Eliminating DOWNTIME by Implementing Continuous Improvement in Quality Management

In any business, your brand, reputation, and revenue are intimately tied to the products you create. For customers facing many options, standing out as the best choice for their needs is worth undertaking. Price, value, and influence all play a role, but nothing is more important than quality. Quality, in its most derivative definition, means your product meets the customer’s expectations. Consistently producing high-quality products etches your brand into customers’ minds as the go-to solution. Implementing quality management system (QMS) software into daily production ensures consistent results that uphold your brand’s standards while also supporting GxP compliance.

However, quality products alone are not enough. Coupled with continuous improvement in quality management, your business will not only produce high-quality products but will regularly enhance the process of doing so, benefiting the company and the consumer. Together, continuous improvement (CI) and quality management are a powerhouse. While QMS software analyzes the process outcome – your product – CI analyzes the developmental process of the product. Working in tandem, the combined systems can generate optimal results daily.

DOWNTIME

Downtime may imply leisure, but DOWNTIME is an acronym for the eight wastes the Lean Six Sigma (LSS) methodology aims to eliminate. Waste includes anything that slows down, hinders, or creates unnecessary problems in development. Lean combats waste to make the process efficient, smooth, and productive by addressing the eight wastes: Defects, Overproduction, Waiting, Non-utilized talent, Transportation, Inventory, Motion, and Extra-processing.

Although seemingly small inconveniences, DOWNTIME wastes add up, reducing process efficiencies and production potential. Even the most advanced QMS software cannot remove every waste; that is why pairing it with CI expedites the process and enhances the QMS’s effectiveness. By utilizing continuous improvement in quality management to eliminate non-value add (NVA) processes – unnecessary and unproductive steps – quality management can focus on critical dimensions to ensure defect-free products and smooth production.

How to Reduce DOWNTIME in Pharma Manufacturing

To integrate continuous improvement in quality management and reduce waste, it’s entirely possible to have QMS software drive the improvement system. Processes like Plan-Do-Check-Act (PDCA) take an iterative approach by using the scientific method to improve the product or service. (Pro-tip: MasterControl QMS software has built-in corrective action/preventive action [CAPA] capabilities that function similarly to the PDCA process and support GxP compliance.) While there are many interpretations to the framework, the basis is as simple as:

• Plan: Develop the problem statement. While it can be difficult, ensure your team does not infer a solution; instead, allow the PDCA process to progress naturally. Focus on defining and writing the problem, documenting what is known, and stratifying the variables of the process. For product-related issues, proven QMS software like MasterControl provides the data needed to fully understand where the process may have gone awry. Then, craft a hypothesis or theory to resolve part or all of the problem and create an action plan to work the issues.
• Do: Put the trial solution(s) into production to test if the hypothesis supports the assumptions and correct the issues. Follow the predetermined actions from the Plan stage, as this is where the rubber meets the road. The iterative nature of the CI process will reveal the activities that align with the best natural solution. Remember, it’s only weird if it doesn’t work.
• Check: Allow the QMS software to shine in this stage, driving and directing the CI process. Use the leading or lag indicator measurements defined in the planning session to monitor the process outputs for variations. Define regular reporting to keep process stakeholders aware of the solution’s success or failure.
• Act: Based on trial results, determine solution(s) to implement into the standard work. Multiple solutions may be implemented at a time, but avoid overloading the process and risking the introduction of more variables. Finally, restart the process development cycle as needed to refine the production process to new, more efficient standards.

CI and QMS: The Keys to Consistent Pharma Quality

While many believe continuous improvement practices are limited in application areas, there is not a single industry, organization, or even process which cannot be improved. The best part is continuous improvement in quality management can be implemented at any time, using PDCA or other iterative approaches to eliminate DOWNTIME wastes. When it comes to impacting someone’s life, there isn’t time to squander on inefficiencies. Therefore, developing robust, effective processes that regularly analyze and reduce waste while also meeting regulators’ expectations for GxP compliance not only boosts operations, but most importantly, gets life-changing and life-saving solutions to people sooner. Humanity deserves the best the human spirit can offer in innovation and improvement.