lilly risk-based cq_ ispe-ccpie china conference 2010_9-19-10

ISPE-CCPIE CHINA CONFERENCE 2010

October 26-29 2010 Beijing

Risk-Based Commissioning & Qualification

Mr. Scott HammConsultant Engineer – C&Q

Eli Lilly and Company

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• Lilly C&Q Program

• C&Q Integration with Capital Project Delivery

• C&Q Keys to Success

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• Commissioning considered a “Good Engineering Practice” and applied to all assets

• Commissioning follows “Good Documentation Practices”

• Commissioning documentation leveraged to support Qualification, avoiding repeat work

• Integrated C&Q/Computer System Validation testing strategy Commissioning supplemented with automation simulation testing CSV & C&Q testing requirements met without redundant testing

Lilly C&Q Program ~ Philosophy

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• Qualification focused on direct impact systems - critical components/alarms/process parameters/operating ranges

• Quality Control buy-in obtained for integrated C&Q strategies

• System-specific testing strategies based on risk assessment results:• Product quality risk (determines qualification requirements)• Technology risk (no automation, complex automation, new technology)• Vendor risk (frequently used vendor, new vendor)

Lilly C&Q Program ~ Philosophy

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Lilly C&Q Program ~ Core Activities

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• User Requirement (UR) documents are required for direct impact and indirect impact systems

• URs are criteria that an asset must meet to satisfy user needs, and serve as the basis for design and testing

• URs shall include the following types of requirements:• Product/Process• Regulatory• Business needs• Health and Safety

• Need to specify which URs are product/process or regulatory

Lilly C&Q Program ~ User Requirements

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A user requirement statement……• Should define what is required, not how requirement is met• Should be independent of design• Should be complete, clear and concise to ensure easily understood• Should be unique – don’t group with other requirements • Should include no ambiguous or subjective terminology (e.g., sufficient) • Must be “testable” or “objectively verifiable” and “traceable” throughout

C&Q via inspection, analysis or demonstration• Must identify all Critical Process Parameters (CPP), Operational Process

Parameters (OPP), and Primary Process Parameters (PPP)• Must exist to record and monitor critical parameters• Must be realistic


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Approved user requirements……• Serve as the basis for design and C&Q testing• Are required prior to Design Review• Serve as the basis for system traceability matrices• Help to manage project scope• May serve as high-level acceptance criteria for testing• Are maintained as living life-cycle documents


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Lilly C&Q Program ~ Risk Assessment• Process risk assessments performed by Development and serve as

inputs to subsequent risk assessments

• Impact assessments performed for all systems to determine impact on product quality/patient safety (direct, indirect, no impact)

• Alternate equipment risk assessment methods (FMEA, Fishbone or Ishikawa Diagram, etc.) may be used for higher risk items. The level of effort, formality, and documentation of this assessment should be commensurate with the level of risk.

• The following should be considered when assessing equipment risk: Technology risk – new or proven Vendor risk - experience with vendor, quality system, etc. Level of automation – none, off-the shelf, configurable, custom Health and safety Environmental

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Lilly C&Q Program ~ Risk Assessment

Risk assessment results utilized to determine C&Q/Verification strategy, which includes:

Level of testing Qualification requirements Use of vendor deliverables Use of off-line testing or simulation Calibration and maintenance requirements Risk factors to be addressed during design review

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• C&Q Plans shall include:• C&Q strategy (based on risk assessment results)• Integration of automation testing with C&Q• How commissioning documents will be used to support Qualification• Required C&Q and automation activities and deliverables• Roles & responsibilities• Acceptance and Release strategy• Review/approval requirements• References

• C&Q Plans must be approved by appropriate SMEs – Quality approval required for direct impact systems

• C&Q Plan summary reports are required to document that plan requirements were met or any deviations to plan

