6 Things You Need to Check to Make Sure Your Supplier's Culture Is a Fit

Quality audits are routine for medical device OEMs. But "cultural audits" take it to another level.

Chris Newmarker

It is one thing to demonstrate that you're producing quality products. It's another thing to understand the people who are behind the quality systems and responsible for delivering on the high levels of quality that are promised.

Officials at the OEM Division of B. Braun Medical (Bethlehem, PA) want the latter from the manufacturers they contract with, as well as the customers that are evaluating them. They advocate a process they call a "cultural audit."

B. Braun summed up the practice well in a white paper on the subject titled "Cultural audits: What are they and why are they essential?" As the document explains: "Cultural audits compel participants to deal with the human aspect of the relationship--something that is an unavoidable fact of business. They help assess the competence, dedication and passion that each party brings to the table. Just because these qualities aren't measurable doesn't mean they're irrelevant. In many ways, they're every bit as crucial."

The cultural audit has been a focus at B. Braun since the late 1970s. "We've always encouraged our prospective customers to meet the people who are behind the systems that are described on a piece of paper," said Tom Black, vice president OEM and international sales and marketing at B. Braun Medical. "Numbers and documentation only tell part of the story. In the end, it's people working with people."

So what should be part of a good cultural audit? Officials at B. Braun say a cultural audit can be as structured or loose as a company wants. But it suggests six important factors to check out:

1. Corporate Mission

Compare your company's mission and vision statements with the mission and vision statements of the company you're planning to do business with.  Is the language similar? Do you share the same values? B. Braun says it's essential to evaluate how companies are upholding their missions, too. So do your research.

2. Company Heritage

Corporate history and heritage, the affects of a new owner of parent company, and cultural idiosyncrasies based on whatever region or country a company is from--all can affect a OEM-supplier relationship.

3. Financial Stability and Management Objectives

Does a potential business partner have sound financial practices? Even more, how does its management respond to adversity?

Black at B. Braun explains: "You want to get a feeling about how well the supplier is sleeping at night in terms of their dealings with the FDA or ISO. That might not be evident in their documentation. You also want to learn how the company has dealt with any issues with the FDA or ISO. Did the company act responsibly, or did it become confrontational and unresponsive? Nothing proves the mettle of a company and its people better than adversity."

Risk tolerance, environmental practices, and corporate directives (i.e. what motivates them) are also important.

4. Innovation and Technology

Almost everyone in medtech claims to be innovative. But are they really? Says Black: "Look for partners that are open to new ideas and collaboration. Ask about how they approach design challenges and what some of their solutions have been. After all, there's no area on the quality audit that quantifies how well the partner thinks. That's an assessment that can be made through a cultural audit."

5. Compatibility at Parallel Levels of the Organization

This is about engineers talking with engineers and quality managers talking with quality managers. It is also about transparent and open communication, which can sometimes be hindered by a single person who proves to be a bottleneck, or an inadequacy of expertise that causes uncertainty.

6. Personal Objectives

It's also important to know whether the people you are working stand to get promotions or bonuses for meeting particular objectives. There is no better way to build trust than to demonstrate that you understand the personal objectives of your counterparts, according to B. Braun officials. 

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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