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.

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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 Investigation Procedure - Overview

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.