A manager overseeing the process development would be in charge of quality assurance, which would be accomplished through audits, checklists, and standard procedures. Quality assurance could be viewed as a more proactive approach to fault prevention. Quality control, on the other hand, is carried out by a dedicated staff tasked with evaluating the product and ensuring that customers are happy in the absence of flaws. The goal is to eliminate quality issues at their source, which is a continuous process.In my opinion, the transition from quality assurance to control should be fluid and rather efficient. Although their tasks may differ, they both have the same purpose in mind: to ensure that the product is of the highest quality. There would be a lot of training, but you'd have to make sure you taught them what to look for and how to exploit the product for problems in order to fix them. With control to assurance, you'd have to help ensure that they're trained to check the process by which the product is manufactured to ensure that it's of the highest quality.
Quality assurance is a set of activities and procedures that continuously occur during the product development phase. The team members must work together to discuss, plan and execute tests to ensure product quality. It has many moving parts and must continually evolve with the product standards.
Quality Control ensures that the developed product meets the standard set by the organization through identifying errors, testing against requirements, and documenting the issues. This is an important job because if they release a product without completely verifying it, it can potentially ruin the reputation of the company.
From the definitions themselves it seems that it would be easier to move from Assurance to Control because Assurance holds a broad job because there are many parts involved in the role of creating a device. While Control deals with the device afterwards, once it's already been made, and works to find any issues. Quality Assurance is a proactive job role while Quality Control is a reactive job role.
QA often deals with the set-up of a product so that it meets quality standards. They give detailed information as to the overall dimensions of the product, how it will function, and for what purpose it will serve the consumer. Some training in QA can include learning how to define processes and knowing how to execute a quality audit. QC ensures that the product will be manufactured and function as it should. This includes calibration of the dimensions and performing testing of the product. Some training in QC can include certifications in self-assessment and having a general understanding of statistics. I believe that QC would have an easier transition into QA because they already have hands-on knowledge of the product while QA has to learn how to assess the problems that could arise when during the production process.
As per this week's lecture, QA is preventative in nature meaning it is a proactive approach to identifying issues in a process that prevent a product or service from meeting user and/or regulatory requirements. QC is more so a reactive approach to ensuring the result, whether that be a service or product, meets standards.
What types of training are relevant to each and how could they differ?
Traditionally, in the medical device industry, QA takes place during development versus QC which is post-development. A relevant form of training for QA is in ISO13485, design controls, and/or includes auditing (planned inspection to report non-compliances in a business's process) or Six Sigma (a quality management system to help a business improve current processes by eliminating defects). Conversely, QC is focused on identifying and isolating defects on individual products and so it requires personalized training on what to look out for on a case-by-case basis depending on the product.
What types of jobs would each of these people have?
I believe there are opportunities in any company/industry that provides a product or service.
In your opinion, is it easy to switch between these roles? Why or why not?
I believe it can be easy to switch between the roles as long as you abide by the same quality systems and use the same tools and techniques to ensure quality.
Is switching in one direction easier than switching in the other (QA to QC, vs. going from QC to QA)? Why or why not?
Again, speaking from a traditional perspective, QC to QA would likely be a more challenging switch because QA occurs while a product is still being developed, therefore, the types of defects that could arise are still largely unknown/unaccounted for.
I agree that the quality assurance role seems to be more about the research on the devices and how they should be properly made/checked focusing more on the paperwork side, and quality control would handle the hands-on side. I think that in most roles in life when people complete the paperwork and set the expectations of how these devices should be created and inspected, the more hands-on work you have in the field the better your protocols will be. Having both technical knowledges of the FDA standards and on-the-floor knowledge of how to measure and inspect would make you very well qualified to be a quality assurance engineer. The same would hold true in the opposite way but switching from control to assurance would be easier than switching to the other way. If you were a quality control engineer and also had knowledge on FDA regulations or the regulations of the country you are selling the product in, that would add immense value as well to your role. That would give you the ability on the fly to address problems that may not have been foreseen, without needing to go find someone works in quality assurance before generating ideas to help solve the problem.
Many people use the terms quality control and quality assurance interchangeably, though they have key differences that distinguish them from each other. Quality assurance is a set of activities that can be performed while designing or developing a product to ensure quality which occurs throughout the making of the product. In contrast, quality control is a set of activities that allows for checking the quality of a manufactured product or project deliverables and identifying any defects with the finished product before distribution. Moreover, the orientation of those is also different. The QA is process-oriented, and QC is product oriented.
The difference between quality control vs. quality assurance is the activities involved. Quality assurance focuses on providing the confidence that you can fulfill quality expectations. In comparison, quality control focuses on fulfilling quality expectations. Quality control is product oriented while QA is process oriented. I think it would be more smother to switch from QA to QC. Though it is very much possible to switch between the two sections, QA is involved in the quality management system that provides additional experience and benefits.
Quality Assurance (QA) and Quality Control (QC) are integral components of product quality management, though they approach it from different angles. At its core, QA is proactive, emphasizing the prevention of defects by establishing robust processes and systems. It sets the stage for products or services to meet predefined standards by developing quality management systems, conducting audits, and ensuring regulatory compliance. On the flip side, QC is more reactive, directly inspecting and testing products or services to determine their adherence to specified requirements, thereby identifying and rectifying defects. From a career perspective, these differences manifest in distinct roles and responsibilities. Someone in QA might serve as a Regulatory Affairs Associate or Manager, delving into regulatory compliance and system development. Meanwhile, a QC professional could be a Quality Control Analyst or Technician, concentrating on hands-on testing and inspection. Although both areas might require a foundational degree in a relevant field such as engineering or science, specialized training often diverges. For instance, a QA professional might benefit more from a Regulatory Affairs Certification (RAC), with training in regulatory standards and quality systems. In contrast, QC personnel may delve deeper into statistical techniques and specific testing methodologies. Transitioning between QA and QC isn't necessarily straightforward due to these distinct skill sets. Nevertheless, in smaller organizations where the lines might blur, there's a possibility for overlap, enabling easier role transitions. Speaking from personal experience, having dabbled in both realms, I've observed that a broader understanding of quality management, gained from experience in both QA and QC, can significantly enhance one's career trajectory and versatility in the industry.
