Transcript Document
Risk-Based Asset 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 66% of disruptions resulted from: • Facility remediation efforts (35%) • Manufacturing issues (31%) Graphic Source: Strategic Plan for Preventing and Mitigating Drug Shortages, Food and Drug Administration, October 2013 © Life Cycle Engineering 2012 3 Recent Focus on Asset Management • ISO 55000 (2014): Asset Management Standards • BSI PAS 55 (2004, 2008): Optimized Management of Physical Assets Standards • ASTM E2500: Pharma-specific Guidance © Life Cycle Engineering 2012 4 Risk-Based Asset Management in Other Regulated Industries • • • • • Commercial Airline Industry Nuclear Power Generation US Military Space Programs Subsea Oil & Gas Drilling (emerging) Many foundational asset management, reliability and maintenance standards written in 1970s1980s © Life Cycle Engineering 2012 5 Asset Management System Implementation Framework Leadership, Policy & Strategy Asset Management System Asset Management Strategy Asset Management Objectives Business Case ASSET Operate & Maintain LIFECYCLE ISO 55000 Compliance Reliability Excellence Process Safety Management Mechanical Integrity ISO 31000 Risk Management Asset Management Capability (Processes, Procedures & Knowledge) Value Delivery Commission Procure & Construct Asset Management Plans Asset Criticality Physical Asset Portfolio Graphic Source: Life Cycle Engineering, Copyright 2014 © Life Cycle Engineering 2012 6 Connection to Operational Excellence Think about the necessary components to sustain manufacturing operations: • Safety • Quality • Productivity © Life Cycle Engineering 2012 7 Benefits of Risk Management MANAGEMENT • Awareness of real exposures INFORMATION Economic Profit DATA • Loss data collection FOUNDATION • Risk indicator data collection • Risk strategy, tolerance • Control selfassessment • Roles and responsibilities • Risk assessment and analysis • Policies and procedures • Automatic notification • Risk definition and categorization • Expected Loss – how much do I lose on average? • Unexpected Loss – how much I could reasonably expect to lose in a bad year? • Knowledge of controls quality • Cost benefit analysis • Improved risk mitigation and transfer strategy • Control Scores – how good are the controls I have in place? • Follow-up action reports © American Society for Quality Management & Control Quality © Life Cycle Engineering 2012 8 How can Risk-Based Asset Management impact Quality? • Requires management of physical assets across the entire asset life cycle Concept Design Procure Install Commission Qualification Validation Operate Sustain Decommission • Provides focus on what assets are critical to the patient (quality & supply) and the business (safety & productivity) • Provides a process for managing resources and priorities – applying most robust risk control strategies to highest risk assets © Life Cycle Engineering 2012 9 Risk-Based Asset Management (RBAM) Model Graphic Source: Life Cycle Engineering, Copyright 2014 © Life Cycle Engineering 2012 10 RBAM: Classify Phase • Process flow mapping • Value stream mapping • Relationship models (hierarchy) The RBAM Classify phase ensures that all assets are documented with parent-child relationships defined. Additional References Hierarchy: ISO 14224 It also defines where value opportunities exist related to asset performance improvements. © Life Cycle Engineering 2012 11 Use/ Location Data Asset Functional Hierarchy (1) Business Category (2) Installation/ Business Unit (3) Cost Center/ Op Unit Typical application of asset criticality is at these levels of the functional hierarchy – referenced in ISPE C&Q Baseline Guide Equipment Subdivision (4) Function (5) System (6) Sub system/Asset (7) Component/Maintainable Item (8) Part/ BOM Graphic Source: ISO 14224 © Life Cycle Engineering 2012 12 Functional Hierarchy Example Benefits of an Optimized Functional Hierarchy: • Event tracking and trending by various groupings: function, systems, etc. • Appropriate system definitions for asset criticality analysis • Comprehensive asset listing of all site components and parts along with associated systems © Life Cycle Engineering 2012 13 RBAM: Analyze Phase • • • • Equipment Criticality Failure Analysis Risk Analysis Risk Ranking The RBAM Analyze phase evaluates risks associated with potential asset failures, quantifies risks and provides a way to prioritize risk control activities. © Life Cycle Engineering 2012 14 Equipment Criticality Holistic Equipment Criticality includes the following impact elements: – – – – Quality Impact – Business Health, Safety & Environmental – – Customer/Patient Supply Mean Time Between Failure (MTBF) Mean Time to Repair (MTTR) Utilization – Single Point of Failure Additional References Criticality: ISPE Baseline Guide for C&Q, Impact Assessments © Life Cycle Engineering 2012 15 Asset Criticality Thought Process Determining function of equipment, system, item process, etc. Is it main equipment or an auxiliary item? Is it a unique item or common with others? Redundancy – Duplication – Alternative Do you have a standby backup? Do you have alternative means to continue normal operation? What is the likelihood of a failure mode occurring? (High/low) Consider