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

Development

Regulatory Affairs

Technical Services

Site Engineering, Maintenance

EHS & Site Services

Operations Management

Communications & Public Affairs

Human Resources

Finance

Managing Director

Supply Chain

Quality & Compliance

Business Systems & Processes

6

Commercial Manufacturing Structure

Consider the Actual Manufacturing itself: Operations Engineering Quality Validation Training Manufacturing Support Technical Services

7

Primary Processing Unit (PPU)Primary Processing Unit (PPU)

Operations

OL

SC

EHS

IS HR

Mfg S

TS

Engineering

QCQA

One Way of achieving this…..QA Quality Assurance

QC Quality Control

TS Technical Services

Mfg S Manufacturing Support

HR Human Resources

IS Information Systems

EH & S

Environmental, Health & Safety

SC Supply Chain

OL Organisational Learning

PPUStructure

8

PPU Management

Operations/ Production ManagerManufacturing Support Manager

Engineering

Technical Services

Documentation

Quality

Investigations

PPU Head

Safety

Shift Managers HR

Training

Quality

Finance

9

Manufacturing Operations

Operations Shift

Managers

Operations Supervisors

Operations Technicians

Operations (Associate)

Director

10

Quality FunctionQuality

(Associate) Director

Qualified Person(s)

(QP)

Quality Assurance

Project Support

Quality Assurance Manager

Quality Assurance Specialists

Quality Assurance

Shift Supervisors

Quality Assurance Shift

Specialists

11

Engineering FunctionEngineering (Associate) Director

Shutdown Co-ordinator

EquipmentEngineering

Manager

Projects

Shift Engineers Equipment & Validation Engineers

Equipment Reliability & Maintenance

PlanningShift Engineering Technicians

Maintenance Operations Manager

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 TeamAt 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

SchedulerDoc Control

Reg Affairs

Engineering Tech Transfer

Steering Committee

Operations

Admin

Validation M&L Quality Process Development

Programme Leader

Cost Controller

17

Sample Shutdown Org ChartShutdown

Project Manager

Shutdown Scheduler

QUALITY

QA Ops Utilities Supervisor

QC Water Micro/Chem

QC Micro Env Monitoring

QC Sample Management

AUTOMATIONENG OPS Upstream Coordination

ENG OPS Downstream Coordination

Eng Ops Utilities ProcurementMRO Stores

ETS SME's

I&C Electrical HVAC Clean Utils Facilities

EHS Specialist

Manufacturing Ops Upstream

AD EngineeringProject Sponsor

Manufacturing Ops Downstream

Shutdown Execution

Tactical Support

Shutdown Execution

Projects Validation

QBMS

Optimisation Projects MCS UpgradeBusiness

Support PlanningSafety Representative

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 PolicySample Extracts from EHS Policy

‘World class EHS performance depends on management leadership and employee co-operation and conformance to company policy and practices.’

‘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.’

‘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.’

21

Early Site Development Environmental ConsiderationsAn 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 ControlLicenceCorporate EHS Department

Local Authority

26

Legal Obligations IPCL Licence

to prevent or solve to prevent or solve

pollution problems rather pollution problems rather than transferring them than transferring them

from one part of the from one part of the environment to another.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

ENERGYENERGY

EFFLUENTEFFLUENT

WASTE PRODUCTSWASTE PRODUCTS

MATERIALSMATERIALS

PRODUCTPRODUCT

WATERWATER

PEOPLEPEOPLE

EMISSIONSEMISSIONSTO ATMOSPHERETO ATMOSPHERE

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 Management 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.

30

Waste Management 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

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

Simple Key Points 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

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 Consider1. 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: 2007What 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

OHSAS 18001

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

40

OHSAS 18001What 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

Revise & Improve

Plan

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

Do

Implement the process

Check

Monitor and measure processes against the OH&S Policy, objectives, legal and other requirements and report the results

Act

Take actions to continually improve OH&S Performance

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: IntroductionSafety Principles 1. All occupational illness and injuries are preventable.

