merck's west point facility embraces rcm
DESCRIPTION
International Manufacturing Conference 2012 Merck Manufacturing Division Life Cycle EngineeringTRANSCRIPT
Merck’s West Point Facility Embraces RCM
AAsset MManagement PProgramRRisk BBased AAsset MManagement
Chris Gould, Merck –
West PointMike Rose, Merck –
West Point
Merck -
West Point Site
2
Merck -
West Point is a 397 acre site that provides a diversified portfolio of products including vaccines and sterile pharmaceutical products
The Journey
•
2008/9
1st
Reliability Engineer
–
2010
FMEAs
Initiated For “Critical Assets”–
2010
PDM Program Initiated–
2010
Reliability Group Established
•
2011
RBAM Program Initiated•
2011
Program Procedures Developed
–
2012
AMP Drafted–
2012
RBAM Evaluations Completed For Site–
2012
Risk Reduction Measures Identified
» 2013 AMP Implemented» 2013 Actions Implemented To Reduce Risk» 2013 “Success” Metrics Developed / Used
•
FMEA:
Failure Modes and Effects Analysis•
PDM:
Predictive Maintenance •
RBAM:
Risk Based Asset Management•
AMP:
Asset Management Program
3
Physical Asset Portfolio of Merck Manufacturing Division
External
EXCEL
Optimize Cost Structure & Productivity
EXTEND
Complementary Businesses
EXECUTE
World Class Supplier & Lead
in New Technology
EXPAND
Serve 80% of the World
Concept/Concept/ DesignDesign
ProcureProcure
Install/ Install/ CommissionCommissionQualificationQualification
ValidationValidation
Operate/Operate/ SustainSustain
DeDe ––commissioncommission
Vision 2020
Target 2015
Asset Management Program (AMP) Strategic Model
4
CorporateVision & Strategy
. .
Merck Manufacturing Division (MMD) Vision & Strategy
5555
1) To create cost-effective management of asset utilization throughout the life cycle to ensure asset:
Reliability
–
Performs as designedAvailability
–
Runs as designed when scheduled to runMaintainability
–
Configured to allow least downtime and highest quality maintenance including safety and ergonomic considerationOperability
–
Can be operated to prevent maintenance failuresCompliance
–
Maintenance completed on prescribed frequency, meeting job plan expectations and following safe work practices
AMP Target Condition
5
2) Trend asset utilization and performance metrics to drive continuous improvement
3) Asset risk is defined and appropriate control actions are taken to mitigate or eliminate the risk considering maintenance programs, continuity and contingency.
4) Establish criteria for asset life cycle and end of useful life –
when an asset becomes obsolete based on cost of maintenance and validation cost.
5) Ensure organizational design supports the asset management plan considering:Organization roles and responsibilityTalent ManagementTrainingLabor StrategyCultureStaffing Model –
considering in-house/outsourcingChange Execution Management
AMP Target Condition Continued
AMP Playbook Chapters
1.
Introduction to asset management
2.
Compliance3.
Reliability
4.
Work execution5.
Planning and scheduling
6.
Asset life cycle7.
Organization design
8.
System support9.
Capital program
10.SME11.Metric Mgmt philosophy12.Configuration Mgmt13.Communication14.
Connection with external groups
Develop detailed playbook or assessment
AMP Potential Benefits
8
Priority Business Impact
Compliance
•
Structured asset management plan provides greater stability:Reduce deviations, thereby ensuring GMP complianceVisible performance measures drives continuous improvementBetter colleague safety from reliable equipment and stable processesFocused loss elimination yielding greater product quality and customer satisfaction
Supply
•
Improved asset healthBetter qualityMore and consistent fill ratesImproved customer experience
Strategy
•
Long-term benefit to be a preferred provider:Proactive strategy Process-driven organizationTransparent governanceEngaged employeesKnowledge sharing
Profit Plan
•
Business benefits may include:Less capital requirementLower energy costGreater utilization of installed capacityIncreased yieldGreater market share 8
999
RBAM Intent & Approach
•
RBAM Mission:–
To always achieve a high level of assurance that Merck’s products and commitments will not be impacted by equipment-related failures.
•
RBAM Intent:–
Address continuity
and contingency
for mission critical assets.•
Continuity: Ability to maintain normal asset function.•
Contingency: Action(s) taken to retain asset function when continuity is lost.
Asset Management Program
Risk Based Asset Management
9
Program Overview
PrioritizeAssets
Core Maintenance Programs
ReactiveCorrective
Maintenance
Proactive
Preventative &
Predictive Maintenance.
Trending
Metrics & Oversight
PMsEvaluate Assets & Issue PMs/
Job Plans
CorrectFailures Determine Cause
Trend Results of Asset Performance
Maintenance programs including processes & training (e.g. valves, air handlers, lubrication, torquing)
Metrics to assess program performanceMetrics reviewed by oversight team and program adjustedSummary Reports and Communications
Predictive Maintenance
12
3
4
3
10
Prioritize Assets
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 Focus Factory Risk Profile
ImplementActions
Finalize & Track Actions•Portfolio •Capital Plan
LOW (LOW (Risk ≤
99))
HIGH ( Risk HIGH ( Risk ≥
130)
MEDIUM (MEDIUM (100 ≤
Risk ≤
129)
CRITICALCRITICAL•HIGH RISK•Compliance = 5•Supply = 5•Profit Plan = 5
Consider Contingency
Consider Continuity
Quarterly Updates
4.