Lilly C&Q Program ~ C&Q Planning

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• Supports risk-based approach• Minimizes or eliminates redundant testing• Supports holistic management of equipment & controls• Streamlines qualification ~ fewer comments/discrepancies• Easier to prioritize system testing activities • Allows for more efficient delivery of automated systems


Benefits of integrating Automation testing with C&Q:

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• Collaboration of Automation and C&Q contractors• Cross-functional Lead Team & Process Teams• Automation integrated into formal commissioning program• Equipment & Automation design alignment• All UR & FRS requirements tested during commissioning• Automation included in design review• Apply common discrepancy & change management processes to

automation and C&Q


Methods of integrating Automation testing with C&Q:

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Lilly C&Q Program ~ Design Review

• Design review is a risk mitigation activity for subsequent C&Q activities.

• Is required for all direct impact & indirect impact systems• Verifies & documents that design meets user requirements and

must include: System ID List of design docs reviewed Review of design docs to ensure requirements are met List of participants involved – include SMEs Review of traceability List of issues and corrective actions Conclusion indicating suitability of design

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Prerequisites for design review:• Approved requirements are available • System impact assessment results• Design documents complete and available• A change management process is in place• Personnel responsible for development, review or approval of

design review documentation must be trained on any defined processes or procedures

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• Completed prior to fabrication of customized equipment or purchase of off-the-shelf equipment to avoid costly rework

• Include automation requirements (e.g., Functional Specifications)

• Typically executed in phases for vendor equipment to avoid schedule delays and accommodate progressing design

• Focus on critical design aspects

• Ensure identified risk factors are adequately assessed and mitigated via design, if possible

• Design review for direct impact systems is referred to as Design Qualification (DQ) and requires Quality involvement and approval

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Lilly C&Q Program ~ Receipt Verification• Verify component manufacturer/model number is as specified• Verify component key aspects are met (e.g., material of construction,

connections, etc.)

• Inspect components for damage from shipping • Verify that required vendor documentation (e.g., operating &

maintenance manuals, material certifications, calibration records, etc.) has been received

• Add and record property tag and record serial number • RV is not required for vendor packaged equipment, but component

data and documentation must be verified. It is recommended that these activities are performed at the vendor site prior to or during FAT.

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Lilly C&Q Program ~ Automation Development Testing

• Verifies that automation was developed to meet design and functional specifications

• Typically completed off-line using a simulation / test system

• Includes, but is not limited to, I/O Assignment Testing, Graphics Display Testing, Basic Control Testing, Alarm Testing, Interlock Testing, and Sequence of Operations Testing

• Required as part of the automation development process. It is not typically required to repeat tests on-line unless the tests are impacted by system dynamics that are not reflected in the off-line environment

• Leveraged to support field testing given adequate configuration management and documentation controls are in place during the execution process

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Lilly C&Q Program ~ Factory Acceptance Testing

• Typically required for vendor packaged equipment• Vendor developed protocols approved by Lilly• Executed to ensure contractual obligations are met• Mitigates risk prior to subsequent C&Q activities• Provides opportunity for Engineering, Automation and

Operations to understand equipment• Evaluate vendors as part of risk assessment strategy so

vendor documentation can be utilized to meet requirements

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Note: This content also applies for SAT.


Lilly C&Q Program ~ Factory Acceptance Testing

• If FAT test results will be used to met requirements or support qualification:

this strategy must be defined in C&Q planning documents it will have to be demonstrated or verified that there was no damage to

the equipment during disassembly or shipping that could impact the integrity of the FAT test results

• Installation aspects are verified during FAT.• Documentation and data requirements are verified during FAT. These

requirements must be communicated to vendors in specifications or contractual documents.

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Lilly C&Q Program ~ Construction Quality Assurance

• Construction Quality Assurance (CQA) ensures that defined specifications and standards are followed and sound construction techniques are utilized when fabricating Lilly facilities, processes and systems.

• CQA ensures that quality concepts and practices are utilized in the construction phase of the capital project to ensure facilities are delivered on time and as specified.

