Efficient and standardised business processes are fundamental to the effective running of a lab or biobank. That’s why it’s so important to have clearly documented Standard Operating Procedures (SOPs). Hopefully your SOPs closely match your business requirements and everything’s nice and rosy. But what if they don’t? Or if your business needs change? In that case you need to update your SOPs. This might include documenting the issue or change as well as noting any corrective and preventative actions (CAPA). You want to be able to handle these updates efficiently. After all, you’ve all got your day job to be getting on with. Could a laboratory information management system (LIMS) help you manage such SOP changes along with any associated CAPA?
Audits to the rescue
So, how do you ensure that your SOPs are still working effectively? Well, an audit works well. But the mere mention of an audit can strike fear into the hearts of many. Done badly they can be really intrusive and disruptive to the normal work processes and that’s counterproductive. If the act of reviewing a process causes that process to change then it’s not capturing a true result. Really effective audits need to be light touch. Plus, they need to be familiar so your team isn’t distracted.
Identify the problem – find your issues
Earlier blogs covered the auditing process itself. Let’s assume that you’ve carried out a light-touch regular audit and your team didn’t bat an eyelid. Chances are you’ve found issues. That’s the whole point of an audit and no business process in the real world is perfect.
It’s what you do about the identified issues that makes the whole auditing process worthwhile. For each issue you need to decide whether it’s a one-off human error or an issue that could recur. It might even be a systemic problem that will recur repeatedly.
Fix the problem – corrective actions
All issues need to be recorded to acknowledge that they existed so you can classify them and record what you did, if required, to avoid recurrence. Many laboratory information management systems (LIMS) allow you to record audits. Some go further, allowing you to record and schedule Corrective Actions and Preventative Actions (CAPA). Such a system should allow you to quickly log a low-risk one-off issue and note the resolution carried out to remedy it. For repeated issues or more systemic problems you need CAPA to manage responses such as staff meetings, formal reprimands, refresher training, etc. It might even require an SOP to be changed.
Don’t forget that these corrective actions themselves follow processes that should themselves be audited! Remember the adage “Who guards the guards”?
Prove it’s better – evidence is key
Well, as you follow these corrective processes, correcting things, training staff and even changing the underlying SOPs, you need to record what you’re doing and the results. That might be a revised SOP document or a training record with requalification certificate. They need to go into your document register and training records so that your current SOPs in the LIMS are up to date.
They also need to be linked to the CAPA records to build evidence that can be produced easily during your next external audit. You need to be able to prove to that external auditor that you’ve “got all the bases covered”.
Once the process has changed and is bedded in you can use the CAPA to target particular areas. This allows you to specifically review the new process or team members after the corrective actions have been implemented. You want to prove the process is working better and to build the evidence that’s so useful for external auditors. You need to be able to demonstrate to external auditors that you’ve not only got efficient processes but also efficient processes for fixing your processes! Formally recording your CAPA allows you to do just that.
It’s common sense that only auditing “once in a blue moon” makes it unfamiliar to your team. Therefore doing it small and regularly makes it familiar and comfortable. If it’s routine then it doesn’t impact on your daily business so much.
But to make the most of those regular light-touch audits you still need to record the results. That builds evidence that you can confidently present to external auditors. It shows preparedness and professionalism and auditors love that. It also makes their job easier – auditors are real people and appreciate such efforts and that’s to your benefit. Good audit feedback has positive implications for your institute’s reputation. Also, efficient processes are generally cheaper to run and give the maximum return on your investment.
What’s not to like? So use your LIMS’ auditing and CAPA management features fully to quality control your processes and reap the rewards for your whole lab.
- ISO/IEC 17025:2017 –TESTING AND CALIBRATION LABORATORIES