Surviving the dreaded audit
May 20

Surviving the dreaded audit

Hands up who loves to be audited! In truth, not many people relish the idea of an upcoming audit. They are often perceived as a looming black cloud and that they get in the way of the day-to-day work or a lab or tissue bank. However, a good audit can really add a shine to your institute’s reputation. With some forethought, and audit management, they can become much less stressful and largely positive experiences. There’s nothing like the warm glow of reading the conclusions section of an audit report and seeing positive points and approval. Good news also spreads upwards through the management chain. Everyone loves praise!

The reality of audits – they’re unavoidable

Audits arrive when you least need them so it pays to always be prepared. If you can carry out your own audits periodically that allows you to spot failures in operating procedures, identify process optimisations. And – importantly – this allows your team to validate their designated processes and check that they’re actually adhering to them. It also provides documentary evidence of your lab or tissue bank process review. Auditors just love that! It’s for this reason that Achiever Medical has added the Audit Management module helping to quickly generate randomised samples for checking and allowing results to be recorded. Evidence is king for the auditors.

There’s never enough time!

You are never given enough notice when an external audit is announced. Preparing at short-notice inevitably means that you’re trying to rope it in when you’re really busy with your day job. The moral is to be ready at all times. It seems that the more you’re prepared the less likely it is that you’ll need it. I think of the number of fire drills we’ve had and our offices haven’t burned down once!

Audits bring tangible benefits

So carry out your own. It’s easy once you’ve got the hang of it and it make external audits so much easier. Your team will relax with the audit process due to its familiarity. They’ll know where the latest versions of their SOPs are and be familiar with their contents. Auditors quickly spot this and is a big “tick in the box”, as you pass on your confidence to them. If you have Biobanking, LIMS or sample tracking software that helps then even better. Pseudo-randomised samples for checking are more trusted if you’re using a computer system to generate the testing cohorts. Also, it’s much easier to produce the logs and evidence of remedial action. That demonstrates best practice to them and efficiency to yourselves. Efficiency = minimised costs and improved reputation.

The secrets to success

It’s important to remember that auditors are not trying to catch you out. There are some simple things that you can do to prepare your lab or tissue bank for an audit.

  • Prepare when you don’t have to – don’t “put your head in the sand”. Allocate a small amount of time periodically, perhaps monthly, to carry out a quick audit. It doesn’t have to take ages
  • Use the tools at your disposal – the computer is your friend. AMS’s Audit Management feature is ideal but you could run it via spreadsheet or similar. The key is to record what you’ve done, what went wrong (nobody’s perfect) and what you did to remedy it and to minimise the risk of it happening again
  • Think like an auditor –They look for areas where you’re not confident so practice makes perfect. If you’ve got a good database system that audits tissue movements automatically then they stop looking at that and look at the human element instead. The more human input to a process the more chance of errors
  • Delegate preparation. You don’t have to do everything yourself. If you’ve planned your audit then hand out the actual checks to your staff. If they’re involved then take ownership and try to improve efficiency so their audit work is easier – that gives benefits all the way!
  • Document SOPs – Auditors go straight to your Standard Operating Procedure documents and expect your staff to be able to do the same. If you can then store your SOPs in your database alongside the data that they relate to. It’s easier for your staff and builds confidence in the auditors
  • Talk to your team – the auditors will! Do your staff know their roles and responsibilities fully? Involve your team in your internal audits and they’ll glow with confidence when the external auditors knock on your door
  • When you document your internal audits, do so “warts and all” – Auditors were typically lab staff themselves and know that things never go perfectly. It’s how you deal with the issues that they’re most interested in, and they love evidence!
  • On the day – stay calm, remember that auditors are humans, too!

With a bit of preparation, audit management and practice you can look forward to your next external audit as an opportunity to “rubber stamp” your efficiency!

About The Author

Gary Rooksby has over 25 years’ experience implementing and evolving corporate systems including manufacturing and quality systems for a range of major clients such as the MOD. For the last 18 years Gary has specialised in Sample Management Software with emphasis on process optimisation and data management. Gary works in partnership with clients and draws on his wealth of experience to help institutes and their teams to maximise the benefits from new and upgraded systems. Business needs are constantly evolving, and Gary loves the changing challenges. Gary always focuses on delivering value to the users, whether that is financial, scientific or simply easing workloads. He believes that the system is never an end in itself; it is a tool to help the users achieve their goals and that principle is always at the heart of any system or data designs.