• CQA is needed due to: • Misunderstandings of requirements and expectations• Errors in construction/fabrication• Non-adherence to specifications

…which have led to:• rework cost• delays in commissioning and qualification• delays in getting to market• delays in payments

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Lilly C&Q Program ~ Construction Quality Assurance

• CQA must be: an expectation of the contractor A deliberate managed process of the contractor a demonstrated capability of the contractor a measured and reported upon activity

• Robust and reliable CQA will improve and streamline the Commissioning and Qualification process which:

reduces total facility delivery time

reduces total facility delivery cost

provides better test data for Validation

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Lilly C&Q Program ~ Mechanical Completion

• Mechanical Completion (MC) is a milestone indicating that the system has been constructed and/or installed in accordance with approved specifications and drawings, and the applicable MC checklists have been completed.

• A Turnover Package (TOP) is also submitted upon MC.

• If the system is accepted as mechanically complete, and the TOP is satisfactory, then control of the asset is transferred from Construction to Commissioning Team.

• A collaborative relationship between Construction and Commissioning Teams is essential for success.

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Lilly C&Q Program ~ Installation Verification• IV is an activity that demonstrates and documents that installed facilities,

systems, and components comply with Lilly installation specifications and vendor requirements prior to start-up. The level of effort varies based on risk.

• IV consists of, but is not limited to, verifications of the following:• Drawings (P&IDs, AF&IDs, etc.)• Component installation per specification and/or manufacturer recommendations• Documentation (material of construction, welding, pressure testing, passivation)• Automation hardware/software• Utility connections• Tagging and labeling• No damage

• IV typically begins prior to MC (e.g., piping verifications prior to insulation, closing up a wall, etc.), but cannot be completed until post-MC.

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Lilly C&Q Program ~ Startup

• All systems are subject to formal startup process using pre-approved protocols.

• Engineering must ensure that systems are safe to operate.

• Setting to work activities involve making the necessary preliminary adjustments before initial energizing of system.

• Once system is energized, Regulation and adjustment must occur to ensure that system is operating in a safe, controlled and stabilized manner within approved operating ranges.

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Lilly C&Q Program ~ StartupStartup protocols should verify the following prior to regulation and adjustment:

Prerequisites: System is mechanically complete and IV execution is complete Pre-Startup Safety Review (PSSR) checklist complete Pre-Startup Environmental Review (PSER) checklist complete

Setting to work activities: Valve line-up Initial set points for process controls and alarms Stroking of automated valves to verify no interferences Proper booting up of control system Proper lubrication of equipment Pump motor rotation is in the correct direction System is properly filled, if applicable

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Lilly C&Q Program ~ Instrument Loop checks

• Instrument loop checks: Verify wiring continuity from a field device to a remote controller I/O Confirm proper scaling and indication on remote monitors (HMI) Provide operational check to confirm proper installation

• We rely on the vendors to perform this activity prior to FAT for vendor packaged equipment.

• For field-assembled systems, loop checks are required after IV is satisfactorily completed and prior to performing instrument calibrations.

• A field calibration also verifies the integrity of instrument loops, so loop checks are often combined with field calibration.

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Lilly C&Q Program ~ Instrument Calibrations

• Instrument calibrations ensure that newly installed devices produce accurate test results prior to operational testing that will be performed to meet requirements.

• Calibration consists of applying a load to an instrument from a test standard and verifying that the local indication and the display reading agree with the test standard within the acceptable tolerance.

• Calibrations are typically performed after field installation and instrument loop checks and prior to Functional Testing.

• However, utilizing a risk-based approach, bench calibrations or factory calibrations may be deemed acceptable (in lieu of field calibrations) depending on the nature of the testing.

• Instrument calibrations may be performed in conjunction with loop checks.

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Lilly C&Q Program ~ Site Acceptance Testing

• SAT typically serves as the final milestone for payment for equipment vendors, so it is important to ensure that all contractual requirements have been met by this point.

