“Life
is not a bed of roses” the similar quote can be fit during
inspection as “FDA Inspection may not be a bed of roses”. You have to ready to
face different questions by FDA inspector whenever he required any information.
If you handle them very politely, honestly and in a balanced
way of communication then everything can move very smooth otherwise you will
offer to ask more question by Inspector during FDA audit.
Now next thing is who will handle them? Off curse! yours SMEs (Subject Matter Experts). The SME will be of respective Machine, respective activity, respective area, and respective task. It is higher management responsibility to make expert yours SME by giving some examples of audit questions, by doing mock audit by top management team, direct interact with yours SMEs and by asking questions from SMEs by creating some scenario of FDA Inspection. After doing these activities it is important to give feedback as what is good and wrong part of interaction during SMEs.
What should do during mock audit: Before
mock audit, check which type of observations given by FDA Inspectors during
audit to your company or other company. Also check what observation found
during internal audit. Is any repetitive observation found during internal
audit and is any similar observation of FDA 483s found during internal audit?
Note down these observations and also cover the
investigation procedure of non-conformances, complaint handling, data integrity
breaches, awareness on ALCOA++ principals, documentation control procedure etc.
Create the scenario of FDA Inspection and treat like a real FDA audit. These
practices will be revision of your FDA Inspection readiness and also beneficial
for yours SMEs to build-up confidence during real FDA audit.
Here I am going to provide some examples of question answers
between auditor and SMEs. Also there will be some lesson point which you can
easily identify them after reading these answers and questions.
These question and answer are taken from a content named
as “FDA guidance to preparing SMEs”
Scenario one: Just the Facts
Inspector: Do you have a procedure for complaint handling?
SME: Yes, we have a
procedure for complaint handling. It’s been recently updated because of an internal
audit observation.
SME: Sure, we’ll get you that information.
Inspector: While we are waiting for the documents I requested, can you tell me what the observation was.
SME: Sure. The observation was that the procedure didn’t require that we document the evaluation we perform to determine whether or not a further investigation is required.
Inspector: What are the actions that you have taken?
SME: One of the actions is overdue. We updated the procedure to require that the evaluation is now documented; a rationale for why we’re not going to perform further investigation, if that’s the case, and the signature of the individual who performed the evaluation. We’re making a change to the software to accommodate this.
Feedback: In above conversations you can see the SME gives extra information due to this, upcoming questions are automatically generated and he has to also give the answer of that questions which might be not in the mind of auditor.
If SME give answer only as “Yes, we have a procedure for complaint handling” in that case the next question of auditor may be “Can you show me the related procedure? or can you explain me how you handle the same?”.
The SME again offer extra information about “the action is overdue”. The Inspector was interested only to know about action taken, not for timely completion of action.
Scenario Two: Silence is Golden
Inspector: Let’s look at the CAPA and the procedure update.
SME: Here they are.
Inspector: What is the change that you made?
SME: We added this section here that requires the evaluation for the need for further investigation now has to be documented, along with a signature of the person who did it.
Inspector: Do you have an effectiveness check?
SME: Yes, the records are checked by another person to ensure that this has occurred.
Inspector: I do not see it here.
SME: Well, we are performing this check. I could show you the records.
Inspector: (pauses.)
SME: Since this will now be a required field in the software, you can’t proceed without entering this information. It’s a very nice system. Would you like to see it?
Feedback: In above conversation you can see, after completion of SME’s answer, the inspector was silent. Then SME further providing extra information however his answer was completed.
Auditor
knows such type of tricks to digging extra information and mostly they use it.
So it is required to train your SMEs to stop talking after completion of their
answers until auditor ask next question. Off course, it is very hardest thing
during inspection and feels awkward but it’s definitely the correct behaviour in
this situation.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.