Quality in 2013: Q&A

December 10, 2012

By Christian Rockwell


With the New Year fast approaching, many industries are under pressure to continue to innovate to stay competitive while outlining growth and company goals for the future. To do so, organizations must continue to ensure that quality products make it to market. In the coming weeks, Sparta Systems will tap its experts to discuss some of the quality-related challenges facing the life science, consumer and manufacturing industries in 2013 and how an enterprise quality management solution (EQMS) can help.

What quality-related challenges are facing your industry in 2013?

For years pharmaceutical companies have done a good job of ensuring that safe products are delivered to the market by executing GxP processes and maintaining well-defined quality units. Globalization and the pharmaceutical industry’s growing dependency on suppliers are beginning to challenge this long-standing “gold standard” of manufacturing. 

In many cases, a company marketing a specific product, might not have been directly involved in the manufacturing process. Even in cases where a company played a prominent role, the original source of ingredients may not be easily traced. Assuring that materials universally meet specifications is increasingly becoming a challenge.

What problems arise in this type of situation?

The industry is managing data in multiple and sometimes redundant systems as a result of both organic growth and growth through mergers and acquisitions. There is rarely one source for necessary information. Organizations may have local or regional disconnected systems for processes that should be global. Most companies have core systems (ERP, CRM, EQMS, etc.) that perform unique functions, but are not connected to each other. Many times data transfer between systems requires a person to copy data from one system and enter it into the other.  This practice is not only inefficient, but is a potential bottleneck and can introduce variability of data.

How does this type of situation affect quality control?

When data sets are disconnected, the industry loses sight and transparency to potential risks. This layered complexity can be referred to as the three dimensions of quality. The first dimension is the core quality processes (audits, deviations & CAPA, complaints, change management, etc.). The second dimension comes from having processes in different systems for each functional area of the business, and then you add the third dimension of geography, where there are different systems and processes in different regions and countries. In this complex environment, when a problem is identified in one area, it becomes difficult to communicate and correct the issue across the enterprise.

What are some best practices for managing and identifying risk across the industry?

Progressive pharmaceutical companies have realized that quality is an enterprise-wide initiative. They have set up a single global system for all quality processes, following the same repeatable process for investigating events, evaluating risk, determining root cause and taking actions. By doing this, they can correct a specific problem and also prevent it from happening at any other location around the world where the same conditions exist. It also allows management to analyze, trend and even predict quality issues.

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