When we meet new people who work with verifications, we’ve noticed that they often find their verifications difficult and time-consuming. The mere idea of starting a verification makes their shoulders drop and faces frown.
We’ve already discussed about quality steps, and the laborious image of verifications may be one of the top reasons that prevent laboratories from climbing up those steps. Getting from step 1 to step 2 seems like it just increases the need to work on evenings and weekends, and it’s hard to see any further.
What makes verifications difficult?
It’s easy to say that lack of sufficient tools makes a verification an unnecessarily discouraging experience. But the truth is, it’s not just about the tools. A big question is also, what should you do in a verification?
There are different ways how laboratories deal with this question. Some have gathered a heavy process around verifications. They may have standardized report templates into which you will need to fill values, but it may still be that it’s not clear how these values should be calculated. Some have a habit of hiring a trainee to do the verification, or they give it as the first task for the new employee to make them learn about diagnostics and verifications.
What’s common for many of these approaches is that verifications are done as seldom as possible. When you start a verification, you will need to start an investigation on how to do it. You will look for existing templates, internal instructions, and information about previously conducted verifications. You will google for verification protocols and best practices. You will gather all possible documentation related to what you are doing to make sure that nothing is missing. You concentrate on writing an essay on the various background information even loosely related to the verification, making sure that every detail that someone else wrote on some previous report will be included, just in case it may happen to be important. The amount of paper you print may be overwhelming.
Still, since ISO tells you what to do but not how to do it, you may be left uncertain about whether your verification fulfills the requirements or not. You may use countless hours looking at graphs, trying to use your scientific intuition on judging visually whether the results are ok or not. It may be that you actually have no idea how to draw a line between what’s acceptable and what isn’t. It may never have crossed your mind that you could really have scientifically grounded goals for your results, and that the results of your verifications could be used for fixing the problems that were found.
On top of that, there’s all the management related to how the measurements are conducted and verification data handled in your laboratory. For example, how to name or barcode samples so that it’s possible for you to use the data, and how to get the data from your instruments. All of this may have to be solved again whenever a new verification starts. There may also be a huge amount of bureaucracy involved in how the results are accepted.
How to make it simpler?
To make verifications less of a burden, we encourage our customers to think about their processes and what’s essential in them. The better you understand what different verification protocols really tell you, the easier it is for you to get meaningful results. There’s no reason to do all this investigation separately for each verification.
It is worthwhile to reduce time spent on gathering background information by creating verification templates that unambiguously explain how a verification should be planned and executed in different situations. These templates can of course be written as SOPs (standard operating procedures), but we encourage all of our customers to define them as templates in Validation Manager. This way, every user starting a new verification project will have all the information at their fingertips when they need it.
You can have standardized practices for verification sample management. When you start using Validation Manager, we do our best to help you in finding easy ways to get your data from instruments to Validation Manager. We can also support you in creating practices for verification sample naming and standardized ways of measuring performance.
Once you’ve created these practices, you can just follow them, and your reports form automatically as soon as you’ve got some data.
Using Validation Manager empowers you to focus on the results and go behind the numbers. Setting goals makes it easy to find the results that need your attention. From the report, you can easily dig into detailed information about samples and their results, instead of juggling between spreadsheets and documents.
Changing the mindset
What’s most important is changing how you see verifications. You can make verifications less heavy than what they may feel like right now.
When using Validation Manager, verifying multiple tests and instruments simultaneously doesn’t take much more effort than verifying only one test in a single instrument. The feeling that a verification project is something huge is more about the process you’ve built around it. Your organization can choose to make them smaller, while focusing more on what’s essential: the quality in your laboratory.
You can make verifications a part of your daily processes with appropriate goals and practices for escalation. This way you can trim your acceptance protocols, so they are less time-consuming. You don’t need to go look for instructions on sample naming and remind yourself of verification protocols or how to use Validation Manager, as they are a normal part of your daily work. Basically, only the amount of data used in verifications will change depending on your verification needs.
You can even evaluate your results and do your reviews right in Validation Manager, and only create Word documents or paper reports when they are really needed.
Would it be possible for your organization to change the mindset towards verifications? Could you stop expecting verifications to be exhausting, and instead aim for a continuous flow of easy verifications? If you can, taking the last step to reach the top of the quality ladder will be surprisingly easy and save lots of your time in the long run.