Aficionados of the theatre, or those who recall the 2015 TV adaptation of An Inspector Calls, will know well the story of Inspector Goole’s late night visit to the Birling household. The knock on the door heralding intensive questioning.
No matter how prepared you are, when the inspector calls there is a tendency to panic: to get all hands on deck and try get everything up to speed in order to host a successful inspection. Being inspection ready is more than just passing the inspection. It is about the preparation, the execution and the ongoing management in order to do the right thing, in the right way, at the right time and to be 100% ready, all of the time.
A typical two year MHRA inspection cycle can seem like a million miles away in a fast-paced pharmaceutical environment. While you are in the thick of it, you may not notice how the new product introductions, reorganisations and new IT systems soon add up. Before you know it, the system you thought was inspection ready no longer exists. The secret to inspection readiness is to ensure that your Pharmaceutical Quality System is used, in full, all the time and kept up-to-date.
Fixing everything last minute was never enough but is now just no longer acceptable. The regulatory authorities are paying more attention to historic performance. If you were out of control six months ago, but suddenly have fixed it two weeks before the inspection, expect to still get written up for it.
Alongside regulatory inspections, companies are now facing an increasing number of customer audits. With the recent updates to medical device legislation, there’s now a three year cycle whereby one in every three inspections is unannounced. Having a culture that reinforces the importance of inspection readiness makes it easier to manage in the long term. As Henry Ford said, “Quality means doing it right when no one is looking”.
So, how do you ensure inspection readiness? And how can you measure how ready you actually are? We’ve broken this down into four key stages: prepare; track; measure; and practise.
Prepare: Inspection readiness must be prioritised as a business objective. After all, in the pharmaceutical industry, without your licences, you don’t have a business. Regulatory authorities are essentially your key customers. They hold the keys to the markets you want to reach. Make it clear and unambiguous to your teams that regulatory compliance is a key business measure.
Track: How ready are you to receive an inspection? How visible is the progress of your key quality projects? Senior management must look at compliance project plans and KPIs with the same interest they would look at a balance sheet or sales figures.
Measure: Using KPIs for monitoring purposes is an effective tool. It is hugely important to use them, not just within the quality department, but across the whole business. Senior management must understand that an increase in overdue actions and deviations are danger signs that cannot and should not be ignored. Equally, the self-inspection schedule must be targeted and resourced to cover all the main systems. Are you performing enough? Are you looking in as much detail as an inspector will? Categorise your findings as the regulatory authority would. If your self-inspections are finding gaps that could be a major observation or a 483, the business and senior management needs to be aware of them and be pro-active in ensuring these areas addressed.