Most people dread an audit and many businesses see compliance as something they have to do to get a ‘tick in the box’. However, with the right foundations and focus on building quality into your standard operating procedures, laboratory compliance can become your every day.
As a technology business, we
put ourselves through experience an ISO audit every year. We have also been present during our customers’ audits conducted by the Human Tissue Authority. So we understand how nerve-wracking compliance and accreditation inspections can be.
Here are our 5 key success factors for laboratory compliance that we think can help remove some of the stress.
1. Know what you want to comply with and why
Labs will often have a legal requirements for compliance, depending on the type of work they undertake. This may be the Human Tissue Act (HTA) if you handle cellular human tissue or the Medicines & Healthcare product Regulatory Agency (MHRA) if your work is in relation to drugs or medical devices. Compliance isn’t just about avoiding breaking the law, though. There are tangible benefits to your lab associated with running compliant processes. Think about those benefits and trying to maximise them.
ISO standards such as ISO 17025 (for testing and calibration labs), ISO 15189 (for medical diagnostic labs) or ISO 20387 (for general sample processing) or industry best practice guidelines, such as ISBER, all aim to help you to operate efficient, logical and audited processes to record and evidence your professionalism. There are many associated benefits in terms of efficiency, finance and reputation that should be carefully considered.
2. Make time to make it happen
The work associated with compliance is not trivial but neither are the benefits. Your lab staff will always seem too busy with their day jobs to undertake process review or audit themselves to provide benchmark timings against which the new processes can be measured. However, you need to make it happen to reap those benefits and you need to make time to make it happen. You can’t just work on process change “around the edges”, you need to schedule time for your staff to be able to focus properly on the work as it is impossible for them to make changes while still carrying out their full day job. You need them on your side, which doesn’t mean just giving them more work!
3. Work in achievable chunks
You and your team both need to start seeing the benefits as soon as possible or motivation will tail off. Set small, achievable targets, working on one process at a time. Get that working, iron out the problems and then learn from the process before you catch up on the work backlog. Then start on the next phase. Try to keep momentum up but you can’t ignore your normal workload for too long.
4. Review regularly
Remember the benchmarks we mentioned in point 2? Checking your new processes against those regularly can help to identify where the big wins have occurred. You can then use that knowledge when designing the next set of changes. It also can really help to boost team morale to share those improvements and show them that their hard work is paying off. Keep everybody on side if you can as they’ll work harder to think about and implement the changes if they see that (a) their work is being recognised and (b) they’re making their day-job easier.
5. Use a database system to relieve the workload
Showing that changes are working and that processes are efficient and being followed correctly can involve extra work. However, using a computer system designed to do this auditing for you can be a real time-saver. Achiever Medical’s automated auditing captures transactional data that can be used to prove that your samples are being handled in compliance with the HTA. In addition, its audit management module allows randomised audits to be quickly set up. The results of these audits are easily recorded, along with issues raised and the remedial work undertaken. This is all makes regular internal audits really easy and the evidence is massively helpful to external auditors. Having it also increases your team’s confidence significantly and a relaxed, confident team will respond much better to a mandatory external audit.
Who knows, you may even enjoy your next audit!