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Preface

In our day jobs we help companies comply with FDA regulations. Frequently, however, we find that the underlying cause of poor compliance performance is a lack of understanding of the basic technology of their manufacturing process. But beneath even that often lies a more fundamental challenge that many organizations struggle with: how to help technical personnel to improve people management skills. In this blog we will touch on some of the non-technical aspects of compliance management.

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October 2013

The Art of Conflict Management

Posted on Oct 27th, 2013 by Norm Howe

When you’re trying to achieve great things with groups of people, like Positive Compliance^TM that I described last time, you will have to deal with conflict:

Solomon, the legendary king of ancient Israel, set the gold standard for conflict resolution that managers have been trying to emulate ever since. When two women each claimed to be the mother of the same baby, he ordered that the child be cut in two and then be divided between the two women.

Transformation to A Strong Compliance Culture

Posted on Oct 20th, 2013 by Norm Howe

¹Anybody leading an organization in a new direction has a tough job. Our company, Validation & Compliance Institute (VCI), was tasked with helping a site of several hundred employees to dramatically improve compliance with FDA regulations. This was an especially difficult project, considering that, like most biotech organizations, the company leaders were technical managers. People

Hilton’s Big Secret to Business Success

Posted on Oct 13th, 2013 by Norm Howe

shower curtain What do you do when you can’t get your department functioning at the level you need? What do you do when little problems pop up randomly every day? Could they have the same root cause that seems to manifest itself in a different way every time? You don’t know.

If this sounds familiar, you’ll know how I felt a few years ago. My department just wasn’t getting the job done; nothing dramatic, but it felt like the death of a thousand cuts. I tried every fashionable cure that the management gurus were spewing out. Nothing worked.

A New Paradigm to Lower the Risk of Vendor Qualification. 2nd Half.

Posted on Oct 6th, 2013 by Norm Howe

Last time I posed the problem that every company struggles to solve, insuring quality raw materials and components. Even intensive on-site audits cannot always find major vendor problems.

To get to the solution we have to answer this question, why don't vendors always comply with the regulations. My answer, based on years of auditing and operations management, is that by far the most common reason is lack of knowledge of the regulations through-out the organization.

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