There are some companies offering coaching on how to “handle” an MHRA inspector.
If you think this is of interest to you then I suggest you STOP and think again. If you have to pay to be coached on handling an inspector/inspection then there is something wrong.
These simple, common sense rules will help anyone with their MHRA inspection, and cost you NOTHING;
1) Do not try to “handle” an inspector; aside from being disrespectful it is highly likely that it won’t work, and will likely get you the exact opposite result to that desired. People are like human lie detectors, and the MHRA inspectors will be able to tell if you are lying or making up information.
2) Be honest; if there is something wrong, there are significant chances that the inspector will find it, so volunteer any issues at the start of the inspection to show them that you are aware of and dealing with the issue.
3) Do not be tempted to falsify missing records; if any of your records are missing, put your hand up and explain why they are missing. You may receive a major or critical, but that is your penalty for poor housekeeping. Re-creating paperwork and “distressing it” is a not a good solution. Also if your records are messy and you want to correct them KEEP THE ORIGINAL DOCUMENTS. Throwing away messy work and replacing it with pristine documents will make it look like you’ve falsified records, even if you had the best of intentions.
4) Don’t be moody or temperamental; The inspectors are doing their job, which is to protect us all and ensure the medicines and devices we use are of a high standard and are safe… they don’t need you to have an attitude that makes their job hard for them.
5) Ensure that you are aware of your regulatory obligations; if you don’t know what you are doing, it will show and things won’t go well for you. Responsible Persons are now obliged to take regular RP training, and this must be carried out and evidenced.
6) Check that your staff are properly trained in the areas they are responsible, and that all training is documented; inspectors will ask your staff short, open questions. “What do you do?” or “How do you check in goods?” Ensure that they know their own areas of responsibility and that they can answer relevant questions. If they don’t have responsibility for a particular area, do not have them sign those SOPs or they will be asked questions they maybe cannot answer.
7) Take notes; make records of anything and everything the inspector says that can benefit your operation, so you do not miss anything. You pay a significant amount of money for the inspection, so get as much value from it as you can. I believe that taking any comments as action points is showing best practice. You can wait for your inspection letter and report, and some points may not be present, which gives you less work… but I would recommend that anything mentioned should be dealt with, and if possible in advance of your letter. Go above and beyond.
8) Ask relevant questions, not distractive ones; if you have questions about your processes or Good Distribution Practice, ask your inspector, but don’t try to make small talk or distract the inspector from their job at hand
9) Don’t ask “What about…” in relation to deviations on your inspection; by way of example do not complain about how stock is received from your main line wholesaler. The inspector is there to review your site, and do not want excuses or diversions, nor can they discuss other sites.
10) Be natural, and relaxed and open; don’t be obstructive or evasive. Answer all questions politely, and advise if you are unsure or do not know something. Don’t try to “blag” responses.
KNOW YOUR BUSINESS!
Not too hard, is it?
If you have nothing to hide, then you have nothing to fear, and should not be nervous. Most people are either scared because of the unknown, or because they know that they have not been compliant.
The inspectorate are visiting to check compliance, rather than catch you out, but anything you have failed to do correctly will usually jump out at them.
What else can we suggest?
Offer refreshments, and show the inspector where the toilet is.
Helpful? We hope so.
Inspections needn’t be as stressful as you might think, especially if you treat your inspectors with the respect they deserve, it’s a hard and often thankless job, and they are there to protect us and our families.
Worried that your systems aren’t up to date?
Need some RP Update Training or Driver GDP Training, Warehouse Staff GDP Training, or a Third Party GDP Audit?
Contact us for a free five minute consultation, and we’ll be happy to look at your operation.
Wherever possible we offer you the best solution for your business, and your pocket.
Welcome to a new Paradigm!
20 Nov 2018
17 Oct 2018
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