1. Manufacturing Process Reliability, Track 2
The Pursuit of Continuous
Improvement in Asset Management:
Merck, West Point’s Journey1
Mike Rose & Chris Gould, Merck & Co., Inc.

2. Introduction
Purpose:
• To present Merck, Vaccine’s journey in implementing an asset management
and reliability strategy.
Background:
• Merck produces a diversified portfolio of vaccines and sterile products;
therefore asset management is critical to successful, sustainable
performance. Merck, West Point, PA is a key vaccine producing site. West
Point, established in 1948, is a 397-acre site and is the subject of this
presentation.
• In 2010, Merck’s West Point facility reestablished a strategic focus on
reliability engineering; evolving from reactive to proactive initiatives.
• All initiatives support management of the physical asset; in alignment with
the goal of assuring supply targets are met with the highest degree of
regulatory compliance.
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3. The Journey
Processes
Programs
3
Long Range Capital Plan

4. The Reliability Engineering Continuous
Improvement Framework
Continuous
Improvement
Current Condition
Target Condition
Opportunities
People +
Maintenance
Centered Asset
Management
Operations Asset
Owners
Operations Focused
Processes and
Communications
Process =
Disconnected
Reliability Processes
Holistic Asset
Management
Approach Aligned
with Industry
Standards
Prioritization of the
Assets and Their
Actions
Performance
RE Performance
Utilizing Traditional
Maintenance
Measures
RE Performance
Utilizing Operations
Centered Measures
Creation of a Set of
Operational and
Maintenance Asset
Health Measures
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5. The Initiatives
1. Prioritization
2. Risk Control Strategies
3. Predictive Maintenance Program
4. Precision Maintenance Program
5. Utility Strategies
6. Asset Health
7. Asset Management Playbook
8. Metrics & Trending
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6. 1. Prioritize Assets (Per the Criteria) & Identify Known Issues
2. Identify Actions to Mitigate Risk
[Focusing on the Critical Assets]
For Each Action, Identify: Priority/Owner/Due Date
3. Develop Risk Profile
LOW (Risk ≤ #)
HIGH ( Risk ≥ #)
MEDIUM (# ≤ Risk ≤ #)
CRITICAL
•HIGH RISK
•Compliance = 5
•Supply = 5
•Profit Plan = 5
Finalize & Track Actions
• Portfolio
• Capital Plan
Implement
Actions
1. Prioritization
Continuity
Redundancy
Contingency
Minimize Impact
Quarterly
Updates
4. Issue Quarterly Report
• New/Deleted/Modified assets
• Completed/New Actions
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7. 1. Prioritization (cont’d)
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8. 2. Risk Control Strategies
• Failure Modes & Effects Analysis: Team-based way of assessing
risk (through identification of failure modes) and reducing the chance
of failures through development of actions to control the risk (e.g.
PMs).
• Simplified Maintenance Review: Merck-developed, team-based, way
of creating a risk control strategy based upon a review of vendor
recommendations and asset history.
• Both FMEA & SMR contain the following
1. Determination of desired state
2. Gap analysis
3. Maintenance strategy
4. Preventive maintenance and job plans
5. Replacement spare part strategy
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9. 3. Predictive Maintenance
• Scope: Vibration >1000
assets & thermography
>3000 assets
• Faults are classified as
Extreme, Serious,
Moderate or Slight.
[Based upon NAVSEA (vibration) & NETA
(thermography)]
• Categories define the
urgency of repair
• All corrective actions are
entered and tracked
within CMMS
AreaofBusiness
Total
Extreme
Serious
Moderate
Slight
Extreme&
SeriousOverdue
A 321 0 4 25 64 0
B 201 0 3 16 39 0
C 66 0 0 9 21 0
D 41 0 3 2 12 0
E 141 0 6 5 42 0
F 268 0 0 17 38 0
Totals 1038 0 16 74 216 0
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10. 4. Precision Maintenance
• Based upon mechanic input and PDM results
• Standardized / Proceduralized
• Systematically rolled out with change management
• Quickly showed positive results
1. Fan Maintenance
2. Pump Alignments
3. Lubrication
4. Elastomers
5. Valves
6. Sanitary Clamps
7. Calibration
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11. 5. Utility Strategy
• A utility strategy was developed to understand utility risk to product
compliance, supply and budget.
• Criteria were developed and each utility in each building was
assessed against this criteria.
Reliability Vision: Provide greater product availability by cost effective asset utilization.
Maintenance and operational plans to minimize asset downtime
Redundant WFI pumps
Zoned utilities or critical product stored in multiple freezers
Contingency procedures to restore normal power or tie in alt power
Asset continues to function
A second asset is available to perform the same system function
Impact of asset failure is minimized
A recovery plan is in place to address the asset failure
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12. Gaps were determined and actions to close gaps were identified, planned and
are in various stages of implementation. Using electrical reliability as an
illustration, examples of scoring criteria include:
• Continuity: UPS systems for critical controls/monitoring
• Redundancy: Double-ended substations with auto transfer
• Impact minimization: Medium voltage cascaded subs
• Contingency: Electrical contingency procedures
5. Utility Strategy
(Setting Target Condition)
Score Risk
<2 High
2 to3.99 Medium
4 Low
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Electrical
Chilled
Water
Plant
Steam
Glycol
Potable
Water
Compressed
Air
Water For
Injection
HVAC
BAS
Continuity 3.40 3.35 3.71 3.23 3.23 4.00 3.44 3.30
Redundancy 4.00 4.00 4.00 3.50 3.88 4.00 3.67 4.00
Minimize Impact 2.80 4.00 4.00 2.81 4.00 4.00 4.00 4.00
Contingency 3.32 2.27 4.00 4.00 4.00 4.00 3.69 3.58

