I believe the people who see quality as a burden are the optimistic thinkers. They are the people who believe ‘it would never happen to me’. This means they see quality as an unnecessary step to prevent a situation that in their eyes, will never happen. Versus the people who see quality as a safe guard guard to protect themselves from an unforseable expensive mistake in the future. I see the point of view from the person who sees quality as a burden because I Am also an optimist who does foresee bad things happening. While on the other, I understand the view point of the person who thinks quality is necessary because I know things do not go as planned and it is better to protect yourself, than hope for the better.
I think I agree with that the QA/QC department seems to be a burden.I think that because during the training of the SOPs in the manufacturing process as well as in the QC department, the scientists or associates don't understand what is happening. Moreover, there should be common sense in their teaching not just following SOPs and expects someone to follow it by heart without making some minor deviations. Moreover, QA/QC department should exist to prevent any complications of lot from happening.
Hello,
The cost of quality is indeed a critical perspective that highlights the long-term benefits of investing in quality assurance and control. Your scenario illustrates this point perfectly. Without QA/QC measures in place, a company might appear to save money in the short term, but the potential consequences can be catastrophic. Complaints about the burden of quality often stem from a narrow focus on immediate costs rather than a comprehensive understanding of the bigger picture. Quality initiatives do require an initial investment, such as hiring quality engineers, documentation, and approval processes, which can seem like an added expense. However, these investments are, in essence, insurance policies against future disasters. When individuals or companies view quality as a burden, they might not fully appreciate the value it brings in terms of brand reputation, customer trust, and legal protection. It's crucial to emphasize that the true cost of quality includes not just the expenses incurred but also the potential costs of product recalls, lawsuits, damage to reputation, and, in the worst cases, business closure.
Like most commenters, I understand that quality control is sometimes a burden due to the fact that it is a very lengthy process involving inspections, measurements, purchasing controls;etc. to ensure the product is safe.However, it is very important that a company that is relatively large should have a quality control department and QA/QC should be done for each product. The quality control team is very necessary for many reasons, such as helping and making sure it meets any requirements the FDA may have for any product, making sure the product has proper labeling, etc. so that the product is as safe as possible. for the customer. This way, the probability of the company being sued because a product has endangered a customer's life is minimal, as well as fines from the FDA for not meeting their requirements.
I believe that quality should always come first when developing, building, all the way up to buying a product in the end. An example i can think of is let's say a company that creates pacemakers comes into the market with a new high-tech pacemaker that about a quarter of the price of the ones on the market now and the battery does not have to be replaced for 20 years, commonly the ones on the market now are every 10-13 years. Unfortunately, as great as that sounds, the quality of the rest of the pacemaker is not well looked into and has a high chance of rusting the circuits within the first 3 years. The original ones on the market are a bit pricier but passed though many quality checks to ensure the product will only need the battery replaced every 10-13 years. Which one would you choose?
People that complain about the cost of quality have equivalents in every step of the process. For example, during development supervisors may suggest that certain statistical checks are irrelevant and that you should skip them and move along. During manufacturing it you may feel pressure to allow certain irregularities and not stop processes to address them. People will always be pushing to keep the status quo rolling while sacrificing quality down the line, and it is the every employees responsibility to push back against this and follow regulations and QA guidelines.
As frustrating as it is to be a QA/QC may be it is quite a necessary step because this ensures that people are not hurt and the cost will definitely be much lower in comparison to if the company were to be sued for a bad product. From work, all the products are allowed out for shipment have through paperwork that is attached to them, and it is to ensure that every step of them can be tracked back to find the source of the problem. It is a requirement that every material and production that is outsourced be attached, so there will be a batch number for every step. It is not just about protecting the company; it is a way to ensure that no one gets hurt from a bad material or mishap in the process. If there is an issue that can also be caught early on and that ensures that they are able to avoid losses because if there is an issue with the machinery, then it can be cleared up as early as possible. Sometimes the cost can be seen as a problem because you are forced to pay people for work and they may not even find anything, but that is precautionary. I think that it is a necessary cost because if it is avoided or costs are cut the outcome will be far worse for people and the company.
The “Cost of Quality” is all about understanding that spending money on QA/QC upfront actually saves a company from far bigger losses down the road. A company that omits quality procedures for financial cost reduction purposes. The initial inspection appears successful yet a faulty product manages to pass through the process. The company will experience legal repercussions through lawsuits which will result in paying millions of dollars in damages and possibly leading to business closure if their product results in harm to users. The company that invests in QA/QC from the start will have quality engineers on board and documentation in place and approval processes set up and products inspected. Yes, all of that costs money, but when a bad lot is produced, it gets caught before reaching customers. The company remains intact without any legal disputes and major financial damage. That’s the true cost of quality, pay a manageable amount now to prevent catastrophic costs later. Quality appears to many as an unwanted weight but it actually functions as a protective investment which safeguards both businesses and their consumers.
