I believe it is important to protect your investments. It takes time and money to build a company. When dealing with medical devices, it can be an even longer process, due to the scientific process behind many of these devices. As stated in the initial post, a lawsuit can cost millions and many people can be hurt due to your negligence. I believe quality is worth the price. Quality is an investment for a company. It is an improvement for any company. It is better to know you have a high quality product as opposed to countless batches that may or may not be a bad product. Many people complain about quality, and it is a tedious process. However, there is more at risk for not only the company but also the employees and their families who could suffer if a company goes out of business.
Oh, how I wish an investment in QA/QC infrastructure was a part of this nation's strategy in addressing and abating the spread of COVID-19. Having quality systems and professionals in place to mitigate risk and liability to the company, as well as its customers, seems like a no-brainer to me. I'm a stickler for wearing your seat belt, and I fret over our ambitions for commercial success usurping the importance of ethical science and customer well-being. For example, the obscene prices for cancer immunology drugs means that the great majority of cancer patients will not be treated with them, despite their less invasive nature and superior survival rates to chemotherapy. One of the attractive characteristics of medical devices is that pricing is more reasonable. Thus, if it meets a need, many people will have access to it.
The cost of quality HAS to be considered a cost of doing business, much like getting a license to operate or getting FDA approval. Having the QA/QC function is actually an investment into the business that yields continuous returns. The theory of economics speaks of opportunity costs relative to a business, but QA/QC prevents "opportunity losses" to the business by identifying production or manufacturing issues early and adhering industry regulations.
Moreover, strong QA/QC metrics can contribute to the brand of the company when they get translated into customer testimonials or when the company's quality metrics exceed industry standards or the performance levels of its market competitors.
Although people might consider investing time and resources on quality beforehand as a burden, it is very important, because like we all know, prevention definitely is better, safer and way less expensive than cure. This is applicable here as well. When a company follows proper quality standards, it does produce products which are of a far more superior quality than its competitors. When the people figure this out by using high-quality products, the company becomes trusted and sales increase eventually leading to more profit. Yes, for this the initial investment may be a burden, however, the return of that investment is profitable. Also, if anything goes wrong with one product, it is the general nature to question everything that follows from the company thereon. So even if for the next product quality measures are used correctly, the sales may be low because of the blow already caused by one low-quality product. This just gives the competitors a chance to go ahead and replace the company's name and fame.
The common perception is that producing better quality will increase costs. But the benefits of quality exceed the costs of quality. It should be noted that quality isn’t an objective, Rather, it’s completely subjective – everyone has their own view of what counts towards a product’s quality. Looking at the above example one could say there is no argument only conclusion and to note the importance of quality in the industry .There should be no compromise when it comes to quality or else it will lead to disaster .Closing the company is a big price to pay when compared to hiring some expertise that could avoid such disaster .
When it comes to quality and its cost sometimes it looks like an additional cost that can be a burden on budget and sometimes is overlooked but in reality it is one of the most important steps in ensuring that early detection of errors that can be prevented is what quality is all about. for example, early phases of a new drug or a machine must be checked multiple times to assure its quality altho it may look as burden on budget but in the bigger picture the cost of quality can be overlooked for what it actually prevents in law suits or injuries that happen afterwards which can not be prevented. So when we look over the cost vs benefits in the end it saves more by implementing and making strict quality measures. Quality make sure that standards are met either by research or meeting organisational standards.
This reminds of me of another reply I made earlier. Quality should be shared across the organization. While a quality organization is important to ensure testing or auditing is performed, manufacturing, supply chain, marketing, everyone needs to develop and support a quality mindset. The medical device industry similar to biopharmaceuticals needs to have everyone "listen" to different perspectives, develop consistent processes to keep the patient/healthcare providers satisfied with product supply but also confident in the quality of the product and supply.
One technique to help align internal resources within organizations is to rotate development opportunities and allow manufacturing, quality and engineering personnel to work in their counterpart areas. Walk in my shoes....
Also folks need to be open to innovative approaches to their work. Need to develop folks to be opposed to different approaches. I come from the Lean Six Sigma space and I remember how important it is to have people develop LSS skills and apply them to their jobs.
Working in an industry where QA/QC are seen as a hinderance to the company's progress in terms of getting the product out on time. Though they are needed in the company to help catch mistakes, bad product and errors made before, during and after production; it is a necessity to have them but sometimes they tend to be a burden.
QA/QC do become a burden in the sense that when Quality Policies becomes extremely rigid and criticize every little thing and wanting perfection then the device in question will take longer time to produce and sometimes never makes it out to the market. Also, when devices has to be reworked, tested or rebuild all together, it carries a lot of financial burdens. Then the company tend to sacrifice quality product just to get their product on the market and get back the capital and profit put into production.
This is a phrase you will encounter sometimes. "The Cost of Quality" is a concept.
Let's say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product might really be great, and not fail. Then, inevitably, it happens.... something goes wrong. You get a bad lot that gets sold and winds up hurting people. You then get sued and lose, and have to pay millions of dollars in damages, which of course makes you go out of business.
Your company is dead.
Now go back in time to the beginning of the company, this time with QA/QC in place. Sure, you have to pay for it. You need to hire Quality Engineers at $60k+ each, etc. You need to create documentation. You need to have approval processes in place. You need to inspect product off the line. You need to do a LOT of things, all of which cost money. But guess what? When that bad lot gets made, you catch it before it goes out! No one gets hurt. No one sues you for millions of dollars, and no one puts your company out of business.
