ISO/IEC 17025 Nonconformance Series: Management Review
By on March 11, 2020
Welcome to the ISO/IEC 17025 Nonconformance Series! In this webinar series, we’re partnering with A2LA to identify the top nonconformances their assessors find in audits.
This is the second installment in our series, and it’s dedicated to management review: the systematic and periodic review of an organization’s quality management system in order to evaluate opportunities for improvement. You can watch the recorded webinar here.
If you missed the first installment on equipment record and calibration requirements, you can view that episode here.
In this episode, we were joined by Frenika Rivers, an A2LA accreditation officer, to learn more about the most common findings surrounding management reviews (Section 8.9) and ways to help you think about how to complete your management review that you may find helpful in the operation of your laboratory.
It’s easy to think of 17025 assessments happening from an external source, but the true work of 17025 happens every day in the laboratory. From the policies and procedures that govern the work of the laboratory come the internal audits that assess the quality and efficiency of those policies and procedures. The management review informs decisions and gives opportunities to discuss lab operations based on the strength of the lab or areas that need improvement. Many labs recognize that the continual improvement of the laboratory comes through the management review.
The key question everyone in the laboratory should ask is: does what I do affect the results we are providing to our customer internally or externally? Management reviews are key to making sure the customers needs are being met.
While 17025 does not prescribe how often a management review needs to happen, your team should decide how often they need to occur for your laboratory. One note of caution: if there are other standards your lab operates by, like forensic lab requirements or FDA requirements, there may be prescribed management review intervals. You want to make sure you comply with the most stringent standard followed by your laboratory.
Frenika recommends that you to think about management reviews in integrated ways in the day to day operations of the lab. They can happen by choosing an input and meeting about it monthly. You may have executive or senior management discuss some areas and other management reviews with supervisors or mid-management. These meetings can be formal, or they can be informal in the form of management huddles, water cooler, coffee or even lunch meetings. They can have different forms and happen at different levels of management. It’s up to you to decide the type of management review that works best for your laboratory.
The first clause of section 8.9 says, “The laboratory management shall review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfillment of this document.”
As a reminder, the management review must occur at planned intervals. You’ll want to consider the risk involved when determining your spacing. You also want to make sure that you’re choosing an interval that complies with the most stringent of the standards that your laboratory follows.
You also need to make sure that the management system is suitable, adequate and effective. Do the stated policies and objectives allow the lab to do the best work for your customers? The nonconformances that arose from this clause were usually tied to the fact that the laboratory had no documented management review. Even if your laboratory consists of only one person (you), you want to be especially sure that you’re holding management reviews to reflect on the life of your lab.
Let Q Work for You!
If you are not familiar with the Qualtrax system, or use it simply as a document management system, you may not realize that the real power of our system is in the process automation capabilities, which we call workflows. By automating processes, including management reviews, you can streamline and prevent deviation from your process. This not only ensures that your management reviews follow the same path every time, but it automatically tracks and documents every step in the process.
When you go back to look at action items from your previous reviews, you will be able to determine what was discussed and what procedures you updated or put in place to improve the functionality of your lab. Having one place to review this information can be very helpful and keeping the process locked down will greatly reduce your risk of a finding in your next audit.
You can learn more about our management review workflow by watching the recording of this webinar, or by setting up a call with one of our representatives to address the specific needs of your team and identify the ways that Qualtrax can keep you on the path to compliance!
Categories: Audits, Compliance Management, Quality Managers
