JETT Equipment Acquisition Model

Version 009
April 19, 2007

User/Consultant (if applicable)

Project C & Q Plan
Aligned with Master Validation Plan

Supplier
Supplier Impact Assessment
PO
RFQ

User Requirement Specification

Risk/ Impact Plan Preliminary Equipment C&Q Plan

Engineering Feasibility Study / Proof of Concept

Proposal Analysis

Proposal

Develop Proposal

PO

Equipment C&Q Plan

May be included in Project C&Q Plan

Develop Functional Specification

Living Documents - Inputs for Revision
S p ec

Review Functional Specification

Approval

Risk Assessment
Joint review with User

Review/Approve Detailed Design

Finalize Risk Assessment

Detail Doc

Develop Detailed Design Documentation

Traceability

Ap p

ro v

al

Review Commissioning FAT/SAT Documents

Test Docs

Develop Commissioning FAT/SAT Documents

Ap

p ro

v al

Execute SAT/Commissioning
Supplier participation is optional

Ship

Execute FAT Testing

User participation is optional

Develop SOPs

Manuals

User, Operational and Maintenance Manuals/Training

Develop and Execute IQ/OQ Protocols

Write Final Summary Reports

JETT Equipment Acquisition Model Version 009 April 19, 2007

USER / CONSULTANT Project C & Q Plan: Overall commissioning and qualification plan for the project. Discusses major philosophy rather than specifics about the equipment being purchased. Aligns with Validation Master Plan. Provides input to the Risk/Impact Assessment. User Requirement Specification: Prepare URS based on established standards and project/process specific requirements. Develop in conjunction with end-users, engineering, validation, and subject matter experts. Requirements are to be specific to the piece of equipment and its intended use. Include product and process GMP requirements, segregate general and business requirements in a separate and clarified part of the document. Perform System Impact and Initial Risk Assessment. Communication of the suppliers role in meeting C & Q requirements. Initiate Requirements Traceability Matrix. Refer to the website www.ispe.org/jett for additional details on User Requirement Specifications. Risk/Impact Plan: Overall project plan, a high level description that provides input into the system and equipment risk assessment. Assessment of supplier quality systems and capabilities and their potential to impact the project. May be completed in-person or via questionnaire. The Supplier is to provide information to support the assessment. Review training, quality systems, support capabilities, documentation management and history in the industry. Control system capabilities, fabrication practices, assembly procedures and certifications. The Structure of the organization, scope of the business, previous experience with the company is also considered in the assessment. Perform assessment and determine if equipment or system is Direct, Indirect, or has No Impact on the product. Preliminary C & Q Plan: Communicates the users expectations of the suppliers role in meeting the project commissioning and qualification requirements. Proposal Analysis: An analysis of all aspects of the proposal provided by the Supplier. Pricing, options, alternate proposals, exceptions and clarifications. Manufacturing and delivery schedules. The use of a bid tabulation form is commonly used to assess the proposal. Equipment C&Q Plan: Provides detail of the commissioning and qualification requirements for the equipment/system. Based on the URS and the initial risk assessment. Limited to equipment or may be included in scope of overall Project C&Q Plan.

Acq Model Definitions -Ver9.doc

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JETT Equipment Acquisition Model Version 009 April 19, 2007

Review Functional Specification: Review the functional specification based upon the URS requirements. Review and document the Requirements Traceability Matrix (RTM). Prepare for Risk Assessment by preparing forms and list of Critical Process Parameters. Review/Approve Detailed Design: The user reviews and approves the detail design documents. Establish acceptable criteria for commissioning tests. A face-to-face meeting at the Supplier should be considered depending on how standard or complex the equipment is. The suppliers input into the risk assessment may also be finalized at this time. Review Commissioning, FAT and SAT Documents: The test documents are to be reviewed based on the URS, Functional Specification and other design documents. Confirm acceptance criteria for the tests to be reviewed in the FAT and commissioning tests. Execute SAT/Commissioning: Testing of agreed to scope and with pre-agreed criteria. Supplier participation is optional. Develop SOPs: Based on documentation provided by the supplier for operation, cleaning and maintenance. Based on internal user practices, procedures, past experience and requirements. Develop IQ/OQ Protocols: Quality/Validation Organization develops the IQ/OQ Test Protocols based on intended operation of the equipment and internal requirements. Unambiguous requirements and predetermined acceptance criteria are incorporated into the protocols. Acceptance testing is limited to critical process requirements as defined in the Risk Assessment. Tests are written to provide evidence of Pass or Fail. Quality change control begins with the approval of the IQ/OQ Test Protocols. Update traceability matrix. Execute IQ/OQ Protocols: Executions of Protocols including annotation of pass or fail for each test and relevant comments. Deviations and failures evaluated, including acceptance and how remedied. Write Final Summary Reports: Disposition of equipment, SOPs and maintenance requirements Final determination of equipments suitability for and acceptance for use for a specific process or use.

