As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have you had a chance to work with or in QA/QC that and had a chance of perception?
How important do you think QA/QC department are in a company, and why?
I think that they are the most important departments for the simple fact that if they didn’t exist, a lot of flawed products would make their ways to patients resulting in harm and even death. Moreover, the Quality department ensure all documentation is done properly, without the right expertise in documenting work performed, a great lifesaving product might not make it to market. Both cases would result in significant financial loses for the company and even lead to a company going out of business.
Just as important as the planning phase of any project or product, the quality of said product or project is vital. Without a quality assurance or control team, a medical device could be faulty without the attention or knowledge of the physician. This would then lead to either a misreading of important vitals or a malfunction of the device. In either situation, the faulty device could cause an early or unwarranted demise, multiple law suits, and a loss of finances for the company, not to mention a stain on its reputation. Any of these results are clearly unwanted, however, they can all be avoided with the presence of a quality control/quality assurance team. Before the lecture, I deemed quality control very important; this is still my consensus afterwards.
Quality management is a vital part of businesses, especially those that deliver products that could affect an individual’s health like those that come from the biotechnology industry. Medical devices and drug components all rely on the nature of QA and QC. These two can be different, but are equally necessary. Quality assurance can be described as process oriented and focuses on preventing defects, while quality control is a bit more product oriented and focuses on identifying defects.
As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have you had a chance to work with or in QA/QC that and had a chance of perception?
How important do you think QA/QC department are in a company, and why?
I think that they are the most important departments for the simple fact that if they didn’t exist, a lot of flawed products would make their ways to patients resulting in harm and even death. Moreover, the Quality department ensure all documentation is done properly, without the right expertise in documenting work performed, a great lifesaving product might not make it to market. Both cases would result in significant financial loses for the company and even lead to a company going out of business.
The whole Quality Unit is critical to the success of a company. The overall plan of a medical device can be present while the device is being manufactured, but the success of the final product, and the adherence to GMP in some cases, is based on the QA/QC team. SEveral problems could occur during the manufacturing process if the proper procedure for regulation compliance is not made clear by the Quality management hierarchy. It is up to the QU team to make sure good products are being made to benefit the patient and to have their best interest in mind.
On occasion, I passively thought the two roles were the same. Until I had opportunity to do QC. There is a clear delineation between the two. QA sets the policy and framework, while QC ensures its implementation and execution. Both roles are distinct and equally important. As it became my opinion some years after QC responsibility that for a company to sell its products, specifically enterprise-level products, the products must work 70% of the time.
Now there are exceptions to this statement, and some products must work 100% of the time – no exceptions! Ultimately, my point is that customer service cannot be over-run with dissatisfied customers, which will be the case if you exceed a 30% product failure rate. Therefore, I agree that QA and QC are critical. A company does a major disservice to itself if they “skimp” on QA/QC.
The QA/QC field and positions within a company shape the success of a product on the market. This field has always been described to me as the lazy role in the company that gets paid to stand around and do nothing. After this course and being able to work in the field, I understand that this role holds major importance for a company. I have been able to work as a QA tech in a meat packaging company before. The assembly line workers were skilled in their tasks, but they were only concerned about product numbers. They were tasked with getting the right amount of meat out the door on time, but the quality of the product was not always satisfactory. As a QA tech, I was able to catch the unsatisfactory product and send it back before it was shipped from the warehouse. This may cause frustration to other workers, but it ensured that the correct quality of the product was leaving the warehouse. If a product reached a store and they did not want it based on quality, then that could mean great financial loss for a company. The QA/QC department is one of the most important for a company to ensure the correct product is going to market.
QA/QC plays an important part in ensuring the correct product makes it to market for consumers. I agree that this carries high importance similar to the planning phase of a project. The imperfections in production may be discovered too late if quality assurance and control were not available. This department serves as a second check on the product or device that is being created for the public. Putting out a faulty product can cost a company millions and can cause life-threatening harm for others at times. I find both quality control and assurance are needed to aid in the success of a product.
