The Fallacy of People Problems, and How to Solve Them

May Feature

Jamie Weiss, PhD,.is a senior consultant at Kepner-Tregoe, Inc., PO Box 704, Research Road, Princeton, NJ 08540, tel. 609.252.2616, fax 609.497.0130, jweiss@kepner-tregoe.com.

One of the most frequently cited statistics in pharmaceutical manufacturing is that 80% of all reportable deviations are “people problems”—deficiencies in human performance. This statistic shows up in our studies of corrective and preventive action processes and investigation reports. Clients with whom we have worked estimate that people problems account for 60–90% of their reported deviations.

But what exactly is a “people problem”?

The case of the red specks
Consider the case of the red specks. A tablet manufacturer found red specks in its final product inspection. Potency was within specifications, dissolution was unaffected, and stability trials were underway, but the appearance specifications required that the tablets be white, not white with red specks. Initially, people pointed fingers and jumped to conclusions: “It must be some kind of degradation.” “I’ll bet it has to do with the coating material getting into the mix somehow.” “It wasn’t the production department’s fault.” “We tested it twice in the lab and it showed up both times.”

When the specks were tested, a spectrographic analysis revealed that they were particles of ferrous oxide—common rust. The investigators developed a detailed process map, considered which process steps could create rust, and went out and took samples. No rust was found. They then broadened their scope to incoming materials and took samples of all raw materials. The investigators found small particles of ferrous oxide in drums that held one of the excipients. They checked unopened drums and found more rust.

The manufacturer sent a letter to the supplier of the excipient, demanding that the supplier perform a thorough root-cause analysis and detail the corrective and preventive actions the supplier would implement to stop the problem.

Through official channels, the supplier responded, saying, “We have conducted a thorough investigation and determined that the source of the deviation is located in the drum we use for mixing the excipient. The inside of the lid of the drum has rust on it. When operators close the lid on that drum too forcefully, the rust flakes off the inside of the drum and gets into the mix. We have classified this as a people problem. Our corrective action is to retrain our people.” An astonished phone call followed, asking the supplier what the retraining would focus on. The answer: “Telling them not to slam the lid so hard.”

Looking for cause instead of blame
In the case of the red specks, people’s actions definitely contributed to the problem: Slamming the lid caused flecks of rust to fall into the mix. But does that make it a people problem? No, it doesn’t. In this case, as in so many other so-called people problems, the deviation was caused not by people, but by the failure to find and correct root cause.

The root cause of the rust in the paint wasn’t human beings; it was the untreated metal out of which the drum was made. If the supplier had been thinking about root cause, he would have aimed his corrective action at the rust and not at the people who made it flake off. Why not strip off the rust and paint the lids with rust-proofing paint so that no matter how hard the lid is closed, there will be no rust to flake off into the excipient?

Looking for cause is harder than looking for someone to blame, but it is the only effective way of eliminating many of the costly, recurring problems that can plague pharmaceutical manufacturers.

Why don’t people look for cause?
Often, the failure to search for the root cause of a deviation is not a lack of analytic skills; it arises from other concerns. In the case of the red specks, getting rid of the rust would have cost more money and taken more time than blaming the problem on people. The company might have had to revalidate the process to ensure the absence of rust. An investigation report might have prompted a visit from an FDA inspector, looking for other parts of this process or other processes affected by rust. Who knows what other problems, rust-related or not, might have been found? Even worse, a major process change might have required an FDA filing. And who knows where that might have led? Retraining operators and taking adaptive action usually appears to be easier, cheaper, and less risky—at least in the short-term. But in the long run, it’s always better to bite the bullet and look for root cause, which is the only way to eliminate problems definitively.

The search for cause
A good approach to searching for causes is to use a proven, rational approach such as classic problem analysis (1), which analyzes special-cause variation by asking:

•   What is it? What is it not?
•   Where does it occur? Where does it not occur?
•   When does it occur? When does it not occur?
•   What is/is not the extent of it?

By using such a questioning process to determine the parameters of a problem, troubleshooters can significantly narrow the search for cause. They can look for possible causes within that limited area, then test them to see whether they account for the data relating to both the problem’s presence and absence.

This analytical approach may point to a mechanical cause: a broken or loose part or contaminated raw material. In these cases, the cause has been found and the problem analysis is complete. All that remains is to select the best action to eliminate the problem.

If, however, the problem analysis indicates that cause lies with the operator, the maintenance technician, or the supervisor, it’s a people problem. In this case, the work is just beginning. (continued)