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.

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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The Journey

Processes

Programs

3

Long Range Capital Plan

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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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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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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1. Prioritization (cont’d)

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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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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

Are

a o

f B

usi

ne

ss

Tota

l

Extr

em

e

Se

rio

us

Mo

de

rate

Slig

ht

Extr

em

e &

Seri

ou

s O

verd

ue

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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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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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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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 to 3.99 Medium

4 Low

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ElectricalChilled

Water

Plant

SteamGlycol

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

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

StrategyRisk Prioritization

Failure Probability5 4 1 to 3

BudgetWork Order

Man-HoursTop 20 Count on site 21-100 Count on site

Not in Top 100 Count

on site

Ranking LegendAttributePriority

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6. Asset Health (cont’d)

Asset Health Assessment

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Supply Compliance Strategy Budget

Uptime DeviationsFailure

ProbabilityWO 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

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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8. Metrics And Trending

To reflect the new initiatives, drive continuous improvement and confirm results

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Budget

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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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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Risk-Based Asset

Management

RBAM

Reactive Corrective

Maintenance

Proactive

Preventive &

Predictive

Maintenance

Asset

Metrics

Program

Metrics &

Oversight

Ma

inte

na

nce

Ex

ec

uti

on

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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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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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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