Risk-Based Commissioning &Qualification Benchmarking Educational Track #1 Agenda Part 1 • • (8:30 – 10:00) ISPE Baseline® Guide Volume 5: Commissioning & Qualification vs. ASTM E2500 – Mr. Robert Chew Overview of C&Q approaches – Abbott, Lilly, Pfizer Break – Vendor areas open Part 2 (10:30 – Noon) • Panel Q&A Wrap-up (10:00 – 10:30) ISPE Baseline Guide Volume 5: Commissioning and Qualification, vs. ASTM E2500 Robert E. Chew, PE President, Commissioning Agents, Inc. My Background in Subject • Official trainer for ISPE Baseline Commissioning and Qualification Guide • Member of team that wrote ASTM E2500 . Key Points to Compare • • • • • Terminology Qualification practices Focusing the effort Roles and responsibilities Managing changes during the project . Terminology • C&Q Baseline guide • • Commissioning Qualification • ASTM E2500 • Verification . Qualification Practices • C&Q Baseline Guide • “To meet the demands of the regulators” • ASTM E2500 • Not mentioned . Focusing the Effort • C&Q Baseline Guide • Impact assessments • Direct impact systems and critical components • V-model • ASTM E2500 • Risk assessment -> critical aspects . and acceptance and release Subject matter experts used throughout . risk assessments. quality control role • ASTM E2500 • • Quality involved in process requirements. critical aspects.Roles and Responsibilities • C&Q Baseline Guide • Quality pre and post approves protocols. Managing Change • C&Q Baseline Guide • QA pre-approved change control implemented at start of IQ/OQ • ASTM E2500 • QA pre-approved change control implemented at start of manufacture of product for distribution . Common Elements • • • • • • Good engineering practices Planning Requirements definition Engineering design reviews Project change management Documented inspections and testing . Risk-Based Commissioning & Qualification Approach Abbott Laboratories Global Pharmaceutical Operations Steve Connelly . Overview Where Abbott Is Today C&Q Approach Commissioning & Qualification Activities How We Manage Cost Lessons Learned . Where Abbott is Today Risk Based Maturity Model* *Adapted from 2007 ISPE Tampa Conference Presentation . & Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment . Risk Assessments) • Tools and Templates • Discretion of the Validation Review Board (VRB) *ASTM E2500-07: A Standard Guide for the Specification. Commissioning. ECM. GEP. Design.Commissioning & Qualification Approach C&Q Approach: • Application of ISPE Baseline® Guide Volume 5: Commissioning & Qualification (last 2 years) • Little to no implementation of ASTM E2500-07* • Level 3 (Risk-based Maturity Model) Implementation: • Corporate policies support Science & Quality Risk Management and includes Good Engineering Practice (GEP) reference • Training ( RBA. Science & Quality Risk Management Qualification Process Flow . Good Engineering Practices Formal acknowledgement of GEP in corporate policy Divisional GEP guideline consists of minimum requirements Additional divisional guidelines are in development for lifecycle management – Calibration – Maintenance – Engineering change management Training to aid site support (implementation) . ) –Technical Evaluation by SMEs •Documented and VRB approved •Determining impact to identifying critical elements Quality Risk Control –Risk Assessment (i. etc) used to enable: •Qualification focus on critical functions and/or components •Leverage limited commissioning testing (FAT/SAT) and •Eliminate some redundant activities (i. etc) *System = equipment.e.e.Requirements Based On Impact Category Three methods: –ISPE-Style System* Impact Assessment Questionnaire –Risk Assessment with any standard method (FMEA. facility. HAZOP. alarms. FMEA. etc. utility . Commissioning When supporting Qualification. Commissioning must include or address: • Engineering Change Management (ECM) – After point commissioning data intended to support Qualification • Testing – Methods described in sufficient detail for repeatability – Documentation confirms critical elements met criteria – Acceptance criteria documented prior to execution – Criteria based on User Requirements – Documentation of observed results Commissioning & Qualification (C&Q) Plans typically contain run rules for project . summarize test results for VRB approval Qualification • When approved. operational testing leveraged in some instances (VRB discretion). document it correctly • Primarily installation activities.compile. where appropriate).Qualification – Equipment User requirements • Product and Process User Requirement (PURS) • General User Requirements (GURS) Commissioning (in support of qualification) • Test it once (or one set of multiple test repetitions. commissioning reports complete the IQ/OQ phase of Qualification with no additional “protocol” testing . as applicable) • APC specific qualification requirements – Traceability matrix = Design Qualifications (DQ) – Commissioning = Qualification except critical items .Qualification – Software (APC/HMI/DCS) Categorization (based on product quality impact) • Managing control issues for critical elements • Supplier Assessments for direct impact systems only • VRB discretion with technical advisory from Subject Matter Expert Holistic Approach • Integrated Qualification document (IOQ for equipment/controls. e.Qualification – Facilities Indirect Impact Facilities .Commission – Design and construction conforming to GEP – Abbott Engineering Standards Direct Impact Facilities – Commission/Qualify – Meet quality specifications (i. Aseptic facility. etc) – Design and construction conforming to GEP – Abbott Engineering Standards . Qualification – HVAC Categorization • Interdependent with facility quality attributes – For example: Continuous monitoring for critical environmental aspects. VRB discretion as to qualify . and room pressure differentials typically critical elements which are monitored and recorded continuously. alarming when parameters exceed specifications. therefore facility and HVAC can be Indirect Impact (HVAC controls would then be qualified) – For example: Temperature. RH. Qualification – Utilities Impact Categories .Typically critical or non-critical Utility systems typically not big source of Validation Change Request (VCR) sources Only regulatory requirement concern is typically Potable Water feed to purification – Purpose of pretreatment usually to preserve life of purification equipment rather than direct impact of water quality . validate everything” C&Q approach versus the risk-based C&Q approach $ Cost comparisons across projects difficult because – Inconsistent reporting and project scope varies widely $ Drive cost reporting model for capital projects needed to: – Address scope differences.How We Manage Cost… $ In 2007. reviewed C&Q costs for several capital projects to: – Establish a baseline – Compare costs for the “traditional. track additional parameters: Number of Qualification Protocols per project Number of Qualified Systems Total Number of Systems – Three parameters documented in C&Q Plan . How We Manage Cost… Commissioning & Qualification Cost Tracking Details • Monthly Capital Project Status Reports are used to track costs and progress • There is a wide variation in the tracking systems used by the engineers for the project costs • Most project engineers / project managers use spreadsheets of their own design to track costs . How We Manage Cost… Opportunities Identified for Consistent Reporting Engineering/Commissioning/Qualification costs categorized below Activities not linear. categorization to clarify “gray” areas of cost reporting ENGINEERING FEP 1-3 User Requirements Functional Specification (Draft) Preliminary Design Detailed Design Construction Loop Tuning Equipment Installation/Alignment COMMISSIONING Risk Assessment Failure Mode Effect Analysis I/O checkout Calibration Functional Specification (Revisions) Factory Acceptance Testing Startup Trouble Shooting Sequence Testing As-Builts (Non Qualified Systems) QUALIFICATION (CERTIFICATION) Validation Plan Design Qualification Equipment Installation Qualification Equipment Operational Qualification Computer Hardware Installation Qualification Computer Software Installation Qualification Controller Modification Qualification HVAC Installation/Operational Qualification Utility Installation Qualification Process Qualification Validated Drawings Samples/Testing Cleaning/Passivation Inspections Engineering Work Orders / Contracts Defines appropriate cost “bucket” for consistency across projects . . all engineers comply however variations due to specialty) Application: Site readiness tools . not same approach (i.Lessons Learned Risk-Based C&Q is an iterative process (one tiny step at a time) Corporate & divisional policies in place. concern about corporate & regulatory audits Sites want to maintain autonomy with guidance.e. although success for various sites. tools developed. common elements.identifying opportunities for closing gaps . ensure compliance Engineering may wonder: Quality = police & spell checkers. Speak.Lessons Learned Listen. “right” the first