Risk and Compliance management in Technical Projects 2017 Global Risk Engineering Conference

Transcription

1 Risk and Compliance management in Technical Projects 2017 Global Risk Engineering Conference Jos Hoedemakers Risk Engineering Zurich Benelux

2 Technical Projects A project is a human endeavor which creates change, is limited in time and scope, involves a variety of resources and is unique. Project Initiation Idea Study Concept Definition Project Realization: Basic design Detailed design Site selection & preparation Ordering equipment and services Erection and construction Pre- commissioning Project Completion: Commissioning Start up Acceptance Handover Project Review Production Service, optimization 2

3 The impact of project stages on budget and commitments Budgets and commitments are defined during initial project stages Expenditures prior to realization stages Impact of changes, Impact life cycle Budget Expenditures Study Concept Basic Project Stages Detailed Realization: 3

4 Project complexity: main contributors PROFIT Costs Timing Quality Resources Waste, by-products Carbon food print Location PLANET PEOPLE Safety Health Employee retention Well being 4

5 Example of project complexity Safety Legislation & Requirements Local legislation, local regulators Occupational safety, Health and Safety Legislation Machine safety, CE-marking Pressurized Equipment Directive PED, ASME Boiler and Pressure Vessel (BPV) Code Constructional Safety, Building Codes Process safety, Prevention Major Incidents, Seveso, COMAH, PSM Hazardous materials, REACH, classification, CLP labelling and packaging of chemicals Hazard assessment; HAZOP, FMEA, MoC Impact assessment, Quantitative Risk Assessment (QRA) Functional safety: IEC 61508, LOPA, SIL Transportation, ADR Food safety BRC, HACCP, FDA Security, ISPS Safety during construction Safety, Health and Environment for Contractors Data security Electromagnetic compatibility (EMC) electromagnetic interference (EMI) Explosion safety, Atex, DSEAR, OSHA Combustible Dust Explosion and Fire Prevention Act of 2008 Storage of hazardous materials General Product Safety Directive 2001/95/EC (GPSD), The United States Consumer Product Safety Commission CPSC Fire safety, NFPA, LPCB, VdS.... SAFETY FIRST 5

6 Why projects might fail? Many reasons, simple & complex : Scope Creep Over allocated Resources Poor Communications Bad Stakeholder Management Unreliable Estimates No Risk Management Unsupported Project Culture The Accidental Project Manager Lack of Team Planning Sessions Monitoring and Controlling Early warning signs are recognized corrective action can be taken. 6

7 What are Project Risks? Events that, if they occur, cause either a positive or negative impact on a project Key attributes of Risk Hazards, threats Triggers, Causes Consequences, impact Positive and Negative Project Risks Areas include: Business Technology Tools Schedule Budget, resources, organization Safety, Environment, Quality Performance Legislation 7

8 Managing project risks Goal Project Risk Management minimize potential negative risks, maximize the opportunities How risky is the project? Is it a new technology or something your organization is familiar with? Do you have past projects to reference? What is the visibility of the project? What is the inherent hazard? How big is the project? How important is the project? Risk management help improve project success selection good projects determining project scope developing realistic estimates 8

9 Project Risk Management Process Assess during each project stage Failure modes; what can go wrong Triggers; causes Impact, consequences Probability Risk appetite, tolerance Risk response control: responding to risks over the course of the project Assessment Methodologies: SWOT Brain storm What If Simulation and modelling FMECA ZHA HAZID, HAZOP FTA QRA.. 9

10 From concept to realization: Risk Assessment Communicate & Document Positive Risks / Opportunities: Accept Exploit Enhance Share Risk Response Planning Negative Risks / threats: Avoid Transfer Mitigate Accept 10

11 Risk and compliance steps from concept to realization Project Definition / Conceptual design Project Scope definition Customer requirements Consensus on project outcomes SWOT; analyses options Product-Market Combinations Basis of design Resources; Project Team Bench marking; similar projects Legal requirements S, H, E Notified bodies for release and approval Stake holder assessment Threats: Expertise, subject matter experts Definition of scope Feasibility Objectives 11

12 Risk and compliance steps from concept to realization Basic design Process Define Overall Requirements Identify technology, Candidate Process Process Provide Input to Feasibility Financial Case Identify Safety & Regulatory Requirements Conceptual / Basic Determine Engineering Approach Conceptual Basic Mechanical Engineering Conceptual Basic Electrical Engineering Conceptual Basic Control & Instrumentation Engineering Conceptual Basic Safety Engineering Define Preliminary Plant Layouts Conceptual Basic Civil/Structural Engineering 12

13 Risk And compliance aspects Basic Inherent hazards Technology Process Flow Diagram Initial risk assessment, design review; Inherent hazards FMEA HAZID, pre HAZOP: HACCP ISO Safety efforts (Costs) Concept Hazard Analysis Development Manufacturing Use Disposal Often experienced curve Compliance responsibility: Machinery Directive EMC Directive Low Voltage Directive Pressure Equipment Directive (PED) Directive on temporary Building Sites ( S & plan) Directive on Explosive Hazards (ATEX) Process safety. Application of hazard analysis Measures for averting risks Post sales Measures/Monitoring Ideal curve Life cycle of product, system, process, operation, procedure (Time) Manage compliance; equipment file, construction file, supplier data Contractor / Manufacturer selection including compliance responsibility Compliance review 13

