It's all about the Details

CHICAGO , January 16, 2014 () – In a big-time reminder of the stakes at play in the package supply chain, we learned that a major pharmaceutical company has recalled from wholesalers all US stocks of a drug introduced last May, due to uncertainty about the ability of 100% of foil-based pouches to provide adequate moisture and oxygen protection.

The company said the action was taken on the “remote” chance that filled pouches that failed to meet barrier requirements could negatively impact the drug’s effectiveness or properties. Also, thankfully, that there were no known reports of patient harm. No indication was disclosed on where in the value chain the defects that led to this recall may have originated.

This action reflects a high sensitivity for patient welfare, and will result in a gap in supply as the pipeline is refilled, but was the correct decision. “When in doubt, protect the consumer” is an appropriate standard for companies who consider integrity, trust and reputation not only core values, but valuable assets to be protected.

Outsiders may never learn the full cost of this particular event if it does not qualify as “material” from a financial reporting point of view, but you can be sure plenty of people are and have been scrambling to assemble the information that led to the recall, implement the recall, find and fix root cause(s), and create replacement packaging and product.

If you haven’t been intimately involved in the investigation and resolution of a major packaging issue or complaint, it might be easy to skim over this event and say to yourself something to the effect that “it’s not a worry for me, because I only deal in (insert package and/or product type here)”.

Instead, this should be one more piece of irrefutable evidence that all of us in the packaging industry must successfully deal in the details, not just some of the time, but all of the time. Putting a package/product combination that delivers what the consumer expects into distribution is dependent on many people getting many details right. From design through raw material choice and sourcing, conversion, product filling, and distribution packaging, there are upfront choices to be made and promises to be delivered on.

Success means having robust systems in place that ensure that the right materials are converted, filled and sealed using the right processes and conditions. The product producer has a whole parallel set of “rights” they have to handle in making the product, in addition to their role in the product packing step.

Robust systems are those that are well understood, characterized and controlled to minimize variation and highlight for correction deviations from ‘right’. It’s hard work, and really never done, because perfection is the only target worth shooting for. The next time you or someone asks why procedures are so detailed and followed so stringently, remember this recall. If you’ve been around long enough, you’ll most likely have your own examples from the past.

In the rush to get done all the things that need doing, the temptation is always there to give one detail or another short shrift. The best advice when temptation to skimp on rigor arises? Just say “No”.

Timothy Bohrer is the owner of Pac Advantage Consulting:

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