tyme Application: Regular/frequent communication with VRB & project team . Quality may wonder: What if engineering doesn’t do its job?. Deliver. Communication is key. Lessons Learned Sustainable Paradigm Shift Sites: Implementation. time & money. accountability & ownership a must for sustainability Resources: People. site retaining technical knowledge Application: Training & support implementation as applicable . Thank you! • Questions will be addressed during the Panel Q&A session (after break) . Eli Lilly & Company Commissioning and Qualification Approach . Eli Lilly & Company Approach to Commissioning & Qualification • C&Q Delivery Strategy • C&Q Metrics • C&Q Lessons Learned • Improved C&Q Delivery Strategy . • • Simulation has been used to commission automation aspects CSV testing has been integrated within C&Q test documents .Recent GFD C&Q Delivery Strategy ~ Baseline Guide approach (’02 – ‘07) • • • • Developed procedures governing C&Q activities Fully commissioned all assets ~ GEP Reserved qualification for critical aspects of DI systems only Leveraged commissioning documentation to support qualification – commissioning subject to GDPs • Involved Quality at C&Q strategy level • In addition. Fundamental C&Q Delivery Strategy ~ for Global Facilities Delivery (GFD) Capital Projects . C&Q Delivery Strategy ~ Results This strategy has resulted in: • Earlier resolution of issues • Opportunity to understand systems • Reduced Qualification time • Reduced Qualification costs • Fewer Qualification comments/discrepancies . C&Q Metrics • Schedule Metrics • Cost Metrics • Discrepancy Metrics . 40 systems . (172 days/system) • Total IQ/OQ duration: 6 months • FT duration/system: 42 days • IQ duration/system: 11 days • OQ duration/system: 17 days • Average # of days from MC to OQ completion: 227 days Note: Metrics for new powder filling facility consisting of approx.Typical C&Q Schedule Metrics ~ Durations • 10 months from facility mechanical completion to OQ completion • Total Commissioning duration: 24 mos. 3% GOAL .C&Q Cost Metrics ~ Historical view C&Q Cost as % TIC 40% 20% 25% 10% 10% 5% No C&Q prog 1998. C&Q prog 2001-2003 5% Full C&Q prog 2002.pres.2001 Part. 0% 1.C&Q Budget Metrics ~ capital projects completed in ‘07 Total Installed Cost $319MM $186MM $180MM $145MM $14.7% (C&Q projects only) C&Q delivery strategy has resulted in a step change in C&Q savings!! .2% Average: 4.7% (incl.3% 4. non-CQ activities) 4.2MM C&Q Cost (% TIC) 6. only) 5.6MM $7.5% 5.5MM $11.3% 2.5% (comm. Lilly C&Q Work Breakdown Structure Lilly budgets/tracks C&Q expenses via 4 primary WBS categories: • • • • Planning & Design Commissioning Qualification Administration New C&Q Cost Data spec recently approved to provide guidance . Subcategory • • • • • • • • • • • • C&Q plans and strategy Initial schedule development Estimating System classification Component classification System C&Q plans Vendor assessments User requirements Design review. drawing review reviews/tag list Engineering requirements Design Qualification Traceability Matrices . spec review.Planning & Design . Commissioning .Subcategory • • • • • • • • • FAT development FAT execution Receipt Verification development Receipt Verification execution Installation Verification development Installation Verification execution SAT development SAT execution Construction turnover packages • • • • • • • • Start-up protocol development Start-up protocol execution Functional testing development Functional testing execution Commissioning packages C&Q plan summary reports FAT travel Supporting documents . Subcategory • • • • • • IQ development IQ execution OQ development OQ execution PQ development PQ execution .Qualification . Administration .Subcategory • • • • • • Training Project management C&Q resource travel Administrative assistance Audits CSV support . Typical C&Q Budget Metrics ~ Cost Breakdown (%) Note: Only includes cost data for C&Q contractor . C&Q Discrepancy Metrics ~ Philosophy C&Q delivery strategy based on risk mitigation approach • DR/DQ reduced risk during Construction/Build, Commissioning, Qualification • Construction quality assurance activities reduced Commissioning risks • Simulation reduced risk during Commissioning (Startup, SAT, FT) • Commissioning (RV, IV, FAT, SAT, FT) reduced risk during subsequent Commissioning activities and Qualification • As risk decreased, the number of discrepancies also decreased resulted in cleaner qualification documentation and better schedule adherence during qualification Typical C&Q Discrepancy