Auditing in a COVID world

Preparing for an audit can be busy enough; agreeing dates, booking travel, gaining access to systems, preparing the agenda/confirmation letter, document request and review can keep an auditor busy in the weeks running up to the audit. Throw a global pandemic into the mix and things get a little more interesting! Postponed dates, hospital access restrictions, travel restrictions, quarantine rules and PPE are just a few of the extra things to think about as we enter the new norm for auditors.

A few extras have made it into my suitcase this time

In addition to the usual audit preparations, constant checking of the government website and entry restrictions into Spain were at the forefront of my mind. Armed with my QR code for Spanish border control to (hopefully) let me in and my letter, signed by Sponsor, detailing my purpose of the trip.

So here I am, off on my first audit overseas since February 2020. With two audits planned back to back, off I go to Spain.

Travel to the airport was pretty normal, except for the use of a face mask during the taxi ride. Upon arrival, the change is noticeable; compulsory face coverings, vending machine stock has been updated and the biggest change of all – security. Anyone who has flown out of Manchester airport will know of the usual queues through security control, however this time, not one person was in the queue.

Out of the travel routine and due to some of my new additional items to pack, there was a bit of a stir at security when I forgot to take the thermometer out of my bag. The suspicious looking item gathered some attention as my bag was taken off to the side to be searched and was definitely not a mistake I would make twice.

Arrival in Spain, I showed my QR code and was granted entry into the country … first stop Malaga. I arrived at the Hilton and checked into my CleanStay room.

The first clinical site I visited required temperature checks upon arrival. This was not a problem as I was taking my temperature at least two times per day as per our new Company COVID Policy which I was trialling for the first time.

The impact of the pandemic was evident throughout the audit; there were difficulties in shipping samples to the central lab due to flight cancellations, a temporary pause to recruitment for all clinical trials at site, reduced onsite hours for site staff and of course a lot more PPE!

Travelling on to Seville was a pleasure, a very quiet train journey through the beautiful Spanish countryside.

Auditing at the Seville site was noticeably different. With the hospital being closed to external visitors, the audit took place in a non-clinical hospital building. This brings challenges in itself with no facility tour or pharmacy visit possible. With very open and adaptable staff, the audit was completed.

Flying back to the UK was very much like the trip out, having completed the passenger locator form online prior to leaving Spain and having my quarantine exemption letter ready to show upon return to Manchester.

The overall experience was different, but not unpleasant. We were grateful to be able to complete onsite audits on behalf of our clients during these uncertain times. Together with remote audits which we have offered throughout the pandemic, we are gradually approaching a new normal for clinical quality assurance.

Erin Smith – Head of QA

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