To be completely honest, I didn't know Quality was an area I could work in as a BME let alone that a department like Post Market Surveillance existed until I received my offer letter to intern in said department. So I didn't have much background to make a judgement on the sector except that it contains a lot of paperwork. I can say it is definitely an important department to have and can also be a complex one as within Quality there are many sub sectors such as Reliability Engineers vs Advanced Quality Engineers vs those who support the manufacturing floors. What they all have in common are that they improve the device development process and institute checks and balances to ensure additional time and money is not wasted on defective products. They also use their findings to improve new designs in the initiation phase to avoid any repeats of mistakes and further errors from occurring that can be easily avoided. While it is a lot of paperwork, there are other aspects such as inspecting products and assisting the manufacturing floor depending on what specific Quality department you support.
As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have you had a chance to work with or in QA/QC that and had a chance of perception?
How important do you think QA/QC department are in a company, and why?
I think that they are the most important departments for the simple fact that if they didn’t exist, a lot of flawed products would make their ways to patients resulting in harm and even death. Moreover, the Quality department ensure all documentation is done properly, without the right expertise in documenting work performed, a great lifesaving product might not make it to market. Both cases would result in significant financial loses for the company and even lead to a company going out of business.
I agree that the Quality Engineering department (QA/QC) is incredibly vital to any medical device company. After this lecture, and speaking to several quality engineers where I work, I think I was able to gain a better understanding of the critically important work that quality engineers do. From my understanding, Quality engineers serve as the ongoing last line of defense to protect the integrity and validity of a product during its entire lifecycle. Mistakes in R&D happen (Which is something I encounter almost on a daily basis as an R&D engineer) and quality is a lifesaver by checking everything to make sure that all the work that is done is up-to-par and working accordingly. I think speaking to quality engineers and listening to the lectures helped me to better understand and appreciate the work that quality engineers do. Prior to these experiences, I didn't have much of an idea of what quality engineers did and underappreciated and undervalued the work that they do.
I recently spoke to a design quality engineer at work and he described his job as having 2 sides: statistics and detective work. Statistics is about confirming the work done by new product development engineers and detective work is what happens when a non-conformance or investigation finds there to be a problem with a product. This problem is then given to him to try to figure out why it comes about... is it the supplier? is it the process? what is causing it to happen? These questions and many others help the engineer design and run studies to answer these questions and create learnings about why things happen, how to improve them, and how to prevent them from happening again.
Does anyone have any similar experiences or thoughts about how interactions with quality engineers has changed their perspective of the work that they do?
Thanks,
Matt
Quality assurance engineers are rock stars of many project teams in their way of adding rails to a project and know when to tell engineers when to hit the breaks. They are the literal phrase of dotting your I(s) and crossing your T(s) in designing medical devices. I consistently work with our quality team when I draft testing documentation to make sure that they are aware of what is occurring within my branch of R&D and if they have any concerns associated with risk. I've also seen their responses for audits and their diligence in project meetings to remind some of the design engineers which documents are needed for project advancement.
To answer Matt's question, I think attention to detail is something that has grown with working with QA. They always find the smallest mistakes when reviewing any of my documentation so I've made more of an effort in my career to try to flush out any grammar or small errors before sending it to their attention. I've also adapted a way of trying to think of projects with a risk association when determining my statistical approach towards sample size calculations and equivalence tests in non-verification activities where statistical analysis isn't required (at least at my current company)
Without a doubt QA/QC is the most important aspect of the medical device development process. Of course, there would be no quality control if there is no R&D or product development process. However, a product idea is just that, an idea. Without the proof that a product is consistently safe and effective it is not a fully functional product. No amount of prior research and development matters if a product can not pass safety regulations. Additionally, QA/QC is a continuous effort for the entirety of a products lifetime while for the most part other departments can turn of their responsibility.
I currently work in R&D and have not worked in QA or QC role. In R&D, because we are focused on improving or creating new formulations and not making the product that gets released, we do not always have to do all the testing that goes into the released product like sterility tests nor do we have to complete any of the release paperwork. However, despite not having any experience in being part of the quality team, I have seen that the QA/QC department is critical in making sure that the product being released to the market is consistently safe and effective for use. If a product does not pass QC testing, then it cannot be released for commercial use. Moreover, if the proper documentation is not completed and by GDP standards, then commercial release is also delayed.
Qa and QC departments are necessary to have for large companies. The purpose of a QA is that the provide a road map, a guide to how the company and projects will run. It creates a code of conduct, gives structure, and creates order. I think without this, a company would be very all over the place, not have a clear set vision of what they want to do nor how they will do it.
