By Rebecca George and Robert J.Binney, Kepner-Tregoe, North America

In our last post, we noted that once the regulatory genie is out of the bottle, there’s no turning back. As manufacturers struggle to meet the challenges of the Food Safety and Modernization Act, they can be sure that regulations rarely become less stringent, and inspections and audits rarely become simpler over time.

We have found there are four phases where thinking clearly will provide manufacturers a key competitive advantage:

1. Building a Plan

When we asked one Director of Quality to describe his role as he sees it, he replied without blinking, “Keep the CEO out of jail.” While somewhat tongue-in-cheek, he underscores the zero-tolerance environment of food safety.

Identifying Potential Problems—asking “What could go wrong?”—identifies the potential risks and their likely causes. To reduce their likelihood requires prioritizing and assigning preventive actions against these causes. And a thorough analysis outlines contingent actions to take to minimize impact, should something go wrong. Setting proper triggers for action creates a panic-free backup plan that troubleshooters can turn to if something does go wrong.

2. Implementing the Plan

Effective Project Management means monitoring progress against the plan and modifying activities, as necessary, to ensure timely execution. Successful organizations understand that setting clear expectations and removing roadblocks are critical to the plan’s success.

3. Managing the Plan

Conditions change, and successful plans change with them. By using a systematic process to clarify concerns, agree on their relative priority, and ensure they are effectively resolved, the team can make sense of a shifting landscape. A well-designed machine may be “set it and forget it” but people are not. Making it easy to do the right thing becomes an ongoing function of leadership. The days of “do it because I said so” are long gone.

4. Deviating from the Plan

The Number One concern we hear from food manufacturers – from the C-Suite to the plant floor – is, “We just don’t know how to troubleshoot effectively.” In the food safety environment, this is no small capability gap. An effective root cause analysis process accelerates issue resolution and shows the logic that auditors expect to find in investigation reports. Transferring shared skills throughout the organization will pay huge dividends over time.


Food safety professionals are the gatekeepers of brand equity. In the food industry, the risks of getting it wrong are high. While no silver bullets can eliminate all of the risks of running an operation, thinking clearly through the issues, planning ahead and applying consistent processes throughout the organization, minimizes the chances that the Quality Department becomes both scapegoat and firefighter.

See the complete published article The FDA is knocking. Are you ready to answer the door? at Industry Today.

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