2. We are all directly responsible for preventing illness and injury.

3. Working safely is a condition of employment.

4. All personnel must be trained in safety.

5. Safety audits must be conducted.

6. All deficiencies must be corrected promptly.

7. All injuries and incidents with injury potential must be investigated.

8. It is good business to prevent illnesses and injuries.

9. Line management must own and role model good safety practices and behaviours.

10. You are our most important asset and the most critical element in the success of a safety and health programme.

48

Safety Statement: IntroductionSafety Rules1. Never work on live electrical equipment or uncontrolled hazardous energy.

2. Never work at a height without the approved fall protection.

3. Never dispose of hazardous waste as non-hazardous waste.

4. Never breach Confined Space Entry requirements.

5. Never by-pass machine guards or safety interlocks.

6. Never use unapproved equipment in explosion rated (Ex) areas.

7. Never operate powered industrial vehicles or equipment without the required training.

8. Never ignore evacuation alarms or interfere with life safety and emergency equipment.

9. Never disregard warning label instructions on chemicals.

10. 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 accident Source - 2007 General Application Regulations

51

General - Corporate & LegalInjury Reporting Guidelines Corporate Requirements

All Lost Time and Restricted work cases should be communicated to Corporate Leadership Team on a weekly basis by EHS

This information should be collated in a SPRS (Safety Performance Reporting System) for Injury data management

OSHA Requirements (Occ Health & Safety Administration) All Lost Time, Restricted Work and Medical Treatment cases must be

reported monthly to Corporate for inclusion in the company Injury data OSHA Report

Irish Statutory Requirements All lost time cases of 3 days or more ( including days off) must be reported

to H.S.A ( IR1 Form) by EHS

52

Definitions of Occupational injury & illness

An injury is a sudden trauma to the body resulting from physical damage

Cuts, sprains, burns etc An occupational illness is a medical condition that results

from exposure in the workplace. It includes acute and chronic illnesses or diseases which may be caused by inhalation, absorption, ingestion, or direct contact

Asthma , dermatitis etc

53

Work Related versus Non-Work Related? Any contribution from the workplace is sufficient to make a case work-

related. If the employee is in the work environment, even if they are not engaged in a work-related task, the case is ‘PRESUMED’ to be work-related.

An accident that occurs off the premises is considered work-related if the employee is engaged in, or present to do work. If an employee leaves the work area for other purposes, then these activities are not work-related

E.g. Employees who travel on Company business are considered to be engaged in work-related activities. However, an accident would not be reportable if the employee deviates from a reasonable route of travel such as a side trip for vacation or visiting friends

54

How to determine if an injury or illness is work-related

An injury or illness is determined to be work-related if: An event or exposure in the work environment either caused or

contributed to the resulting condition OR

Significantly aggravated a pre-existing illness or injury. In all injury classifications an OH opinion is required.

There are some exemptions to this rule (e.g., injury/ illness arising from voluntary participation in flu vaccine, blood donation or recreational activity)

A clear medical diagnosis is necessary to identify these exemptions and referral to Occupational Health for clarification is appropriate.

55

How are work-related injuries/ illnesses classified ?

First Aid Medical treatment Work restricted case Day away/ Lost Time case Fatal case

56

Restricted Workday Case In Context

Fatality

Lost Workday Cases

Restricted Workday Cases

Medical Treatment Cases

First Aid Cases

Near Miss

57

OSHA Definition of First Aid Case

Any injury or illness which can be treated on site by a trained First Aider or OHA

Cleaning / flushing or dressing wounds Using hot or cold therapy (for treatment of burns/ soft tissue

injuries) Using eye patches Removing foreign bodies from the eye using only irrigation Removing splinters or foreign bodies Drinking fluids for relief of heat stress

58

OSHA Definition of Medical Treatment

Medical treatment is any treatment other than first aid treatment. The definition focuses on the nature of the treatment given

and not on the person administering the treatment (e.g. physician, physiotherapist etc)

E.g. a doctor prescribes medication or applies sutures or surgery to treat a condition arising from a work related injury/illness