The people who think that going through QA/QC is a burden don’t understand the consequences if it is not done. Yes, going through those processes will take additional time and perhaps additional resources. In the long run, it will pay off and the customers will keep coming back. For example, if your company is putting out a new type of bandaid but they don’t do quality testing, it may be fine at first, but eventually complaints from customers will come in about various issues such as skin irritation and adhesion issues. However, if your company puts in the time and effort to do quality testing, customers are more likely to buy the product multiple times.
This is really thought provoking. This basically saying you either pay now to prevent any issues or pay later in lawsuits. I can see why quality can seem like a burden because it costs you. However, I think a better way of looking at it is sure quality costs you, but lack of quality costs you more. That's why QA/QC are important so that you don't end up paying more than you need to later on. It saves you more money to do quality control but it most definitely costs you less than a lawsuit. I think when people say quality is a burden, they probably mean their money is going to waste, so they end up confusing cost for waste. Personally, I don't really think quality is a burden because you're paying to prevent any issues from turning into greater problems. If you don't spend your money now to prevent any issues, you're essentially creating a bigger problem for yourself in the long run.
This is a harrowing example that reveals not just a risk in the product itself, but also a potential breach of trust in those who are supposed to solve a patient’s problem. Those who neglect the need for an effective QMS within their organization underestimate the dangers of doing only the bare minimum to meet initial FDA approvals, without really “assuring” and “controlling” the quality of the product they bring to market.
In my career so far, I’ve been fortunate not to meet anyone with that mindset. Most of my mentors across the functions I’ve worked in stressed the importance of sparing no expense in maintaining quality. At times, my employers even launched full initiatives, beginning with their “guiding principle,” as you put it in the lecture, toward QA and QC. These included mandatory training sessions for managers that examined leadership issues tied to poor quality and performance. Managers would then bring those lessons back to their teams, which motivated us — myself included — to uphold a high standard of quality, even in the smallest tasks that contributed to the larger Quality System.
I have also gained some insight into what leads to this mentality in courses teaching Total Quality Management (TQM), despite emphasizing leadership and culture more than product development. One lesson from that course stood out: an organization's performance can often be traced directly to its executive leadership. Specifically, company culture and accountability trickle down to every employee, shaping both internal and external outcomes. This is why employers must invest in what we call “organizational excellence,” reflected in standards like ISO 9001.
With this in mind, leadership needs to foster a mindset that not only complies with but exceeds regulations such as ISO 13485 and the FDA’s 21 CFR 820. Doing so not only strengthens QMS implementation but also builds a culture of continuous improvement that prevents risks before they reach customers. Ultimately, quality should be seen not as a burden, but as an investment that safeguards patients and ensures the long-term survival of the company.
The "Cost of Quality" truly makes it clear to me that QA/QC isn't just a department that slows things down; rather, it's a kind of insurance for the entire business. Yes, it costs money to hire Quality Engineers, create documentation, and put approval processes in place, but these costs are predictable and under your control. On the other hand, the consequences of ignoring quality assurance (QA) can be disastrous enough to completely shut down a business and include unpredictably occurring litigation, recalls, regulatory penalties, and reputational harm. Indeed, I would contend that QA/QC contributes to the development of a responsible corporate culture. They guarantee that products are not only manufactured to satisfy regulatory requirements but also to safeguard the end users who rely on them by emphasizing documentation and inspections. Even a life-saving product might not make it to market without this scrutiny, or worse, it might hurt patients once it is on the market. Such failures can have repercussions that go beyond money, affecting not only the company's reputation but also the industry at large. Do businesses occasionally undervalue these indirect costs of subpar quality, such as the erosion of client trust or reputation? That, in my opinion, is among the most often disregarded effects of not prioritizing QA. It's also intriguing that folks occasionally lament that QA is a hassle. This, in my opinion, stems from a short-term mentality that values cost reduction and manufacturing speed over long-term stability. Those individuals might not be aware that QA provides benefit that isn't always immediately apparent. For instance, even though it may not appear like an instant "win" on paper, a corporation can save millions of dollars by averting a recall or identifying a minor flaw before it spreads. This raises the question of where efficiency and quality should actually be balanced. Is it feasible for a business to prioritize both, or does one usually take precedence over the other?
