Johnson & Johnson consumers complained about berry-flavored Pepcid being mingled with mint-flavored tablets. These complaints should have been the early warning system that would have uncovered failures and trends in managing/controlling the manufacturing process.
This means that process discipline broke down in at least two areas that haven’t been the focal point of our attention:
(1) The method for handling complaints failed. If handled properly, customer complaints could have served as a gold mine for data on where things were going wrong.
(2) The manufacturing system failed. Processes were either broken, not followed, or not maintained.
In both cases, processes are the key. J&J will need to reevaluate its culture to understand how it evolved to the point of allowing vigilance in process management to fall off. This is reminiscent of the theme that surfaced in the Toyota recalls.
A key lesson from the Toyota and J&J stories is this: companies have to manage the basics. Neglecting them is not an option. The cultural attributes that enabled success must be maintained and nurtured. Both of these companies have a reputation for keeping an eye on their processes. They know that processes do not manage themselves. It will take a lot of digging to find the root of the underlying cultural shift that created these issues.