59

Restricted Workday CaseAn injury is considered to be a Restricted Work

Case if an employee cannot perform all of the ‘routine functions’ of their job. Departmental assignments cannot be altered so that

employee’s injury is not classified as a ‘restricted work case’. For recordkeeping purposes, an employee’s routine functions

are those work activities the employee regularly performs at least once per week

E.g. If a medical recommendation advises that a person avoids lifting and it is a requirement for his/her role then it must be logged as a Restricted Work Case

60

Lost Workday Case

A Lost Workday Case is an occupational injury that is serious enough to result in an employee being away from work for one day or more. The day of the injury is not counted Shift work days off should be considered

61

OSHA Injury/ Illness Classification TeamA team will meet to confirm the work-relatedness of the

condition and determine the classification of the injury where there is ambiguity

This team will usually consist of: Head of Department Supervisor/ Manager of employee injured OH Advisor EHS specialist EHS Manager Subject Matter Expert (e.g. Occupational Hygienist,

Ergonomist) as required

62

Sample Injury Cases

Case No Date Incident Injury Classification

X 3 Apr Caustic splash to Face/ Eyes in Buffer Prep

Burn to eyes -prescribed drops

Medical Treatment

Y 14 May

Slip outside Female Locker Room

Forearm Fracture – Cast & Surgery

Lost Time

Z 28 Nov Injury to left hand small finger using wrench

Minor fracture requiring splint

Restricted work

63

3) Schedule

Schedule Phases High Level Milestones High Level Schedule Schedule Breakdown Integration of Project Phases Schedule Optimisation Assumptions & Risks

64

Schedule (Design to Sustaining Production)

Design Construction Qualification Start-Up Regulatory Submission Commercial Production Long Term Outlook (Ramp Up, Optimisations,

Shutdowns, New Product Introduction)

65

High Level Milestones

Break up Work into Milestones - easy way of viewing overall schedule to ensure on track

Sample List of Milestones: Prelim Design Report (Issue Wk 1) Detailed Design Phase Proposal (Issue Wk 6) Value Engineering & Scope Revision (Wk 10) Start Detailed Design (Wk 11) Long Lead Equipment & Cleanroom Panel System ordered (Wk 11) Plant shutdown (Wk16 - Wk38) Process Start-up (Wk 35 - Wk 38) All systems operational (Wk 52)

66

Milestones for Sample 2010 Project The key Milestones up to Regulatory approval include:

Detailed Design Start 11th July ’10 Place Equipment PO’s 8th Aug ’10 Construction Start early Feb ’11 Commissioning Start early June ’11 Mechanical Completion end Nov ’11 IQ Start mid Oct ’11 Commissioning Complete early Feb ’12 IQ Complete end Feb ’12 OQ Start end Nov ’11 OQ Complete early June ‘12 PQ Start mid Dec ’11 Media Fills Start end Aug ’12 EMEA Approval June ‘13

67

High Level Milestones - Sample

68

High Level Schedule Prelim Design Study Scope, Schedule, Cost

Detailed Design Detailed Design of the Process, Utility and Facility systems

Procurement & Procurement of the Process, Utility and Automation Contracting equipment

Tendering & Awarding of the construction contracts

Demolition & Prepare the area and complete construction worksConstruction Fit out (including cut ins and tie ins to existing site

systems if applicable)

Commissioning Commission new Utility, HVAC & Facility systemsPossible re-Commissioning of existing systems

modified to allow connection of new facility supplies

Commission process equipment

69

High Level Schedule Qualification IQ & OQ of facility and utility systems

[IQ,OQ] IQ & OQ of process equipment

Engineering Runs Integrated line and system testing

PQ Performance Qualification of the new systems in an integrated run

Development Production of Development BatchesBatches

Media Fills Carry out Media Fills

70

High Level Schedule Stability Maintain filled material for a 6mth period

under controlled conditions with stability testing to prove integrity of filling process

Regulatory Filing Prepare & submit Regulatory Filing and

& Approval achieve approval

Commercial Production of product for saleProduction

71

High Level Schedule - Sample 1These phases are organised generally in the following sequence:

