Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good afternoon forum

What will be the consequences on using an equipment that is  not calibrated. The calibration service has been schedule but  I can't stop production due to this issue. How I can be able to have a deviation and continue using the equipment until calibration is performed.

1) Will the scheduled  calibration be performed prior to the end of the month of the due date?  If so, you can specify this leeway in your SOP and continue to use the equipment until calibrated.
2).  If you are out of calibration (beyond the end of month the cal is due) you must take it out of service.

I do not suggest deviation, but that doesn't mean it isn't an option.  Anyone?

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Mary AnnGreenawalt
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Original Message:
Sent: 13-Feb-2017 14:18
From: Anonymous Member
Subject: Calibration

This message was posted by a user wishing to remain anonymous

Good afternoon forum

What will be the consequences on using an equipment that is  not calibrated. The calibration service has been schedule but  I can't stop production due to this issue. How I can be able to have a deviation and continue using the equipment until calibration is performed.

Assuming you are manufacturing medical devices, I have two suggestions for you:
1) Do you have a secondary way to check your manufacturing specifications without using this calibrated equipment? If so, write a deviation to follow this process until the tool is properly calibrated.
2) Take the manufacturing on risk (assuming it is not a health risk).  Document all devices that were manufactured using the uncalibrated tool so that if there are complaints or returns due to a defect, it can be evaluated against the manufacturing decision to use uncalibrated equipment. The biggest consequence of this approach is you may end up having to recall all of these devices.


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Rene' Hardee
Regulatory Affairs Specialist III
Sun Nuclear Corporation
Melbourne FL
United States
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Original Message:
Sent: 13-Feb-2017 14:18
From: Anonymous Member
Subject: Calibration

This message was posted by a user wishing to remain anonymous

Good afternoon forum

What will be the consequences on using an equipment that is  not calibrated. The calibration service has been schedule but  I can't stop production due to this issue. How I can be able to have a deviation and continue using the equipment until calibration is performed.