Professional Documents
Culture Documents
Management
David J. Mierau, PE, CMRP
Director, Reliability Solutions
Life Cycle Engineering
10-MAR-2015
Asset Management Risks
Robust Quality System:
Compliance with Asset Risk
Control Strategies such as
Preventive and Predictive
Maintenance Plans
Business Continuity
Planning: Integrating the
supply chain network and
having good governance
systems
Graphic Source: ISPE Drug Shortages Prevention Plan Introductory Summary, ISPE, August 2014
Life Cycle Engineering 2012 2
Impact of Manufacturing Disruptions
Drug Shortages by Primary Reason for Disruption in Supply in 2012
Asset Management
Strategy
Business Value Delivery
Asset Management Case
ISO 55000 Compliance
Objectives
Operate &
ASSET Reliability Excellence
Process Safety Management
LIFECYCLE
Maintain
Mechanical Integrity
Asset Management ISO 31000 Risk Management
Capability Asset Management Plans
Procure &
(Processes, Procedures Commission
Construct Asset Criticality
& Knowledge)
(1)
Typical application of
Use/ Location Data
(4)
Function
(5)
Equipment Subdivision
System
(6)
Sub system/Asset
(7)
Component/Maintainable Item
(8)
Part/ BOM
Equipment Criticality
Failure Analysis
Risk Analysis
Risk Ranking
Additional References
Criticality: ISPE Baseline Guide
for C&Q, Impact Assessments
Quality/Reg.
Environmental, Health &
Safety Impact
Asset
Recap. EH&S
Value
Decom.
Asset Business
Criticality
Downtime Impact
Yield/Discard Losses
Maintenance
PdM: Infrared
Thermography
Life Cycle Engineering 2012 27
RBAM: Measure Phase
OEE
TCO
Asset Utilization
MTBF
MTTR