Soluzioni innovative di Full Service per Impianti Produttivi Farmaceutici Flavio Beretta ABB PS&S
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Soluzioni innovative di Full Service per Impianti Produttivi Farmaceutici Flavio Beretta ABB PS&S Asset Performance Services Maintenance Engineering & Consulting Manager 1 • ABB Facts • ABB Consulting Service Processes & Competences • Maintenance Quality System, Calibration & Metrological Laboratory • ABB Full Service® • Process – phases • Key performance Indicators • Full Service Partnership Development (First Step) 2 Facts about ABB Power Products Sales: $6.4 billion Transformers, high- and medium-voltage switchgear, breakers, automation relays • • • • • 3 Power Systems Automation Products Sales: $5.9 billion Sales: $4.0 billion Substations, FACTS, HVDC, HVDC Light, power plant & network automation Low-voltage products, drives, motors, power electronics, and instrumentation Headquarters: Zurich, Switzerland About 104,000 employees in around 100 countries Orders in 2005: $23.6 billion Revenues in 2005: $22.4 billion Listed on Stockholm, Swiss & New York exchanges; traded on virt-x • Process Automation Sales: $5.0 billion Control systems and applicationspecific automation solutions for process industries Robotics Sales: $1.7 billion Robots, peripheral devices and modular manufacturing solutions for industry A leading power and automation technology company with strong market positions in its core businesses ABB Global - Local Service ABB Service Competencies Globally Projected with Local Resources: Global revenues of $3,7BUS (2005) ABB develops advanced tools, training and methods for Maintenance Excellence Over 20,000 direct service employees worldwide Strong local organizations in more than 40 countries Local service organizations provide speed in responding to problems, language and cultural alignment They are backed up by a global service infrastructure of product and solutions experts, advanced software tools, and a global communications infrastructure Together we can deliver specific expertise anywhere and anytime it is needed Maintenance Maintenance developed developed as as Core Core Competence Competence 4 ABB Services Spectrum Performance Performance Directed Directed Maintenance Maintenance Partnerships Partnerships Designed to Compliment And Enhance Each Customer’s Unique Maintenance Strategy Self Self Maintenance Maintenance 5 Dedicated to Industrial Maintenance 6 ABB pioneered the Full Service partnership concept We deliver these services in more than 22 countries around the world The total number of employees in Full Service business is over 6,000 We currently have over 150 active Full Service Partnership Agreements Industry specific organizational support for Oil & Gas, Metals & Mining, Pulp & Paper, Chemicals, Life & Scienze, Electronics, and Food & Beverage Consult Collaborate Create Value • ABB Facts • ABB Consulting Service Processes & Competences • Maintenance Quality System, Calibration & Metrological Laboratory • ABB Full Service® • Process – phases • Key performance Indicators • Full Service Partnership Development (First Step) 7 ABB Consulting Service Maintenance engineers and consultants support every Performance Service contract during definition & delivery and provide consulting services to assist clients in managing their maintenance activities • • • • • • • • • • • 8 Plant performance benchmarking Maintenance excellence and best practices Organization and competency development Performance improvement, e.g. energy efficiency or process improvement Quality Assurance & Validation Improvement GxP / impact Assessment Metrological Laboratory & Calibrations Computer System Validation Health, safety and environment Change management Project engineering and support Over 600 reliability & maintenance consultants World Class Reliability ® Benckmark Total Plant Reliability® Process People Equipment/Tools Measurement Project mgt. Performance mgt. RCM /RBI Block Diagrams Material mgt Multi-Skills LCC Reliability data mgt. Contractor mgt. ODR Standardization Customer Scheduling Team management Predictive tasks Training Planning Roles & Resp. Basic PM & Calibr. Financials Safety & Quality Org. structure Impact Assessment Business process Work Identification Vision & mission Failure investigation Bad Actors Asset Management Empowerment Prevention Reliability Scorecard Business Management Processes and Alignment World Class Reliability™ Benchmark Industry Best Practices 9 Integrated Systematic Processes Leadership Policy & Strategy Results Partnership Fulfillment Maintenance Concept Client