Audit Days Based Upon Number of Employees

[Tom W]

Audit Days

Does anyone else feel that basing the number of audit days on the number of employees makes very little logic? Wouldn't it make more logic to base it on the organization and what they do as well as there size. I work for a company with three different locations. Two of the locations have around 17 employees. With the discount for no design of product responsibility we still have 1.5 days. Every time the auditor comes in he is done after the first day and yet we are paying for 1/2 of another day.

Our system has been evolving for six years and is pretty easy to audit; especially since the same auditor has come almost every time through Qs and now into TS. Why do we have to pay for extra days when they are not needed? Even our registrar agrees, yet they say they are bound by the rules of the road.

Anyones comments would be appreciated. Just venting!!!

 

[SteelWoman]

I think particularly with TS the audit day requirements are ABSURD. We have about 200 employees and the intial TS audit, even with the allowable reductions, is 5 days?!!? I'm with you - our experience has been that after a good solid day or day and a half at the most of auditing, I'm at at LOSS as to what an auditor is going to DO for the other 4 days?! We have several processes, but they're just not that complex and we have a VERY robust system - incredibly easy to audit.

I tried and failed to get our registrar to reduce the audit days based on a history of extremely strong audits (we've had 5 audits in the last 3 years with ZERO findings of any kind). They denied it because we haven't been audited under TS - only QS?!

More money in the pot for all involved, I suppose.

 

[Teri - 2011]

We had 9 (yes, not a typo, nine) audit days for our initial audit to TS.
I too felt what are we going to do??

However, each day was filled (with value added activities). Much to my surprise.
IMHO, I think it varies with EACH company.

Since each regristrar & auditor have different approaches, how could they standardize it any differently?

 

[Tom W]

I agree with both of you. We had two auditors for 4 days each. on auditor was in one facility for the 4 days and the other auditor split 2 days in each of our other 2 facilities. Just seems like a lot of time to look at the same thing over and over. I can see if they are finding things to improve or making it useful through "suggestion" that they always give, but it has to be value added - not just because that is what the book says.

I wish this could be fexible and left up to the registrar after a basic minimum time.

 

[wrodnigg]

The intention behind these regulations (i know that from MedDev) is AFAIK, that there are some guidelines which notified bodies have to follow. So there should be less dumping-offers, less "low-quality" assessments...

Any kind of regulation has its good and bad sides. And it is very very difficult to fit them all...

~ghw

 

[Sam]

Just curious. Has anyone re-calculated the audit days required using the new formula on the IAOB website. You may be in for a surprise.

 

[Tom W]

Just curious. Has anyone re-calculated the audit days required using the new formula on the IAOB website. You may be in for a surprise.

Do you have a link? Or is it www .iaob. com or something similar?

 

[Sam]

Do you have a link? Or is it www.iaob.com or something similar?

www.iaob.org Under FAQ

 

[Tom W]

www.iaob.org Under FAQ

Thanks Sam, I went to that and still think it is nuts. The audit days that it should take to audit our three facilities and look really good at everything should be no more than five days for one auditor. Not 8 days for two auditors. I am just amazed at registrars that are "filling" audit days with little to no actual auditing because they have seen it all already, yet the organization has to pay for it.