Failure Investigation Procedure

The Failure Investigation Procedure defines the process of conducting a failure investigation when a medical device fails to meet product performance specifications. Failure investigations are intended to determine root cause for failure and to provide adequate solutions to correct and prevent problems from reoccurring.

The Failure Investigation Procedure applies to product performance failures. The procedure applies to but is not limited to the following circumstances:

• A critical component, subassembly, or device that does not meet specification

• An adverse event that warrants investigation

• Customer complaint trending that warrants investigation

• A failure investigation that is recommended prior to conducting the actions associated with a Remedial Action Plan

The Failure Investigation Procedure provides instruction on investigation initiation, execution, and closure processes. The procedure includes report forms and a remedial action decision tree.

• Investigation triggers for device or component failures

• Initiation, execution and closure of the investigation

• Root-cause documentation and remedial-action decision support

For the customer report that triggered an investigation, see the separately sold Complaint Handling Procedure; to evaluate repeated signals, see the separately sold Complaint Trending Procedure. Those two are included in the Complaint Handling Procedures Bundle. This Failure Investigation Procedure is not included in that bundle.

Supplied as editable Microsoft Word documents with related forms in a digital download.