Acq Model Definitions -Ver9.doc

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JETT Equipment Acquisition Model Version 009 April 19, 2007

SUPPLIER Supplier Impact Assessment: Initiated by the User, the assessment may include a supplier audit which includes a review of the suppliers quality systems, engineering practices, manufacturing capabilities, documentation standards and the ability to deliver equipment and services. Engineering Feasibility Study/Proof of Concept: The Suppliers confirmation of their ability to produce the required equipment and associated deliverables. Based upon a detailed review of the URS and other project specifications with the supplier. Based on the complexity of the study, a separate PO may be required. Develop Proposal: Provide details on the deliverables that will be presented to the User, include standards and practices that are adhered to. A project plan that includes the design (software and hardware), manufacture, testing, start-up and commissioning of the equipment. Pricing, options, alternate proposals, exceptions and clarifications. Manufacturing and delivery schedules. Provide input to Risk Assessment based upon the ability of the equipment to comply with the User Requirements as needed. Develop Functional Specification: A specification that details the functionality of the equipment and how it satisfies the URS Requirements. May include detailed specification in lieu of a Detailed Design Specification. Existing documentation is to be used when available, new documents will need to be developed for custom equipment. Include all operational modes of the equipment such as normal operation, start-up, shut down, clean out, CIP, SIP and alarms. Include quality requirements, such as operational parameters, tolerances and required operational efficiencies. The Functional Specification is traceable to the User Requirement Specification. Risk Assessment: A documented review with the End User. Standard methodologies should be used, for example, FMEA (Failure Mode Effects Analysis). Use Risk Assessment to determine the parameters required to be qualified in addition to commissioning activities. For customized equipment, to be conducted prior to the final design plan and design work. Refer to the website www.ispe.org/jett for additional details on Risk Assessment.

Acq Model Definitions -Ver9.doc

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JETT Equipment Acquisition Model Version 009 April 19, 2007

Develop Detailed Design Documentation: A set of documents that detail specifications for the design of the hardware and software of the equipment. This can include: Assembly drawings, P&IDs, schematics, BOMs, application software, etc. The Hardware specification details the components including, but not limited to; piping, valves, materials of construction, instrumentation, the suitability of the equipment for its intended use and user constraints included in the URS. The Software specification details but is not limited to; the form, function, operational sequences, failure modes and responses, Operator Interface design, programming standards, inputs and outputs, as well as what will be provided to control the equipment as detailed in the URS. Design elements are traceable to the URS and FS and form the basis for qualification testing. Develop Commissioning / FAT/SAT Test Documents: Commissioning documentation confirms the equipment is designed to operate as specified. The documents include testing required to confirm the proper and safe operation of the equipment including hardware, software, all interfaces (Operator) and other GEP (good engineering practices) activities. Acceptance criteria shall be provided for all tests and shall provide evidence of Pass/Fail. FAT (Factory Acceptance Testing) shall refer to test protocols developed for execution at the Suppliers facility. SAT (Site Acceptance Testing) shall refer to test protocols developed for execution at the Users facility. Execute FAT testing: The FAT testing confirms the equipment and ancillary deliverables conform to the specifications. Typically this testing will result in a punch list of items to be corrected prior to shipment or start up on site. If the results of testing will become a part of the commissioning and qualification, the User will need to place the documents under project level change control. User, Operational and Maintenance Manuals / Training: Documentation and other deliverables are to be provided as detailed in the URS or other specifications.

Acq Model Definitions -Ver9.doc

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Printed: 4/25/2007