You’re almost there. The finish line is in sight with only one hurdle remaining: your audit to achieve ISO/IEC 17025:2017 accreditation. We know this is one of the biggest hurdles you’ll face in getting your lab up and running, so we called in an expert to help address one of the major factors in the process: assessing validation.
We spoke with Halima Alli, Technical Program Manager-Medical/Quality Compliance Manager at Perry Johnson Laboratory Accreditation (PJLA), to dig a little deeper into what assessors are really looking for during an audit when it comes to validation. There is a lot of detail in her presentation, so if you missed the webinar, we encourage you to watch it now.
If you’re just interested in the highlights, here are some of the key takeaways from our conversation:
The standard says that laboratories must be able to demonstrate competency and the ability to generate valid results. Your assessor will be looking for you to demonstrate competency in both your training methods and testing personnel.
“The greatest testing method in the world is not so great when it’s in the hands of someone who may not know the ins and outs of it,” Halima says. “We are looking at reliable processes for detecting and preventing problems.”
Your decisions are only as good as the data you’re using, so taking your matrix into account is critical in proving the validity of your test methods.
“The matrix always has to be taken into consideration when you’re looking at methods,” she continues. “You may be able to find a standard method that is already validated using plant material, but things get interesting when you get to edibles, extracts and oils. Gummies can be hard to work with because of the different qualities of the matrix.”
If you have to modify a method, make sure that you address anything about the matrix that could change the performance of the method and whether those performance changes are going to impact your intended use, that is, how your results will be used. For the most part, your answers will likely revolve around safety, quality of the product, and dosing (for medical applications).
“You need to establish more performance criteria when you are looking at the validation of a method versus verifying a standard method,” Halima cautions. “You need to establish that a method can meet all of your acceptance criteria.”
The testing and training branch of the Qualtrax platform allows you to ensure your staff is up to date on all training records and gives you the ability to quickly see where your training gaps are. You can design your tests and trainings however you want, and because Qualtrax will automatically score your tests, you can choose to follow up specifically with individuals who need additional training to meet the competency requirements. This can save you a lot of time and effort, allowing you to focus primarily on the problem areas, while maintaining confidence in the rest of your compliance road map.
As you are designing documents or record-keeping systems, make sure that you capture the information you need for analysis without sprawling into too much unnecessary detail.
“Particularly with laboratory-designed forms [for corrective actions], they capture a lot of information that isn’t really needed for later analysis,” Halima says. “When you’re designing documents and record-keeping tools, make sure they’re designed to capture what you need. Make them useful, not just something that you have to have because the standard says they shall be retained.”
Qualtrax allows you the flexibility to custom build a corrective action workflow to capture only the data you need. This streamlined approach allows you to quickly sort through corrective actions, determine if they need additional follow up, and manage the process automatically with email notifications letting you know when subsequent steps in the process have been completed and are ready for review.
This allows the assessor the opportunity to review your package before he or she arrives on site, saving time and allowing most of their time to be reserved for observation. Your assessor is going to be interested in seeing how you’re using your method from day to day and observing your colleagues actually engaging in their work.
The way you put your package together is critical in allowing your assessor to determine if you have conformed to the standard in your validation. The presentation of the data and your analysis should demonstrate that the principles of the standard were followed in planning, performing and documenting the validation.
“On a few occasions, the validation packages that I’ve received have been Excel spreadsheets with many numbers on them,” Halima says. “It’s good data – there’s nothing wrong with this data – but where I’m at a disadvantage is that I don’t know what this data is for. It’s very helpful if I can have a summary of the data that you are collecting or generating from your test method and what you are doing with it.”
In addition, when the information is not presented in a clear and concise manner, assessors are more likely to dive into the weeds and start asking more probing questions to ensure that you really are on top of your game. In short, having the package tied up with a neat little bow will save you a lot of stress too!
All branches of the Qualtrax platform – Document Control, Testing & Training, and Workflows – sit on top of a Reporting function that will allow you to create the ideal package to deliver to your assessor. You can even use the platform during your audit to immediately call up any document, training record or custom report on demand during your on site assessment.
The flexibility of the Qualtrax system is unparallelled and can be a significant asset to labs that are operating under the constraints of limited personnel and financial constraints. We have never had a customer lose accreditation while using our system, which is a track record we’re very proud of! We wish you the best with your accreditation and would love to help you improve your audit-readiness!
If you’d like to learn more about how Qualtrax can simplify the accreditation process for you and your team, please contact us!