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.
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 > 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.