Your company gets to live another day.
This is the concept of the Cost of Quality. If you put money into Quality BEFORE bad things happen, you have a chance of averting something awful that will put you out of business because it costs you much MORE to fight the lawsuits than it does to hire the people to prevent them.
Now think about people in the world, whom you will meet, that complain about Quality and how it's a burden. Thoughts?
In Both cases , there are advantages and disadvantages . first of all, let me say this. no one is creating a business and be sued later on. Any types of businesses require critical thinking. We lay down plans , think about it over and over before putting it to existence. If you create your company without thinking about the inconveniences , thinking about saving all the time , in one word you are cheap , this is the type of stuff will happen down the road. I will prefer hire an engineer to do my job. Think about google, apple etc they are paying millions of dollars to people to get the job well done. They get sue but not like the first case without any engineers to fix the problems beforehand.
This is a great discussion topic. I have always been a huge supporter of the saying "measure twice, cut once". In other words, be absolutely, positively sure of what you're doing before you do it so you don't have to pay for your mistakes. While I do see why people think that quality is a burden because of the amount of people that would need to be paid and the extra time that needs to be taken to ensure a safe and good quality product is released, I do not agree with their complaints. If you want to make millions and save millions later, take the necessary precautions and spend a few thousands now.
I think a lot of people have a poor ability to visualize past the present. Those who think quality control is a waste of time and money really only see the fact that they have to pay for quality engineers and thus spend more time and money on a product that they want to release. They see timelines and budgets and the "selling of a device" and anything, such as quality engineers, that may delay or increase the budget is a burden. They may also be overly optimistic about their product. They might view quality control as a burden because they may assume that their product is fine and that it won't fail. They may be quick to assume that, if the product has not failed yet, the product has no chance of failing in the future. Personally, I think this kind of mindset is selfish and shallow. It puts money, timelines, and assumptions over precaution. It might be a strategy if a person is willing to release and sell a device and then use the revenue gathered via not paying for quality engineers and by releasing the product faster without attention to the quality of the device to pay for lawsuits that inevitably occur when the device fails.
Anyone who thinks of medical devices as such probably shouldn't be allowed to sell them, to be honest. That places selling a product over the very people you are selling the product too.
As I am still new in industry, I have yet to meet someone who believes Quality is a burden; but from the perspective of a Supplier Quality Engineering Intern, if I ever do meet someone who believes this, I would be quite concerned to say the least. The consequence to not paying for a Quality system to be established is the make-or-break for a companies future because a defective lot will go out eventually. And if it is not caught in time, not only could your company be at risk for closing as in the scenario mentioned above by Professor Simon, but depending on the risk of the device, human lives could be lost. Additionally, the effects of having a Quality system make the business run much more smooth and efficiently. This is an internal check to be sure the products being put onto the market with your company name are the best they can be, and proven so through test validation. Without a Quality system, if an internal problem were to be identified, an effective step by step process to correct for it would not be in place. Therefore rendering the job even more difficult from the start.
Just last week I overheard my coworkers complaining about how certain quality policies have gone too far and may be causing more damage than good. My company recently opened a new location and the manager ordered 10 new workstations for the technicians. These workstations were ordered through corporate to ensure the correct workstations were selected. After assembling the workstations, the quality department told the manager that the workstations were not compliant with their policy and needed to be changed. They went on to explain how although the style of workstation is correct, the color of the frame is not aligned with the policy’s color code. Since the workstation is the wrong color, the workstations have to be disassembled, sent back, and new workstations must be assembled. The company will end up paying technicians to do all of this work which does not seem cost efficient. Can you think of similar scenarios where quality policy has gone too far?
As I've said in a previous reply, Quality is a necessary delay. There needs to be a sort of "checks and balances" in a company during a project. While the engineers and researchers have the practical knowledge to act on a procedure, if it is not in regulation, it can hurt the company.
Some people that I know who work in construction and manufacturing constantly complain about regulation and often overlook it. Some procedures are swept under the rug or others just decide to turn a blind eye to it for the sake of moving the project forward. It may even work for some time until something is designed poorly, a laborer is hurt, or worse. These people I know also love to talk about big business yet still complain about the necessary regulatory processes that come with it. If these people were really concerned about profit as well as how a product turns out, quality would be a top priority.
Quality can seem as a burden or an annoyance because it is like a person constantly at your shoulder waiting to scold you or questioning your actions. IT may seem like a lot or overwhelming because a department may ask about every little detail, even the ones you think are not so big, but when looking at the larger image, having those little details helps paint a proper picture if something were to go wrong.
It definitely can be frustrating having someone or a department cause delays or push you back on schedule because of how much questioning they put in to make sure a project is safe and ethical, because sometimes those deadlines need to be met and it is out of your control if QA/QC put you behind schedule.
Although it is somewhat like a burden I think it helps to have the quality being constantly on top because it creates habits for workers to make sure they document every single thing to not get sloppy or lazy. I have experienced it before where yes everyone knew what I was talking about within the project, but if the project were to be replicated to others, they would not understand because these tiny details that help explain the project were missing.
It helps a lot to have a QA/QC simply because when something could potentially could wrong, they can ensure to reduce that risk astronomically. On top of it, they teach you to be thorough, be clear with your work, and stay organized. The biggest factor QA/QC bring to any company is that they create a system of organization that can be traced back to any prior small detail which could help in case something went wrong, or just if they needed to change an experiment to be financially within a budget.
