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“What are your responsibilities in this lab?” “Can you show me how you are doing the integration of your chromatogram and why?” “Where are the instructions you follow for doing this activity?” “Are you trained to do this operation?” “Is this equipment calibrated?”...
These are some of the questions an auditor (customer auditor, authorities or auto-inspections) can ask… And he could ask many more. Audit is a usual and often mandatory activity practice in many sectors to check the compliance of your work with references (GxP, ISO, Pharmacopeia) and/or requirements. The results of an audit can be of paramount importance for a company.
Now how should you be answering the questions of an auditor?
If there are no mandatory rules to follow, there are well some tips that can help you to answer.
The 3 different ways of examination during an audit
The auditor has 3 different ways to prospect:
Watching: Observation of the lab/production activity
Reading: Checking of the paper or electronic documentation (SOPs, WKIs, Lab-books, filled templates, database, reports, references, labels…)
Questioning: Interviewing operators, technicians, managers, supervisors,… is a very frequent activity during an audit. It is thus important that the answers received are in line with what he sees or what he reads.
Generally, a good auditor will use at least two of these ways for each of the topics in the scope of the audit (sometimes at different moments).
You are under hot questioning of the auditor: keep cool!
To be questioned by someone can be stressful. Many people don’t like to be interrogated by someone else, not by a colleague who is doing a self-inspection and certainly not by an authority or a customer representative. Keep in mind however that the auditor is not your enemy. The auditor is only there to check if the activities in the scope of his/her investigation is done according to some reference. The auditor is not there to judge anyone.
Here are some practical tips that can lower the pressure:
1. Be sure you have well understood the question
Do not hesitate to ask for repeating the question if you are unsure. This is not a problem. If you don’t speak the language of the auditor fluently (audits often take place in English), you can ask a colleague to translate. Or sometimes a translator is accompanying the auditor.
2. What if you don’t know the answer of the question?
In this case there are 2 options. You can simply say “I don’t know”. Or you can refer to the people whom you think they know the answer.
The worst thing you can do is avoiding the question or making a guess. More than that, you should answer only to questions in the field of your responsibilities. For example, if you are responsible for the visual control of the filling, you should only answer to questions related to the visual control and not to the sterility tests made, even if you know the answer (leave this to the guy in charge of the sterility tests and spare you some stress).
But again, don’t make a guess. If your answer is wrong and the auditor discovers it, he/she will become suspicious. The auditor cannot trust the rest of the audit anymore and he will come back to go into more detail to understand why he/she received a wrong answer. He/she can for example begin to look into detail to your training plan or check what is written (or not written) in the SOPs.
3. You don’t want to be interviewed because it makes you nervous
Ok, it is not always possible to avoid the questioning. However, as audits are nearly always announced, you can inform your manager (or the main auditee) that you don’t want to be questioned. If possible, the people accompanying the auditor can try to direct him/her towards another competent colleague more in ease with interviewing.
4. Answer only to the question… and nothing more
Auditor: “What are your responsibilities?”
Auditee: “I am in charge of the visual control of the vials. I make also the necessary sampling to send to the sterility test department”
Don’t show him how you are making your visual control or your sampling. He doesn’t ask so far. If he wants to know these details, let him ask that first.
Auditor: “What are the requirements to declare the compliance of your solution?”
Auditee: “The pH should be between 7.2 and 7.4 and the level of impurity A should be < 0.5%. A visual control is also done, and the solution should be transparent.”
Don’t begin to explain how or where you are measuring the pH. He doesn’t ask that.
Auditor: “Do you have a SOP describing this method?”
Auditee: “Yes”…. and nothing more. If the auditor wants to see the SOP, let him/her ask for it.
Auditor: “Can you show me where the samples are stored?”
Auditee: Show where the samples are stored (a cupboard, a fridge, a room, …) and don’t add any comment.
To satisfy most of the auditors, you should keep the following tips regarding open and closed questions in mind:
If the question is closed (cf. example 3 and 4): Answer to the question or show the auditor what he/she is asking and don’t say/do anything more. The answer should be short. Yes or no, a list of reference, the name of an equipment,...
If the question is open and the scope is large (cf. example 1): try to be complete, but summarize.
If the question is open and the scope is restricted (cf. example 2): give a detailed answer (but only in the scope of the question).
5. You have to consult a SOP/ Instruction to answer conveniently
There is absolutely no problem with that. Take your time (OK not too much). Simply inform the auditor that you prefer to consult the written instruction before answering.
As the audits are generally announced, you could also re-read the instructions prior to the audit. The more you are prepared, the easier the answering will be.
6. Be careful with humor
If you don’t know the auditor (which is generally the case) or if you are stressed by the audit, it is better to not use humor because it can be misinterpreted.
The questioning is one of the usual ways frequently used by auditors. Clear and correct answers are essential for the auditor, as these answers will be confronted also by what he sees or what he reads. Answering only to what is asked is key. By answering or showing more, you risk giving the auditor the stick you will be hit by. Let the auditors do their job and let them find the potential stick by themselves.
QA audit expert