Siebel Life Sciences Guide > Managing Corrective and Preventative Actions > Process of Managing Corrective and Preventive Actions >

Creating a CAPA Record


Corrective actions can be created and viewed in these screens:

  • Corrective Actions. When a CAPA record is created in this screen, no default type is associated with the CAPA.
  • Product Issues. When a CAPA record is created in this screen, the default type is Product Issue.
  • Repairs. When a CAPA record is created in this screen, the default type is Product Analysis.

When a CAPA is created from the Product Issues or the Repairs screen, a CAPA number is assigned automatically. You can configure the application to copy information from the Product Issue or the Product Analysis record to the CAPA record. Review the configuration of the Create Product Issue button (see About Configuring Adverse Events and Complaints Capture) for an example of a similar configuration.

This task is a step in Process of Managing Corrective and Preventive Actions.

To create a CAPA record in the Corrective Actions screen

  1. Navigate to the Corrective Actions screen, then the Corrective Action List view.
  2. In the Corrective Action List, create a new record and complete the necessary fields.

    Some fields are described in the following table. Note that some of these fields are filled in when the CAPA is first created, and other fields are filled in later in the CAPA investigation.

    Field
    Comments

    Accounts

    The accounts requiring the fix.

    Actual Fixed

    The date when the fix was actually implemented.

    Area

    Classification for the corrective action. The Type field constrains this drop-down list.

    Asset #

    For example, the asset number of the first machine to which the fix is applied.

    CA #

    Unique number to identify the CAPA. It is auto-generated when the CAPA record is created.

    Codes

    Typically, select codes of type Corrective Action.

    Example uses:

    • Use codes to indicate the root cause of the CAPA.
    • Use codes to classify the CAPA.

    Comments

    Use this field to record and share short notes during the life cycle of the CAPA.

    Corrective Action

    Detailed description of the corrective action and its root cause.

    Fix Age

    Number of days since the Actual Fixed date.

    Lot #

    For example, the first lot number to which the fix is applied.

    Mfg Name

    Typically this is the (internal) manufacturing site.

    Serial #

    Serial number of the asset. This field is automatically populated if there is a serial number associated with the asset.

    Status

    Changes to this field are tracked in the Approvals view.

    Sub Area

    The Area field constrains this drop-down list.

    Sub Status

    The Status field constrains this drop-down list.

    Target

    The version of the product targeted to have the fix.

    Type

    The type of corrective action: Product Analysis, Product Issue, Manufacturing, Preventive Action, Other.

  3. Drill down on a record in the Corrective Action List.
  4. Click the Related Products tab, create new records for the products related to the CAPA, and complete the necessary fields.
  5. Click the Product Issues tab, create new records for any product issue related to the CAPA, and complete the necessary fields.
  6. Click the Product Analysis tab, create new records for any product analyses related to the CAPA, and complete the necessary fields.
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