Field Corrective Action?

SBrumbaugh

Registered
During an inspection, it was found that several units were missing a screw. These units were shipped and are in use at customers. Is reaching out to customers of impacted units to have the screw added to the unit(s) considered an FCA?
 

ChrisM

Quite Involved in Discussions
I've certainly come across this terminology (FCA) before in the medical device industry. Generally it means that your organization has to visit the customer site to undertake unplanned work to make the device conform to intended specification. It's not something that you can "trust" the customer to do by sending part(s) and instructions.

You have an number of things to consider - is it essential that the missing screw is fitted to ensure product functionality and/or safety; can the device continue to be used in the meantime; can fitting the missing screw wait until the item next requires maintenance/servicing; who can fit and check and report back that the screw has been correctly fitted etc...
 

SBrumbaugh

Registered
I've certainly come across this terminology (FCA) before in the medical device industry. Generally it means that your organization has to visit the customer site to undertake unplanned work to make the device conform to intended specification. It's not something that you can "trust" the customer to do by sending part(s) and instructions.

You have an number of things to consider - is it essential that the missing screw is fitted to ensure product functionality and/or safety; can the device continue to be used in the meantime; can fitting the missing screw wait until the item next requires maintenance/servicing; who can fit and check and report back that the screw has been correctly fitted etc...
The screw is necessary to provide a rotational stop, preventing kinking in tubing, thus potentially impacting functionality of the product. The organization was quick to want to organize a list of impacted product and ship the screw to the customer, and I feel this may warrant a more formal process.
 
We have done this in the past, we call it an FMI - field modification instruction - sometimes it is done by the customer (and billed to us) and sometimes we send a crew to the customer to do the mod. We do consider it a corrective action and also make a PA plan (usually incorporating the FMI) to prevent future issues. This usually happens after a prototype is put into service and issues and modifications arise after the fact due to environmental problems (product is mounted to close to interfering pipes, lines, other controls, etc.)
 

Bev D

Heretical Statistician
Leader
Super Moderator
I am used to the term “field action” which covers proactively bringing teh product back for repair/rework to performing the action in the field a tthe Customer site.

Usually there are formal reviewed and approved instructions for both…
 
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