• It is not necessary to repeat all tests that were carried out during FAT; however, discretion is necessary to determine repeatability.

• SAT should verify that all FAT punchlist items have been satisfactorily addressed.

• SAT is a great time to conduct operator training, if time permits• Depending on level of risk, SAT results may be utilized to meet

requirements or may not be performed at all.• The SAT strategy must be defined in C&Q planning documents .

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Lilly C&Q Program ~ Functional Testing• Functional Testing (FT) ensures that the system is functioning as specified by

testing equipment design ranges, which may exceed operating ranges• FT ensures that all operational user requirements are met• FT is executed after system startup and prior to OQ (if applicable)• FT may not be necessary for less complex systems with minimal functionality

or that require qualification (e.g., floor scale) • FT may be integrated with SAT for low risk vendor systems• FT may include performance testing for risk mitigation purposes.

Utility sampling prior to utilities validation Airflow pattern testing Temperature mapping

• FT may include cycle development to determine parameter configurations

• FT strategies must be defined in commissioning planning documents

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Lilly C&Q Program ~ Functional TestingTypical FT test cases are as follows:

• Operating parameter verification (pressure, temp, flow rates)• Utility POU service availability• Utility quality checks (particulates, hydrocarbon content)• Filter integrity testing• Noise-level testing• Software and control system configuration verifications• Security testing (physical and logical)• HMI display verification• Parameter limit verification• System to system communications• Sequence of operations testing• Alarm/interlock testing• Power loss verification

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Lilly C&Q Program ~ Commissioning Packages

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Upon completion of all commissioning activities, a commissioning package and associated summary report is required to summarize commissioning results.The commissioning package should include all commissioning documentation and associated TOPs.The summary should identify:

• Description of compliance to commissioning plan• Departures from plan and recommendations, if appropriate• Open items and associated dispositions• Recommendations for release to service or Qualification• Signatures of individual recommending release of asset and

appropriate technical resources – Quality sig required for DI systems


Lilly C&Q Program ~ Installation Qualification

• IQ is only required for direct impact systems and will verify that all critical installation requirements and specifications have been met.

• IQ will provide documented evidence that systems, equipment and instruments have been fabricated and installed to meet predetermined specifications and requirements, and that software applications are installed as designed.

• IQ leverages commissioning documentation (e.g., RV, IV) vs. repeating checks.

• Strategy for utilizing commissioning documentation to support IQ must be documented in C&Q Plans, which must be approved by Quality.

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Lilly C&Q Program ~ Installation Qualification

All critical installation user requirements plus IQ requirements governed by Corporate Standards verified during IQ for direct impact systems. Typical test cases are:

• Drawing Verification• Critical Component Verification• Critical Component Calibration• Maintenance Verification• Verification of Critical Specifications• Hardware/Software Verification

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Lilly C&Q Program ~ Operational Qualification

• Operational Qualification (OQ) is only required for direct impact systems and will provide documented evidence that systems, equipment and instruments operate as intended throughout all anticipated operating ranges.

• OQ may leverage commissioning documentation (e.g., FAT, SAT, FT) vs. repeating checks.

• Strategy for utilizing commissioning documentation to support OQ must be documented in C&Q Plans, which must be approved by Quality.

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Lilly C&Q Program ~ Operational Qualification

• OQAll critical operational features verified during OQ for direct impact systems. Typical test cases included verification of:

• Critical process parameters• Critical alarms and interlocks• Critical data recording• Critical functionality• Standard operating procedures

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Lilly C&Q Program ~ Transfer of Care, Custody and Control

• OQ• Transfer of Care, Custody and Control (TCCC) is a formal process to transfer

the care (maintenance), custody (ownership) and control (operational responsibility) of an asset from C&Q Team to the Owner.

• Once GFD C&Q responsibilities have been completed for a system, the GFD Project Manager will issue a TCCC letter. Any incomplete items shall be documented on an attached punch list which identifies responsible parties.

