ISO 55000 ISPE NJ – November 2014

ISO 55000
ISPE NJ – November 2014
ISO 55000 - Background
• PAS55 parts 1 and 2
– UK Standard on managing physical assets
• Development of ISO standard began in 2010
– Pharma incorporated into US TAG (technical
advisory group) through representation from
• ISO55000 parts 1-3 released in 2014
ISO 55000 - Background
• ISO 55000:2014 Asset management -- Overview, principles and
– Provides an overview of asset management, its principles and terminology, and
the expected benefits from adopting asset management.
• ISO 55001:2014 Asset management -- Management systems –
– Specifies requirements for an asset management system within the context of
the organization.
• ISO 55002:2014 Asset management -- Management systems -- Guidelines
for the application of ISO 55001
– Provides guidance for the application of an asset management system, in
accordance with the requirements of ISO 55001.
ISO 55000 - Asset Management
System - Timeline
Source: IMC2013
ISO 55000 – Asset Management
• Asset
– Anything which adds potential or actual value
• Physical
• Financial
• Intellectual
• Asset Management
– The Balance of cost, opportunities, and risk
against desired performance of assets to achieve
the organizational objectives
ISO 55000
• Focused on the value proposition of assets
• Scalable for any organizational size
• Does not define how, only what
ISO 55000
• International Standard for Asset Management
Managing the
Organizational objectives
Aligned with Organizational
Asset Management
Asset Management
Asset Portfolio
Policy, objectives, and processes
to achieve objectives
Coordinated activities to realize
value in alignment with objectives
Assets that exist as part of the
portfolio which require strategic
asset management
Asset Portfolio
• Understanding of criticality
– Business value proposition
– Risk
• Definition of value expectation
• Design for total cost of ownership
– Not cradle to grave but lust to dust
Managing Assets Responsibly
Final Design/
Close-out/ Startup
95% of Life Cycle Costs are determined by engineering decisions made before the plant is even built!
By the way costs to operate and maintain an asset are 60-80% of total Life Cycle Costs,
Still we place too much importance on acquisition costs of assets
Asset Management System
• Development of Asset Management Policy
and Directives
– In alignment with ISO 55000
• Assessment of value delivery
– Metrics
– Re-assessment of strategy
Certification vs. Alignment
• Alignment
– Standardized approach
– Reduced LCC
– Safety
– Environmental
– Stays at business unit level
• Certification
– Potentially lower insurance premiums
– Possible risk if imbedded in quality structure
The BMS Rx Approach
• Corporate Policy on Asset Management
• Directives for core practices
Asset criticality
Alignment and balancing
Lubrication practices
Storeroom management
EAM utilization and data integrity
• Site owned improvement
• Common understanding and lexicon
– Uptime Elements
Backup Slides