Explain the difference between QA and QC, and think about the differences that each of these have as a career. For example:
What types of training are relevant to each and how could they differ?
What types of jobs would each of these people have?
In your opinion, is it easy to switch between these roles? Why or why not?
Is switching in one direction easier than switching in the other (QA to QC, vs. going from QC to QA)? Why or why not?
Spiral Medical Development
www.spiralmeddev.com
In my experience working in a regulated production setting, the QC and QA teams have existed essentially as two sides of the same quality coin. Quality control typically proactively executed their duties during production alongside the production team, ensuring the quality of the production process and products, while quality assurance generally took place after production, but (ideally) before the final release of the product or service. QA sought to (somewhat reactively) identify and remedy quality issues in the production process or product.
In my opinion, it is relatively easy to switch between the roles, though I would say it is easier to go from QA to QC than the other way around. Though the specific duties of each role are different, the foundational knowledge and ultimate goal are similar. I'd say that while at minimum QC personnel only need to understand the procedures relevant to their position, QA personnel need to have a more systems-level understanding of the entire process, along with the implications and the regulatory considerations of the quality process, to include the responsibilities and actions of the QC team.
Quality Assurance would be in the hands of a manager over seeing the process development, they perform assurance through ways of audits, checklist and standard procedures. Quality assurance could be seen as more of a proactive procedure to prevent defects. While Quality control is used by a specific team responsible for testing the product and keeping customers satisfied from defects. Eliminating quality problems at the source is the goal and are genuinely on going process.
In my stance I see the potential of switching from quality assurance and control should be fluid and relatively smooth. Maybe the roles of both different but they have a goal of making sure the product is of top quality. There would be a extensive amount of training, but with assurance you would have to teach them what to look for and how to exploit the product for defects in order too remedy them. With control to assurance you would have to help ensure train them to inspect the process of which the product is made for peak quality.
From my reading I have found that the Quality Assurance (QA) lead in a medtech or pharmaceutical company is tasked with:
- providing support during the new drug or product development stage from late stage feasibility the transfer into commercial or clinical manufacturing (every stage of the process).
- Review and approve design control and risk management activities.
- Work with research and development team to identify and resolve product issues.
Generally, it was required that this person have a minimum of a bachelor's degree in engineering, science, technology or a related field. For lead positions an advanced degree was preferred.
Also knowledge of:
- Regulatory standards affecting devices, biologics, and pharma product,
- ISO standards,
- US Code of Federal regulations, and
- EU regulations were required.
ASQ defines QA as "all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality."
Conversely, Quality Control (QC) is more focused on the inspection aspect of quality management. The inspection process may apply to products, processes, or service- here the goal is to ensure that the focus of the inspection is correct and meets specifications.
It appears that the primary roles of QC inspector/lead are:
- Internal and supplier incident reporting in performance reporting system,
- Analyze results from incident investigations to determine failure modes, root causes, and corrective actions, and
- Ensure that procedures established in the Quality Management System (QMS) are implemented and maintained.
I have not read of preferred education requirements, however must positions favored experience in quality control or an ASQ certificate in quality control. ASQ defines QC as "the operational techniques and activities used to fulfill requirements for quality."
Hi Marvin, thank you for your post. Question, do you believe that the same type of personality/person could work in QA and QC? For example, from my experience a biostatistician has a very different personality then a behavioral science professional. Intellectually it appears that a person working in the quality profession, may be able to work in either QA or QC, but considering personality types do you consider that the same personality would be best suited for either position?
Personally, I would prefer to work in QA as it fits with my overall personality.
Hi Julian, since you work in the "regulated production setting" would you prefer to work in QA or QC? What are the roles of the QA and QC person in a research laboratory setting?
regulated production setting
Hi Julian, since you work in the "regulated production setting" would you prefer to work in QA or QC? What are the roles of the QA and QC person in a research laboratory setting?
regulated production setting
My work in the regulated production setting refers back to my time spent as a clinical chemist in a high-complexity toxicology laboratory, not my current position managing a research laboratory. CLIA and CAP define the roles and responsibilities for QA and QC personnel in clinical laboratory settings. QA/QC in basic research is more of a best practice, as basic research laboratory work is not regulated in the same manner as clinical laboratory work.
Given the opportunity, I would rather work in QA, though I would enjoy occasionally doing QC work. I find the repetitive nature of QC to be somewhat therapeutic, though generally more physically demanding. QA generally requires a more systems-level approach to quality, while QC is mainly focused on work at the production or department level.
Quality Control is a set of activities designed to evaluate a developed work product. Quality Assurance is a set of activities designed to ensure that the development and maintenance process is adequate to ensure a system will meet its objectives. Quality Control forms the process , Quality Assurance follows the process. Quality Control is product oriented , Quality Assurance is process oriented. Quality Control identifies defects after a product is development and before its release, Quality Assurance improves development so that no errors appear after development.