• If the system is acceptable, the TCCC letter will be signed by the Project Manager and the Owner, at a minimum. Once the TCCC letter has been approved, the Owner will take full responsibility for the asset that is transferred.

• Upon TCCC, the Owner can now commence with post-OQ activities (e.g., PQ, Sterilization Validation, Cleaning Validation, Process Validation).

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ISPE-CCPIE CHINA CONFERENCE 2010 38

Lilly C&Q Program ~ Governance• External regulations and guidelines (e.g., ICH Q7A, 21 CFR, EU GMP

Guide, ISPE Baseline Guides, GAMP Guides) govern Lilly C&Q.

• Lilly Global Quality Standards (GQS) describe asset implementation principles and state minimum requirements for GMP assets.

• Lilly Global Engineering Standards (GES) state minimum Commissioning requirements for assets.

• Lilly Corporate Computer Systems policies and procedures state minimum requirements for computerized assets.

• Lilly GFD procedures required for use on GFD projects.

• Lilly GFD Library of “Best Practices” and standardized forms made available for worldwide use.


Lilly C&Q Program ~ Standards Governing C&Q

• GQS201, Commissioning & Qualification

• GQS103, Change Management• GQS105, Documentation and Data• GQS110, Validation Practices• GQS202, Facilities• GQS203, Equipment• GQS204, HVAC and HEPA Filters• GQS205, Utilities• GQS206, Water

• GQS215, Maintenance • GQS220, Calibration and Measurement• GQS225, Facilities, Utilities, Equipment

and Computer Systems Periodic Review• GQS230, Computer Systems• EFS-2001, Commissioning• EFS-2101, Maintenance• EFS-3001, Measurement Uncertainty• EFS-2302, Automation Life Cycle

Management

The following Lilly Standards govern C&Q:


Lilly C&Q Program ~ Procedures Governing C&Q

• GFD-CAQ-300, Commissioning and Qualification Program

• GFD-DES-205, User Requirements• GFD-CAQ-302, Commissioning and

Qualification Plans• GFD-CAQ-304, Design Qualification• GFD-CAQ-305, Factory and Site

Acceptance Testing• GFD-CAQ-306, Receipt Verification• GFD-CAQ-307, Installation Verification• GFD-CAQ-308, System Start-Up• GFD-CAQ-309, Functional Testing

• GFD-CAQ-311, Commissioning Packages• GFD-CAQ-312, Installation Qualification• GFD-CAQ-313, Operational Qualification• GFD-CAQ-315, Mechanical Completion• GFD-CAQ-317, Transfer of Care, Custody

and Control• GFD-BP-109, Discrepancy Management• GFD-ADM-606, Change Management• GFD-CAQ-607, Good Documentation

Practices• GFD-ADM-608, Qualification of GMP

Service Providers• GFD-ADM-609, Project Information

Management

The following is a list of GFD C&Q SOPs that are required to be followed:

In addition, a Master Specification was developed to define asset data & documentation requirements for equipment vendors.


Lilly C&Q Program ~ Highlights• GFD Quality System *• Systems engineering based approach to Requirements definition *• GFD SOPs governing C&Q• Project Change Management procedure *• Discrepancy Management best practice *• C&Q collaboration site *• Master Specification for data & documentation *• C&Q Tools (e.g., discrepancy database, document database, lessons

learned, etc.) *• C&Q leadership role• Maintenance package development leadership role• Project Information Management leadership role *• C&Q training courses available• Comprehensive C&Q Monthly Metrics report *

* New within past 4 years.


• Supports risk-based approach

• Earlier resolution of issues • Opportunity to understand systems• Faster Qualification

• Fewer Qualification comments/discrepancies

Lilly C&Q Program ~ Advantages

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Time to take a break!!

