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.
Practise: Being inspection ready also means practising for the day itself. Unforeseen circumstances and poor organisation on the day can ruin months of preparation. By ensuring there is a process in place to handle inspections, it means that when there are audits taking place, everyone knows their role. Subject Matter Experts (SMEs) should be identified for all key quality and technical aspects and they should be incorporated into the inspection planning.
When audits are taking place, communication is hugely important within teams and across the company. The hosts in the front room will be there with the inspector to ensure it runs smoothly and liaise with the back room staff.
While you can’t predict everything an inspector will request, you can predict some key topics. They are going to look at deviations, change controls, out of specification reports, management review meetings, etc. Prepare as much as you can in advance. Once the inspection starts, the back room will be hit with an increasing number of document requests and queries. By getting your house in order and planning what you can in advance, you are buying the back room valuable time.
The back room is where the magic should happen. Collecting the data requested, checking it and printing it out. The runners will then take the documents back and forth. Ensuring the inspection runs as expected and communicating expectations are hugely important. Be a swan. Look calm and well presented – even if you don’t feel it under the surface.
Practice mock inspection questions and, most importantly, if you don’t know the answer, don’t panic – follow these three stages:
- Stay calm, listen and make sure you fully understand what is being asked.
- Ask for clarification if you don’t understand and don’t worry, you can’t know everything.
- If you don’t know apologise and say you don’t. The worst thing you can do is guess or bluff. The inspectors will know and it won’t go in your favour. Make sure you take note of the question to follow up and consult with an SME.
The typical inspector interview tends to follow this process: the scope, the questions, the answers and the follow-up.
Here are a few tips of what to do and what not to do in an inspection:
- Make “off the cuff” comments and jokes with the inspector.
- Discuss potential problems and what to do about them.
- Get aggressive or argumentative – be professional.
- Use the inspection for your own views or criticise the company or other departments.
- Try to fill silences.
- Use laptops and answer calls when being interviewed by the inspector.
- Be co-operative, confident and positive.
- Remember NOTHING is off the record.
- Answer the question asked and don’t stray off the topic.
- Stay calm.
- Prepare other personnel for questions, but don’t huddle secretively.
- Always use your own software logins for any system.
Remember: the inspectors are not there to try and catch you out. It is your chance to demonstrate compliance. Inspectors are human and have years of practical experience behind them.
In summary, to make inspections work to your advantage, make it part of your culture and ensure you prepare, track, measure and practice. If you do all of that then it should be a walk in the park and you will never fear that late night knock on the door.