By JAMIE WEISS, Senior Consultant, Kepner-Tregoe Inc.
A pharmaceutical company produced a compound using three ingredients. One of them, Substance A, had a tendency to stick to the grinding machine, causing shutdowns, and costing money for maintenance and cleanup. The producer decided if they ground Substance A finer, they could prevent it from sticking to the machine. The change was within the process specifications, so they made it, and their headaches then went away.
Shortly afterward, across the street, at their sister facility that blends the three substances together, they opened the barrels of Substance A and found it caked solid — only removable with a hammer and chisel. The finer grind solved the problem of sticking, but led to a new problem — caking.
Recognizing Solution-Caused Problems
Many of the issues our clients ask us to facilitate can be characterized as solution-caused problems. That is, the client has a problem, they find the cause, they put a corrective action in place to fix the problem and, all of a sudden, they have a different problem and often a much bigger one.
Like the caking problem, the following examples, revised and disguised to protect client confidentiality, are typical solution-caused problems:
- The Switch — A chewable tablet failed a hardness test and became too hard after 12 months of aging. Speculation in the company’s lab focused on how the winter weather’s low-humidity might have caused excessive hardness. But the weather was no drier than previous winters, begging the question, “Why did the hardness begin when it did?” It was finally discovered that, unknown to the drug manufacturer, a supplier had changed the starch content of one of the tablet’s excipients — with no thought to the effect on the final product — increasing the starch content by more than 25 percent. That increase, combined with the low humidity, caused the hardness failure.
- The Fix — When black specks appeared in an ingredient, the manufacturer’s analysis identified them to be small pieces of shredded gasket material. These findings were sent to the ingredient supplier, who quickly responded that they had corrected the problem by inserting a 704 stainless steel mesh filter to separate out the black specks. The black specks disappeared, and everyone was happy. But a month later, the client began noticing shiny specks in the same ingredient from the same supplier. When analyzed, these shiny specks turned out to be 704 stainless steel.
- The Improvement — A billion-dollar-a-year drug failed appearance tests for color, suddenly putting patient confidence, company revenues and shareholder value at risk. This top-selling tablet was supposed to be white, but instead, was coming out dark yellow. While safety and efficacy were determined to be uncompromised, the pills just didn’t look right, especially to patients who had previously been using them. As a result, the manufacturer suspended production for more than six months. The cause was then eventually traced to a supplier who unilaterally decided to remove a substance with some potentially undesirable effects from part of the blend. The supplier believed he was being a good corporate citizen, but unknown to him, the ingredient he swapped out had played a key role in stabilizing the color; without it, the hue varied unacceptably.
Types of Solution-Caused Problems
Solution-caused problems are expensive, disruptive and much more common than may be suspected. When discovered and analyzed, they lead to embarrassment, some finger-pointing and a lot of head-wagging. If we deconstruct them, we can see that they come in different types and each should be approached differently.
1. Containment-Caused Problems — The stainless steel specks problem is an instance of failing to find the root cause in the first place, and of adopting an interim action instead of a permanent corrective one. Think of it as a containment-caused problem. The unasked question up front is clearly: “Why was the gasket material getting into the blend in the first place, and how could this be prevented?” Perhaps the gaskets have changed in size or shape or composition; perhaps the recommended replacement period has been exceeded; perhaps some change in the process — in speed, temperature or pressure — has subjected the gaskets to unexpected wear.
2. Problem/Relocation Problems — In the caking problem, the change did solve the local problem of sticking, but caused a downstream problem of caking. Again, failure to consider potential problems with a corrective action led to a new problem. Perhaps some potential problems were considered within the grinding process, but the range did not extend to the mixing process; the organization would have immediately vetoed the change if they had been aware of the effects it would have on other manufacturing areas. We see this often in process re-engineering or Six Sigma, where it goes by the name of sub-optimization. In the problem-solving sphere, it looks like the old carnival game of “Whack-a-Mole” — each time you hit a symptomatic mole, it pops up again somewhere else. What is needed here is not more or harder whacking, but rather a better, more precise hammer that gets past suppressing the symptoms to attacking the root cause.
3. Opportunity-Caused Problems — The hardness and appearance failures might better be labeled as opportunity-caused problems. Someone changed a variable, for what they thought was a positive reason, without thinking it would affect the final product. Once again, no one asked what might go wrong if they implemented the change; after all, they were trying to improve the process/product, not degrade it. However, when taking advantage of an opportunity, you are taking an action, and actions can have unintended consequences. You are also making a change, and causes come from changes.
4. Failure-to-Communicate Problems — All solution-caused problems are compounded by communication problems. As the prison guard in the classic movie, Cool Hand Luke, was fond of saying, “What we have here is a failure to communicate.” In all of the cases cited above, someone failed to communicate a change that could affect the process one or more steps downstream, blindsiding those who worked where the problem manifested itself.
5. Failure-to-Understand-Change Problems — Any time you introduce a change into a process, you are potentially introducing variation. It does not matter whether the change comes from trying to resolve a deviation from expected performance or from trying to optimize a process. Changes cause problems, and change is change — it needs to be adequately analyzed and managed. Particularly today, when ever-more Lean systems are ever-more tightly connected, second-order cause-of-the-cause and effect-of-the-effect ripples need to be carefully considered.
Please tune into the Chemical Equipment Daily for part two of this two-part series. What’s your take? Please feel free to leave a comment below! For more information, please visit www.kepner-tregoe.com.