How a Large Company Overcame Quality Disconnect with EQMS [Case Study]

medical devices qualityThe strategy of developing point solutions as quality issues arise can, over time, transform into an intricate web of disconnected data sources and quality management systems. Throw in a few M&A events along the way and you’re likely dealing with hundreds or even thousands of quality processes that preclude any type of enterprise communication or collaboration. Growth and complexity go hand-in-hand, especially when it comes to quality.

The good news is that if this sounds familiar to you, you’re not alone. In fact, you’re probably among the hundreds of quality executives we’ve spoken to that are, or were, candidates for a major quality software upgrade. Rather than completely wipe out the existing processes, though, many are taking a more tactical approach, standardizing select functionalities with enterprise quality management software (EQMS).

During LNS’s Global Quality Advisory Council meeting in June, Jim Sarafin, Director of Quality Control at Sigma-Aldrich, a global life sciences and high technology company, shared his experiences with standardizing global quality processes. In this post, we’ll dive into his experiences.

A Global Medical Device Company’s Approach to Quality Management Technology

Headquartered in St. Louis, MO, Sigma-Aldrich has approximately 9,000 employees in 40 countries. Due to the company’s history of growth and market penetration in several industries, today it has over 187,000 products that serve a range of customers within pharmaceutical, biological, and chemical industries. Many of these products are manufactured in multiple locations dotting the globe, each with its own set of quality systems and processes. Management identified process standardization, along with system integration and customer complaint notification, as areas where quality software could deliver significant benefits for Sigma-Aldrich.

Spearheaded by Sarafin, Sigma-Aldrich elected to implement the SAP QM module on top of its enterprise-wide SAP ERP system, choosing to view SAP QM as a supporting solution rather than one that worked standalone. As an extension of its ERP system, it was a natural move for the company to continue with SAP for quality management.

Sigma-Aldrich chose to implement SAP QM at a slow, incremental pace, and is still in the process of phasing a few minor legacy systems out. As is the case with many enterprise software implementation decisions, Sarafin noted that a few systems will continue to be held in place, as the company didn’t see enough ROI in replacing them.

Similar to the experiences of other companies that have undertaken an EQMS implementation, the solution's ability to centralize and standardize previously siloed processes and functionalities has advanced the organization's capability for managing quality. Especially in large, globally distributed companies like Sigma-Aldrich, the consolidating characteristics of EQMS are instrumental in delivering an ROI that will appease executives. 

Sigma-Aldrich has reaped several benefits already from the SAP QM implementation. The company has now standardized many of its protocols and production processes for identical products manufactured in multiple locations, and greatly improved QC data visibility. Additionally, it added the capability to derive certificates of analysis from a single source, and now has the capability to view inventory management in real time.

At the global level, Sigma-Aldrich has greatly improved complaint notifications for the different types of non-conformances that can occur during production. The company can now address these non-conformances at a global level instead of just on a site-by-site basis. EQMS has enabled the ability to infuse aspects of corporate quality and oversight that were previously challenging to achieve.

The Importance of Cultivating a Quality Culture

While the IT component of an upgrade delivers obvious and immediately quantifiable results, it is important to factor in the cultural component of your organization, both in benefits and responsibilities. The people and processes around a software solution may be as important as the IT itself, and Sarafin recognized the importance of having a clear vision of what the IT structure will eventually look like.

“Ironically, in setting the system up, you are probably the least knowledgeable in the consequences of your actions,” he said. “And those are when the most critical decisions need to be made.” It’s important to ensure that the system architecture is as well-designed and intuitive as possible to secure user adoption in the earlier stages. Workers on the shop floor should view the implementation as something that aids their day-to-day operations, rather than a hindrance.  

What We Can Learn from Sigma-Aldrich

EQMS systems are far from a one-size-fits-all solution to quality management issues. When exploring possibilities for an EQMS implementation, it’s important to accurately gauge what your needs are, and what level of ROI you’re likely to achieve with different IT functionalities. It’s also important to have the right people in place, both to effectively construct an IT architecture, and foster the right behaviors in shop-floor workers.

LNS Research's next Global Quality Advisory Council meeting is scheduled for September, 17. The meeting will focus on managing quality risk and compliance in today's competitive global market. For more information, follow the link below.

Global Quality Advisory Council

All entries in this Industrial Transformation blog represent the opinions of the authors based on their industry experience and their view of the information collected using the methods described in our Research Integrity. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.

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