Beyond Compliance: Establishing a Quality Culture Is a Key Strategy to Ensuring Efficiency

Total Quality

quality culture
Rather than focusing on disparate systems to meet regulatory compliance, companies should focus on a total quality culture to improve product development and workflow processes.
Image source: Flickr CC user U.S. Army RDECOM

When it comes to releasing a product to the public, quality control and assurance are crucial. After all, no company wants to face a product recall six months later or a citation of failure to meet regulatory guidelines. Unfortunately, quality management phases can be tedious, often resulting in bottlenecks. However, these phases cannot be ignored, which means companies must look at ways to minimize bottlenecks instead.

The Importance of Maintaining Quality Systems and Processes

Quality control and assurance are crucial to the biopharmaceutical field, with research and development cycles consisting of complex procedures that require quality every step of the way. A quality management program helps guarantee that companies release sound products capable of living up to expectations.1 Yet, in an increasingly competitive field that favors fast release cycles, many firms view quality management as a roadblock to efficiency. Some ways quality management can slow the product release cycle include:

  • Complex international supply chains that can make it difficult to source ingredients and ensure their quality
  • Economic factors that encourage unexamined cost-cutting, which can result in compromised processes
  • Increased scrutiny by regulatory agencies

To address these concerns, companies often invest in systems intended to address perceived compliance and regulatory risks. But more often than not, these systems are superficial fixes that overlap and actually add more complexity and inefficiency to a company’s quality management program.2 Rather than eliminate the issues, they merely reinforce existing bottlenecks.

Focus on Establishing a Total Quality Culture Rather than Disparate Quality Systems

Rather than thinking of quality as something to be achieved by tools and processes, it can help companies to think of quality as a mindset and set of behaviors. By approaching quality as a culture that should pervade an entire organization, it becomes easier to select the tools that will enable success rather than hinder it.3 Now, bottlenecks can be eliminated and release cycles streamlined because a total quality culture looks at management processes as a whole system, rather than as a series of separate projects. For example, instead of using separate systems for maintaining safety data sheets and sourcing ingredient inventory, an organization could adopt a tool that does both simultaneously.

Fostering a total quality culture streamlines the quality control process and sets your product up to succeed. Rather than reworking products to improve quality, a strategic quality culture focuses on reworking the process, which naturally leads to a quality product. This method will result in more consistency and workflow efficiency, which increases productivity, minimizes costs and bolsters your company’s competitive advantage in a crowded field.

It can be a shift to go from viewing quality management as a series of unlinked processes that slow down product development to seeing it as an organizational culture that affects all strategic areas. And when executed properly, a company can not only meet compliance guidelines with ease, but can ensure product and procedural quality as well. If you are interested in learning more about the considerations that need to be taken in account to establish a quality culture, then please request our BIOVIA Total Quality Solution Brief. Or if you’d like to implement tools that will enable your company’s quality culture to succeed, then contact us today to learn more about BIOVIA Total Quality.

  1. “Quality Assurance: Importance of systems and standard operating procedures,” January-March 2011, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3088954/
  2. “Developing and Sustaining a Quality Culture,” December 2, 2011, http://www.pharmtech.com/developing-and-sustaining-quality-culture-0?id=&pageID=1&sk=&date=
  3. “Are You Ready to Build a Culture of Quality?” February 13, 2013, http://www.pharmacompliancemonitor.com/are-you-ready-to-build-a-culture-of-quality/4197/

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