Value ABB Value Maintenance Operations Plant Performance Improvement Quality Assurance & Validation HSE Quality 10 People Management Finance and Cost Supply Chain People Value Information ABB Full Service® Site Execution Phases Partnership Fulfillment Deploy Common Strategy Communicate Client Value Listen to the Customer Renew Contract Maintenance Concept Understand Plant Requirements Perform Reliability Studies Establish Maintenance Plans Install Maintenance Management System Manage Life Cycle Maintenance Operations Generate Workorders Prepare Work-orders Execute Work-orders Complete Work-orders Plant Performance Improvement Capture Actual Performance Improve Equipment Performance Implement Best Practices Deploy New Technologies Quality Assurance and Validation Improvement Jointly define/refine QAV migration strategy 11 Assess current QAV status in relation to agreed scope Refine QAV Master Plan Implement QAV Master Plan Manage Quality Lifecycle QA & Validation Improvement- Activities Quality Assurance & Validation Improvement Jointly define/refine QAV migration strategy • Arrange QAV strategy sessions • Clarify and articulate joint QAV approach • Define R&Rs • Agree policies & procedures • Agree ABB QAV scope • Agree cont. improvement objectives & KPIs • Identify milestones and define timescales 12 Assess current QAV status in relation to agreed scope • Review policies, proceedures, methodologies • Check audit history • Undertake QAV review of a sample of ”in scope” QAV systems and processes • Documented documentation gap analysis of in scope existing systems • Assess transferring people and culture Refine QAV Master Plan • Organise annual QAV joint review •Inspection / audit findings •KPI’s •Continuous improvement •Regulatory change • Prepare and issue annual QAV report + recommendations Implement QAV Master Plan • Delivery of agreed scope: •Operations •Projects •Improvements • Manage resource •Training •Recruitment •Competence Manage Quality Lifecycle • Manage QAV lifecycle: •Concept •Design •Implementation •Operations •Change •Retirement •Replacement / • Migration • Audit readiness •Documentation •People • Maintain currency •Regulatory developments •Periodic review •Revalidation •Change control Scope of Validation Services Life Cycle Change control URS and VP may be reversed Validation Plan (VP) Validation Report (VR) Business Processes & User Requirements Specification (URS) SOPs Migration Specification, Build and Qualification Supplier Audit/ Part 11 assessment Functional Design Specification (FDS) GxP assessment defines critical functions, data and configuration and later can include traceability to qualification protocols Training records GxP/Risk Assessment Hardware & Software Design and Configuration Specification PQ should continue after go live to fully test operational performance Cutover Qualification (CQ) Performance Qualification (PQ1) Other End-User Documentation Operational Qualification (OQ) Update Part 11 assessment Installation Qualification (IQ) Software Integration Testing Good Programming Practice & Software Source Code Review Traceability within the specifications and the GxP Assessment 13 Performance Qualification (PQ2) The OQ box could be split into: Functional OQ, System Integration Qualification (SIQ) - focusing on interfaces, Only qualify critical configuration, functionality and data GxP Competence • • 14 ABB Engineering Services QA&Validation team • Review of compliance with cGMP/GAMP requirements / impact assessment. • Optimization of maintenance procedures. • Assessment of impact on validation • Interpretation of pharma regulations and design guides across all core disciplines • Rapid Change-Over Full Service process inherently supports regulatory environment • Builds on well defined and documented processes; • Provides methods and tools to define and follow appropriate detailed SOPs for maintenance; Maintenance Concept - Tools Maintenance Concept Understand Plant Requirements • Codification standard • Standard industry equipment tree 15 Perform Reliability Studies Establish Maintenance Plans Install Maintenance Management system Manage Life Cycle • Equipment classification • FME(C)A • 5 Maintenance Strategies • CBM-Techniques • RCM Turbo • ELMAS • Impact Assessmet • Industry specific PMs • Basic PM summary • Standard job plans • Back to basics • Lubrication review plan • Basic operator care • Autonomous Maintenance • Risk Based Inspections (RBI+) • Load instructions • CMMSDatastream • Predefined Failure Codes • Maintenance types • Priority matrix • CMMS – Datastream • Life Cycle plan template • Maintenance Plan