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C&Q Integration with Capital Project Delivery

Profile

RequirementsProcurement

Design

Qualification

Commissioning

Construction/Installation

Validation

Planning

Operations/ Maintenance

Project

Owner

System Classification

Component Classification

DQ/EDR

Simulation/ SW Checklists

RVIV

FATSAT

FT

IQ OQ PQ

CSDR

Loop checks/Initial Cals

Startup

Commissioning Package

Construction QA

Approve CQMP

Approve SCQPs

Design Gate Reviews

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C&Q Integration with Capital Project Delivery ~ Project Phases

The primary phases of capital project delivery are:• Planning – crucial timeframe when C&Q delivery strategies and processes

are defined and requirements are established to ensure efficient C&Q delivery• Design – timeframe when the facility design is established to ensure that

facility requirements will be met• Construction – timeframe when vendors and contractors construct the facility

and equipment in accordance with design documentation• Commissioning – timeframe when testing and verification occurs to ensure

that the facility and systems have been constructed, installed, and operate in accordance with design documentation

• Qualification – timeframe when critical aspects of direct impact systems are verified and tested to ensure user requirements are met

During project delivery, each of these phases overlap for the project, but the C&Q activities that occur during these phases for a system are very well defined. The C&Q activities that are performed in each of these primary phases will be summarized on the slides that follow.


C&Q Integration with Capital Project Delivery ~ Planning phase

The following C&Q activities occur during the planning phase of project delivery:

• Begin User Requirement development • Develop C&Q/CSV strategy – obtain alignment• Develop administrative strategies/processes – obtain alignment

(e.g., change management, discrepancy management, document/ data management, risk management)

• Begin development of C&Q Master Plan• Begin evaluating C&Q contract resources


C&Q Integration with Capital Project Delivery ~ Planning phase (Change Management)

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• A change management process must be in place to manage all proposed changes during C&Q

• Change management process in affect after Basic Engineering (Design Gate 2)

• Trend Management is used to manage changes prior to Gate 2

• Site Change Control becomes effective upon turnover to site or system acceptance (typically upon completion of OQ)

• Automation (software/code) changes managed informally by vendors/ contractors (with Lilly oversight) prior to turnover to Lilly

• A software configuration management process may be implemented to manage software changes after turnover to Lilly


C&Q Integration with Capital Project Delivery ~ Planning phase (Change Management)

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• A proposed change must be reviewed and approved via the change management process if it impacts:

Design intent

• The project manager must approve all changes; appropriate SME’s must approve technical changes; and Quality must approve changes to direct impact systems

• A change form is used to document, review & approve change requests

• A change log is used to document all project changes

• Approved changes must be communicated to applicable stakeholders

• The change management process must be understood and followed by all project personnel

Schedule Cost


C&Q Integration with Capital Project Delivery ~ Planning phase (Discrepancy Management)

• A discrepancy management process must be in place to manage discrepancies or non-conformances during C&Q.

• Discrepancies are: Departures from the intent of a test Results that do not meet the expected results or acceptance criteria Departures from an approved planning document or procedure where it is

necessary to deviate from what is currently approved

• Discrepancies are not: Normal commissioning activities, such as adjusting configurable parameters or

aligning valves. Typographical errors or missing steps, unless they alter a test’s intent or

acceptance criteria. Good Documentation Practice (GDP) corrections (e.g., entry errors, date

issues, write-overs, etc.)

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• Discrepancies are required to be:

Documented Uniquely identified & include document type (e.g., RV, IV, FT, IQ) Noted in applicable test document if resulting from testing Resolved via a corrective action or rationale for why the

discrepancy is acceptable Approved by appropriate personnel as defined by project team Logged into a discrepancy database or spreadsheet Categorized (e.g., mechanical, automation, documentation, etc.) Attached or referenced in each system’s C&Q package

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The discrepancy form/database contains the fields listed below: System name System ID Document type Document number Test case number Page number Discrepancy number

Discrepancy description Originator Date initiated Corrective action Date closed Discrepancy category Approvers

These discrepancy metrics will serve as a measure of C&Q performance and will provide valuable data for future process improvement or six sigma efforts.