13. 6. Asset Health
Asset Health compares pertinent attributes to specific targets
to understand asset performance.
Asset Health Criteria
Undesirable Marginal Acceptable
Supply Uptime <80% 80-89% 90-100%
Compliance Equipment Deviations 3 or more 1 to 2 0
Strategy
Risk Prioritization
Failure Probability
5 4 1 to 3
Budget
Work Order
Man-Hours
Top 20 Count on site 21-100 Count on site
Not in Top 100 Count
on site
Ranking Legend
AttributePriority
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14. 6. Asset Health (cont’d)
Asset Health Assessment
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Supply Compliance Strategy Budget
Uptime Deviations
Failure
Probability
WO Hours
Asset 1 No 72% 0 3 487
Asset 2 No 85% 3 4 290
Asset 3 Yes 97% 2 3 1229
Asset 4 No 87% 1 4 212
Asset 5 No 91% 2 4 107
Asset 6 Yes 100% 0 3 30
Equipment
Description
Business
Critical

15. 7. Asset Management Playbook
 System Support
 Asset Life Cycle
Management
 Capital
Management
 Organization
Design
 Connection with
External Groups
 Communication
 Work Execution
 Configuration
Management
 Compliance
 Maintenance
 Planning &
Scheduling
 Subject Matter
Expertise
 Continuous
Improvement
 Reliability
• Created to support the site’s 5 & 10 year strategic plan
• Based on PAS 55 & ISO 55001
• The elements are being addressed as part of the journey
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16. 8. Metrics And Trending
To reflect the new initiatives, drive continuous improvement and confirm results
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Budget

17. Area 1 Area 2 Area 3 Area 4 Area 5 Area 6
Business Line 1
Business Line 1
8. Metrics And Trending (cont’d)
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18. Reduce the risk of asset
performance significantly
affecting compliance or supply
Unexpected downtime &
“issues” of business critical
assets are reduced
Availability of business critical
assets is increased
Business critical asset: Performance significantly impacts compliance or supply
Deviations
Personnel Safety Events
Supply
Discards
Engagement
Continuous Improvement
RELIABILITY GOALS DESIRED BUSINESS IMPACTS
Take-Away 1: People
Speak in Customer’s Language
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19. Risk-Based Asset
Management
RBAM
Reactive
Corrective
Maintenance
Proactive
Preventive &
Predictive
Maintenance
Asset
Metrics
Program
Metrics &
Oversight
MaintenanceExecution
Asset Evaluation
Simplified Review
Spare Parts, FMEA
Determine Cause
Root Cause (RCA)
Failure Database
Failures Correct
Trend Results of Asset Performance
Asset Availability, Asset Health
Metrics to Assess Program
Performance
Quarterly Report
Maintenance Strategy
Predictive
Preventive
Communicate Performance
Quarterly Report &
Quarterly Report Out
Core
Maintenance Maintenance Programs
Elastomers, Valves, Sanitary Connections, Lubrication, Bearings, Air
Handlers, Alignments, Torquing, Calibration
Other Actions (e.g. Capital, CR, Operator)
Take-Away 2: Process
Clear, Concise, Standardized
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20. Three high impact operational areas were evaluated for their
performance over time with respect to deviations, transfers to
inventory, proactive maintenance and total maintenance man-
hours. All had similar results:
1. Reduced equipment/automation related deviations
2. Increased transfers
3. Improved ratio of preventative versus corrective maintenance
4. As expected, maintenance manpower was lagging. In two of
three cases maintenance manpower decreased, but in one
case the manpower had increased slightly.
Take-Away 3: Performance
Quantitative & Qualitative
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21. Questions?
Reference 1: The Pursuit of Continuous Improvement in Asset Management: Merck, West
Point’s Journey, by Mike Rose & Chris Gould, Merck & Co. Inc., to be published in Uptime
Magazine
Chris Gould, Executive Director, Engineering [christopher.gould@merck.com]
Mike Rose, Associate Director, Engineering [michael_rose@merck.com]
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