Meeting all the requirements for regulatory compliance can be challenging even if your lab is currently accredited, if you are looking for certification or just interested in getting better at maintaining your accreditation or certification. In this article, we’ll note some challenges and how to overcome them. It is best to work side by side with a clinical lab consultant to avoid these common pitfalls in your laboratory procedures and reduce the chances of compliance strain.
1. Could your Standard Operating Procedures be creating variation instead of standardization?
Standard Operating Procedures (SOPs) can be hard to manage in today’s ever-changing lab space. However, this is important during compliance audits so it’s worth getting the documentation in shape. SOPs can go wrong when steps are performed out of order, the SOP references outdated equipment, or if a frequency of process completion is stated and not adhered to. If this happens you will fall out of compliance. A rule of thumb is to complete the steps of any process as written in the SOP. If there’s a process that does have flexibility make sure to add a statement like, “The following steps are not required to be performed in order”. Also, it’s a good idea to review your protocols to see if you are performing any steps in excess and avoid having outdated versions around the lab. SOPs are typically reviewed by assessors and may include observing individuals perform the procedure in front of the auditor.
2. Avoid the process and equipment traceability trap
If using measurement devices for calibration or verification services, ensuring their traceability is critical. This means proving the instrument has an accurate methodology and that the measurement uncertainty can be verified by your tool. To assure testing validity, when using a thermometer, for example, it would be important to show that the thermometer has documentation accounting for its accuracy (ex. NIST traceable). Otherwise, you have no way of tracking the validity of your measurement basis. Make sure to talk to a clinical lab consulting about instrument validation to avoid this pitfall.
3. Regarding document storage: don’t forget to record or else it will be interpreted as if it never happened
Another area where labs struggle is secured storage for lab data and records. When meeting regulatory compliance standards, having backups of validation documents, procedures, and training is critical. Invest in fireproof safes/cabinets, secure servers, and quality fire suppression systems to save you from the pain of re-doing work if records are lost. For digital records, consider converting documents to a secured file type (ex. Pdf) before archiving.
Meeting compliance standards doesn’t have to be hard. With the guidance of a clinical lab consulting you’ll be able to incorporate solutions more easily into day-to-day procedures. Preparation and the right tools will make your lab a regulatory compliance superstar!