Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

During the keynote I shared Axendia’s infographic “Food for Thought” on Compliance vs Quality.

To illustrate the point I asked:

Would you rather…

Eat Bad Food in a Clean Restaurant?


Eat Great Food in an Unsanitary One?

In response, I received a variety of recommendations for great roadside food vendors :).

During the keynote, I also pointed out that key drivers in the transition from Compliance to Quality are incentives.  Human beings are very good at doing what we are incentivized to do. Today, incentives for the Quality department personnel center on ensuring compliance with regulatory requirements, and internal procedures, as well as ensuring documents and forms are filled out according to SOP. By contrast, there is often little incentive to drive change aimed at improving process.  In fact at many companies, change is perceived as “bad”; ensuring Compliance is “good”.

That afternoon, while driving through the city I came across a scene like this one:


Do you see the Compliance vs Quality paradox in this picture?

Why is the operator the only one wearing a helmet?  The answer: he is being compliant…

According to a published report, Mumbai’s joint commissioner of police, said his approach to enforcing the helmet law would be two-pronged: “impose fines on riders (operators) who didn’t wear helmets and counsel pillion riders (passengers) to wear them.”

This enforcement focused approach incentivized motorcycle operators to meet the compliance requirement by wearing a helmet. But it’s only a compliance incentive…  If you look closely, you will see that the chin strap is not even fastened.

Since there is not a compliance incentive for pillion riders (passengers) to wear a helmet, every child I saw on a motorcycle in Mumbai did not wear a helmet.

The goal of properly wearing and securing a helmet is to improve safety and outcomes in the event of a crash.  The goal that was incentivized – that of Compliance – was met, but the outcome envisioned – safety of all riders and pillions – was a dismal failure.

This Paradox is present in our industry as well.  Historically, we have developed processes, implemented systems and rolled out incentives that are focused on meeting regulatory requirements.  This is like putting on a helmet without the chinstrap, and letting your family ride without them.

Let’s instead focus on driving a culture focused on Quality improvements across the organization to improve outcomes.

To learn more about the Compliance vs Quality paradox, read:

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