In my bit of industrial experience, I have worked in various companies ranging from medium to large corporations. Their level of performance and quality was proportional to their size (or, better stated, their budget), which determined how much they could invest in quality assurance and control. Larger organizations wouldn’t just direct those efforts toward their products, but also into how they managed employees. Because of this, I noticed a visible level of confidence among their ranks, which varied depending on the company’s investment in quality practices.
I saw a greater emphasis on the Quality Management System within the larger companies, where leaders stressed the importance of maintaining a high level of quality in our daily operations, which directly contributed to the products’ development and production. This resulted in very few or nonexistent failures internally with development and externally with product performance. Smaller companies, on the other hand, tended to focus only on the production side while neglecting employee workflow and culture. This often created a toxic environment where the highest standards of development & product quality they claimed to have were difficult to achieve.
To add, I’ve taken a Total Quality Management (TQM) course that outlined the concept of “organizational excellence” and how management (as high as senior leadership) needs to motivate their employees to guarantee their organization can implement and maintain an effective QMS, let alone QA/QC processes; it “trickles down” to even the most basic roles of an organization.
So I’d like to hear your thoughts: if you were in a leadership role, how would you approach investing in a successful QMS for your organization? Would you focus first on initiating a system, maintaining existing standards, enhancing what’s already in place, or a combo of the three, to ensure patients receive the best product or service?
Feel free to add other potential initiatives!
I would definitely focus on initiating a quality management system. I think that a good quality management system not only enhances the quality of the operations of whatever company you may be in, but it will also hopefully ensure that quality is implemented in a consistent thorough way. While Quality managements systems are mandatory by law for medical device companies, having a well thought thorough one will provide far more benefit for an organization than a poor system. I think you made a great point in how a good QMS system will also "trickle" down those values to all of its employees not just those involved in quality. In my job, I have also seen how the quality team works to make sure that all employees understand the reason behind quality decisions, so that they don't feel arbitrary and are involved in operations tasks so it never feels like they don't know what is actually going on. A good QMS system can ensure the patients receive the best product or service they can.
In my opinion, quality management is what really ties everything together in a company. QA and QC are both important, but without a solid quality management system, they can’t work as effectively. I think of QA as the system that prevents mistakes and QC as the part that checks for them, but quality management provides both with direction and structure.
When a company takes quality management seriously, everyone becomes more responsible for quality, not just the QA/QC team. It helps ensure that products meet standards, problems are identified early, and the process continues to improve over time. I think it also builds trust between teams, because everyone knows what’s expected and why quality matters.
So to me, quality management isn’t just about following rules; it’s about creating a culture where doing things right the first time becomes natural. That’s what really improves QA and QC in the long run.
I would enhance what is already in place rather than initiating a system that would take more time. A thorough review of the QMS would include revising sections that need to be improved on so that they reflect the current practices of the company. The QMS would adhere to FDA & ISO standards as well as the company’s mission and quality policy. However, the QMS review may also determine that certain procedures or records at the company require document change requests or staff retraining in order to satisfy compliance. It is also important to set quality objectives that are justifiable and can showcase continuous improvement initiatives. Moreover, as leadership, there can be staff or team evaluations to decide how tasks should be delegated. New departments can be established for document control, training, and complaints for better efficiency.
I would enhance what is already in place rather than initiating a system that would take more time. The QMS would adhere to FDA & ISO standards as well as the company’s mission and quality policy. A thorough review of the quality manual would include revising sections that need to be improved on so that they reflect the current practices of the company. However, the quality manual review may also determine that certain procedures or records at the company require document change requests or staff retraining in order to satisfy compliance. It is also important to set quality objectives that are justifiable and can showcase continuous improvement initiatives. Moreover, as leadership, there can be staff or team evaluations to decide how tasks should be delegated. New departments can be established for document control, training, and complaints for better efficiency.
