Are Manufacturing Personnel Required to ReDemonstrate after intital Demonstrations?

N

NoeM7283

#1
I currently work for a medical device cell culture company that adheres to 21-CFR-820, 21-CFR-210, 21-CFR-211; ISO9001 and ISO13485. Within our training program, we train manufacturing personnel using a combination of OJT and computer-based learning. We have personnel demonstrate and record that they are competent on the processes prior to allowing them to perform the work by themselves, along with re-demonstrating and record the continued competency in the process every 2 years. It has recently come into question if we need to continue require the personnel to re demonstrate competency every 2 years from a regulatory stand point. Does anyone have any insight where i might be able to locate evidance whether or not if we need to continue to re-demonstrate competency on the processes past the initial demonstration?
 
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dwperron

Trusted Information Resource
#2
I don't know about any 2 year requirements in 21-CFR, but neither ISO 9001 or 13485 requires any two year competency certification requirements. It is possible that your organization realized that your personnel will be required to demonstrate competency on your biannual accreditation renewal and interpreted that you need to document the competency every 2 years, but that is not a requirement in the standards.
13485 section 6.2 requires you to document processes of establishing competence, providing needed training and ensuring awareness of personnel. You will need to show how you evaluate the effectiveness of these actions, and the two year re-demonstation cycle is a way to do that.
 
#3
Worse, if you had a significant change within the 2 year timeframe, you could be in trouble, Using time as a basis for doing anything like this, as well as audits etc. is ineffective. I'm not sure what "accreditation" DWPerron is posting about, but CBs rarely require such a thing.
 

dwperron

Trusted Information Resource
#8
Right, that's accredited CERTIFICATION, not a company being accredited...(per your post #4)
Sorry, I should have used Certification instead of Accreditation, not that is makes much difference in this case.
The certified organization is still being held to the 13485 requirements.

Here is what ISO says:
ISO 13485 Medical devices

Who is ISO 13485 for?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Certification to ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
 
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