On site Technical File Review by our NB

SteveK

Trusted Information Resource
#1
With our previous NB I sent Technical Files on a disc to their offices for review (too big for email). However, our very new NB is planning to review four technical files by three auditors on our site over two days next year. Now I know TFs were reviewed first hand during an normal audit in the past (when stuff was less complicated), but I thought nowadays all NBs did reviews remotely. It is just there would be added costs for accommodation, meals, travel etc. which all seems unnecessary.

What are other peoples thoughts and current experience in this respect?

Is it just a money making plan?

Steve
 
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Remus

Involved In Discussions
#2
Re: On site Technical File Review?

Notified Bodies have to perform technical file audits on site. European Commission is writtign nonconformity if they wont. Thats why they are sending auditors.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Re: On site Technical File Review by our NB?

The pressure being exerted onto NB's to stop the assembly line approach to assessments should be paid attention to, by accreditation bodies.

The commoditization of system certification has to stop, or else.
 

rcjpedro

Starting to get Involved
#4
If I only knew then what I know now!

I've had both on-site and off-site TF reviews.

Unfortunately my experience is that different auditors will have different opinions regarding the same subject!

I'm now in the process of responding to a open TF CAPA resulting from an off-site review.

On site reviews can have auditors doubts settled on the spot, off site reviews will almost always have doubts settled with a TF CAPA.

If your NB charges for CAPA review, review costs will absolutely surpass auditor travel and accommodation expenses.

In the future we are only considering on site reviews.

Unless your TF review raises no questions from the new auditor.
 
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