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First AABB inspection


aj2018

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Ditto to Malcolm's comment. I don't think you have much to worry about. And remember the worst that can happen is that the CAP/AABB representative will find something, you correct it, your process gets improved, and life goes on. Also keep in mind that if you disagree with the ding from the inspector, you can always appeal it. You win, you win. You lose, you're back to "And remember...".

Good luck. I am in my AABB window myself. My window closes 3/31 and I'm retiring 4/1 - something tells me I could have timed this a little better!

Phil

 

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My advice from 2 years ago still holds true.  Be honest with them, smile, breathe, and ask a lot of questions.  If they cite something, there's no harm in asking them for how others do it.  AABB assessors are not allowed to offer suggestions, but if they are ASKED, they are allowed.  They won't put it in writing, but they will be very helpful.

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  • 1 month later...
39 minutes ago, amym1586 said:

Well I just finished my first AABB inspection.   I'm so glad it's over!  We did get 1 nonconformance (seems pretty minor and an easy fix) but everyone here is happy with that. So I'm guess I'll try to be happy too.

One non-conformance?  You should be hugely excited, very proud of your staff and yourself, and, in addition, getting yourself around the outside of a very large glass of champagne!  Well done!!

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20 minutes ago, Malcolm Needs said:

One non-conformance?  You should be hugely excited, very proud of your staff and yourself, and, in addition, getting yourself around the outside of a very large glass of champagne!  Well done!!

Oh good! I feel better now.  I think I was being a little too hard on myself.

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20 hours ago, amym1586 said:

Oh good! I feel better now.  I think I was being a little too hard on myself.

Goodness no! We were told we did well in our last inspection only getting 13 minor non-compliances. I thought it was bad as when I managed the inspection in my lab we only got 4.

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My favorite pre-assessment/inspection advice is; "They can't kill you and eat you.  That's against the law."  You did great.  They will look and look and look until they find something.  With only one easily corrected non-conformance, I would say you have nothing to worry about.  

Well done and congratulations to you and your staff.  :clap:

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I've been through 7 or 8 now.  My first was terrifying, now I'm OK with it.  Between AABB, TJC, FDA, FACT, DPH and any other acronym you can mention, I've been through a lot of inspections / surveys / assessments. :)

I do find AABB to be wildly inconsistent.  I suppose that is part of the nature of peer assessors, but until this last assessment, we have always had an AABB employee as the lead.  It really feels like they can't leave unless they find something.  Rarely it's significant, often several small / trivial non-conformances, but never none.  Our TJC and FDA are almost always without citations.  FACT, we might get one small ding (they are ruthless if you've never had one).  We've even had AABB, FDA and TJC in the same year.  TJC = clean, FDA = clean, AABB = 20 non-conformances.

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I think having only one is excellent (20+yrs AABB inspector/assessor).  It never bothered me to not find any non-conformances (a very rare occurrence).  I always dreaded my Summary sessions when the inspector would say: "I knew I'd really have to dig to find something in Dave's lab."  That's not what it is all about.  I have to agree with Cliff that since AABB went to an assessment vs an inspection the process has become more subjective and hence a bit more inconsistent.  I always tell folks to be proactive for your lab - the assessor isn't always right, they have biases (which they should leave at home).

Great job!

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2 hours ago, Cliff said:

It really feels like they can't leave unless they find something.  Rarely it's significant, often several small / trivial non-conformances, but never none. 

I agree Cliff, and it is the same in the UK (for certain of our inspectors).

The more they have to dig, the more inappropriate is their non-conformance (usually), and the more ridiculous they look, as it causes so much resentment that, in the end, it is counter-productive (but, give them a clip board and a peaked cap, and many of them - Not all David Saikin! - get above themselves).

If they did it fairly, they would have a MUCH better result themselves, if only they realised, but hey..........................

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21 hours ago, Malcolm Needs said:

I agree Cliff, and it is the same in the UK (for certain of our inspectors).

The more they have to dig, the more inappropriate is their non-conformance (usually), and the more ridiculous they look, as it causes so much resentment that, in the end, it is counter-productive (but, give them a clip board and a peaked cap, and many of them - Not all David Saikin! - get above themselves).

If they did it fairly, they would have a MUCH better result themselves, if only they realised, but hey..........................

If you want to dig  you can find something anyplace you go.  I think many inspectors feel that they must find something when actually what they need to be doing is making certain that standards/regulations are being adhered to.  Usually there is more than one way to meet the requirement.  I found that if  you focus on the quality portion of an inspection any significant outliers are fairly apparent.  I would say that in my 20+ yrs inspecting that most of the non-conformances dealt with updated standards that had not made it into policy/procedures  . . . all were pretty easy fixes.

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