Quality control is not only a matter of saving money, actually. I think it will bring much more profitable good to the company if they did great job on quality control. First, quality control is defined with the acceptance criteria of a good before it goes to the market. This means we only need a good standard to meet that if the manufacturing technique could do it, this would not be a problem. The only cost left would go to the human resource. If the whole company has a spirit of making every product nearly perfect, then the staff cannot be inattentive to their duties because they want to save their job. That will not be considered as a big cost since all you need is to build up a good spirit. If the reputation is built to known as nearly to zero complaint every year, the sales growth would no longer be a problem. Besides, in the long run, the biggest benefit of maintaining good quality is that there will be no expense on going to courts, facing with angry comments online, or trying to cover up bad news coverage, which could go much worse and the amount of cost is enough to make the business go bankrupt.

In my opinion quality control is an integral part of any company and is worth every single dollar spent on it. Companies serve to customers who have specific needs and it is the quality engineers' responsibility to make sure that the products developed by that company meet those needs. They go through a list of specifications and evaluate the product output against these specifications. If something is wrong, then they have to go back and find the root cause to prevent further and possibly bigger issues in the future. This department is especially important in a medical device or pharmaceutical industry where serious harm can be done to human health by releasing unsafe and poor quality products.

It goes without say that the implementation of a QC/QA system in a pharmaceutical/medical device company is a vital necessity. With costs aside, the lack of a quality system can easily compromise the well-being of a patient, which according to lecture can result in a business not only going under, but also result in its personnel being incarcerated. The reason for this is evident in that a business without a QC/QA system is simply gambling on human life. One technique of properly implementing a quality system is through the use of CAPA (corrective and preventive action) system, which is a quality management system that the FDA requires and looks for during audits. A CAPA consists of QA personnel along with members of other departments, ideally those involved in the manufacturing process, to identify and eliminate root causes of defects and inconsistencies along the production process in an effort to improve both the product being processed and other similar complications within the company.

(1) CAPAs are also easily perceived as burdensome for a few reasons: First it requires cross-functionality from all departments taking part in a particular project, which can result in communication complications between personnel who only specialize in their own field of interest. Secondly, CAPAs can be overused to the point that they exceed the FDAs standards, such as including too much detail in reports and prolonging investigations for months. CAPAs are also said to have protocols that focus more on being reactive than proactive (more corrective than preventative) in that quality departments prioritize the handling of an adverse incident rather than focus on preventing such incidents from ever occurring in the first place. This could be attributed to a quality department's lack of understanding a manufacturing process and only being able to address issues by "finding out the hard way". Nonetheless, when it comes to ensuring the safety and efficacy of a medical device, it's better to invest over than under in its quality.

Are there any other quality-based systems implemented in medical device companies? What are their pros and cons? Are there any ways these systems can reformatted to be less burdensome while still ensuring the quality of the product?

(1) https://www.greenlight.guru/blog/corrective-action-and-preventive-action-capa-medical-devices#3

I think most companies view the QA/QC departments as being a burden because of the amount of questions that need to be addressed before the release of a certain product. People may be on a time crunch to release certain lots of that product and so they get frustrated when confronted by QA/QC. However, the QA/QC departments are necessary in order to prevent any negative outcomes for that product. If quality was overlooked, there may be potential to get sued, or possibly a patient will become seriously hurt. Quality is also necessary when it comes to audits. Auditors love asking tough questions and so quality will assist in making sure that everything is as error-free as it can be.

Quality is not the place to start trying to save money. The quality departments are the last line of defense before a process, procedure, or products gets released and there should get a large amount of money supplying QA/QC. The burden that everyone is talking about is the time element. Once a document gets submitted to QA, it starts a timer. The longer that timer ticks, the worse it looks for auditors. Companies want quality to either approve or reject change notices within a week or two of submission. Once the change notice sits there longer, it looks like quality is having a hard time to approve the document, and then the FDA or auditors look into the documents further. It is worthwhile to invest in your quality department to avoid defective products being sold, extensive audits by the FDA, and happy engineers who get their change notices approved.

Now think about people in the world, whom you will meet, that complain about Quality and how it’s a burden. Thoughts?

Those that complain about QA/QC are not the ones that should be in charge of such a role. Quality control and quality assurance is valuable and essential to a company in preventing any legal issues occurring. Through simple compliance of the methods necessary before sending off a new medical device, this ensures the quality of the medical device as well as its safety.Additionally, following through with the regulations QA/QC must meet, it makes auditing quick and easy. Those that dread audits, are most likely slacking off in their QA/QC jobs. Getting engineers who understand the importance of QA/QC to a company, are detail oriented and meticulous, will most likely succeed in this department, therefore, creating an environment for success.