14 Risk and compliance steps from concept to realization Detailed Process Piping & Instrumentation Diagrams Functional Specification for Equipment Control Requirements Specification Satisfy Safety Requirements Plant Operating Procedures Detailed Detailed Mechanical Engineering Detailed Electrical Engineering Detailed Control & Instrumentation Engineering Detailed Layout & Construction Building & Plant Services Detailed Civil/ Structural Engineering Safety Engineering Assessment 14

15 Risk and compliance checks Detailed review: ISO 12100,HAZOP, FME(C)A, RAMS, pressure relieve, explosion zones, ignition source assessment, HACCP, QRA, TRA, HRA, MIA, MER Risk Management Concept / Safety Concept + residual risks Functional Safety Plan (SRS) Equipment specification suppliers, contractors Document control Terms and conditions FAT / SAT Concept Construction Files SHEQ plan design stage 15

16 Risk and compliance steps from concept to realization Construction Commission Process & Handover Plant Commissioning Plan Train Commissioning Personnel Commission Plant Preform Acceptance Testing Handover Plant for Operation Construct & (Pre-) Commissioning Construction Plans Establish Constructions Services Erect Plant as Built Surveys Pre-commission Handover to Process Commissioning Construct & Pre-Commission Plant 16

17 Risk and compliance checks construction SHEQ plan erection, construction, prevention policy CAR insurance Acceptance testing procedures Construction team including management and supervision Temporary facilities and services Site Acceptance Tests, Factory Acceptance Tests Test and validation functional safety systems Review test results (own manufactured and contractors) Pre- commissioning Mechanical Complete Pre start up safety review PSSR Commissioning Ready to Operate Start up Acceptance Completion construction file 17

18 Project Completion: Review & Evaluation Review project Adapt the processes, technologies, tools and techniques. Innovate: use new methods, technologies and tools. Adapt Continuous Improvement TIME TO INNOVATE 18

19 Contributors to effective risk management Risk management practices dependent on a number of inter connected principles: good Governance standards, processes & procedures appropriate Risk Appetite designing risk controls in early effective risk management Systems ongoing independent Assurance an accountable Risk Culture. Standardize the risk assessment process: Integrated Project Risk Management Framework Risk Identification Overview Risk Profile Risk Response Overview Templates Monitoring & Control: continuous 19

20 Benefits Risk Management Early identification of potential risks Facilitates setting priorities Increases chance of project success Enables more efficient use of resources Promote teamwork by involving personnel in all levels of the project Information for tradeoffs is based on priorities and quantified assessments Identify hidden risks, early warnings Manage quality, planning & budgets Good project risk management often goes unnoticed Well-run projects appear to be almost effortless

21 Questions? Thanks for the opportunity to present to you today! Jos Hoedemakers Zurich Risk Engineering Benelux 21

22 Additional info: Project Management Institute (PMI) CMMI PMI Government SIG NIH Project Management Center of Excellence Zurich Hazard Analysis (ZHA): Federation International des Ingenieurs 22

23 Attachement: example risk and compliance framework Phase Machine specific Process-specific Others 1. Project definition Quick Scan Quick Scan Quick Scan Examine legislation Examine legislation Examine legislation 2. Start project Define scope Examine need for inspection by notified body Define scope Examine need for inspection by notified body Define SHEQ requirements Stakeholder analysis 3. Basic design Define manufacturer Discuss Compliance issues Compliance engineering Initial risk assessment (EN-ISO 12100) Compliance engineering Initial risk assessment (HAZID, HAZOP or pre ATEX zoning) Compliance engineering Initial risk assessment HACCP, QRA) 4. Detailed design Detailed risk assessment (EN-ISO 12100, integration assessment) Risk management concept Functional Safety Plan Final purchase specifications Concept technical file Detailed risk assessment (HAZOP, FMECA, pressure relief scenarios, ATEX zoning, ignition source assessment, integration assessment) Risk management concept Functional Safety Plan Final purchase specifications Concept technical file SHEQ plan design phase Detailed risk assessment (EN-ISO 12100, RAMS, HACCP, QRA, TRA, HRA, MIA, MER, integration assessment) Risk management concept 23

24 Phase Machine specific Process-specific Others 6. Release and hand over Commissioning Pre Start Up Safety Review Commissioning (safe working Final risk assessments Final risk assessments regulations) As Built Files As built technical file Final risk assessments Final user manual Final user manual Safety training and LOTOTO Final explosion protection Final explosion protection document instructions document EC declaration of conformity Formal release and handover EC declaration of conformity Technical documentation ' as built ' technical documentation ' as CE marking built ' Formal release and handover CE marking Formal release and handover 7. Evaluation Evaluation Improvement actions Evaluation Improvement actions Evaluation Improvement actions 8. Operating phase Management of change process Modification protocol for functional safety Periodic risk assessment Maintenance plan Management of change process Modification protocol for functional safety Periodic risk analysis (PHA) Maintenance plan Management of change process Periodic risk analysis (occupational safety) Periodic inspection and testing Update Standard Operating Procedures, instructions Training Procedures to report defects and incidents Internal Audits Performance indicators (KPI s) Management reviews 24

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