This is a great discussion to have! Yes, quality is costly. However, it is important to determine whether or not your company wants to invest in preventing later complications or attack them as they come. I understand that the developmental stages of a new medical device or service can be rather expensive, but does this exempt the need for mitigating risks? There is a risk in waiting for complications as opposed to preventing them. By improving quality and contributing to the quality control process, companies could actually lower costs significantly. This allows companies to focus on assuring quality throughout the development process.
Cost of Quality is the upfront cost for a guarantee in good faith practice for a product. The integrity of your brand is the reputation you have with your loyal customers. As a former quality lab technician for a food ingredient company, I understand the company's burden and consumer expectations. No one wants to be sued and lose their business for taking shortcuts on quality, yet it happens more often than you think. I am not sure of the people who are complaining about good quality and the burden however, you will hear complaints if a product is of poor quality.
From a cost side managing the burden of the bottom line and profits is one to be met with ethics, company value, and client-customer expectation. A core value for the company I worked for was safety first. From that core value, the mission was for every employee to every customer we put safety first. That means hiring a quality engineer, having an outside consultant for quality assurance to analyze the company’s quality control protocols. The added measure of specialty band-aids that could be detected by a metal detector so that if it was accidentally mixed into a product, it would not end up in someone’s products is the cost of quality. Every small step to reduce risk is an investment cost that will yield a far greater return and longevity for your company.
My dad always tells me that you get what you pay and prepare for. I use this advice in everything that I do and believe many people should incorporate this in how they maneuver throughout their work and personal lives. I do not believe quality is a burden if it prevents or mitigates sentinel events. At the beginning it can seem like a burden because many do not want to address that idea of some things not going as planned or use funds for a hypothetical situation; however, I believe that those who prepare harder at the beginning have a better outcome than those who bypass the planning and preparation process because as mentioned in the initial response, the company in the second scenario was able to recover from the problem whereas the first company was not and lost everything.
There are some aspects of the quality process in industry that I could understand how people may see it as a burden but overall, I do think it is extremely necessary and worth it. It shouldn't be considered a burden or waste of money/resources because, without these methods of assurance, there could and likely would be big trouble for a company. Building a system to ensure quality can be expensive and time-consuming, but the repercussions that can come from lawsuits and recalls are surely much more expensive and can be detrimental for a company. So to those that think the Quality process is unnecessary or burdensome, I would challenge them by asking whether they would prefer to have a lawsuit! Issues with the product, labeling, applications, etc will always happen but if there is a Quality Unit in place (QA/QC) these issues can be caught before any of the circumstances become too large for the company to handle and, if lucky, even gets out to customers. The quality department is integral to a company and all of its functions. Personally, I believe that those who complain and say Quality is a burden must not be too well versed on regulatory requirements and the importance of following them.
Yes I can see how you may look a quality as overrated.But it is every essential if you want your company to keep striving.you should look at quality as your front like of defense when it come to your product that you are producing because they are the ones that are going to let you know what is good and what is bad.which can prevent you from paying millions in damages and going out of business.
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?
I think this situation is the reason my father used to tell me, "its better to have and not need, than to need and not have." Quality Engineers are the gate keepers to the success of a business and without them, companies run a huge risk of losing more than they bargained for. Quality engineers are the people within a company that establishes processes that a company needed in order to optimize manufacturing and costs. They are also individuals who investigate the initial causes of problems and creates a corrective and preventative plan of action. It is necessary and vital for a company to invest in people who are qualified in protecting them and helping them to produce products that maintain the integrity and safety of its product.