In short to say, quality assurance is the process of managing for quality; while quality control is used to verify the quality of the output. Quality assurance ensures that the techniques or methods that are designed for the product are implemented correctly. It recognizes the flaws in the process ie. it is preventive in nature. Quality control is a reactive process. It evaluates the results against acceptance criteria and helps in determining accept/reject status. But both are part of quality management.
According to my experience, quality assurance is a preventive measure. The whole process includes auditing, inspection and action to ensure the quality of products. Quality control is a way to test products through testing. It requires professional teams and equipment to test devices and eliminate quality problems at the source.
In my opinion, it's easy to switch between the two roles. Despite they are different roles, the two kinds of work have the same purpose, both of which are to ensure high-level performance of medical devices. The difference between them is only the focus on different aspects. Quality assurance is carried out from the perspective of prevention. The work of quality control is to check the existing problems of medical devices through testing. These two jobs are not contradictory, so I think it's easy to switch between the two roles.
While QA ensure the quality in the process by which products are developed, QC focus on identifying defects in the finished products. By preventing defects during the process of making the product, it focuses on improving development and testing process i.e. it is a proactive process. On the other hand QC identifies and corrects defects in the finished products i.e. it is a reactive process.
A QA person has to learn how to plan to avoid quality problem through the process and systematic documentation. His job is to assure good quality management system and the assessment of its adequacy. Periodic conformance audits of the operations of the system. Whereas a QC person has to learn about all the activities or techniques used to achieve and maintain the product quality, process and service. He is responsible for a specific team that tests the product for defects. Verification is an example of QA and validation/software testing is an example of QC.
According to me it is easy to switch from QA to QC, but not vice versa. QA person is aware of the manufacturing process as well as the ability to diagnose the fault. Whereas QC person only can identify and correct the defect. They're not very familiar with the process of product developed.
Focusing on the questions of switching roles, I don't have experience in either but based on the explanations of each role in the lecture I would expect it to be easier to switch from QA to QC. A QA person switching to QC already knows the whole process behind designing the system and reviews and evaluations necessary, so they're familiar with the bigger picture of QC. In switching roles, they would primarily have to learn how to go about taking any measurements or tests needed to evaluate the product.
I think it would be more challenging for someone who had always worked with carrying out the evaluation to then have to learn how exactly it is decided what needs to be tested and the structure that'd be best for evaluating. Though, experience in going through the evaluation process would give some insight into the QA process, I still think going from QC to QA would be more challenging.
Explain the difference between QA and QC, and think about the differences that each of these have as a career. For example:
What types of training are relevant to each and how could they differ?
What types of jobs would each of these people have?
In your opinion, is it easy to switch between these roles? Why or why not?
Is switching in one direction easier than switching in the other (QA to QC, vs. going from QC to QA)? Why or why not?
QA is more of a preventative role focused on the overall process of something, whereas QC is more of a reactive role focusing on the individual product. Someone in a QA role will manage the QMS and develop procedures to ensure the roles of every individual involved in developing a device are clear, ensuring that all of the bases are covered. These procedures will usually cover a broad range of devices, depending on the type of device, material used, manufacturing method, etc. Someone in a QC role will performs the checks to make sure that when the device is being developed, everyone is following the procedures in place, and the device will perform as intended. QC individuals moreso focus their reviews on a part by part basis, rather than the process as a whole.
Most of the time, QA and QC roles will role up to the same Manager/Director/VP at some point, so it would probably be pretty easy to switch between roles. I don't think switching from one role to the other is necessarily easier or harder than the other, as experience in each role would prepare you for the other. There would be a learning curve for each though. Going from QA to QC, you would have familiarity with the procedures and requirements that need to be followed from your time in QA, so you would know exactly what to look for when performing your reviews in QC. However, QC individuals typically need to understand the performance requirements of the device to properly preform their reviews, which individuals in QA don't typically get exposure to. Going from QC to QA, you would have experience actually executing and following the procedures from your time in QC, so you would be able to identify any gaps and implement improvements in QA. However, it may be tough looking at things from such a broad view in QA since people in QC are only focused on specific devices.
Quality Assurance sets the standards that are required by the particular product and Quality control execute those, so both of them go hand in hand.
As mentioned before QA is more of a preventive role while QC is more of a reactive role.
I think a lot of research goes on with the QA as they are the one who will give the overall blueprint as to how to go about with the project at hand while the QC will follow the SOP's laid down by the QA department and make sure everything falls within the scope.
I think it would be easier for someone in QA to switch to QC rather than the way around as the work is focused on the project at hand as QA is involved in the QMS of the company setting the standard operating procedures and working with other departments.
