Although quality can be burdensome due to several factors mentioned in majority of the posts here; I think that its worthwhile for companies to implement it, especially for companies in the medical/healthcare space. Quality Assurance/Control makes sure that the processes and procedures that a product undergoes are within the company's guidelines as well as the Federal Regulatory agencies that govern them. This ensures, or minimizes, that the product that goes out the manufacturers will do what its designed to do and not cause any harm to end-users. This will also prevent, or minimize, recalls and lawsuits that will cost the company more money to settle.
I think new technology that has huge potential should not be delayed in reaching to the people who really need it. But once the product reaches them, its stability, durability and reliability take center stage. There maybe patients who appreciate the mind blowing technology the device uses, but all of the patients care about how well they can rely on its ability to help them, how long can it deliver the same results and if the overall product and its durability is worth their money. Quality control ensures all the above conditions are met.
Sometimes quality control might seem to be slowing the whole process down due to its farsightedness about vague possible device failure scenarios. I think taking sensible measures to prevent the slight occurrences of these scenarios is also important to ensure the safety and ultimate commercial success of the product. One can think of it this way: the more time, resources and cycles of quality check a product undergoes, the more reliable each of its feature is and the more confidence it builds in the customers.
Quality departments are often seen as standing in the way of innovation or creativity. However, their primary directive is protection. Protecting the company from FDA/NGO intervention. Protecting the company from releasing bad products. Protecting the business in general. But as described in the scenario posed by Dr. Simon, the quality department is the ounce of prevention that is worth far more than the pound (or millions of pounds) of cure. It is often very difficult when looking at the quality department externally to appreciate what they do. They are often seen as the "no" department, or the "try again" department. But they are critical to ensuring that the "yes" that you do get, is safe, and within guidelines set forth by governing agencies.
I think that inmost departments that are impacted by quality there is usually not enough focus on the big picture. In most departments the main focus are the goals of the particular department. While the quality department would focus on keeping the entire company safe by following the rules set down by the FDA. Most other departments are motivated by their own department goals. I have worked in an environment where even working in other departments can get you in trouble. Department are only concerned with progressing their own agenda. I think that instinctively quality became one of their other department that could take away from one focusing on their own department goals. In addition to that, quality can even act as an hindrance to progressing the goals. Once all department can focus on their own agendas as well as understand the all the benefits of following the rules, or rather not have to deal with the consequences of not following the rules. There may be more harmony between quality and the other departments.
Quality is the necessary inconvenience that is needed in product development and essential in building a strong company with a good reputation. Yes, people working in other departments complain about the quality department all the time. The quality department has too many regulations, too much paperwork, causes to many delays, is bossy, is unnecessary, and so on… But when a patient buy a medical device would prefer a pricier product that is high quality over something that isn’t. The customers need to trust the company is putting money and resources into providing high quality products, because at the end of the day these medical devices are being used to improve a patient’s life and if something was to go wrong with the device it is on the company and the company will end up losing a lot more money than they would have if they spent it on hiring a couple more QA/QC engineers per year. A good quality department can save the company a lot of money in the long run and companies should invest more money in the quality departments as they expand to ensure that all products are being made at the same high standards.
I can see how quality is a burden if it's not well executed, GxP for example which guides quality manufacture, testing, development and approval of drugs. These guidelines ensure that a product is safe and fulfills its intended use. If after product is released, still company sees low customer satisfactory and product had to be recalled. In this senerio, it is a burden.
When quality standard is met, no faulty products leave the company. All of the systems, structure, reviews, and evaluations necessary to ensure that product or services meet requirements. Evaluated quality results against acceptance criteria and determining accept / reject status. PDAC cycle is followed, Plan, Do, Check, Act. And the 4 Management Principles accomplished: Planning, Performance, Measurement, Improvement. In this situation, no recalls and lawsuits, I will think it's not a burden.
As some see it as burden, the potential burden on the overall value product should be a considered, but more importantly we should continually stress the benefits of predictable consistent quality to the entire team and identify the cost of poor quality to the overall performance of the organization.
I believe that medical devices act as a tool for treating or diagnosing a patient and hence, it may play a bigger role than doctors themselves in some instances. While doctors, nurses and other medical staff are held to a rigorous performance standard, It is the responsibility of Medical device manufacturers to meet the highest standard of quality for their products. When a person is complaining about quality, he/she is definitely cutting corners. He/she certainly is not following practices that support consistent quality manufacturing nor is he/she aligning with regulatory, enforcement, compliance approaches with those practices.
