Abbott Project Management Playbook

Useful Links • Construction / Startup / Commissioning • Project Change Evaluation Log • CE Capital Project Schedule Extension Form • Request for Project Scope Change Form, CFM 1040 • Asset Information Form (AIF) Library • IT Specific Templates (Business & Technology Services PMO Processes and Templates Library)

8.6 Q UALIFICATION / V ALIDATION

DEFINITION: What is Qualification / Validation?

Qualification / Validation may not be required based on project scope and/or product impact. In some cases, Commissioning is sufficient and would be determined by division specific policies / procedures. If required, qualification / validation activities would provide sufficient evidence that process / system requirements are repeatedly met under commercial conditions. In either case, the risk-based decisions should have been considered and made during the planning phase and pre-approved in a Project Validation Plan (PVP), which should now be executed. Qualification / Validation activities should be inclusive of product, package, software, equipment, facilities, and utilities. Success at this phase of the project is entirely dependent upon preparation and due diligence at previous project phases to properly document design requirements. Approved design deliverables and checkpoints throughout the project will enable clear success criteria and predictable results at this phase. Elements/Process/Details:

V-Model

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