Check points for Failure Investigation

Dear Friends.

In continuation to my previous blog on checklist for inspection readiness, I would like to share the checklist for failure investigation.

Effective failure investigation program.

• Is there a written SOP covering failure investigation that has been approved by the Quality.
• SOP for investigation include a clear definition of events requiring and investigation that include: 
• Exceptional events, 
• Unexpected events, 
• Out of specification results, 
• Product or Process failure etc.

• Standard procedure covers the requirement that all investigation activities to be documented.
• SOP states that all investigation drive to a Root Cause or most likely Root Cause.
• Is root cause properly defined as the most likely primary cause for the event noted.
• Are investigation is initiated and completed as per the defined timeline.
• Containment procedure is part of SOP.
• List of specific requirements for the investigation.
• Provision for verifying the effectiveness of actions taken as a result of an investigation.
• Are SOP covers the review and approval of investigation by Quality, including cause, rationale CAPA and conclusion 

Investigation Containment

• Is containment of the problem a specific elements of each investigation.
• Investigation SOP specifically requirement for quarantine of potentially impacted product, limitation on impacted equipment and documentation of these actions.
• Time limits for initiation of an investigation is followed or not. For example, is initiation of an investigation required with one days of discovery.
• Investigation SOP specify role and responsibilities for initial investigation activities.

Conducting  investigation:

• Investigation SOP specify documentation requirements of the investigation.
• Role and responsibilities specified in the investigation SOP.
• Are specific tools routinely used for root cause identification (such as fishbone diagram, 5 Why's etc.).
• Considered unacceptable or inadequate to close an investigation without identifying the root cause.
• Are all investigation activities documented, including: photograph, inspection of reserve sample, analytical testing reports, equipment inspection, problem solving activities etc.
• Quality unit shall be part of every failure investigation.