history of failures for equipment Consider possibility and frequency of failures What are the consequences of failure? Any production losses as a result of failure? How much? Any safety, environmental, or business losses as a result of failure? What is the likely period out of operation? Can the repair be done onsite? Are spare parts available? How long to get parts if not in stock? What is the longest time for repairing the failure? © Life Cycle Engineering 2012 16 Typical Asset Criticality Considerations Quality/Reg. • Asset Recap. Value EH&S Asset Criticality Decom. Environmental, Health & Safety Impact Business • • • • Inventory Logistics Supply Chain Reliability • • • Downtime Impact Yield/Discard Losses Failure Rate (MTBF) Utilization Single Point of Failure Maintenance • • Mean Time to Repair (MTTR) Maintenance Cost © Life Cycle Engineering 2012 17 Asset Criticality Criteria Example © Life Cycle Engineering 2012 18 Criticality & Risk Control Strategies Asset Criticality Tier Criticality Additional Analysis Risk Control Strategy Top 15% A Asset Specific FMEA PdM, PM, NDE/MI, OC, Redundancy Top 35 to 15% B Asset Type FMEA PdM, PM, NDE/MI, OC Top 65 to 35% C PdM, PM Top 85 to 65% D Simplified Maint. Review OEM Maintenance Lowest 15% E None Minimal PM Contractor RTF – Run to Failure © Life Cycle Engineering 2012 19 Analyzing Criticality Data Look for quality and safety “outliers” – High quality and safety scores in lower tiers (low overall criticality value scores) © Life Cycle Engineering 2012 20 Additional Analysis: FMEA Failure Mode & Effects Analysis • Evaluation of asset (system) risk • Dual focus: functions & components • Evaluate each potential failure mode & cause • Establish risk ranking scales to calculate risk Risk = Severity x Occurrence x Detection • Establish risk thresholds for taking mitigating actions • Quantify risk reduction Additional References IEC 60812 MIL-STD-1629A © Life Cycle Engineering 2012 21 FMEA Risk Categories FMEA Risk Calculation Risk Priority Number (RPN) = Severity x Occurrence x Detection © Life Cycle Engineering 2012 22 FMEA Risk Categories FMEA Risk Calculation Risk Priority Number (RPN) = Severity x Occurrence x Detection © Life Cycle Engineering 2012 23 FMEA Risk Evaluation for All Failure Modes & Causes © Life Cycle Engineering 2012 24 Risk Reduction Summaries © Life Cycle Engineering 2012 25 RBAM: Control Phase • • • • • • • • Standard Work Operating Procedures Preventive Predictive Condition Monitoring Remote Monitoring Operator Care Critical Spares The RBAM Control phase is the application of risk control strategies recommended from the Analyze phase © Life Cycle Engineering 2012 26 Asset Risk Control Strategies • Based upon recommendations from the FMEA and analysis of the “to-be” RPNs – New or updated maintenance plans – Replacement or upgrade projects – New setup or operating instructions • Risk reduction will not be realized until recommendations have been implemented PdM: Infrared Thermography © Life Cycle Engineering 2012 27 RBAM: Measure Phase • • • • • OEE TCO Asset Utilization MTBF MTTR The RBAM Measure phase ensures compliance with documented risk control strategies and provides data for continuous improvement © Life Cycle Engineering 2012 28 Key Performance Indicators Trending Equipment Quality Events/Deviations © Life Cycle Engineering 2012 29 Recognized Industry Standards for KPIs/Metrics • SMRP Best Practice Metrics Guide • BSI Standard EN 15341 – Maintenance Key Performance Indicators • ISPE Good Practice Guide: Maintenance Understand Leading/Lagging Indicators: • Low compliance to maintenance schedule (overdue maintenance work orders) is a leading indicator for asset reliability © Life Cycle Engineering 2012 30 Risk-Based Asset Management (RBAM) Model Review Graphic Source: Life Cycle Engineering, Copyright 2014 © Life Cycle Engineering 2012 31 Other Elements of Asset Management to Consider • • • • • • • Asset-Related Capital Delivery MRO Stores & Materials Management CMMS & Data Historian Support Organizational Design Maintenance Work Execution Maintenance Planning & Scheduling Reliability Engineering Processes – Loss Elimination, Root Cause Analysis, Critical Spares, etc. © Life Cycle Engineering 2012 32 Create Your Risk-Based Asset Management Program • Establish a Corporate Asset Management Policy and require risk-based processes • Your Drug Shortage Prevention Program should reference the Asset Management Policy as one element of the Prevention Program • Establish or update procedures and processes for the phases and processes of RBAM • Begin with the Classify phase (field data gathering, value stream mapping, relationship models) & Asset Criticality in Analyze phase © Life Cycle Engineering 2012 33 Take Action and Measure Results • Consider a pilot area/plant to implement and demonstrate improvement • Build & implement new risk control strategies for asset operation and maintenance • These activities reduce risk and improve operational stability! © Life Cycle Engineering 2012 34 Questions & Discussion Risk-Based Asset Management Exhibit Table #541 David J. Mierau, PE, CMRP Director, Reliability Solutions Life Cycle Engineering 10-MAR-2015 [email protected] www.LCE.com © Life Cycle Engineering 2012 35