Anon,
When referring to use of a "Robot" might be better to refer as an "automated inspection" is this would be more the lingo a regulatory authority or auditor would be accustomed - that is of course in your situation it is an automated inspection. As an example, visual inspections by operators are often replaced with automated inspections using cameras or sensors. In fact, most automated inspection methods are already done 100% which is why companies deploy these on automated lines or to remove a human-being from missing an inspection or having subjectivity introduced. The simple answer is the automated inspection needs to be validated and then periodically reviewed to ensure it is functioning and continues to inspection the parts/components as required. There is no need to continue the human based inspection unless you determine (risk based) this is needed. In some cases, companies conduct 100% inspection though automated means and then do a small sample periodically to confirm. All of this depends on the type of device, component/part being inspected, risk of missing the inspection (accepting bad or rejecting good), and should be determined as part of the validation activity.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Mar-2023 02:31
From: Anonymous Member
Subject: Robots for complying with the 100% manual inspection of vials - Is the acceptable from a regulatory perspective
This message was posted by a user wishing to remain anonymous
Filled vials are subject to 100% visual inspection. This activity is manually performed. Would the Regulatory Authorities accept Robot that mimic the human inspection method as a compliant means for 100% visual inspection. If the robots are deployed for the 100% inspection, would we still need to have human based inspection say either on a sampling basis or based on the rejection rate of the robots. Would be interested to hear the views on this