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 Genzyme

• ISO55000 parts 1-3 released in 2014

ISO 55000 - Background

• ISO 55000:2014 Asset management -- Overview, principles and

terminology

– 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 –

Requirements

– 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

5

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

7

Managing the Organizational objectives

Asset Management Objectives

Asset Management System

Asset Management

Asset Portfolio Assets that exist as part of the portfolio which require strategic

asset management

Policy, objectives, and processes to achieve objectives

Aligned with Organizational Objectives

Coordinated activities to realize value in alignment with objectives

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

8

Managing Assets Responsibly

Concept Scope BOD Final Design/ Procurement

Construction Close-out/ Start-

up

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

10

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