Another "Show me the shall" - Improvement note on something trivial

R

RosieA

#1
I recently completed a surveillance audit and received an improvement note on something I thought was unbelieveably trivial. I'll share it and you can tell me what you think.

I have an internal audit report that is available in electronic form for those who like to type, and in hard copy for those who prefer to hand write their audits. My procedure allows for either. There is a spot on the form that asks if the item audited was in compliance, and your choice is YES or NO. On the handwritten form, you circle it, and on the electronic form you can either highlight it, or remove the word that doesn't apply. The electronic form has a box around this area, the hard copy form does not. Otherwise the content and format is exactly the same from one form to the other.

The auditor wrote an observation because one form has a box around this area and the other does not. he claimed they were different forms and should have had separate form numbers.

This kind of comment adds no value to my QMS and I said as much. I look to ISO auditors for feedback that provides clear improvements to my QMS, and this one most certainly did not.

Comments?
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Push back on that auditor for a silly finding. If he refuses to pull it or close it, file a complaint with the registrar and with the registrar's accrediting body(ies).

Hershal
 

RoxaneB

Super Moderator
Super Moderator
#4
RosieA said:
...received an improvement note...
Is an Improvement Note the same as an Opportunity for Improvement? Don't you have the ability to look at it and say "No, we're not going to do this"?
 
#5
Yes, it is a trivial issue. Did you challenge it at the time it was written? Did you challenge it at the closing meeting? If the answer to both questioons is no, then you will need to address the OFI. Some registrars don't require you to respond to an OFI, but some do. The auditor has already hinted that you are using two different forms. And no matter how trivial it sounds; you are. The next time it could be a minor.
 
R

RosieA

#6
Sam said:
Yes, it is a trivial issue. Did you challenge it at the time it was written? Did you challenge it at the closing meeting? If the answer to both questioons is no, then you will need to address the OFI. Some registrars don't require you to respond to an OFI, but some do. The auditor has already hinted that you are using two different forms. And no matter how trivial it sounds; you are. The next time it could be a minor.
Yup, I sure did "mention" it during the audit and during the closing meeting. The auditor's comment was "I know auditors who would write a finding for this" to which I responded, "And I would have fired that registrar if they supported a finding like that." I invited him to show me the "shall", and, of course, got nothing substantial.

Since it was an OFI, and I do not have to respond to it, I let it go. (grumpily, I might add) The Auditor teased me about it several times during the audit in front of other managers, who all thought it was a hoot that the QA Manager got an OFI. Some days you eat the bear, and some days..."
 
#7
RosieA said:
The auditor wrote an observation because one form has a box around this area and the other does not. he claimed they were different forms and should have had separate form numbers.
That sounds a bit silly imo... :nope: Is your system by any chance so good that he had a hard time finding more value adding stuff?

In any case he ought to be old enough to realize that what you see on screen is not always what you get when you print it...

/Claes
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#8
Sam said:
The next time it could be a minor.
I disagree. If an auditor tried to give a minor for such a slight difference between the written form and the electronic form I'd laugh before 1. Contesting it and asking the registrar for a different auditor in the future, or 2. Looking for another registrar. This is unconsequential nit picking if I've ever seen it.

Had the form content differed, or if the layout was *significantly* different, I might agree, but not in this case. My main focus would be content of the form. Even if the layout was different, one could argue that the form on the computer was a data entry issue while the form on the floor is the 'official' form.

My :2cents:
 
A

Aaron Lupo

#9
I would disagree and argue the fact as well, you stated it is a report not a form. The only thing I have question on Rosie is the company you work for is a Medical Device company correct? If it is I would have asked if your system is Part 11 compliant (electronic records, signatures) if not I would have dinged you for that.

In an case if you disagree with the OFI call your registrar and file an appeal.
 
R

RosieA

#10
No, Aaron, it's not medical devices. I moved out of that arena almost 5 years ago.

I was really P.O.ed about this OFI, but got no where fighting it, so I decided to defer in order to avoid making the rest of the audit a celebrity death match.
 
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