A quality management system must include strategic vision and full support by senior leadership. In the 2015 edition of ISO 9001, Section 5 Leadership, 5.1.1, Top management shall demonstrate leadership and commitment with respect to the quality management system :5 followed by ten (10) direct commitments to ensure that there is focus on support, management, continuous improvement, resourcing, communication and effectively integrating the requirements of the QMS into the organizations business processes. From a consumer perspective, senior leaders (not just those focused on quality) should be held accountable for the QMS and its outputs. When you are assessing your suppliers, it is critical to examine the objective evidence, which demonstrates top management commitment and dedication to the QMS. In ISO 9001:2015, there are new requirements for change. Specifically, there are 4 6.3 Planning of changes, 8.1 Operational planning and control, 8.3.6 Design and development changes and 8.5.6 Control of changes. Once a QMS and processes are established in an organization, there may be changes necessary to mitigate risk as well as implement continuous improvement. The mechanism in which change is assessed and implemented must be carried out in a planned and systematic manner6 and consider several areas, including why the changes are being made and possible outcomes, how the QMS may be affected, as well as how this change will be resourced appropriately6. In the pharma industrys quality systems, these stipulations (as well as several others) are already incorporated, however, for some businesses this may be a new way of working. In many change control processes, an interesting consideration is the potential for unintended consequences that result from the change being implemented. The process approach integrates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking to enable an organization to plan its processes and their interactions. Simply stated as per the standard, the PDCA cycle allows an organization to ensure that its processes have sufficient (managed) resources and opportunities for improvement are identified and resolved5.
Falkonrys new release brings users improved usability, ease of integration, and increased throughput leading to even greater asset utilization ISO 45001 and operational performance. It enriches our core differentiation, using multivariate analysis within a simple time-based display, enabling Utilizing A Quality System May Improve Your Operation SMEs to make quick, meaningful and impactful decisions. Falkonry provides double digit operational improvements to users in the hybrid and continuous process industries, including oil and gas, fine chemicals, metals, mining and minerals, power, semiconductor, and heavy industry. All industries share the need to increase asset performance, production throughput and quality. Falkonry bolsters these initiatives by adding pattern recognition to real-time data streams, using the knowledge of resident subject matter experts to add context to the analytics. The results can then be integrated back into the operations for process control and operations tuning. Operations teams dont want time consuming data science projects, they are looking for products that allow them to do more with the data collection, storage and operations management systems they already use said Greg Olsen, SVP of Products, Falkonry. Our recent product update makes it extremely easy to add advanced pattern recognition to an existing operational data environment like OSIsoft PI. Process engineers, maintenance engineers, and other operations specialists are able to use our product directly to identify conditions of interest to incorporate that capability in their real-time monitoring applications. Falkonry has global customers in APAC and North America. Falkonry technology is offered via an annual subscription model and can be deployed in the cloud or on-premises. Users, such as equipment, manufacturing, and process engineers, can rapidly apply Falkonry to their own operations after minimal training. Falkonry customers typically receive measurable results within days and weeks, as opposed to months and years for conventional approaches.
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