When everything within your quality system seems to be running like a well-oiled machine, it is easy to get stuck in a rut and perceive a lack of corrective actions or deviations as a signal that nothing needs to change. However, just because something works well does not negate the fact that it can be improved.
It is important to keep in mind the “current” part of cGMP. As with all quality standards, cGMPs are rather broad in nature, not prescribing how something is to be accomplished, just that it must be accomplished in an effective and efficient manner. Just as periodic reviews of published methods produce updates, a periodic review of internal procedures can help to identify new and potentially useful methods of completing tasks and fulfilling quality requirements.
So how does one go about identifying opportunities for improvement? Here at Gateway we employ a variety of methods that can help identify opportunities. SOP reviews, internal audits, and preventive actions are all an important part of a solid and reliable quality system. They are also methods of broader involvement and ownership. The Gateway quality system is designed to include everyone in its operation, as QA should act more as stewards rather than rulers.
Sometimes it is also beneficial to accept help from the “outside”. Ask yourself who owns your quality system. The answer should be everyone that uses it. Those who interact with it often most likely know the system inside out; however, looking at it from a different angle can prove useful and perhaps even innovative. Consider various departments and functions within your own company that may not directly interact with the quality system on a daily basis.
It is our belief that the most effective and efficient quality system will continue to improve by finding and incorporating better processes. As we approach our third year in business, Gateway is looking forward to challenging ourselves to grow and improve with everyone’s help, guidance and input. With the idea of continuous quality improvement in mind, challenge yourself and your quality system to really evaluate all the moving parts to determine if something can be done differently in order to create a more valuable output. If you just ask, you might be amazed at the suggestions for continuous quality improvement, as well as the potential outcome.