Even though some people consider quality control as a burden, quality control is an important faction of the company. Quality control help ensure if the product is working properly, if not they can stop releasing avoiding the company being sued for millions billions of dollars. Companies need to sell well working product, so they can make money if not they will lose money and possibly their company. The test procedures can usually take long, delaying the release of products but it is necessary so that the product pass all criteria unless can harm instead of helping.

Quality assurance and quality control are important because they make sure the products follow procedure and prevent any future disasters in the company and undergoes are within the company’s guidelines as well as the Federal Regulatory agencies that govern them. Even thought some think of it as being a burden, however, it helps companies to avoid any projects failures at the end. The Quality processes can be improved and that can help get the product out in a timely manner as well. Quality will impact the work of a lot of departments and may end up slowing down the development process but it can help the company save a lot of money later and as mentioned to avoid ant projects failures. so, personally I believe that quality assurance is important for companies.

The quality policies usually come off as a burden because they are usually at every step of the medical device development evaluating and cutting things short and asking for steps to be redone until it passes it correctly. Quality just seems annoying to any innovation from the perspective of other departments, especially the R&D. But in the quality's perspective, they feel like they hold the responsibility of any potential failure in the market and not the R&D because quality is the one that let the product fly under the radar. The quality department also sees that there is a tremendous trust given from the customers who buy and use these products and that the customers must in return be given the best device with minimal to no failure. The quality is also the department that must deal with auditors and external evaluations of practices and processes. The quality department has a huge responsibility and carries the fate of the company after products are released and therefore they must be fully respected and cooperated with. Time and money shouldn't be seen as a burden in quality but rather it should be seen as a good investment.

I agree with most of the people here, Quality can definitely be demanding for medical and pharmaceutical companies out there. It is the most important core factor in the high cost of delivering good quality products to the consumers. In an industry, when changes are to be made to any product, then the roles of quality assurance, quality engineer, and regulatory compliance are approached. Their roles are to monitor any engineering change controls on a product which eventually enhance the quality of the product. However, while making the changes, their roles also includes to not interrupt the result of a product in the manufacturing department. Ensuring this and making a quality product can be burdensome and difficult for the company as it takes away the available resources from another task. On the other hand, it is an efficient process that will deliver a good and quality product and not risking company for delivering a product that needs work to be done.

I think this has especially become a problem in American culture where people are constantly looking for a lawsuit. Hoping to win the big bucks, they will take a company down at any cost. Companies are filled with anxiety over getting sued. It is no longer about true quality and making sure the product is the best that it can be, but rather absurd measures to prevent lawsuits.

QA/QC is seen as a burden because of how stringent the engineer's need to be to make sure no bad lots get approved and shipped out. From an R&D standpoint, QC Engineers are the thorn in the side that can't be removed but in actuality these QC Engineers are more than likely saving the company. There are definitely ways to streamline the QC process without raising the odds of a bad lot and that would take away a majority of complaints that people have about Quality, since it is such a time consuming step. In fact, steps to streamline the process should be taken whenever possible so that products do not get caught up in the Quality process for more than a week or two at most and a stronger flow of great products get shipped out every month.

Complaining about the quality assurance and management in any company and considering it as a burden that can be waived, means complaining about being globally competitive and a customer long-term satisfaction.
Within these days where medical devices companies are growing very fast, it may be very risky to abandon the important role of Quality management in any organization. Without QA/QC/QM, a company would require engineers, scientist, and researchers to take that responsibility in achieving customer needs and meets FDA regulations & requirements. Demanding that extra work from engineers and other employers who are not really specialists in Quality would be a waste of their time and energy, which would delay the workflow of products, which would for sure lower the company outcomes and revenue. Thus, it would be risky to expect engineers instead of quality specialized employers to conduct quality functions. It would also mean being prepared for any accident failure, that may cost the company millions of dollars in addition to human lives. The cost correlating with products prevention and detection related to quality issues is usually lower than the company failure cost.

From other departments point of view, I understand why they can sometimes regard Quality as a burden. Ultimate, Quality gets to determine if their project gets to move to the next phase or get complete rejected. Imagine spending time and energy in research and design to be finally rejected at the end. It might be the best feeling ever. however, it might not be so much of a huge problem if the other departments weren't emotionally invested in their project, which most of the time they are. Now, from a manger point view, I don't understand how they could consider Quality to be a burden. I mean, of course, the necessity of Quality comes in handy with extra money investment for the company, however that investment is worthwhile considering what a tremendous apport Quality in avoidance of those legal issues and dissolution of the company.

QA and QC are very important and crucial , especially when it comes to medical devices where we are dealing with such complicated products. If anything goes wrong it's more about the hurt/damages done to the people rather than only about money. So it is very much needed indeed.