C&Q Integration with Capital Project Delivery ~ Planning phase (Data & Document Management)

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• A process must be defined to manage asset data & documentation.

• Need on-time delivery of accurate, complete data & documentation to support asset delivery, startup, turnover and ongoing lifecycle operation.

• Asset data and documentation requirements must be communicated to the vendors and contractors up front in procurement documents.

• Asset data and documentation requirements are included in Lilly Specification Section 01910, Data and Documentation Requirements.

• A Project Information Manager is assigned to all capital projects - sole responsibility is the manage data, documentation and drawings.


C&Q Integration with Capital Project Delivery ~ Planning phase (Risk Management)

Project delivery strategy is based on risk mitigation approach.

• Construction Quality Assurance activities reduce risk during Commissioning

• Design Review reduces risk during Construction/Build, Commissioning, Qualification

• Development Testing reduces risk during Commissioning (Startup, SAT, FT)

• Commissioning (RV, IV, FAT, SAT, FT) reduces risk during subsequent Commissioning activities and Qualification

• As risk decreases, the number of discrepancies also decreases - resulting in cleaner qualification documentation and better schedule adherence during qualification

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Design

Construction

Commissioning

Qualification

- DQ- DR- Risk Assessment - Inspection

- Code Reviews- Simulation- CQA - RV / IV

- FAT / SAT- FT

Risk of Failure

- IQ / OQ / PQ

Project Progression


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Design

Construction

Commissioning

Qualification

Project Progression

- DQ - DR- Risk Assessment

- Inspection- Code Reviews- Simulation- CQA - RV / IV

- FAT / SAT- FT

Risk of Failure

Time Req’d to Address Changes

Number of Discrepancies


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Design

Construction

Commissioning

Qualification

Project Progression

- DQ- DR- Risk Assessment - Inspection

- Code Reviews- Simulation- CQA - RV / IV

- FAT / SAT- FT

Risk of Failure


Risk of Failure

Invest Early or Pay More Later



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C&Q Integration with Capital Project Delivery ~ Design phase

The following C&Q activities occur during the design phase of project delivery:• Execute C&Q Design Gate Review protocols to ensure we are on track • Complete User Requirements• Review design documentation (specifications/drawings)• Perform design reviews/design qualifications• Perform system and component level impact assessments• Identify Critical Operational Data (COD) and perform measurement

uncertainty analyses• Determine system boundaries• Complete C&Q Master Plan• Hire C&Q contractor• C&Q schedule development• Estimate C&Q costs


C&Q Integration with Capital Project Delivery ~ Design phase (System Boundary Determination)

• System Boundaries: Must be clearly defined and documented for all systems Must remain consistent through project delivery Are preferably documented using drawings (e.g., P&IDs), but other methods may be

used Must be defined for effective asset implementation planning and execution

• System Boundaries are necessary for: Impact assessments Design reviews Planning and documenting C&Q activities Organization of vendor/contractor deliverables Maintenance strategy development Performing Periodic Reviews Maintaining a consistent understanding of system scope among various

stakeholders/users


C&Q Integration with Capital Project Delivery ~ Design phase (C&Q Schedule)

• C&Q schedule inputs are required at the end of conceptual design (Design Gate 1) and at the end of Basic Engineering (Design Gate 2)

• The steps to build the C&Q schedule are as follows:

1. Incorporate systems once system list is established2. Incorporate C&Q activities required for each system3. Incorporate typical activity durations4. Incorporate C&Q logic reflecting activity interdependencies5. Incorporate system interdependencies6. Review in detail and refine durations


C&Q Integration with Capital Project Delivery ~ Design phase (C&Q Estimates)

• C&Q cost and headcount estimates are required at the end of conceptual design (Design Gate 1) and at the end of Basic Engineering (Design Gate 2)

