Documentation is key.
Documentation must be designed and structured in order to be useful to everyone involved in the manufacturing process. Documentation of Quality Management Systems must be available and understood by all personnel that have an influence over product quality. This requires a top-down approach to how a manufacturer organizes their knowledge of the process, starting with big picture processes, and further defining how the Quality Management System applies to total control manufacturing.
How and Where to apply Quality Management Systems.
When implementing a Quality Management System, a manufacturer should consider how and where to apply the systems so they do not over-engineer solutions where problems will not exist. This, again, ties back to Quality Risk Management and understanding the results and quality specifications required for each stage of manufacturing.
Quality Risk Management should be considered from the beginning of Quality Management System development. Implementation of Quality Management Systems cost companies money, and should be selectively used where risks exist, rather than a company wide implementation. While all companies could benefit from full applications of QMS, there are many activities that would have no benefit from such systems.
Quality Assurance and Quality Control.
QMS is not a self operating stand alone system – it requires Quality Assurance and Quality Control Departments. These departments, which are separate from production, are the managers of quality. It requires investment into identifying the appropriate processes and resources that must be controlled to meet Critical Quality Attributes.
Essential Elements of the Quality Management System.
At a minimum, QMS should include process performance and product quality monitoring, CAPA, change management, and management review. These systems are the essential elements to ensure that products meets Critical Quality Attributes, and that product quality is continuously improved.
Action you can take:
It’s no small challenge to build a Quality Management System. While we normally have direction actions, we feel it is highly valuable to have a 5-10 hour block with one of our consultants in order to set up the systems. If you prefer, you can directly hire a seasoned Quality Assurance manager, and they will be able to set your Quality Management System up from the start.
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