Review (MPR) • Reliability Modeling (RAMP) • Early Equipment Management • Design reviews • LCC/LCP • ABB Facts • ABB Consulting Service Processes & Competences • Maintenance Quality System, Calibration & Metrological Laboratory • ABB Full Service® • Process – phases • Key performance Indicators • Full Service Partnership Development (First Step) 16 Maintenance Quality System E.g. SOP’s 17 Maintenance Quality System E.g. SOP’s 18 Maintenance Quality System E.g. SOP’s 19 Calibration & Metrological Laboratory E.g. SOP’s 20 Calibration & Metrological Laboratory Use customized CMMS to do: • Reverse traceability for reference standards • Inspection forms for “As Found” and “As Left” variance results with Pass/Fail auto triggers • Process control limits and manufacturer-recommended specifications • Custom reports for FDA calibration certification • Expands processes to regulated equipment • Reduce total cost of calibration by eliminating paperwork, cost of second-system validation, and frequent calibrations 21 Calibration & Metrological Laboratory Equipment Classification 22 Calibration & Metrological Laboratory Equipment Classification 23 Calibration & Metrological Laboratory Equipment Classification 24 Calibration & Metrological Laboratory Metrological chain 25 Calibration & Metrological Laboratory Calibration Report – Loop check 26 Calibration & Metrological Laboratory Calibration Report – Loop check 27 Calibration & Metrological Laboratory Calibration Report – Single check 28 Calibration & Metrological Laboratory Calibration Report – Single check 29 • ABB Facts • ABB Consulting Service Processes & Competences • Maintenance Quality System, Calibration & Metrological Laboratory • ABB Full Service® • Process – phases • Key performance Indicators • Full Service Partnership Development (First Step) 30 ABB Full Service® Process - milestones ABB Full Service® -Process Prospecting Screening Common business fit Partnership development Mobilization Contract Implementation management & Infra in place and readiness to start Win-win-win ABB FS with agreement MMMP implemented Business case identified Strategy check 31 Feasibility Study development Value created and contract renewed ABB Full Service® Process - phases ABB Full Service® -Process Screening Regional sales • Present business concept • Agree on business fit • Complete Confidentiality Agreement • Buy in from Organization • Agree on Feasibility Study Sign Letter of Authorization (LOA) 32 Feasibility Study Partnership development Mobilization Project mgr Project mgr LOA LOI Agreement Start-up • Prepare the Feasibility Study • Establish Partnership Development team • Deploy start-up resources • Implement MMMP • Set up site organization and facilities • Train needed new skills & knowledge • Implement communication and support processes • Employ new maintenance practices • Perform on-site assessment • Quality Assurance & Validation assessment • Analyze improvement potential • Present Feasibility Study results and ABB Proposal (Improvement potentials ($)) Sign Letter of Intent (LOI) • Build the solid foundation • Develop Maintenance Management and Master Plan (MMMP) • Develop Quality Assurance & Validation Master Plan (QAVMP) • Develop mobilization and communication plan Sign Maintenance Alliance Agreement Start-up mgr Implementation • Engage subcontractors • Prepare MMMP implementation • Prepare QAVMP implementation ABB manages people & assets Contract management & development Start-up&site mgr Site mgr • Implement new performance measurement system • Update MMMP Contract renewal • Manage Win/Win/Win Partnership • Implement continuous Performance Improvement • Report Client Value • Assess Site Quality • Update MMMP • Update QAVMP • Update QAVMP Maintenance Strategy & Tools in Force Contract Renewal Key Partnership Commitments In a role of Maintenance Service Partner, ABB commits to: • Provide a comprehensive benchmark maintenance assessment of current customer performance relative to industry leaders • Jointly develop Preventive maintenance & Calibration plans that enhance the customer’s business strategies • Jointly develop Computer System Validation activities • Jointly develop GxP Impact Assessment to define critical Equipment • Write specific SOP’s and Implement the Maintenance Quality System • Identify and continuously track relevant maintenance and production Key Performance Indicators (KPIs) • Provide competent leadership and resources to deliver jointly identified goals • Set-up continuous competence development to respond production challenges • Develop and implement the selected maintenance tools and