After you create disposition decisions, you can create one or more non-conformance profiles in the NPI client application. A non-conformance profile is the framework that defines how a non-conformance is handled and the disposition decisions, action plans, and approvals used to correct a non-conformance.
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Important !If you don’t create disposition decisions first, the Disposition Decisions area of the Non-Conformance Profiles window will be blank, and you will not be able to save non-conformance profiles. See Create disposition decisions for more information. |
The Non-Conformance Profiles window is where you set up all non-conformance profiles for your manufacturing operations.
Log into the NPI client application.
Select Templates and Standards
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> Define Quality Standards, then select the Non-Conformance Profiles tab.
The Non-Conformance Profiles window has three main sections; you can select the Gray arrow to the left of each section name to show or hide its options:
Document, Review, Verify, Assess
In this section you specify MRB participants, select disposition decisions, add supporting documents for the profile, specify escalation and reporting options, and select a disposition approval profile.Action Plans
This section of the window is where you set up all aspects of a disposition decision: repair/correction action plan, containment action plan, root cause analysis, corrective action plans, preventive action plans, effectiveness checks, and approvals.Initiate Closure
This section of the window is where you can specify a final approval workflow and the items required to close a non-conformance.