Additionally, having both help keep like a balanced system. The QA sets the standard while the QC makes sure the standards are met and above. Having a QA helps to avoid any issues in a game plan while the QC would test the products to avoid any issues. It’s a balancing effect between the two because without the QA a company wouldn’t have an outline to follow and without the QC the company wouldn’t have someone to check and correct.
Taking this class has opened my eyes to how much a company really relies on making sure things are done in and order and that order is met, and without this, it could be very messy when it comes to a recall, checking an item, or making sure a project gets done.
Quality is an important factor when it comes to any product or service. With the high market competition, quality has become the market differentiator for almost all products and services. Quality control is essential to building a successful business that delivers products that meet or exceed customers’ expectations. It also forms the basis of an efficient business that minimizes waste and operates at high levels of productivity. A quality control system based on a recognized standard, such as ISO 9001 published by the International Organization for Standardization, provides a strong foundation for achieving a wide range of marketing and operational benefits. Therefore, all manufacturers and service providers out there constantly looking for enhancing their product or service quality. In order to maintain or enhance the quality of the offerings, manufacturers use two techniques, quality control, and quality assurance. These two practices make sure that the end product or the service meets the quality requirements and standards defined for the product or the service. There are many methods followed by organizations to achieve and maintain the required level of quality. Some organizations believe in the concepts of Total Quality Management (TQM) and some others believe in internal and external standards. The standards usually define the processes and procedures for organizational activities and assist to maintain the quality in every aspect of organizational functioning. When it comes to standards for quality, there are many. ISO (International Standards Organization) is one of the prominent bodies for defining quality standards for different industries. Therefore, many organizations try to adhere to the quality requirements of ISO. In addition to that, there are many other standards that are specific to various industries. Since standards have become a symbol for products and service quality, the customers are now keen on buying their product or the service from a certified manufacturer or a service provider. Therefore, complying with standards such as ISO has become a necessity when it comes to attracting customers. Every organization that practices QC needs to have a Quality Manual. The quality manual outlines the quality focus and the objectives of the organization. The quality manual gives quality guidance to different departments and functions. Therefore, everyone in the organization needs to be aware of his or her responsibilities mentioned in the quality manual. Quality assurance revolves around the process of manufacturing. QA is proactive: it deals with all activity associated with building a product. The role of quality assurance is to ensure that the production protocol is going according to plan. Quality assurance is a safeguard against production error and thus occurs before any quality control takes place. QA can be overseen by a company manager, client, or third-party representative. Project audits and methodology/standards development are forms of quality assurance. While quality assurance emphasizes the manufacturing process, quality control focuses on the product. Quality assurance is proactive, while quality control is reactive, identifying errors and figuring out how to best remedy them before the product goes to market. Quality control can involve inspection, testing, reviewing, and analysis. Ultimately, the quality control specifics are determined by the product’s unique features and functions. For instance, quality control for an automobile differs from quality control for a cosmetic product. QC is usually performed by a quality control inspector or a designated team. Having quality assurance in place helps companies maintain high standards of manufacturing. Quality control ensures that the final product reflects these high standards and satisfies the customer’s needs. Incorporating both quality assurance and quality control into production helps companies save time, money, and resources. Evaluating the caliber of an operation as well as the resulting products is a constantly informative undertaking. By thoroughly monitoring how a product is made and the ensuing result, companies can better understand where they should be allocating their attention and resources to. Manufacturers with a solid track record of delivering both quality assurance and quality control have faster turnaround times, durable production procedures, and loyal customers. Quality assurance and quality control are paramount to an organization’s long-term success.
Prior to this course, I saw QC/QA as a nuisance and believed most companies conducted them to "check the box" and not really correct any errors found. I have a friend who owns a clothing brand we were talking about one night and he was explaining to me how much time and effort he puts into QC and ensuring the best product is put out. He also discussed with me how important it is and how emphasizing this portion of his business has helped his business grow. This conversation changed my perception to a degree, while i know some companies don't care for QC, those that do it show in their product and brand longevity. I think QC departments i vital and when leveraged and utilized properly can change the trajectory of a company. Part of QC is listening to constructive feedback from customers and consumers, they literally tell you what is wrong and what they would like to see, it doesn't get much more straightforward than that.