72

High Level Schedule - Sample 2

ID Task Name Start Finish Duration2008 20102009

Q4Q2 Q1 Q1 Q3Q2Q4Q1 Q3Q3 Q2

2 0w15-Feb-0815-Feb-08Full Funding Approval

3 2w28-Feb-0815-Feb-08Equipment Procurement

4 52w26-Feb-0929-Feb-08Equipment Fabrication

5 8w23-Apr-0927-Feb-09Installation

6 8w18-Jun-0924-Apr-09Commissioning

7 8w13-Aug-0919-Jun-09Qualification

9 8w12-Nov-0918-Sep-09Demo Batches

10 6w24-Dec-0913-Nov-09Media Fills

11 9w25-Feb-1025-Dec-09Exhibit Batches

12 26w26-Aug-1026-Feb-10Regulatory Approval

8 5w17-Sep-0914-Aug-09Development Trials

1 18w08-Feb-0808-Oct-07Preliminary Engineering

Eng Scope

73

Schedule Breakdown

Schedule can broken down into chunks Each piece of Equipment will have it’s own

individual schedule Allows individuals to focus on their own

particular area of interest All these individual schedules are part of one

overall master schedule

74

Individual Equipment Schedule - Sample

ID Task Name Duration2008 20102009

Q4Q2 Q1 Q2 Q4Q3Q1Q1 Q3Q3 Q2

2 0wFunding Approval

3 4.6wProcurement

5 60wDesign and Fabrication

7 14.4wInstallation

10 26wQualification (IQ OQ PQ)

11 18wProcess Validation

1 9.2wPreliminary Engineering

Q4

9 13.4wCommissioning

8 0wMechanical Completion

6 0wFilling Line Delivered

4 0wFilling Line PO

Actual Start

25-Feb-08

29-Apr-08

29-Apr-08

30-May-08

30-May-08

29-Jul-09

30-Jul-09

09-Nov-09

09-Nov-09

10-Feb-10

11-Aug-10

Actual Finish

28-Apr-08

29-Apr-08

29-May-08

30-May-08

23-Jul-09

29-Jul-09

06-Nov-09

09-Nov-09

09-Feb-10

10-Aug-10

14-Dec-10

75

Integration of Project PhasesA Project needs Project Phases to be well Integrated:

No phase of the project can be executed without consideration of the subsequent phases

This places a significant emphasis on developing an integrated project life cycle to ensure that activities carried out in each phase are aligned and supportive of the activities in the subsequent phases

For successful project integration the following needs to happen early in the implementation phase:

Formally Identify and Appoint the key facility personnel with responsibility for leading each of the project phases

76

Integration of Project Phases Hold a series of Project Implementation Workshops to ensure that the:

− Project scope is understood− Project ‘life cycle’ is understood− Key implementation issues are reviewed and understood− Clear ‘buy in’ and ownership of the implementation strategy is achieved− Implementation schedule is tested, understood and owned by all parties

Some of the key ‘integration’ issues and philosophies that will be key include: Qualification

− Early agreement on Qualification & Validation strategy− Calibration− Information leveraging to support Qualification− Scope of OQ versus PQ

77

Integration of Project Phases Factory Acceptance Testing (FAT)

− Engineering or Qualification activity− Information leveraging to support Qualification

Process Equipment Vendors− Roles onsite− Extent of time required onsite

Other projects that would affect the main project− Other Projects in the building e.g. new Clean Steam Generators− Other Projects on the wider Site e.g. new Warehouse

78

Integration of Project Phases - Sample

79

Schedule OptimisationAggressive Schedule A facility start up schedule is always very aggressive, particularly

with pharmaceutical facilities given the type of facility and the technology involved. For example the complexity of the formulation process and the use of filling lines are key schedule challenges.

