CPPT 9010: Facility Design & Operation

1. CPPT 9010: Facility Design & Operation D.I.T. DT275 Masters in Chemical andPharmaceutical Process Technology 15th December 2009 Clement Farrar BA BAI MSc MIEI

2. Lecture Overview 1) Organisational Structure 2) Safety & Environmental 3) Schedule, Start Up & Commercial 4) Preventative Maintenance

3. 1) Organisation Structure • Overall Site Structure • Commercial Manufacturing Structure • Overall Project, Start Up Structure • Future (Shutdown Structure)

4. Overall Site Structure • HR • Finance • Training • IS • Safety • Occupational Health • Calibrations • Catering • Cleaning Services • Landscaping • Mail Service • Facilities

5. Site Leadership Team Managing Director Supply Chain Development Operations Management Regulatory Affairs Human Resources Technical Services Site Engineering, Maintenance Communications & Public Affairs Business Systems & Processes EHS & Site Services Quality & Compliance Finance

6. Commercial Manufacturing Structure Consider the Actual Manufacturing itself: • Operations • Engineering • Quality • Validation • Training • Manufacturing Support • Technical Services

7. Primary Processing Unit (PPU) One Way of achieving this….. QA Operations QC Engineering OL PPU Structure TS SC Mfg S EHS IS HR

8. PPU Management PPU Head Engineering Operations/ Production Manager Manufacturing Support Manager Quality HR Shift Managers Training Quality Investigations Safety Documentation Finance Technical Services

9. Manufacturing Operations Operations (Associate) Director Operations Shift Managers Operations Supervisors Operations Technicians

10. Quality Function Quality (Associate) Director Quality Assurance Shift Supervisors Qualified Person(s) (QP) Quality Assurance Manager Quality Assurance Project Support Quality Assurance Specialists Quality Assurance Shift Specialists

11. Engineering Function Engineering (Associate) Director Equipment Engineering Manager Maintenance Operations Manager Projects Shutdown Co-ordinator Shift Engineers Equipment Reliability & Maintenance Planning Equipment & Validation Engineers Shift Engineering Technicians

12. Other Considerations Other Considerations for Organisation • Audit Preparation • Documentation Group • Admin

13. Start Up Project Team • Generally a large scale Project, such as a new build, will have both Facility & Consultant (Engineering) Teams • The Org Chart opposite outlines a sample split of roles and responsibilities Project Manager Facility Facility Team

14. Start Up Project Team • An outline of the required Facility team • Note that not all functions would be involved full time Facility Project Sponsor Facility Project Manager

15. Start Up Project Team At the start of the project implementation, the following must be established: • Organisation Charts for both Facility and Consultant Teams identifying all personnel with project responsibility and accountability • Matrix of team roles and responsibilities – facility and consultant

16. Sample Project Org Chart Steering Committee Programme Leader Scheduler Doc Control Cost Controller Admin Tech Transfer Operations Validation Process Development M&L Reg Affairs Quality Engineering

17. Sample Shutdown Org Chart

18. 2) Environment, Health & Safety

19. Environment, Health & Safety • Introduction • Legislation • Key elements of BS OHSAS 18001:2007 • Safety Statement • Injury Classification

20. Environment, Health and Safety Policy ‘We are dedicated to the principle that all workplace incidents, illnesses and adverse environmental impacts are preventable. We will continue to drive down the environment, health and safety impact of our operations by improving process safety, reducing waste, emissions and discharges and by using energy efficiently.’ ‘World class EHS performance depends on management leadership and employee co-operation and conformance to company policy and practices.’ Sample Extracts from EHS Policy ‘All employees are encouraged to actively participate in environment, health and safety matters and work in partnership with management to assure compliance and support continual improvement.’

21. Early Site Development Environmental Considerations An Environmental Impact Assessment (EIA) should be conducted prior to construction of a Facility. This assessment identifies potential environmental impacts and as a result measures can be put in place to mitigate these impacts. The primary impacts assessed are: • Wastewater Treatment • Noise Control • Air Emissions • Waste Generation

22. Early Site Development Environmental Considerations • CONSULTATION is key during early site design and development • Planning Permission can be granted quickly and without any objections as a result of effective design to minimise potential environmental impacts and also excellent consultation with local residents and interest groups.

23. Early Site Development Environmental Considerations • The facility must maintain a good environmental performance and continually meet and improve on the early message delivered for the facility i.e. the site will not cause an adverse environmental impact or create a nuisance for local residents. • The environmental context of the site remains as important e.g. surface waters from the site generally discharge to a local river - and generally these water bodies have a high amenity value and need to be protected.

