There is a common perception that laboratories run on cutting edge technology to help them perform precise analytical techniques. For some laboratories, this may be true, but there are still several laboratories that use paper notebooks, excel spreadsheets or software (decades old) to record and process test results.
First let’s address implementing change. This could be considered a lifelong study. I’ll cover this succinctly before moving onto problem solving and the root cause analysis pocket guide providing a simple technique for both. If we get the problem solving bit right then implementing change becomes a whole lot easier.
When you walk into the lab to start your shift, do you get excited to launch your LIMS or do you dread to use it because it’s too complicated? We all want to be excited to use LIMS, but in reality, there are so many reasons why we’re stuck with this complicated beast of a LIMS that we don’t want to use. “The business can’t afford to upgrade the system”, “We don’t have time to manage the project if we did change systems”, “The business bought this system without consulting the users so we have to use it” – the list of reasons could go on and on. Despite all the obvious reasons for not being excited to use a LIMS, there are genuine quality operational concerns for a lab using a LIMS too complicated for its users. These operational concerns are what I call the ‘side-effect’– muda.
GxP compliance in the pharmaceutical industry is a hot topic. With increasing numbers of drugs coming onto the worldwide market, it is important for pharmaceutical companies to make sure they operate within industry guidelines from development to production. Many companies use a Laboratory Information Management System - or LIMS - to facilitate compliance and ensure they have everything in place during regulatory body audits.