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 Hamm
Consultant Engineer – C&Q
Eli Lilly and Company
1

Risk-Based Commissioning & Qualification
• Lilly C&Q Program
• C&Q Integration with Capital Project
Delivery
• C&Q Keys to Success
2

• 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
3

• 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
4

Lilly C&Q Program ~ Core Activities
5

• 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
6

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
7

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
8

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
9

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
10

• 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
11

• 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:
12

• 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:
13

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
14

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
15

• 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
16

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.
17

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
18

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
19
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.
20

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
21

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
22

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.
23

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.
24

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.
25

Lilly C&Q Program ~ Startup
Startup 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
26

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.
27

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.
28

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 .
29

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
30

Lilly C&Q Program ~ Functional Testing
Typical 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
31

Lilly C&Q Program ~ Commissioning Packages
32
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.
33

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
34

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.
35

Lilly C&Q Program ~ Operational Qualification
• OQ
All 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
36

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).
37

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
42

Time to take a break!!
43

Delivery
44

C&Q Integration with Capital Project Delivery
Profile
Requirements
Procurement
Design
Qualification
Commissioning
Construction/
Installation
Validation
Planning
Operations/
Maintenance
Project
Owner
System
Classification
Component
Classification
DQ/EDR
Simulation/
SW Checklists
RV
IV
FAT
SAT
FT
IQ OQ PQ
CSDR
Loop checks/
Initial Cals
Startup
Commissioning
Package
Construction
QA
Approve
CQMP
Approve
SCQPs
Design Gate
Reviews
45

~ 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.

~ 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

~ Planning phase (Change Management)
48
• 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

~ Planning phase (Change Management)
49
• 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

~ 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.)
50

• 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
51

52
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.

~ Planning phase (Data & Document Management)
53
• 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.

~ 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
54

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
55

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
56

Design
Construction
Commissioning
Qualification
Project Progression
- DQ
- DR
- Risk
Assessment - Inspection
- Code Reviews
- Simulation
- CQA - RV / IV
- FAT / SAT
- FT
Risk of Failure
Number of Discrepancies
Risk of Failure
Invest Early or Pay More Later
Number of
Discrepancies
57

~ 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

~ 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

~ 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 established
2. Incorporate C&Q activities required for each system
3. Incorporate typical activity durations
4. Incorporate C&Q logic reflecting activity interdependencies
5. Incorporate system interdependencies
6. Review in detail and refine durations

~ 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 Cost
as % TIC
40%
20%
10%
5%
25%
10%
6%
Current Target
3%
62

63
0
5
10
15
20
25
30
0
5
10
15
20
25
30
Jan-03
Feb-03
Mar-03
Apr-03
May-03
Jun-03
Jul-03
Aug-03
Sep-03
Oct-03
Nov-03
Dec-03
Jan-04
Feb-04
Mar-04
Apr-04
May-04
Jun-04
Jul-04
Aug-04
Sep-04
Oct-04
Nov-04
Dec-04
Jan-05
Feb-05
Mar-05
Apr-05
May-05
Jun-05
Jul-05
Aug-05
Sep-05
Oct-05
Nov-05
Dec-05
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
#ofPersonnel
Month/Year
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 phase
The 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 phase
The 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

Delivery
67

• 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
68

• 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.)
69

• 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
70

• 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
71

• 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
72

• 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
73

Questions and Answers
74

Thank you!
感谢您的时间
75

Lilly Risk-Based CQ_ ISPE-CCPIE China Conference 2010_9-19-10

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Destacado

Destacado (6)

Similar a Lilly Risk-Based CQ_ ISPE-CCPIE China Conference 2010_9-19-10

Similar a Lilly Risk-Based CQ_ ISPE-CCPIE China Conference 2010_9-19-10 (20)

Lilly Risk-Based CQ_ ISPE-CCPIE China Conference 2010_9-19-10