Out-of-Box Failures during installation, complaint?

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PRFire

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Our company manufactures and installs medical devices / instruments. Installation is done by our internal field service team. Occasionally, the installer will find that a cable is missing or equipment requires realignment or adjustment as a result of transit. Customers are not aware of the issue and these issues are resolved during the installation process. Do these issues occurring post release need to be reported as complaints or can these just be reported in the installation report?
 
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Unless you are required to treat them in a specific way by a medical regulation, you are free to define how to treat them in your QMS. Consider whether reporting them in an installation report will drive corrective actions. Who reads the reports? Will they take action to resolve the missing cable issues? Will someone work on developing better packaging to prevent misalignment during transit? Will it get more attention if it is treated as a complaint?
 
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PRFire

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Yes, OOB failures are analyzed and trended to drive corrective actions. We seem to have duplication of records for this issue because we currently report them as complaints and also as part of our service reports.

Edit: reference regulation being 21 CFR 820.
 
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