More Samples Than We’re Supposed to Have

All Situation Room examples are constructed and not descriptions of actual events.

Published on: February 5, 2024
Walter Routh
Categories: The Situation Room
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What is the stability situation?

As part of our “Pull-Inventory” process, where we double check inventory of each study as samples are pulled, we discovered that we had 15 excess vials of material on hand vs. what our inventory system indicated we should have. The study is going on its fourth year now, but we just implemented this “Pull-Inventory” process recently, and prior to that we only spot-checked inventory, which explains why this discrepancy was not detected sooner. As area supervisor I was thinking that excess inventory isn’t a problem and was ready to ignore it since the study only has one more year, but my director insisted that we investigate, starting with a check of inventories for studies in the immediate vicinity of this one.

Sure enough, she was right. After inspecting 15 studies on the same shelving unit, we found that one had a deficit of 15 vials. The deficit-study was located just below our excess-study and was packaged in the same nude vials (no labels) for another R&D packaging study. To further confirm the situation, the excess-study called for 15 vials to be pulled at each time point while the deficit-study only called for 3 vials. We don’t have cameras to observe sample handlers, but it is evident that someone pulled 15 vials from the wrong study at some time in the past. Only 6 people have access to these chambers, but the deficit study has been running for three years, so we don’t know for sure when this happened. The vials would’ve been placed in a labeled bag for delivery to the lab, but received as a “single” sample, not 15 or 3, so a review of lab records didn’t help.

How should this be resolved?

After reviewing the “Components of keeping an acceptable Inventory”, listed in the feature article of stabilityhub.com’s February 2024 newsletter regarding Stability Inventories, I settled on a root cause and corrective action for this inventory event. What do you think it should be? Should we retrain all of the dispensing personnel on our storage and dispensing procedures? Should we require that studies similar in appearance be segregated more—at least not right next to each other? Should we ensure that individual vials are labeled, even if there are thousands of them? We’d love to hear your thoughts.

We Want to Hear Your Thoughts!

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    We must have correct information on hand to ensure that our company’s financial and compliance goals are synchronized. Where do we get that information?

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    What can you do when an intelligent stability chamber environmental monitoring system reveals more details than your quality system is prepared to know?

  • March 5, 2024

    When you have a good working well mapped photostability chamber but get wildly variable results from one sample to the next, how can someone prove variability in light exposure caused it?

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A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!

A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!