Various options can be reviewed to reduce / significantly improve the schedule; some of which are: Need to have a structured and ‘controlled’ project Design phase must have qualification life cycle requirements agreed

and integrated from the start Need to have a controlled procurement phase where vendors are

brought on board early with clear scope definition and project execution life cycles to hold them to

80

Schedule Optimisation Lead times for modular cleanroom components Construction period to allow practical sequencing and a good quality

of construction Allowance for dedicated commissioning periods per system

[commissioning is a critical phase in the project, it must be carried out in a structured fashion to ensure a successful subsequent qualification]

Benchmarking from recent similar projects

81

Assumptions & Risks

There are many risks to the facility start up schedules that have have to be monitored and managed

82

Assumptions & Risks

Examples of Key risks to schedules are: Fixed shutdown constraints - typically there is virtually

no float within the given shutdown period Long Lead items must be procured by certain date Reliance on Package Vendors for validation

documentation must be managed closely Design review & HAZOP approach to be agreed Validation document review will require extensive

Facility resources and may prove a bottleneck

83

Assumptions & Risks Key assumptions underpinning the project schedule are:

Integrated ‘one team’ approach between Vendors (particularly engineering design) and Facility

‘Can do’ / ‘make it happen’ attitude Integrated Design / C&V team PO’s will be placed as early a possible to allow vendor design

information to flow as early as possible - this will allow a more robust design

URS’s content will be focused on user requirements - they will not be detailed engineering specifications

Quick and efficient turn around of documents from Facility Automation ‘sub projects’ [MCS & QBMS] are fully integrated

and controlled as a fundamental part of the main project - tight control required to ensure delivery on time

84

Assumptions & Risks No significant scope changes - for this type of project the impact of a

change is significant given the significant knock-on to design documentation, vendor documentation, automation and commissioning/ qualification protocols

Cleanroom package will be negotiated to allow detailed cleanroom design to be fully integrated with the full design

Commissioning will be completed per system prior to qualification starting on that system

Commissioning of process equipment can progress with commissioned clean utilities

Commissioning & qualification logic will be as follows: Systems will move directly from mechanical completion to commissioning to qualification with minimal constraints / holds imposed from other systems

85

Assumptions & Risks Facility System Owners identified and available during the detailed

design phase to attend FAT’s, coordinate Facility input to system snagging, provide Facility lead for systems through completion, commissioning & qualification phases

Sufficient Facility Operations & Maintenance personnel allocated to the project from construction completion / FAT phase

Progress from IQ to OQ and OQ to PQ is based on minor deviations outstanding

Dedicated project change control ‘sub committee’ for the project [to review and approve change controls arising post the start of IQ]

86

4) Preventive Maintenance

ObjectiveEnsure routine maintenance work is performed so that GMP equipment and associated ancillary systems shall be maintained to continue to perform in a qualified/ validated state

87

Maintenance Management System Preventive Maintenance Work

All Relevant Areas in the facility

Maintenance Management System (SAP)

Engineering Stores/ Spare Parts (SAP)

Relevant SOPs - possible examples: Maintenance Work Procedure Maintenance Management System Procedure Engineering and Operations Stores Procedure

88

Maintenance Management System Manage Equipment Register & associated Maintenance

History Records

Run a Preventive Maintenance program Maintenance Task List Maintenance Plan

Direct the Corrective Maintenance program Track equipment malfunction Facilitate analysis of maintenance information

Facilitate asset Spare Parts replacement, storage, control and records

89

Preventive Maintenance Overview

AREA MANAGERS

MAINTENANCE TECHNICIAN OR CONTRACTOR

Equip LogbookWork Activities

Work Order

Activities

ENGINEERING & OPERATIONS

STORESEng Stores

Review

SOP’s

MMS Reports

AREA MANAGERS/

QA

Maint Requireme

nts

SYSTEM ADMIN

Maintenance Management, Spares Management

90

MMS (SAP Plant Maintenance) Roles MMS Administration

Create Corrective Maintenance Work Orders Print Work Orders Display & Print Reports Feedback Information from completed Work Orders Alter Details on Assets, Maintenance Task Lists & Plans

MMS Operator Create Corrective Maintenance Work Orders Print Work Orders Display & Print Reports Feedback Information from completed Work Orders

91

QUESTIONS???

clement.farrar@gmail.com