• C&Q targets typically between 3 and 5% of Total Installed Cost

• In addition to providing estimates for C&Q activities, do not forget the following:

Document management

Project management – meetings, reporting, scheduling

Travel – can be significant if there are many FATs



No C&Q ‘98- ‘01

Full risk-based C&Q‘03- ‘07

Partial risk-based C&Q‘01-’03

C&Q Costas % TIC

40%

20%

10%5%

25%

10%6%

Current Target

3%

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C&Q Contractor Headcount - Actual vs. Forecast

Forecast Total Actual Total

This graph shows typical C&Q contract resources needs


Lilly C&Q Process – Construction phase

The following C&Q activities occur during the construction phase of project delivery:• Implement Construction QA program• Perform Receipt Verification (RV) on components• Develop/execute Factory Acceptance Testing (FAT) protocols• Install vendor equipment on site• Develop Site Acceptance Testing (SAT) protocols• Develop Installation Verification (IV) protocols• Develop Startup protocols• Verify asset Mechanical Completion and begin IV execution, as appropriate• Review turnover documentation• Turnover assets from Construction to Commissioning Team


Lilly C&Q Process – Commissioning phaseThe following C&Q activities occur during the commissioning phase of project delivery:

• Execute IV protocols• Execute Startup protocols• Execute SAT protocols• Perform Instrument Loop (IL) checks• Perform Instrument Calibrations (IC)• Develop/execute Functional Testing (FT) protocols• Develop Maintenance packages• Develop Commissioning packages• Develop Qualification protocols


Lilly C&Q Process – Qualification phaseThe following C&Q activities occur during the qualification phase of project delivery:

• Execute IQ protocols• Develop/execute OQ protocols• Develop/execute PQ protocols, if applicable• Develop C&Q summary reports






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• Properly define User Requirements Testable, verifiable, applicable Not too prescriptive, no design details, no guesses Include C&Q in review/approval process Ensure product/process knowledge is used as basis *

• Ensure project team alignment up front System list and system boundaries Processes (e.g., document control, discrepancy

management) Testing strategies (get QC approval) *

C&Q Keys to Success

* New ASTM E2500 guidance

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• Schedule management Ensure competent, dedicated resources available to

manage Ensure activities/interdependencies are clearly

understood Hold process teams accountable for schedule adherence

• Change management Have Quality group focus on changes with potential to

impact product quality/patient safety only * Don’t implement formal change control too soon Don’t confuse change control with version control Ensure commissioning change process is well understood Ensure construction changes are communicated to team

C&Q Keys to Success (cont.)


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• Vendor management Ensure vendors understand equipment, documentation, data &

timing requirements up front - clearly define in specifications Don’t ask vendors to follow internal procedures/templates Accept standard deliverables/equipment - perform revisions/

system modifications and integrations on site, if necessary * Provide sufficient interface with vendors

• Clearly define roles/responsibilities Define early in project - align objectives Clearly communicate to team Ensure sufficient number of site technical resources/SMEs * Use experienced contract resources


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• Minimize turnover of key personnel Minimize strategy changes/learning curves Get right people upfront Get management commitments

• Document and data management Clearly define program for managing documentation and data Manage/track all docs and data using dedicated resources

• Risk management Take advantage of risk assessment results to perform right-size

testing that is streamlined * Consider technology, vendor and product quality risk


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• Integrate CSV with C&Q Collaboration of C&Q and CSV contractor efforts Integration of commissioning/CSV testing to verify all UR & FRS

requirements Include automation in URs, design reviews, etc. *

• Use Simulation programs to: test software troubleshoot software problems develop/dry run protocols


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• Training Ensure that anyone involved with C&Q is properly trained on the

applicable procedures and processes

• Leadership C&Q program Project Information Manager (data and docs) Maintenance Package development

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Questions and Answers

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Thank you!感谢您的时间

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lilly risk-based cq_ ispe-ccpie china conference 2010_9-19-10

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