24. Exercise What environmental programmes are in place at your current/ a previous place of employment? • Is there good Employee Awareness • Are there good/ novel Environmental Initiatives • What could be improved upon?

25. Legal Obligations Integrated Pollution Control Licence Corporate EHS Department Local Authority

26. Legal Obligations IPCL Licence I Integrated P pollution C Control L Licence to prevent or solve pollution problems rather than transferring them from one part of the environment to another. The IPC License regulates the entire Site and ensures that all processes, procedures and materials are managed in a way that does not cause environmental pollution. The next slide demonstrates the interaction of a Facility with key Environmental Aspects

27. PEOPLE MATERIALS EMISSIONS TO ATMOSPHERE ENERGY PRODUCT WATER EFFLUENT WASTE PRODUCTS

28. EHS Management System “Say what you do and do what you say you do” • Ensure all tasks are RISK ASSESSED and controls implemented to: • Minimise Waste Generated • Minimise Water and Energy Usage • Prevent Spillage • Generate STANDARD OPERATING PROCEDURES (SOPs) • Personnel must be TRAINED on relevant procedures: • e.g. Waste Management & Spill Control Procedures • All Major Spills and Environmental Incidents must be reported immediately.

29. Waste is highly REGULATED in Ireland. There is ‘no grey area’ with respect to waste - procedures must be followed accurately. The HIERARCHY of waste management stipulates that prevention is the most preferred option. Policy of Prevention, Reduction, Recycle and Re-use. Waste Management

30. ENSURE correct segregation procedures in place HAZARDOUS Waste must NOT be mixed with Non-Hazardous Waste BIOHAZARDOUS Waste must be segregated Utilise approved containers/ bins for hazardous waste Waste Management • SOPs must ensure: - • Full and accurate labeling • Full logbook entry

31. Environmental Protection - Employee Responsibility • Spill Control (ALWAYS Notify Supervisor where a spill occurs) • Waste Segregation and Disposal • Minimise Water and Energy Usage • Adherence to Procedures

32. Watch what you put down the sink Solvent/ detergents - use the proper amount Turn off equipment, lights, PC’s etc when not in use Minimize waste - eliminate, reuse and recycle Know your spill procedures Report faulty Plumbing Follow recycling procedures for paper, card, foil, cans & batteries Create a Culture Simple Key Points When in doubt...Ask!

33. Simple Environment Friendly Initiatives • Consider car sharing initiatives - halve your costs • Consider Cycle-to-work initiatives • Promote the use of e-mail • Use double side when Photocopying • Promote Recycling

34. Safety Programmes to Consider • Occupational Health & Safety • Industrial Hygiene Program • Radiation Safety Program • Bio-safety Program • Occupational Health Program • 2. Operational Safety and Fatality Prevention: • Work at Height • Confined Space Entry • Control of Hazardous Energy • Electrical Safety • Material Handling Equipment • ATEX • Slips Trips and Falls • Manual Handling and Ergonomics

35. Safety Programmes to Consider 3. Loss Prevention and Life Safety: • Fire Detection and Protection Systems Program 4. Emergency Preparedness: • Emergency Response Team • First Aid Management 5. Contractor Management: • Craft and Sustaining

36. What does Health & Safety Legislation mean for the Company and its Employees? • Health & Safety legislation defines the minimum regulatory requirements that must be adhered to in order to ensure the safety, health and welfare at work of all site personnel and contractors • Legislation imposes specific duties/ obligations on: • The company as an employer including directors, managers, and supervisors of personnel • The employees • Contractors and their employees • Failure to comply with the legislation can constitute an offence under the legislation and lead to a fine or imprisonment or both on conviction in court • Everyone must comply with their legal obligations and conduct their activities in a manner which complies with the regulatory requirements

37. OHSAS 18001Health and Safety Management Systems

38. BS OHSAS 18001: 2007 What is OHSAS 18001? • International Occupational, Health and Safety (OH&S) Management System Standard • Defines the requirements for establishing, implementing and operating an OH&S Management System • Structured approach to OH&S management • Usually a corporate business objective

39. What is OHSAS 18001 Traditional OH&S management usually meant reacting to work related incidents rather than planning for the control of work related risks. The emphasis is placed on practices being pro-active and preventative by the indication of hazards and evaluation and control of risks OHSAS 18001

