APHL Laboratory Internal Audit Plan | 9
Report of Findings
(Nonconforming
Activities/Actions)
• Reports go to section audited (supervisor and/or section manager) with a copy to management
• Auditee responds to audit with any required corrective actions
▫ Response and/or results of root cause analysis with a statement of action: Detail any corrections made while
identifying the underlying cause. Include a statement of the corrective action for each nonconformity/deciency.
Perform a root cause analysis of the problem or use another form of analysis such as Dene, Analyze, Resolution,
Action(s) taken, also known as “The Five Whys;” cause mapping; shbone diagrams; or Plan, Do, Check, Act (PDCA)
▫ Proof of commitment: Indicate changes in documentation. If there was a written procedure that was not being
followed, then provide other evidence (e.g., document name and section if updated)
▫ Objective evidence of compliance: Provide copies of laboratory records demonstrating compliance or provide a
timeline/deadline of when the compliance will be achieved.
■ Auditor reviews corrective actions and responds
■ Auditee/section responds if necessary
■ Final report reviewed by management
■ Follow-up if needed
Quality Function
Approval and Date
This section should include the signatures/dates of the management staff accountable for the audit ndings. It is
recommended that nonconformances and corrective actions be shared with all staff in the relevant laboratory section.
Effectiveness
of Actions
(taken over time)
This section should describe the effectiveness of actions taken over time in response to identied internal audit
nonconformance(s). The specic nonconforming activities determine whether immediate actions, corrective actions or
both are executed. For example:
• Review immediate correction for effectiveness. This may include reviewing specic logs (after a period of time
determined by the remediation plan) to ensure nonconformances are appropriately documented.
• Review corrective actions for effectiveness. This may include updating an SOP, retraining and monitoring periodically
over a longer period of time (typically 3 months to 1 year).
Documentation of ndings from the review(s) should indicate whether the actions taken were effective. If so, the results
should be shared with staff and acknowledgements signed by appropriate management.
If the results were not effective, a root cause analysis should be performed if not completed already, and further
corrective actions identied, with a new plan and another review for follow-up effectiveness.