approaches such as OEE and Reliability Centered Maintenance • Improve production effectiveness by utilizing ABB’s world-class maintenance management processes, tools and approaches 33 Success Factor Manufacturing Excellence z z z Reduction of Labour Cost Reduction of Spare Parts Increase of assets expected life Cost: Capacity: z Increase capacity of the process z Increase availability of the process z Improve reliability of the process z Improve relationship between maintenance, production, management and suppliers 34 Safety / Quality: z Improve the Quality of output z Target zero defect in process z Target zero break down of equipment z Enhance safety measures and environmental awareness z Guarantee respect of specific industries’ rules (FDI,GMp, GLp.) Key Performance Indicators, Example Safety Ed.v.tot. Maintenance cost/unit Tavoite Ed.12 kk tot. Moving average Ed.v.tot. 60 % Kk tot. Availability Ed.v.tot. tavoite Tavoite Ed.12 kk tot. Moving average 100 % 55 % 50 % 45 % 40 % 95 % 35 % 30 % 25 % 20 % ´96 ´97 ´98 ´99 ´00 90 % 0 Oct Nov Dec Jan Feb Mar Apr May Jun Jul ´96 Aug Sep OEE ´97 ´98 ´99 ´00 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Customer satisfaction Ed.v.tot. Tavoite Ed.12 kk tot. ´96 ´97 ´98 Ed.v.tot. Tavoite Ed.12 kk tot. ´00 Ed.v.tot. Moving average 90 % Jul Aug Sep Kk tot. tavoite 50 100 % 95 % Oct Nov Dec Jan Feb Mar Apr May Jun Urgent maintenance work Moving average 100 % ´99 95 % 85 % 90 % 80 % 75 % 85 % 70 % 80 % 65 % 75 % 60 % 55 % 70 % 50 % 65 % 45 % 40 % ´96 ´97 ´98 ´99 ´00 60 % Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Tavoite ´97 ´98 ´99 ´00 0 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Training days Completed PM-% Ed.v.tot. ´96 Ed.12 kk tot. Moving average Ed.v.tot. ´96 ´97 ´98 ´99 ´00 tavoite Ed.v.tot. 35 ´98 ´99 110 % 105 % 105 % 100 % 100 % 95 % 95 % 90 % 90 % 85 % 85 % 80 % 80 % ´00 Mar Tavoite 110 % Apr May Jun Jul Aug Sep Oct Nov Dec Ed.12 kk tot. Moving average 75 % 70 % ´97 Feb Employee survey Kk tot. 75 % ´96 Jan Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep ´96 ´97 ´98 ´99 ´00 0 70 % Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec ´96 ´97 ´98 ´99 ´00 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Full Service Key Deliverable: OEE* Theoretical production time Planned production time Available operating time Net operating time Valuable operating time Stand-still losses Speed losses Yield losses * Overall Equipment Effectiveness 36 Planned downtime Planning Factor „Six major losses“ OEE* = 1 Breakdowns 2 Setup & adjustment Availability Factor 3 Idling and minor stops 4 Reduced Prod. speed 5 Defects & reworks 6 Start-up losses x Performance Factor x Quality Factor Joint Mission: Production Effectiveness Factory 1 : layout Improvement teams RCA action RCM program Real TPI/ Process Data Management Gross GrossOperating OperatingTime Time Net NetOperating OperatingTime Time Valuable Valuable Operating Operating Time Time Unplanned Unplanned down Time down Time Losses Losses Loss Lossofof speed speed Loss of Loss of Quality Quality Equipment Equipment Failure Failure Setup Setup & & Adjustment Adjustment Idling Idling & & Minor Minor Stops Stops Reduced Reduced Speed Speed Defects Defects in in Process Process Start Start up up Losses Losses Capture plant performance in real time 37 Potential Impact of Maintenance OEE Planned downtime 100 % Downtime losses Equipment failure, maintenance, set-up & adjustment Speed losses Reduced speed, minor stoppages Quality losses Defects and start-up losses Valuable operating time 50 % 38 Effective maintenance organisation & processes / TPM Consistent OEE measurement and analysis CMMS as a systematic tool Reliability analysis of equipment Preventive maintenance & Calibrations Systematic methods for continuous improvement / Kaizen Set-up time reduction/ SMED Equipment life-cycle management x Improved machine setting Accurate follow-up of minor stoppages Optimization and increasing speed of robots and other equipment x Systematic search for quality losses’ root causes Systematic management of calibration Example of O.E.E. result Available operating time 2136 h Not planned production 200 h Preventive maintenance & Calibration 57 h Planned production time 1879 h Technical downtime 20 h Change over downtime 40 h Organisation downtime 13 h Gross production time 1776 h Net production time Quality losses Valuable operating time 39 Availability 94,51 % 30 h Technology downtime Speedlosses Planning factor =87,97 % OEEpf = 74,81 % Performance 94,00% Quality 95,73 % 107 h 1669 h 71 h 1598 h OEE = 85,05 % Technical Availability 98,93 % Examples of