QKM is a set of business processes that combines information from numerous sources and turns it into knowledge. It makes the knowledge available wherever it is needed to inform the work being done to help achieve the company's quality and compliance objectives. As such, it is a key element in quality management.
QKM is not an expensive technology investment. A robust set of processes can be built using relatively simple tools that are probably already in-house.
Knowledge and quality challenges are faced in the pharmaceutical and animal health industries due to the rapid proliferation of laws and guidance, and the accelerating increase of foreign health agencies performing GMP manufacturing inspections. In addition, the increase in outsourcing of manufacturing and development operations increases the potential for quality and compliance issues. Use of the QKM tool aids in avoiding and preventing potential issues for a fraction of the cost of remediation after problems are discovered either by the company or by a health authority.
Developing and implementing QKM makes further use of the work already done in the GMP surveillance process. It also leverages employee experience and knowledge and provides a means of sharing that experience and knowledge where it is needed. It helps inform decisions and avoids duplication of work, which wastes employee time and company resources. It provides a one-stop-shop for quality and regulatory information and knowledge within the company. It provides a competitive advantage and implements operational excellence.
You can check out my in-depth webinars on the topic on the Webinars page on this site. You can contact me here. I can be available for web or in-person presentations to detail the importance of QKM and how it will benefit your company.
I may also available as a consultant to come into your company and work hand-in-hand with your quality, regulatory, and IT staff to implement a real-time QKM system at your company.