Metrics 1230 discrepancies resulting from Construction QA activities 2800 discrepancies during commissioning 130 discrepancies during qualification Typical C&Q Discrepancy Metrics ~ Categories applicable Not too prescriptive. Change management 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 Ensure automation changes are reflected in design docs . verifiable. Clearly define data and documentation requirements 3. no design details. no guesses Include C&Q engineers in review/approval process 2. Properly define User Requirements Testable.C&Q Lessons Learned 1. Custody and Control SOP Discrepancy Management Best Practice • Developed new specifications governing the following • • • Vendor data and documentation FAT/SAT C&Q cost data • Defined new project information management role • Implementing new requirements definition process based on systems engineering principles • Implementing formal Construction QA program .Current GFD C&Q Delivery Strategy ~ Enhanced Baseline Guide approach (last 2 years) • Conducted several six sigma initiatives to improve C&Q processes • Developed additional procedures and best practices pertaining to C&Q • • • • GDP SOP Change Management SOP Transfer of Care. Current GFD C&Q Delivery Strategy ~ Enhanced Baseline Guide approach (cont. testing Elimination of “all or nothing” approach to software testing Allowance for risk-based delivery strategies Leverage offline or simulation testing to meet requirements • Assessing risk in areas beyond product quality to streamline C&Q delivery • • • Vendor risk Technology risk Automation strategy • Leveraging vendor testing to support commissioning vs. just using as contractual gate/risk mitigation The resulting C&Q delivery strategy will hopefully be realized as another step change in C&Q savings! Potential C&Q costs as low as 3% of TIC .) • Developed Automation Lifecycle Management engineering standard to accommodate integration of CSV and C&Q resulting in: • • • Elimination of duplicate requirements. design reviews. Questions? Q&A . Risk Based Commissioning & Qualification Benchmarking Presented by: Nick Andreopoulos Senior Manager/Team leader Pfizer Global Engineering Peapack. MI . NJ Chris Beltz Senior Manager/Team Leader Pfizer Quality Operations Kalamazoo. Agenda • Basis of C&Q Practices • C&Q Program Management Approach • C&Q Cost Management • Key Lessons . Current C&Q Practices • Primarily based on C&Q Baseline® Guide 5 • Certain sites have streamlined C&Q process • • • • C&Q “Lite” version for small projects and minor equipment changes Leveraging of Commissioning tests into IOQ Applying some ASTM concepts – Focusing IOQ on risk to product quality/patient safety Functional Level Impact Assessment .Replacing Component Level Impact Assessment • Currently developing and piloting full ASTM E2500 based Verification approach at targeted sites . Engineering and Automation/IT • Quality requirements defined in Corporate Quality Standards • C&Q Approach defined in Global Practices • Sites develop their own procedures and validation master plans based on the global documents .C&Q Program Management • C&Q supported jointly by Quality. C&Q Cost Management • C&Q costs that are associated with equipment qualification are included in Project Capital budgets. Process Validation and Cleaning Validation are not included in project budgets • C&Q cost managed by Project team . Key C&Q Lessons Learned • Upfront involvement by key stakeholders in the Assessment steps to define the appropriate scope for qualification • IOQ scope should be focused on critical aspects/functions. All other testing is GEP • Testing documents should be based on SME execution and leveraged. where possible. from vendors. Level of documentation should be commensurate with risk to product quality/patient safety. • Roles/Responsibilities need to be clearly defined at the outset of projects . Risk-Based Commissioning & Qualification Benchmarking Educational Track #1 Part 2 . Robert Chew Overview of C&Q approaches – Abbott. Pfizer Break – Vendor areas open Part 2 (10:30 – Noon) • Panel Q&A Wrap-up (10:00 – 10:30) .Agenda Part 1 • • (8:30 – 10:00) ISPE Baseline® Guide Volume 5: Commissioning & Qualification vs. Lilly. ASTM E2500 – Mr. Eli Lilly Nick Andreopoulos. Pfizer Chris Beltz. Abbott Laboratories Dave Dolgin. Commissioning Agents Matt Warhover.Thank You!! • • • • • • • • • • Robert Chew. Abbott Laboratories Scott Hamm. GLC Manager . Commissioning Agents Steve Connelly. Pfizer Great Lakes Chapter Board and Directors Ron Dunn. Eli Lilly Rick Gunyon.