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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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.
Device failure investigation and root-cause records
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.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Nonconforming Material, Failure Investigation and CAPA for workflow guidance, a checklist and common mistakes.
