The thought of a lab audit might be enough to bring you out in a cold sweat. The dread of an audit for some is akin to a phobia. Desensitisation is said to be the most effective cure for a phobia – would this approach work for audits, too? Making lab auditing a part of your daily routine so it becomes habit might sound difficult. If it’s built into your everyday processes – it no longer becomes something extra for you to think about. But where do you start?
As the start of the well-known phrase goes ‘little and often…’
If you carry out a little audit work on a regular basis it quickly becomes a part of your weekly or daily routine. And you can do this without a major impact on your workload. You could schedule, say, an hour each Friday afternoon to spot-check your samples and processes carried out during the week. If you then log the results in a formal log, you will quickly build a body of testing evidence to show management and the external auditors when the time comes.
It also means that you’ve got a good chance of spotting an error – and correct it as soon as it happens. If someone is not following a process properly, correcting this while it’s still fresh in their minds (or at least not “ancient history”!) means it’s more likely to stick. And you can nip it in the bud before it escalates. However, it might even be that the process itself is wrong and you need to change this quickly.
Through this spot-checking approach you can identify any problems quickly – and resolve more easily before they become entrenched. And doing this in small chunks means that it’s not a major event in the minds of your lab staff. The regularity breaks down the dread.
Make lab auditing part of your actual work process
Taking it a step further, you can even make a spot-check part of your actual process so that every process has a validation step. For example, every time you carry out a dispatch one of the last steps is to randomly select someone else’s dispatch from the past week. As part of this you can check the paperwork and write the result as an Audit Log activity in your Laboratory Information Management system (LIMS). If you write it into your Standard Operating Procedures (SOP) you no longer see it as “audit work. It’s just a step in your normal dispatch process.
And if you build it into your business process flow charts and documentation your team won’t forget. When you do have an external audit, the auditors will be impressed – your lab processes are now self-validating, and you have built in “best practice validation”!
Plus, when the auditors interview your lab – your team will know where the latest versions of their SOPs are and be familiar with their contents. This will help with your team’s confidence all of which is a big “tick in the box” for auditors. If your LIMS software supports this -then even better.
Use LIMS features to help build your evidence
Some LIMS systems such as Achiever Medical have proactive auditing features that you can use to schedule and track your lab sample and storage audits. Oversight reporting dashboards then allow you to see your progress at a glance – including your audit evidence, process performance and any issues. With this quick and easy access to lab auditing information, your board and auditors will have confidence in the quality of your operations. And if the worst happens and you do have issues, you can spot and fix these before they become ingrained and costly.
Share your lab auditing results with your partners
Confidence in and metrics about optimised processes are not just good in-house stories. Share the positive results with your customers and partners. Perhaps a periodic newsletter telling them about improvements. Let people know when you receive good feedback from auditors. That all builds external confidence and reputation. Everybody wants to be associated with a winner!
Look for the business benefits
Breaking down the phobia and avoiding the cold sweats is all well and good but that’s not the only benefit of self-auditing.
There are lots of other benefits such as reducing the frequency of an issue being spotted by one of your customers or partners. Avoiding “egg on your face” is always a good thing as that impacts on your reputation as well as the costs associated with fixing such issues urgently. Working “on the back foot” is always more difficult. Spot the issue before it goes out the door and you’re much better off.
Spotting an issue with one of your lab processes early saves you making the same mistake time and time again and avoids the repeated costs of that incorrect process. The result is a cumulative cost saving. And saving money is always a good thing in these cash-strapped times.
Plus, you’ll gain other benefits including improved team morale and confidence as well as reputational benefits. External auditors pick-up on your team’s confidence. And if you get a glowing review from auditors make sure you share that with your team as it all feeds back to create a positive vibe.
Dread and cold sweats? They’re a thing of the past. You might even start to look forward to external audits, or is that going just a little too far?…
- Achiever Medical System Blog 2019 May 02 “5 Key Success Factors for Laboratory Compliance” – https://www.interactivesoftware.co.uk/2019/05/02/5-key-success-factors-for-laboratory-compliance/
- Achiever Medical System website article “Easing some of the pressure during audit inspections” – https://www.interactivesoftware.co.uk/how-to-guides-and-brochures/