At the end of my interview with Kevin Lorenc (PerkinElmer’s VP for Corporate Communications) last year (see The Globalization Initiative at PerkinElmer, Inc.), he invited me to check back this year with his team to find out how much progress they had made in integrating globalization “as just another business process.” During the LISA Forum Europe in Berlin a few weeks ago, Claude Lamoureux (Quality Manager, Information Management Quality and Regulatory Management) was kind enough to share their latest news.

First, some background on how PerkinElmer is implementing its Globalization Initiative …

50% of PerkinElmer’s revenue base and workforce exists outside of the U.S.

The drivers for the initiative were originally two-fold: (1) the realities of being a global business – more than 50% of PerkinElmer’s revenue base and workforce exists outside of the United States; and (2) its transition from a predominantly product-focused company to a client-centric organization, which demanded that the company restructure its processes to align more directly with the needs of its customers.

Ensuring regulatory compliance is only the first step to successfully entering any market

Operating in a regulatory environment adds another level of complexity to globalization and how to implement it enterprise-wide. PerkinElmer's expanding global presence, combined with its objectives of customer excellence and full regulatory compliance, continues to drive the need for greater globalization and localization of its customer content. As Lorenc pointed out, ensuring regulatory compliance is only the first step along the path to successfully entering any market. High quality, after-sales service to customers is also required. The challenge is to put the right level of local resources and sound customer feedback processes into place at the right magnitude to support the revenues.

LISA's Globalization Assessment Method + Six Sigma = Globalized Business Processes

PerkinElmer has applied LISA's Globalization Assessment Method within the Six Sigma environment to integrate globalization practices (e.g., internationalization and localization) into other business processes of the company. Well-supported by a sustainable quality system, this initiative drives towards simultaneous shipments and business optimized compliance.

Editor’s Note: For more information on LISA's Globalization Assessment Method, log onto the LISA web site as a Member. Click here and scroll down to The Globalization Audit.

Editor’s Note: For details, log in as a Member on the LISA web site and click here to download a copy of Lamoureux’s presentation, Globalization Assessment of Business Processes in a Regulated Environment.

PerkinElmer’s Globalization Assessment is based on three objectives. Its strategic business goals include revenue growth, geographic expansion and a high-quality user experience. Standardization is required due to acquisitions/mergers, organizational changes and process harmonization. Legal and regulatory requirements include the European Union Directive 98/79/EC (In-Vitro-Diagnostic), ISO 13485:2003 (Medical Devices), national regulations (U.S., Brazil and China) and the Sarbanes-Oxley Act of 2002 (U.S.).

Applying Six Sigma practices to building a globalization business case means that Lamoureux and his team have consistently measured fragmented practices, investigated root causes, and analyzed how these affect the organization and the business.

Lamoureux asked the following questions during his interviews with managers and executives throughout the organization. How can the company remain compliant without delaying time-to-market? How do language versions enable PerkinElmer to become a better company? How can the company determine what needs to be translated and what doesn’t? What activities can and should be outsourced? How can the company leverage its content to maximize its use and exposure at the international level? How much has the company lost in revenues because of launching localized versions too late? What is the cost of NOT developing and implementing globalization procedures in its business processes?

Business goals do not always integrate well with regulatory requirements

The interviews confirmed that business goals do not always integrate well with regulatory requirements. Compliance and localized versions can be achieved, but sometimes at a cost that is too high. Internationalization and localization practices were far too fragmented. Globalization was not possible without a clear strategy backed up by committed resources.

The assessment showed that PerkinElmer’s product development practices needed to focus more on customers, rather than on products. In other words, globalization was still being considered as an issue of retrofit, rather than of architecture. It also became clear that there was a great deal of legacy knowledge to leverage, i.e., capture the heritage!

Here’s Lamoureux’s candid assessment of where PerkinElmer stands today vis-à-vis its ongoing journey to integrate globalization into the rest of its business processes:

As a result of our Globalization Audit, we decided to make some changes in the organization to enable us to move to the implementation stage. One of the key changes was to enlarge the task list for my position so that I could really drive the necessary behavioral changes within the organization.

At the same time, unfortunately, we have continued to collect evidence to support the fact that if our our recommendations regarding internationalization had been applied three years ago, we would be in a stronger position now. For example, the mentality has been to focus on the big rush to push the English product out the door and to retrofit and optimize for other versions later. Now that the U.S. market is maturing, the big drive is for Asia.

It's not a question of relevance, but of legislation

Such geographical expansion is not yet self-evident, though. Local regulators are becoming very, very serious about enforcing regulations. For us, the question is no longer whether localization is necessary. It has become a pre-requisite to doing business in the first place. Even once we are compliant, we will need to increase local customer support for our local products.

Geographical roadmaps are now required before development begins

The good news is that we now have objective evidence that any Product Manager can understand, i.e., if you do not define the geographical roadmap for your product throughout most of its lifecycle, then you have a problem, and a serious one in markets such as China. The evidence is helping to drive the behavioral changes that I alluded to earlier.

Furthermore, from a Quality Management point of view, Quality Managers cannot authorize the development or launch of products without verifying the product's globalization readiness. This includes the geographical roadmap and the plan for internationalization and localization. As a Quality Manager, this means that I play a diversified role. Consulting and coaching are sometimes offset by my acting as a referee between very discordant opinions.

Where are we otherwise? There’s a lot of emphasis on Asia and India now. However, the potential for leveraging the cultural requirements and local business practices of our in-country colleagues in product development is not yet fully realized. We have developed an interface to feed this input into product management to help them define product requirements. The mentality is slowly changing.

We must control what happens at the source, i.e., the product design stage

As part of our strategy to implement sound globalization practices, we will catch the cultural-specific input with this tool and use it as input into our Product Development process. Then, we will be strict about how well cultural and regulatory requirements are defined and translated into specifications. We regard this as the source of all that we do – we have to get it under control, and we must increase local customer input to ensure proper internationalization at the right stage in the process.

We know that our localization process has been optimized fairly well (based on what we are currently given upstream), although we are facing limitations there, e.g., technology limits and so forth. We now have to go through a lot of changes for China, so all of the efforts must be defined, because that requires support from production, logistics and documentation, among others. But once we get internationalization under control through proper product requirements, we will be able to make any necessary changes downstream, e.g., in localization.

Once we can launch our products properly, we will focus upper management on the need to globalize our back office processes properly, e.g., increasing customer support for those products (on which we have spent a lot of effort). Steadily, we are integrating globalization as just another business process.

What Kevin pointed out a year ago remains true for anyone focused on implementing a globalization initiative:

It’s all about working within the corporate culture. The bottom line is that we will work within the core business processes used at PerkinElmer to make change happen.

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Claude Lamoureux is Quality Manager, Information Management Quality and Regulatory Management for PerkinElmer Life and Analytical Sciences in Turku, Finland. Under his direction, PerkinElmer has successfully addressed the need for highly regulated multilingual instructions for use, while integrating high quality, standardized processes. He holds a B.A. from Concordia University in Montreal, Canada, a Masters in Translation Studies from Turku University, and is currently working on an MBA at the Tampere University of Technology.