Responding to Audit Findings

When findings are issued as part of a QMS audit, a finding owner is assigned.

  • For external audits and findings, the finding owner is the internal person responsible for managing and documenting the finding response from the supplier.
  • For internal audits and findings, the finding owner is the person who is responsible for addressing this particular problem that was found as part of the audit.

To respond to external findings:

  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. If a CAPA must be completed as a result of the finding, select Yes and record a description of the supplier’s CAPA, including the CAPA Due Date.
  3. Click Save.

To respond to internal findings:

  1. Navigate to the internal audit finding and click Edit (pencil icon).
  2. Open the Response Details section, provide the response.
  3. If a CAPA and/or Effectiveness Check must be completed as a result of the finding, select Yes. If you select No, you must provide the Rationale.
  4. Click Save.
  5. Optionally, open the Root Causes section and click Create. Fill out the details of the root cause and click Save.
  6. If you answered Yes to CAPA or Effectiveness Checks, open the CAPA Action and/or Effectiveness Checks sections and add at least one record.
    Each CAPA Action and Effectiveness Check will follow its own workflow through to completion.
  7. Optionally, you can associate the finding to another quality event. Open the Related Events section and click Create to add it.
  8. Optionally, you can associate Library References or Attachments to the finding.

When you are finished responding to the finding, you can complete the task

  1. Click Complete for the Complete Response task.
  2. Click Complete.
    The QA reviewer will receive a task to approve the finding response.