This is where the phrase "Proper Preparation Prevents Poor Performance" comes into play. It is a necessary department to have when Murphy's Law goes into effect. QA/QC are vital processes in the developmental pipeline and as much as people love to gripe and complain about the department, they're usually saving the company's you know what when things hit the fan. I'd take the burden of having to re-start a project over due to a bad batch or contamination than a multi-million dollar lawsuit that could lead to bankruptcy. It's a necessary burden and one that quite literally could save the future of a company when FDA approvals are at play. QA/QC helps mitigate small issues before the become major problems that could turn into warning letters from the FDA or even worse, project shutdown. Departments like QA/QC have to be put in place to ensure product control and quality remain precise and accurate for each batch produced. Once a company becomes known for producing less than quality products, who would want to purchase or even use something known for it's below average or nonexistent QA/QC department? Certainly not any reputable biotech or pharmaceutical company.
@reshamn I completely agree with you. Quality in my opinion can be summed up in one word...Integrity. It's literally the integrity of your company. Essentially what you do when the customer isn't looking. The Quality Department of a company must operate at a high and efficient level to mitigate costs, but it is absolutely necessary. For example I once worked for a large water company that will remain anonymous. This company had a troublesome Quality department for a number of years from what I gathered. During my time there, we had to recall several batches of water and even made the news a few times. It was awful. I worked in the lab as a microbiologist and unfortunately many of the other lab workers did not have a scientific background nor did they take positive samples from the tanks seriously. It was more of a mundane routine to them. Just plate the samples and dump them each day instead of actually reading whether cultures had grown or not. Had we all reported the positive cultures regularly we could have saved the company millions of dollars in lost supply. I recall the company having to stop shipment to California in the middle of a drought during the summer which was just terrible and ridiculous. I ultimately resigned and decided to return to academia, however, the thought of no checks and balances in the quality department regarding something as vital and precious as the water we drink was completely baffling to me and quite the corporate shock to say the least.
@cmassah15 I agree with your point of view on this topic. Consumers put their trust in businesses that are creating products for the marketplace. That trust is broken when shortcuts are taken and the consumer isn't aware until the deception is revealed. In the scenario you posted, its unfortunate that the shady dealings of your last company made you feel like changing your career path. Employers expect employees to remain loyal to the company even when they are not following proper procedures and that's not justifiable in any situation. Integrity should never be challenged against loyalty. At that point, it becomes a matter of morality and doing what's right.
I used to work for a company that tested medical devices before they got sent out to clients. Companies would send samples from their lots to test for microorganisms, bioburden, endotoxin, etc. Often times we would get samples that had problems with them such as hair inside the device or missing pieces and things of that nature. Would often laugh amongst ourselves as to how the companies could have missed that. Those types of things should have been caught by their QA/QC departments, especially when we saw the same problems with the same clients reoccurring. However, we also had a QA/QC department looking over our work. We often find found it very tedious and annoying to have to fill out paperwork and make adjustments a certain way. We were forever in fear of being audited either by the FDA or internally. Often I find that the hands-on workers at a company have the most hated relationship with regulatory matters but also have the highest impact as they are the ones designing/manufacturing the product.
It seems that in both situations there is a cost, but in the situation of no QA/QC there is also the matter of reputation on the line. It looks worse in the media to send out a product to people and not test how it would inevitably affect them once in production. There is more to lose when the chance to check is not taken seriously. On the topic of Quality being a burden, it may be during the process but it becomes worth it in the end. Quality can be ‘nit-picky’ on many details concerning the design and regulation. They can question each part and want a reason for why certain procedures, parts, and machinery are used. Then goes the documentation and budget to complete all these tests. It can be very tedious and burdensome. But overall, it’s better to find an issue with the product from someone within the company who has the resources to fix it rather than an injured and angry consumer that would try to take the issue to court. Quality checks may be a long and expensive procedure but overall it ensures that the company can release a product in its best condition and with the confidence to have their name attached to it.