Quality is one of the important factors when it comes to a product or the service. Quality of a product differentiates for all the products and services. Quality control is important since it is essential to build a successful business and satisfies the needs of the customer. Quality control and assurance is an important part of product or medical devices. Quality control and assurance is to protect their customers and all it protects the company from being losing millions of dollars on litigation and other charges. If the product is not good, then the image of the company becomes bad in the market as it not able to maintain the quality of the product. It is better to pay quality engineer rather than losing million for the bad quality products. Customers always prefer the products and services which has good quality and doesn’t cause any harm. If the quality is good them it stands out from its competitors. So, quality control and quality assurance no only protect the customers but also the company.
Having a Quality department in your business is like having a plunger in your bathroom. For the longest time it will just sit there and remind you that you spent money to buy it. But if something happens and you need it, by god you are thankful its there. A quality department is a higher risk/reward than a plunger but the principle of the situation is still there. People who argue against having a quality dept might not understand the implications of not having one but they will definitely understand what happens if the only toilet in the office building is clogged and there is no way to fix it. Teach them with what they know.
I do not think that Quality is a burden and that companies should focus on hiring the right quality personnel so that they do not need an excess of quality employees. Without Quality a company puts a lot more stress and pressure on themselves to make sure that on top of their own jobs, that quality methods and regulations are followed as well as ensuring all of the products are up to spec. Quality may not be the most essential piece to the company but it is needed to save a company just in case something does happen. 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. Quality is just like insurance where everyone should have it, it may cost a lot of money at the moment but it is there to protect you and make sure that someone is there in case something bad happens. Also, by helping manage and create the processes, quality can create a clear and efficient method for getting the job done, while following FDA regulations. With smaller companies where everyone may split roles, you may only need one Quality personnel to do QA and QC but with bigger companies, experienced Quality personnel is very important.
Quality is a huge part of any successful business operation.
From my experience working in a hospital, when there is a meeting and it is time for Quality to report there are always huge sighs. Maybe it is just because of the nature of the job, but it seems that most of the other departments do not like the Quality Department (or the regulatory Department now that I think about it). In the hospital setting, I think it is because Quality forces you to own up to the mistakes you make instead of you just pushing them under the rug. That creates a discomfort that a lot of people do not like so they associate that discomfort with the Quality Department & Voila, the dislike of the Quality Department is born.
Everyone complains about Quality being a burden but when people think about it in the long run, it’s very beneficial. It might be a hassle to go through all the procedures and documentations that quality wants you to do, and many people might think that can slow the process but quality is supposed to save the company from any mistakes that would occur. The product that is being created should not harm anyone in the future and that’s what quality goes through to make sure every instance is avoided. The QA department improves the quality of the product for the consumers. It’s necessary to have quality even if there are extra tasks to deal with like paper work and documentation. Spending more money in the beginning can mean saving so much more later on. Many people who believe quality is a burden, forgets that it saves the company and the people working on the product, so much money and liability.
For this, it's important to do a Cost-Benefit Analysis to see how much "bang you get for your buck." Paying for quality is important in order to avoid legal liability for any mistakes that produce very negative results. However, one important that should be considered is that the gap between cost and benefit needs to be high, which needs to happen in order to make the highest profits possible. The hard part of investing in quality assurance is knowing how much is required to ensure that your quality remains high. In economics, there is a law called "The Law of Diminishing Returns," which simply states that investing too much in one area will lead to negative results in the long run and can even slow processes down. Knowing how many employees to hire and making the optimal procedure for R&D are very hard things to do because it's not a clear answer. It's true that a company may be able to live another day if it commits a crime and loses a fortune through a lawsuit, but you also have to consider that companies that don't produce and innovate constantly won't live for long and will probably suffer because of competition. If customers are mostly unsatisfied with what a business is offering, then it will not survive as it's survival ultimately depends on the customer.
I can understand why it would be a burden. Especially since you have to spend money on a quality engineer but it would be smarter to spend the money earlier than having to deal with it later and possible having to give up your company because of all the money you will have to spend if something goes wrong. It would be more beneficial to spend the money earlier instead of later. You will make more by avoiding legal liability in the beginning before sending the product out and having it fail. It might be a big burden since people will complain about Quality but avoiding it from the beginning will cause the project to have a better end. But of course the Quality processes can be improved and that can help get the product out in a timely manner. But overall Quality is important and can save the company as a whole.
People who complain about quality control probably are very short sighted in general. Quality control is basically insurance. You buy insurance just in case something goes wrong, like getting sick, into a car accident, or your house burns down or floods. It costs money in the mean time, and you may never need it. If something does happen, you'll be glad you spent the money then and saved in the long run. Quality control is definitely a protection plan for your future. Big companies can survive lawsuits but they shell out billions. Small companies can't afford to do that. Spending a fraction of the cost on "insurance" is the best way to protect your future endeavors.
