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.
I agree that the quality department is one of the most important in a medical device company. I view QA/QC as a mini FDA within a company that is continuously evaluating products and processes to prepare the company for audits by the actual FDA. If a company's quality department is diligent then visits from the FDA should bring no surprises. Especially for medical devices, the efficacy of the quality department can be the difference between putting out successful products or products that the FDA has to recall. Working in quality seems to involve a lot of paperwork and reading, so it may not the right path for me personally but I think as an engineer it is of utmost importance that I understand the significance of the work that quality does. Many companies seem to view quality as a bunch of annoying red tape slowing down their process, but the quality department has the same goals as the rest of the company; produce the best, most efficient, safest product.
I believe Quality Assurance and Quality Control are extremely important especially when it comes to medical devices as it is going into me, you, your loved ones, etc. I feel as though none of us want to have something that is not of quality to put into our or other's bodies with the risk of harm or death. Lives are to precious to be not checking on quality of the product in the long term. Short term solutions maybe have a slight decrease to try and patch up things, but long term should always be quality controlled and assured.
Before this lecture, I had a vague perception of quality being kind of an afterthought. This lecture has shone a light on how involved and important quality is as a department. I did not realize how detailed all of the quality objectives were, and how their conclusions can feedback to the rest of the development process.
I see that Quality is very crucial in todays market where it is a key differentiator for various products and services. Both QA and QC are essential for businesses to meet customer expectations. QA focuses on proactive measures in the process while QC is very reactive ensuring that the final product meets required standards.
People expect good quality products and as you've said, if QA/QC didn't exist, there would be more flawed or faulty products on the market reaching the masses and could lead to harmful situations. Quality Assurance is about preventing issues from happening and is more process oriented. Quality Control is about identifying issues with the product and is more product oriented. They may be different but they are very important. They may as well be the most important aspects of a product because a product of poor quality is in risk of receiving lawsuits and you end up paying significantly more than what you needed to. So in short, QA/QC are important to identify and prevent issues with the product and ensure that the product is reliable and safe.
I have always believed that QA and QC are fundamentally important for well functioning device and or company. My thought have not really changed after the lecture and they've really only been reinforced by the information provided in lecture. I have not worked in QA/QC in industry, however I have had some experience with these processes through my capstone project. My advisor was very adamant on catering the capstone project so that the skills learned within it could be applied to industry. Part of that experience was very dependent on proper quality control and quality assurance throughout the course of the project. This led to a more streamlined and developed product by the end of the project which we were able to deliver on all requirements successfully. The documentation practices that we undertook proved to be very important as well and impacts the lab we worked under to this day in a positive way.
In terms of importance within a company, the QA/QC department is vital for the success, safety, and efficacy of a device and the well being of the company. Ensuring a device is meeting regulatory standards and is passing all checks and balances is crucial in order to protect the consumer using the product, but also the company. Ensuring GDP is a crucial aspect of a devices development and if an FDA audit were to occur without it, the company for lack of better term would be screwed. The QA/QC departments are essential for ensuring the success of a company.
When I initially thought of QA/QC, I mostly imagined it as a "final check" phase in which goods are simply evaluated to determine if they pass or fail prior to shipment. My perspective has undoubtedly shifted as a result of this talk. I've come to understand that QA and QC are far more proactive and comprehensive than I had previously thought. In particular, quality assurance (QA) focuses on creating the comprehensive set of procedures, records, and guidelines that guarantee a product is reliably safe and efficient long before it is put through testing. Although I haven't had any direct experience in QA/QC, I did gain an understanding of the value of documentation in regulated settings during my internship, which made me realize how important QA is. Even a product that works flawlessly might never be approved for sale if the proper documentation and records aren't kept. I agree that QA/QC departments are among the most important parts of a company. They not only protect patients from potentially dangerous products but also protect the company itself from financial losses, recalls, and legal consequences. In a sense, QA/QC provides the backbone of trust between a company and the public. Without it, there would be no way to guarantee safety or credibility.
