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Inspection Questions

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I am going back through the AABB/CAP checklist, and I have a couple of questions.

Do you find that inspectors tend to look at certain things moreso than others? If so, what are they?

Regarding TRM.32250 Record Retention  (Revised 8/22/18), under QC records it lists "irradiation dose delivery." Now, we do not irradiate units here. We get them from our local blood supplier, and they send sheets with the invoices that has this information on it. Am I suppose to keep these if the blood supplier keeps this information and can send it to me, if needed? It does not appear that we have kept these in previous years, but this is my first inspection solo, and mama wants to nail it.

If anyone has any words of wisdom, advice, or good jokes-- I'm all ears! Thanks!

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You don't need to keep those records about irradiation.  You are not performing it.

As an inspector I almost always look at standards which I have been cited for.  (I always disliked when the inspector said: "I knew I'd have to look really hard to find something in Dave's lab).  That's not my style.  I only dig if what I am finding merits such.

I always look to verify you have corrected any prior deficiencies (these are given to us as part of the packet).

I observe your staff and attempt to correlate what they are doing with what your policy/procedure says they should do.  I also ask your staff (without a senior staff member accompanying me) about their work environment, employer, ability to attend CE programs.

I want to see your quality stuff, especially any reports which you should have generated based on your QP.  If you don't have anything it will be a long day for both of us.

I will want to observe a transfusion or at least speak w a nurse about transfusions.  Nursing training for transfusion and knowledge of reactions - this will be from Nursing Ed/Admin

I don't want to review your procedure manual unless you ask me to look at specific items or you have added something new.  I do want to see your table of contents so I can see what you do - I may take a peek at something there that piques my interest (I may also ask you if I might have a copy if it is something I'd like to bring to my own operation).

There are lots of funny stories but you'll have to be inspected by me to hear them. (actually, most of them are quite sad as they involve citations).

I tell your staff to relax because when I go back to work I do the same thing they do.

 

I was an AABB inspector/assessor for 20+yrs.  Still a CAP Team Leader.

 

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2 hours ago, David Saikin said:

You don't need to keep those records about irradiation.  You are not performing it.

As an inspector I almost always look at standards which I have been cited for.  (I always disliked when the inspector said: "I knew I'd have to look really hard to find something in Dave's lab).  That's not my style.  I only dig if what I am finding merits such.

I always look to verify you have corrected any prior deficiencies (these are given to us as part of the packet).

I observe your staff and attempt to correlate what they are doing with what your policy/procedure says they should do.  I also ask your staff (without a senior staff member accompanying me) about their work environment, employer, ability to attend CE programs.

I want to see your quality stuff, especially any reports which you should have generated based on your QP.  If you don't have anything it will be a long day for both of us.

I will want to observe a transfusion or at least speak w a nurse about transfusions.  Nursing training for transfusion and knowledge of reactions - this will be from Nursing Ed/Admin

I don't want to review your procedure manual unless you ask me to look at specific items or you have added something new.  I do want to see your table of contents so I can see what you do - I may take a peek at something there that piques my interest (I may also ask you if I might have a copy if it is something I'd like to bring to my own operation).

There are lots of funny stories but you'll have to be inspected by me to hear them. (actually, most of them are quite sad as they involve citations).

I tell your staff to relax because when I go back to work I do the same thing they do.

 

I was an AABB inspector/assessor for 20+yrs.  Still a CAP Team Leader.

 

One other thing I do is to have you select 5 components which have final disposition.  Then see that every person that dealt with that component had a competency for what they did - including those who transfused.

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On 6/3/2019 at 2:47 PM, EAB81 said:

I am going back through the AABB/CAP checklist, and I have a couple of questions.

Do you find that inspectors tend to look at certain things moreso than others? If so, what are they?

 

What I quickly realized was that no 2 inspectors/assessors focus on the same thing.  As David noted, they seemed to focus on things they were either cited for or had cited others for recently.  Over the years I had been cited for something that had passed all previous inspections because the inspector simply did not like the way we did it.  When I challenged the citation with the inspecting organization the citation was often over ruled, not always but often enough to make the challenge worth while.  My best advice is to prepare the best you can and consider the inspections a learning experience and hope that David is your next inspector.  On a side note I was a Blood Bank inspector for CAP for 30 years so I had ample experience on both sides.  One last bit of advice, never ever argue with an FDA inspector!  :coffeecup:

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I agree with John.  Challenge whenever you think you are in compliance.  I always do - win about 60% of the time.   Many inspectors can't see the forest for the trees.  There are many ways to do things that comply.  Just because the inspector disagrees does not always mean they are correct.   I find this moreso with CAP than AABB but sometimes the latter exude hubris (doesn't mean you are wrong).  Worse case scenario - you have to update something.  AND NEVER ARGUE W THE FDA.  I've seen those folks go to great lengths to find a needle in a haystack if you give them a hard time.  I won't elaborate here but . . . take our word for it.  Besides, they can take you out in handcuffs if they think you deserve it.  (there is an enforcement arm).  Good luck.  You'll do fine.

 

 

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On 6/5/2019 at 6:32 AM, John C. Staley said:

What I quickly realized was that no 2 inspectors/assessors focus on the same thing.  As David noted, they seemed to focus on things they were either cited for or had cited others for recently.  Over the years I had been cited for something that had passed all previous inspections because the inspector simply did not like the way we did it.  When I challenged the citation with the inspecting organization the citation was often over ruled, not always but often enough to make the challenge worth while.  My best advice is to prepare the best you can and consider the inspections a learning experience and hope that David is your next inspector.  On a side note I was a Blood Bank inspector for CAP for 30 years so I had ample experience on both sides.  One last bit of advice, never ever argue with an FDA inspector!  :coffeecup:

It is important to remember that inspectors are human and as John says, they can and do cite things because it's not how they do it. Don't take it personally. Their way may give you a good idea for improving your way. At the same time, don't be afraid to challenge a citation if you feel that you've met the intent of the standard and can prove it.

I definitely don't recommend arguing with an FDA inspector ;) - you are probably not going to win.

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Also if you have implemented or updated your computer system, a new instrument/analyzer, or any other process be ready to show documentation regarding validation. 

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