ABB Full Service® OEE Improvement 84% Chemical & Life Sciences plant Paper mill 90% 83% 85% Actual 82% Contract 80% 81% 80% 75% 79% 70% 78% 77% 65% Year 1 Year 2 Year 3 Year 0 Year 1 Electronics 70% 80% 60% 70% 50% 60% 40% 50% 30% 40% 20% 30% 10% 20% 04 12 04 11 04 10 04 09 04 08 04 07 04 06 04 05 04 04 04 03 04 02 04 01 40 Year 3 Year 4 Year 5 Steel mill 80% 0 Year 2 Year 1 Year 2 Year 3 Year 4 10% 0% Ar e a1 Ar e a2 Ar e a3 Ar e a4 Ar e a5 Examples of ABB Full Service® Cost Reduction Chemical plant Electronics 15 000 000 € 250,000 13 500 000 € Maintenance hours reduced by 40% 200,000 12 000 000 € 10 500 000 € 9 000 000 € 150,000 7 500 000 € 6 000 000 € 100,000 4 500 000 € 50,000 3 000 000 € 1 500 000 € Start-up After 3 yrs Year 1 Paper mill Year 2 Year 3 Year 4 Year 5 Year 6 E Manufacturing 160% 17% reduction 140% Production volume Maintenance cost Maintenance cost/ton $/t 120% 100% 80% 60% 40% Year 1 41 Year 2 Year 3 Year 1 Year 2 Year 3 Year 4 • ABB Facts • ABB Consulting Service Processes & Competences • Maintenance Quality System, Calibration & Metrological Laboratory • ABB Full Service® • Process – phases • Key performance Indicators • Full Service Partnership Development (First Step) 42 Where Do We Go From Here? • ABB Proposal: • Conduct a Feasibility Study • Perform quantitative and qualitative analyses against industry leaders • Define improvement potential in areas of OEE and maintenance as an outcome of the assessment • developed during the first Year • Present the Business Case for taking further action • Implement structured process to identify financial improvement potential • Decisions will be based on the outcome of the assessment • ABB commits to improvements at each phase 43 Analysis scheme BOTTOM -UP Quantitative Analysis Qualitative Analysis 44 TOP -DOWN Analysis of Maintenance Management Approach Maintenance Benchmark comparison Analysis of Maintenance System Analysis of Productivity Analysis of Maintenance Activities Analysis of Assets Analysis of Direct Maintenance Spend Analysis of Indirect Maintenance Costs Qualitative Analysis of the Site For this we use a slightly modified version of the questionnaire for Self-assessment of our ABB Full Service® sites. The performance excellence is checked according to the EFQM Excellence Model (European Foundation for Quality Management) 45 All info captured in Benchmark database Maintenance Management Approach - Result Leadership 1 Business Results 0,8 Profitability 0,6 Effectiveness & 0,4 efficiency Role of maintenance Building relationship Cost Management Maint & Prod Mgmnt Strategy development & implementation Knowledge exchange & networking 0,2 People Results People Management 0 Competence management Competence & motivation Motivation management Safety & environment Resource Management Client Results HSE mgmnt Finance & cost mgmnt Client satisfaction Information mgmnt Client value Maintenance Functions Your plant Benchmarking against 75 % level of our Full Service sites 46 Material mgmnt Partnership Contractor mgmnt Maintenance concept Facilities, tools, etc Maintenance operations Plant performance improvements Shutdown mgmnt Results of the Feasibility study The Feasibility Report contains the following information: Expectations of a feasibility study State of assets 100% Human relations The ”road” from the present situation to the desired one 47 20% M Concept, Competence Resources State of assets 100% Human relations OEE/effectiveness si Vi l oa /g on Technical documentation n ti o Ac l an p c ur so Re Tools and methods e nc ete mp Co n tio va oti Human resources 60% Organization 40% 20% Maintenance methods 0% Spare parts Maintenance planning The vision (the “desired” situation) Improvement potentials with the corresponding impact on the result of the company Recommendations of what to do to achieve improvements plan How to continue Technical documentation Maintenance costs Subcontracting Maintenance management Present situation Maintenance methods Maintenance costs Maintenance planning Subcontracting Maintenance management Desired situation es Customer satisfaction The result of Maintenance the maintenance processes Collaborators’ Information/ development analysis 80% Workshops, etc Organization 0% Spare parts © ABB Performance Services - 5 The current situation (the “as is” situation). Strengths and weaknesses of the current maintenance operations 60% 40% Workshops, etc Action plan OEE/effectiveness 80% Human resources Strategic planning Management ABB Full Service® Maintenance Outsourcing For Pharmaceutical Production Improve manufacturing performance & maintain compliance 48
