office of Generics Drugs created, Office of Pharmaceutical Quality created Service provided? Outsourcing is increasing; Placing more emphasis on Quality Systems as more services are contracted to vendors So Agency scrutiny is increasing and outsourcing is increasing; what is the industry doing to ensure a high level of quality is maintained?

4 What are some of the recognized standards that apply to Cal & Maint. in our industry? ISO 9000: Quality Management 20 years ago this was a requirement ISO 17025: General Requirements for Testing & Calibration Laboratories Established in Used by industry to qualify calibration service providers

5 What are some of the Asset Management Standards? ISO 55000: Asset Management New. Issued on January 24 th 31 countries involved Multiple industries on committee

6 What is ISO 55000? The ISO series will comprise three standards: ISO provides an overview of the subject of asset management and the standard terms and definitions to be used. ISO is the requirements specification for an integrated, effective management system for assets. Note: defines requirements for a management system, in the same way as ISO 9001 specifies a quality management system, and ISO covers an environmental management system. ISO is not, therefore, a specification for an asset information management system (sometimes called "enterprise asset management" system). IS provides guidance for the implementation of such a system.

7 What is an Asset? Assets, and value realized from them, are the basis for any organization delivering what it aims to do. Whether public or private sector, and whether the assets are physical, financial, human or 'intangible', it is good asset management that maximizes value-formoney and satisfaction of stakeholders expectations. It involves the coordinated and optimized planning, asset selection, acquisition/development, utilization, care (maintenance) and ultimate disposal or renewal of the appropriate assets and asset systems. Insights into the integration and optimization of asset management have developed since the 1990s (from the North Sea oil & gas industry and the Australian public sector), to identify a range of essential business processes, alignment activities and system integration features that yield very significant performance benefits.

8 Benefits of Optimized Asset Management The tangible results of joined-up, risk-based, whole life cycle asset management are increasingly proven around the world. They include: Alignment of processes, resources and functional contributions (instead of departmental silos and competing, short-term priorities) Creating a transparent audit trail for what is done, when and why. Better understanding and usage of data and information to provide informed and consistent decisions. Improved Financial planning (capital expenditure) Consistent, prioritized and auditable risk management. Alignment and coordination of existing initiatives, including competency development. Greater engagement of the workforce, including leadership, communications and cross-disciplinary teamwork.

9 Background What is ISO ISO (International Organization for Standardization) World s largest developer of voluntary International Standards Network of 163 national standards bodies. ISO is derived from the Greek isos, meaning equal. Based in Geneva Switzerland Goal is to Respond to a need in the market

10 Asset Control: Challenges Questions Do you know the total cost of ownership for assets? Does your CMMS system calculate RAV or replacement asset value? Do you know the capital asset dollar limits at your site? Are your CMMS assets aligned with your sites financial system s asset list? If not, how are these reconciled? How are instruments inducted into your program? Does your site have issues related to lost instruments? Does your site have issues with instruments being purchased without the calibration department s knowledge?