Professional Documents
Culture Documents
AcquisitionModelVer9 PDF
AcquisitionModelVer9 PDF
AcquisitionModelVer9 PDF
Version 009
April 19, 2007
Supplier
Supplier Impact Assessment
PO
RFQ
Proposal Analysis
Proposal
Develop Proposal
PO
Approval
Risk Assessment
Joint review with User
Detail Doc
Traceability
Ap p
ro v
al
Test Docs
Ap
p ro
v al
Execute SAT/Commissioning
Supplier participation is optional
Ship
Develop SOPs
Manuals
Page: 1 of 4
Printed: 4/25/2007
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.
Page: 2 of 4
Printed: 4/25/2007
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.
Page: 3 of 4
Printed: 4/25/2007
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.
Page: 4 of 4
Printed: 4/25/2007