Creating a CAPA Request

You can create a CAPA request that is a formal request to create a CAPA. You can create a CAPA request from a complaint, Equipment Service Request (ESR), Non-Conformance Report (NCR), or an audit finding. You can also create a CAPA request directly and add complaints, events, ESRs, NCRs, and audit findings as data sources.

Before you begin:
  • To create a CAPA request from a complaint or ESR:
    • You must be a Quality Manager, or a Complaint Investigator who is an assignee or the owner of the object.
    • The complaint or ESR must be in the In Process state or the Closed state.
  • To create a CAPA request from an NCR:
    • You must be the owner of the NCR or an assignee.
    • The NCR must be in the Review state or the Closed state.
  • To create a CAPA request from an audit finding:
    • You must be a Lead Auditor for the selected audit or an audit member.
    • The audit finding must be in the Closed state.
See Also
Submitting a CAPA Request for Review
  1. Perform any one of the following actions.
    • From the top bar, select > CAPA and Audit > CAPA > Create CAPA Request.
    • From the CAPA Requests page toolbar, click Create New.
    • From the Complaints List page, Equipment Service Requests List page, or the NCRs page, select the required objects, and from the page toolbar, select Actions > CAPA > Create CAPA Request
    • From the Related CAPA page of the complaint, event, ESR, NCR, or audit finding, click Create CAPA Request from the page toolbar.
    The Create CAPA Request page appears.
  2. Enter the following details.
    Field NameDescription
    Type Click to select the type as or its subtype. When you select the subtype, the custom attributes that are added to the selected subtype are listed in the Custom Attributes section of the page.
    Note: You can create a subtype for the context object using the Data Model Customization app. For more information, see Installation and Setup | Customize | 3DEXPERIENCE Platform | 3DSpace Data Model | Data Model Customization | Specialize Data Model | Specialization Types | Creating, Editing and Deleting a Specialization Type.
    CAPA TypeSelect a CAPA object type. You can select Corrective or Preventive. This field appears only when you create a CAPA request from the CAPA and Audit Management app. By default, the type is set to Corrective if you create a CAPA request from a complaint, event, ESR, NCR, or audit finding.
    TitleType the required title.
    Note: If you are creating a CAPA request in the context of NCR or My Findings, the title of the NCR or My Findings is auto-populated in the Problem Statement field of Create CAPA Request page.
    Problem StatementDescribe the problem.
    Note: If you are creating a CAPA request in the context of NCR or My Findings, the description of the NCR or My Findings is auto-populated in the Problem Statement field of Create CAPA Request page.
    .
    SeveritySelect a severity. You can select Critical, High, Medium, or Low.
    Source TypeSelect the source type through which the problem was identified.
    ScopeSelect the scope of the CAPA request.
    Custom Attributes Type the additional information for the custom attributes that are selected as subtype of the CAPA request.
  3. Click Done.
    The CAPA request is created.

The CAPA request properties page appears.