Respond to an Audit Finding

The owner of each audit finding will receive a task to provide a response to the finding. There are some differences between responding to an external finding for an external audit versus responding to an internal finding for an internal audit.

Respond to an External Finding

To respond to an external finding:

1. Navigate to the external audit finding and click Edit (pencil icon).

   

2. Open the Response Details section and record the response provided by the supplier.

3. Specify if a CAPA is Required as a result of the finding.

4. If CAPA Required was answered Yes, record a Description of the supplier’s CAPA.

5. Record the CAPA Due Date.

6. Click Save.

   

Complete the Complete Response Task

To complete the Complete Response task:

1. Click Complete for the task.

   

2. Click Complete.

   

   The QA reviewer will receive a task to approve the finding response.

Respond to an Internal Finding

To respond to an internal finding:

1. Navigate to the internal audit finding and click Edit (pencil icon).

   

2. Open the Response Details section and provide a response.

3. Specify if a CAPA and/or Effectiveness Check is Required as a result of the finding. If you selected No for either, you will need to provide the rationale.

4. Click Save.

   

Record the Root Cause for an Internal Finding

You can record one or more root causes for an internal finding.

To record a root cause:

1. Open the Root Cases section of the finding and click Create.

   

2. Fill out the details of the root cause and click Save.

   

Create a CAPA Action for an Internal Finding

To create a CAPA Action for an internal finding:

1. Open the CAPA Actions section of the finding and click Create.

   

2. Fill out the details of the CAPA Action, including Current Due Date.

3. Click Save.

   

Define Team

1. Navigate to the CAPA Action and click Manage Team.

   

2. Specify an Owner for the CAPA Action and one or more QA Approver(s).

3. Click Save.

   

Create an Effectiveness Check for an Internal Finding

To create an Effectiveness Check for an internal finding:

1. Open the Effectiveness Checks section of the finding and click Create.

   

2. Fill out the details of the Effectiveness Check, including Current Due Date.

3. Click Save.

   

Define Team

1. Navigate to the Effectiveness Check and click Manage Team.

   

2. Specify an Owner for the Effectiveness Check and one or more QA Approver(s).

3. Click Save.

   

Complete the Complete Response Task

To complete the Complete Response task:

1. Click Complete for the task.

   

2. Click Complete.

   

   The QA reviewer will receive a task to approve the finding response.