Issue Focus Factory Quarterly Report11
12
Prioritization Tool
Failure ProbabilityCompliance
SupplyStrategy
Profit
Failure Probability[% per lot / run]
Compliance[Impact of a single failure]
Supply[Impact of a single failure]
Strategy Profit Plan[Impact of a single failure]
Multiplication Factor N/A 4 3 2 1
1 Insignificant None None Not listed on Capital Plan, LROP, Transformation, Portfolio
None
2 ≤ LOW ≤LOW ≤LOW ≤LOW
3 LOW < Failure Rate ≤ MEDIUM LOW< Impact ≤MEDIUM LOW< Impact ≤MEDIUM To be listed on Capital Plan, LROP, Transformation, Portfolio.
LOW< Impact ≤MEDIUM
4 MEDIUM < Failure Rate ≤ HIGH MEDIUM< Impact ≤HIGH MEDIUM< Impact ≤HIGH MEDIUM< Impact ≤HIGH
5 > HIGH > HIGH > HIGHListed on Capital Plan, LROP,
Transformation, Portfolio > HIGH
Min Max Symbol Description10 99 L Low100 129 M Medium130 250 H High
Impact Assessment Probability of equipment having a failure based upon historical events. [NOTE: Failure = Inability to perform designed function]
If asset fails, impact on GMP compliance, product quality, environmental compliance, personnel safetyIf asset fails, impact on the ability to meet supply requirements, considering product impact, discards and/or critical path production time lostAlignment with Capital Plan, Long Range Operating Plan, Transformation, Portfolio If asset fails, impact to Profit Plan considering cost impact of a failure (e.g. discards or lost transfers) and savings benefits due to improvements
Impact Scores
Risk LevelFailure Probability x [Compliance x 4 + Supply x 3 + Strategy x 2 + Profit Plan x 1]
Total Score Risk Level
12
Prioritization Results
For illustrative purposes only
Critical Assets Meet One of the Following:Risk Level = HIGH, or Compliance = 5, orSupply
= 5, orProfit Plan
= 5
Numbers shown for illustration purposes only
ABCDEF
13
% shown for illustration purposes only
A B C D E F
14
Prioritization Results
For illustrative purposes only
Critical Asset Count
For illustrative purposes only
Numbers shown for illustration purposes only15
Average Asset Risk Level (%)
For illustrative purposes only
Numbers shown for illustration purposes only16
Maintenance
Strategy
•
What is an FMEA? (FFailure MModes and EEffects AAnalysis)–
A team-based, structured way of assessing risk and reducing the chance of failures through development of actions to control the
risk (e.g. PMs).
•
What is a SMR? (SSimplified MMaintenance RReview)–
A team-based, structured way of developing a maintenance strategy based upon a review of vendor recommendations and failure history.
•
FMEA & SMR Process1.
Gap analysis2.
Maintenance Strategy3.
PMs
& Job Plans4.
Replacement spare part identification5.
Spare parts availability
17
PDM -
Vibration Program
For illustrative purposes only
Numbers shown for illustration purposes only
Focus Factory
Total Machines Extreme Serious Moderate Slight
Serious Repairs Overdue
A 121 0 0 9 45 0
B 125 0 2 14 24 1
C 181 0 4 22 41 1
D 8 0 1 2 0 2
E 256 0 6 23 66 1
F 167 0 3 18 59 0
G 94 1 1 17 25 1
952 1 17 105 260 6
3rd Qtr 2012 VIBRATION FAULTS ‐ Open Work Order Status
18
PDM –
Thermography
For illustrative purposes only
Numbers shown for illustration purposes only
Focus Factory
Total Machines Extreme Serious Moderate Slight
Serious Repairs Overdue
A 973 0 1 2 2 1
B 1219 0 0 0 0 0
C 1479 0 0 0 1 0
D 8 0 0 0 0 0
E 678 0 0 0 0 0
F 475 0 0 0 0 0
G 405 0 1 0 2 1
5237 0 2 2 5 2
3rd Qtr 2012 THERMOGRAPHY Failed Scan Open Work Order Status
19
Reporting
Electrical Continuity & Contingency
Capital and Project Status
Predictive Maintenance Metrics RBAM Status
Quarterly Summary Report to Plant•
Roll-Up of Plant•
Summary of Each Focus Factory
Quarterly Report-Out to Each Focus Factory (Tailored to each Focus Factory)
Both Written And Oral Quarterly Summaries Enhance Change Management
20
Key Takeaway
Developing an action-oriented asset- based prioritization process
sets the
foundation to:
1. Understand Asset Priorities
2. Work on the “Right Stuff”
3. Reduce Asset Risk
4. Make Problems Visible
5. Address Problems Continually
22
Questions?
22
Mike RoseAssociate Director -
Engineering Merck -
West [email protected]
www.Merck.com
Chris GouldExecutive DirectorMerck -
West [email protected]
www.Merck.com