I believe the QA/QC department is one of the most important departments in a company. The Quality System is what ensures that defective, unsafe, and overall bad products do not make it to customers. If a company didn't have this aspect, they surely would not be in business long and would likely be bombarded with lawsuits and recalls. Before I really understood what QA/QC did, I always looked at that department at my current workplace and thought to myself "what do they even do?" My perceptions have changed a lot after this lecture. Other departments may see the things that QA/QC does as small and minor but these small changes have a huge impact on the company as a whole. Even with all of the hard work that other departments put into a product, in this case a medical device, if there is something wrong with it that will make it unsafe or simply unsatisfactory it will ultimately not be successful. There needs to be a quality plan and guidelines for a medical device in order to obtain the same high standard for everything produced. It is also vital that everything produced is double-checked on the back end to ensure this standard was upheld because those producing can make mistakes and miss important factors that could be detrimental to the product and business. Without QA and QC, a company would not succeed for long.
Prior to this lecture, I had visualized quality control as a process companies had to do to appease the FDA and get their products out on the market. I assumed that companies would cut corners during this process to get their products approved so they can get a return on their investment. I thought that the reason many products were recalled was due to cutting corners during the quality control process.
While I have not worked directly with the Quality Department, I have an understanding of what role they play in the company. QA/QC department plays a crucial role in any company, particularly with ensuring that their product is safe for consumers. The department ensures that the products placed on the market to be sold meet requirements, guidelines, and regulations that help determine whether the product does what it is supposed to do in a safe and effective manner.
I think the Quality assurance and control department plays an essential role in reducing the risk of the product. Any false would become a disaster for the company and patients. QA and QC departments must care about everything in the document and make them compliant and correct. They need to set up a serial procedure and check that the idea is accessible. Making the new product can follow the FDA instruction. Although QA/QC costs a lot of time and slows down the marketing of products. The idea can not come to market without QA/QC department's examination.
As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have you had a chance to work with or in QA/QC that and had a chance of perception?
How important do you think QA/QC department are in a company, and why?
I think that they are the most important departments for the simple fact that if they didn’t exist, a lot of flawed products would make their ways to patients resulting in harm and even death. Moreover, the Quality department ensure all documentation is done properly, without the right expertise in documenting work performed, a great lifesaving product might not make it to market. Both cases would result in significant financial loses for the company and even lead to a company going out of business.
Quality control and quality assurance are both important in their ways. Quality assurance ensures that the product or services are up to standard. Quality control evaluates the finished product or service and determines whether a product is up to the standards and able to go on the market. However, if I had to choose one specifically, I would say quality control is more important because it is one of the last steps before the product goes on the market. If we are not careful in the quality control step, it can lead to significant failure since most of the product will be dealing with humans and can cause complications if the product does not work correctly.
Though I did not have any industrial experience, after learning from this lecture, I think this section is vital for any company, including medical device companies. The Quality assurance process verifies that the product will continue to function as the customer expects. And quality control is essential to safeguard the company's reputation by preventing products from being unreliable and increasing trust on the side of consumers. Overall these help to maintain a high standard of manufacturing and ensures that the final products reflect these high standards and satisfy customers' needs.
The QA/QC department is hands down the most important department within a company. As Dr. Simon mentioned in another post, "cost of quality" is dependent on the incorporation of a department specifically dedicated to maintaining and ensuring the quality of the product during the manufacturing process. As a laboratory professional in a hospital, I have not seen QA/QC from a medical device development standpoint but I've had the opportunity to work closely with our departmental Quality Specialists who prepare our laboratories for state and Joint Commission inspections. As we work with many different instruments, consumables, and reagents, traceability of each and every sample that comes through the lab is critical to the role of the Quality Specialists. Without these professionals, patient results may be skewed and go unnoticed. When there are patients that depend on the results of their tests to begin treatment, not catching a mix-up of results, a bad lot, or a defect in bioinstrumentation may cause a delay in treatment or even a patients' life. QA/QC is extremely important across the biomedical field and are essential to the success of an organization.
@delany My experience as a quality professional has been very enriching. I have worked in both quality assurance and control. What I have found delightful is being a contributor to making delicious, safe, healing and reliable products for the community. I have contributed as a chemist, auditor, compliance officer, and working in production controls. My background covers food, beverage and pharmaceutical products. Moving within and between these career fields has offered a very wide range of compliance standard and knowledge. Quality control offers the ability make sure raw ingredient, in-process and finished product, and packaging materials meet all specific requirements. Quality assurance allows you to support in seeing the product gets to the public safely.