From my understanding QC and QA are very different but they kinda have the same function as during my working as QC/QA intern at pharma company and manufacturing associate at another one . I was doing investigations in the first one and in what I saw is the QC are the ones who the SOP to follow and are the scientists to check for the products during HPLC and dissolution tests and so on while the QA are the brains for the company or have the archives for every LIMS worksheet. However, in another pharma company, the QA are the ones that have direct eyes in the logbooks so they are kind of the brain of the procedures of the manufacturing process but they are kind of making the company more conscious about the process. It isn't just the company making one person doing the process but making other persons like verifiers as well as QA to minimize the mistakes. Switching from QC to QA is easier than otherwise as QC is lab work and it takes multiple training to actually do it while QA is kind of the experience as well as the knowledge of QC. Moreover, QA is more about paperwork which the person would excel at after working with QC. I think The training of QC is going to be GMP and GDP along with the lab equipment while the training of QA is more about regulation and how to make deviations and CAPAs.
Quality Assurance and Quality Control are similar processes, but both are needed to ensure medical devices meet quality and regulatory standards. Quality Assurance (QA) is a more proactive process that focuses on the method of device production and works to prevent any issues that could cause the devices not to meet regulatory standards. Quality Control (QC) is a more reactive process in which devices are checked to ensure no flaws during the production process.
In theory, if the QA department is successful in fine-tuning production processes, then the QC department should have less work because there would be fewer devices that suffer from production issues. However, in the real world, there are many aspects that are very difficult to control that can result in production flaws, so active QA and QC departments are needed. Do you think that an individual can work in both QA and QC simultaneously or should the job be split between two individuals?
Hello,
QA and QC are two distinct facets of ensuring product quality, each with unique responsibilities and career trajectories.
Quality Assurance (QA) primarily focuses on the development and implementation of processes and systems to prevent defects and ensure that products or services meet quality standards. Training for QA roles often involves a strong foundation in quality management systems, regulations, and standards like ISO 9001. Relevant positions in QA include Quality Manager, Quality Assurance Specialist, and Compliance Officer. These roles require skills in auditing, process improvement, risk management, and regulatory compliance. On the other hand, Quality Control (QC) centers on the inspection and testing of products or processes to identify defects and deviations from quality standards. QC professionals are trained in testing methodologies, statistical analysis, and the use of testing equipment. Job titles in QC include Quality Control Inspector, Laboratory Technician, and Test Analyst.
Switching between QA and QC roles is possible, but it may come with certain challenges. Transitioning from QC to QA can be relatively easier because QC professionals often gain a solid understanding of the products and processes they are inspecting, which can be valuable when designing effective quality management systems. However, it may require additional training in quality management principles and regulatory requirements. Conversely, moving from QA to QC might be a bit more challenging because QA professionals are often more involved in process design and compliance management, and they may need to acquire hands-on testing and inspection skills.
Quality Assurance (QA) is assuring that specific procedures and protocols are being conducted properly to avoid any possible errors that may ruin the production of a device or a results of a specific study. Quality Control (QC) are procedures that ensure a product is safe and usually follows after QA. I have only worked alongside QA but I believe the two positions are very easy to switch into from both directions. My question to everyone is which role do you think would serve better as an entry level position.
Quality assurance is responsible for establishing - defining, documenting, maintaining, implementing a QMS. In other words, quality assurance sets up the system, monitors the system, and fixes it. On the other hand quality control receives the results and checks whether the product meets the defined quality assurance criteria.
Regarding the explanation I gave above, I guess it's easier to go from QA to QC than the other way around . Also, I think a QA definitely needs more experience to handle the job properly, because the QA person has to think about the minimalist details that the product can have, create all the methods and make sure everything is in line with FDA and regulatory requirements.
QA is a proactive process that seeks to prevent defects from occurring within the product development process. QA designs the processes and improves upon them to maintain quality. On the other hand, QC is a reactive process that identifies and corrects defects after they have occurred. QC performs inspections and testing of finished products to verify that either the product has met or has not met its standards.
While someone in QA may complete ISO training to understand the standards that are to be adhered to, someone in QC should be exposed to training for using various measuring instruments and metrology practices. Some potential titles one could have working in QA include QA Engineer, Validation Engineer, and QA Auditor. In QC, the titles of QC Engineer and QC Technician can be held.
Since QC and QA are closely related and work with one another, I think that switching between QC and QA is probably more manageable than switching between other, very different departments. If I were to switch between these two departments, I would probably choose to switch from QC to QA. Experience actually identifying defects in products would be valuable to bring to a QA role, as it would give you a better perspective of the repercussions of flawed systems and processes.
QA focuses more on preventing defects by observing the process that involves the development of, lets say a device. QC is about detecting defects on the final product once it is finished. One involves training in studying the processes behind making the device to understand where there could be issues. The latter involves training in testing specific attributes of a device. I feel as if QA to QC would be easier since you're going from understanding a process to a specific testing. On the other hand it would be more complicated to understand QA as it is more broad and requires understanding a bigger process.