40. OHSAS 18001 What does it mean for Facilities? • The facility should operate an Occupational Health & Safety management system (OH&SMS) that meets the full requirements of an international and highly recognised standard. • It will help to ensure that there is a continual cycle of planning, implementing, reviewing, and improving the actions that the facility takes to meet its OH&S obligations. • It will prevent incidents and injuries and protect those who work at the facility. • It will help to ensure a consistently high rate of compliance is achieved. • It will provide a framework for continual improvement in OH&S performance

41. OHSAS 18001 OHSAS 18001 Features include the following elements: • OH&S Policy • Planning • Implementation & Operation • Checking & Corrective Action • Management Review

42. OHSAS 18001 • The OHSAS Management System fits the traditional Plan–Do–Check–Act Model Plan Establish the objectives and processes necessary to deliver results in accordance with the organisations OH&S Policy Act Take actions to continually improve OH&S Performance Plan Revise & Improve Check Monitor and measure processes against the OH&S Policy, objectives, legal and other requirements and report the results Do Implement the process

43. BS OHSAS 18001: 2007 Standard - Methodology • The Plan-Do-Check-Act (PDCA) model can also be briefly described as follows: • Plan: establish the objectives and processes necessary to deliver results in accordance with the organization’s OH&S policy • Do: implement the processes • Check: monitor and measure processes against OH&S policy, objectives, legal and other requirements, and report the results • Act: take actions to continually improve OH&S performance

44. Legal Requirement for Safety Statement: SHWW Act, 2005 • Employer shall prepare a written ‘Safety Statement’ based on the risk assessments carried out, specifying the manner in which the SHWW of his or her employees shall be secured and managed including: • The hazards identified and the risks assessed • The protective and preventive measures taken and the resources provided for protecting SHWW • Emergency plans and procedures • The duties of his or her employees • The roles and responsibilities of personnel with respect to SHWW • The arrangements made regarding safety representatives and consultation with employees

45. Legal Requirement for Safety Statement: SHWW Act, 2005 • Employer shall bring the safety statement to the attention of: • His or her employees, at least annually and following any amendments • New employees upon commencement employment • Other persons at the place of work who may be exposed to any risks • Employer shall bring to the attention of persons exposed to specific risks the relevant extracts of the safety statement including the risk assessment and the protective and preventive measures taken • A copy of a safety statement, or relevant extract of it, shall be kept available for inspection at or near the workplace

46. Overview of Safety Statement • A facility's Safety Statement must be located in an easy access location • It is a summary document describing the main elements of the OHS management system at the facility • It also constitutes the OHS Manual as required by the BS OSHAS 18001: 2007 standard and therefore the contents of the safety statement are arranged to replicate the content of the standard, namely: • Introduction • EHS Policy • Planning • Implementation and Operation • Checking and Corrective Action • Management Review

47. Safety Statement: Introduction Safety Principles • All occupational illness and injuries are preventable. • We are all directly responsible for preventing illness and injury. • Working safely is a condition of employment. • All personnel must be trained in safety. • Safety audits must be conducted. • All deficiencies must be corrected promptly. • All injuries and incidents with injury potential must be investigated. • It is good business to prevent illnesses and injuries. • Line management must own and role model good safety practices and behaviours. • You are our most important asset and the most critical element in the success of a safety and health programme.

48. Safety Statement: Introduction Safety Rules • Never work on live electrical equipment or uncontrolled hazardous energy. • Never work at a height without the approved fall protection. • Never dispose of hazardous waste as non-hazardous waste. • Never breach Confined Space Entry requirements. • Never by-pass machine guards or safety interlocks. • Never use unapproved equipment in explosion rated (Ex) areas. • Never operate powered industrial vehicles or equipment without the required training. • Never ignore evacuation alarms or interfere with life safety and emergency equipment. • Never disregard warning label instructions on chemicals. • Always report incidents to line management.

49. Injuries • Outline the legislative and corporate requirements for reporting injuries and illnesses (EHS) • Define & distinguish between First Aid, Lost Workday Case, Restricted Work Case and Medical Treatment (EHS)

50. General - Corporate & Legal • All company locations should have a programme established to promptly investigate, record and report all occupational injuries and illnesses to ensure national regulatory requirements are maintained • All employers have an obligation to prevent accidents at work. Where accidents occur the employer must investigate the causes and implement action to prevent reoccurrence of the accidentSource - 2007 General Application Regulations