This is a really great post! I agree with everything you said. Some people like to take the easy route in everything they do. However, what these people fail to realize is that taking the easy route most of the time is only beneficial during that specific moment. In addition to cutting back on costs (e.g. hiring employees, purchasing better materials, etc.), companies may also attempt to cut back on time for completing and releasing their products, which can result in lower quality products as well. I think that if companies were to spend more money hiring reliable and knowledgeable employees, as well as allocate more time for the proper completion of a project (with sufficient quality control and regulatory checks), they’d lower the risk of faulty products substantially. As a result, they would also lower the risk of the company failing. Some may argue that spending extra time and money on product development causes delays and less profit for the company, but in reality, this extra time and money puts the company in a better position for success that will ultimately cause its expansion and higher profits. Will taking extra steps and spending more money to ensure efficacy of medical devices cause setbacks in product development? Probably. However, these setbacks are minor compared to those a company would face if a product were to injure a customer. The concept you mentioned is apparent in nearly every company, and even in daily living. I’ve had several experiences where taking the easy route wasn’t as beneficial as I thought it’d be. How many times have you decided to take an easy route and faced some consequences from your decision?
To give some insight to the prior posts question, there was a time this summer during my internship that I witnessed someone take the easy route and face consequences later down the road. This past summer I was an intern at a civil engineering firm, a field I knew very little about as I studied biomedical engineering in my undergrad. Part of my job was to go to job sites and inspect the work being done in compliance with the set plans for the construction. Early in my internship I was inspecting a crew putting sanitary sewer pipe on a job site for apartments to be made. The sanitary sewer piping is the first pipe put in on a job site since it is the deepest pipe on the job site, therefore it is crucial that it is at the correct depth for future work to be done. In this case, it was getting towards the end of the day and the crew was about ready to go home but needed to insert one more run of sanitary pipe. Instead of ensuring the work was done correctly and complied with the plans, they eyeballed the depth of the pipe and put it in to end the day. A couple weeks later I was on the same job site with a different crew that was to put in storm water pipe, that sits above the sanitary sewer piping. As you could have guessed when that crew reached the area where the prior crew did not carefully measure the depth of the sanitary sewer pipe there was an issue. The new crew had to stop their work for the day and spent the entire day fixing the prior mistake. Obviously this cost them time and money to fix a prior mistake rather than continuing their work they were responsible for. This example may not pertain to medical device development, but it allowed me to experience the consequences of taking the easy route rather than making sure the work was done with quality. This also pointed out that in projects when one person takes the easy route this may not just effect them, but also everybody else later down the road. When you notice someone taking the easy route how should you go about making sure it is done correctly?
The example Dr. Simon shared truly reflects the importance of QA/QC. Given I work as a clinical engineer who provides imaging services, I would like to share another perspective - this time on the impact a lack of QA/QC can have on a patient since my position is more so focused on post-market surveillance as opposed to a traditional quality assurance role that everyone might be more used to which is at the pre-market stage where manufacturers of these imaging equipment, such as GE, Siemens, and Philips, focus on the prevention of defects at the process level. As someone who works in the healthcare sector to maintain the quality assurance of imaging equipment, it is my responsibility to ensure each patient receives the same high level of care and that hospitals and/or clinics can sustain a normal workflow efficiency. In addition, my position does also include aspects of quality control given I regularly perform corrective maintenance on imaging equipment and must be reactive in identifying defects. Imaging is commonly a part of a clinicians medical decision making process, therefore if any of the equipment being used is not in compliance with the manufacturer's standards and a regulatory agency's requirements there is the potential to do more harm than good - either through a misdiagnosis, missed findings, or putting the patient at risk due to unnecessary radiation exposure. So the cost here is beyond financial loss but a patient's life.
The concept of the cost of quality is very important and applies to every company in the healthcare field. This concept is particularly important when maintaining quality requires a commitment of money and time. I would like to mention that while the initial post mentions how not having a QMS in place will affect the company monetarily in the long run, a more important factor that should be the motivation behind having a system in place is to ensure the safety of the patient and consumer. Whenever you hear about product recalls or unknown side effects of medical devices or drugs, the most common reason is that the company most likely cut corners while doing their quality checks. This lack of thoroughness and focus on detail can result in severe harm to patients. This is why the financial benefit in the long run is not the main reason why the cost to have thorough quality processes is worth it, being able to ensure the safety of the consumer is a major reason to have a proper quality system.
