Document toolboxDocument toolbox

Create a non-conformance profile

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. 

 

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.

 

Define Quality Standards button

The Non-Conformance Profiles window is where you set up all non-conformance profiles for your manufacturing operations. 

  1. Log into the NPI client application.

  2. Select Templates and Standards Templates and Standards button > Define Quality Standards, then select the Non-Conformance Profiles tab.


    Non-Conformance Profiles window

 

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.

 

 

 

 

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