Just Put Them in Stability

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

Published on: February 7, 2025
Walter Routh
Categories: The Situation Room
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What is the stability situation?

Our stability group supports all domestic manufacturing, which is a corporate function-Global Stability. I’m the corporate Quality Manager and have been tasked with absorbing a Sr. Manager from the Manufacturing Quality group of a small plant that is being shut down. In this case, due to their elevated title at that other site, the transferee will oversee our stability program and be given a new title of Stability Manager—equivalent to their old hierarchical position. Unfortunately, this manager has no stability experience, nor did they apply or interview prior to being assigned to the position by upper management.

The problem isn’t this new Stability Manager, but the attitude of upper management where Stability is brushed aside as somehow less important. I wonder if things have been going too well for the group so that the critical aspects of Stability are overlooked—we’ve had no recalls in several years and no confirmed stability failures of active product in almost two years. The focus of management has been on manufacturing and R&D primarily, but not on their post-market quality, except to force us to reduce costs and absorb additional products into our stability program from around the country.

How can we increase the prominence of stability in upper management’s focus?

How should this be resolved?

We held a stability open house to ensure we started our “Stability Awareness” campaign on a positive note, then at that event we networked with various department heads and ultimately arranged informative presentations at their department meetings. We look forward to making the same presentation with upper management, but meanwhile we hope for a little “trickle-up” effect.

What actions have you taken to raise awareness and heighten management vigilance regarding Stability?

We Want to Hear Your Thoughts!

  • March 2, 2025

    Your Honor, where do we turn if money is not available to purchase stability chambers and alternative storage options are not readily available? Budget timing and quality roadblocks are putting stability chamber space in danger of overflowing.

  • January 4, 2025

    Samples swapped identities when human error caused incorrect storage conditions to be tested, but the only evidence is historical data trends. How can they prevent the error and shore up sample integrity?

  • December 7, 2024

    When an unidentified impurity pops up on stability testing of a topical drug-containing cosmetic, internal political conflict erupts regarding filing strategies. Should they delay filing and ID the impurity or push ahead favoring the cosmetic side of the product?

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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!