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QA/QC for a Medical Device Project

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(@yroberts)
Posts: 30
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Quality Control is product oriented involving low/mid-level employees, while Quality Assurance is process oriented with high-level employees implementing responsibilities.

QC is inspections of the quality of a product and classifies it under the domain of QC. QC does not guarantee quality, but rather controls it. While QA ensures the proper operation is done in the right manner, QC ensures the results of what you have done are as per your expectations. They are interdependent to each other.

Briefly define two factors that influences each quality assurance and quality control for a medical device project. If you can, include tools and techniques used to implement the factors you listed to support. 

 
Posted : 11/09/2021 7:53 pm
(@sheila-sarathy)
Posts: 40
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Any flaw that can be discovered in the manufacturing of a medical device, would be a substantial factor that influences quality assurance with regards to a medical device project. They (the QA team) usually preemptively end up catching the potential flaws and defects before the device is manufactured with them. A technique that they utilize to be able to find these flaws is being able to proactively prevent the flaws from happening. They are being progressive in refining the manufacturing processes within their procedures and polices. A technique they use to allow them to do this is comparing their standards and regulations to documents and publishes such as the Code of Federal Regulations (CFR) for the FDA, or ISO 13485.

As for a factor that influences quality control of a medical device project, that would be; any flaws that happened to have slipped the radar of the quality assurance team. The quality control team member would have to catch those flaws so they can be fixed or removed before the initial distribution process. They essentially have to begin their thorough evaluating process after product development is complete. A tool used to allow them to carry out their tasks, are various testing/inspecting methods and processes to assure that the product complies to predefined product requirements. 

 
Posted : 01/10/2021 8:51 am
(@hmara)
Posts: 76
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Last year I developed a medical device for BME capstone at NJIT. Based on what we've learned this last week in Dr. Simon's lectures; I would say that the management body (In our case the professor/customer) are on the QA side. Us, as the project employees, are the QC side. In a med device project, some employees on the team may be tasked with evaluating the device based on criteria provided by the management body. In our case, we needed to create the criterion we tested for; simultaneously taking on the role of QC and QA. In reality, a medical device project would be sanctioned by a company who is seeking to fit a need. To bring their idea to fruition, they'll meet with the management body and craft a general scope for the project. Then the company will send it to the QA team who will use the scope to create the quality policy. From there all relevant quality procedures will be outlined. Then it will be the QC team's job to evaluate the device before, during, & after development to ensure that it meets/passes the outlined quality criteria.

 
Posted : 09/10/2022 4:21 pm
(@sm2744)
Posts: 78
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I think that a factor that is influenced by Quality Assurance is the continuous training employees undergo during their time with their department in the company. For example, at my past internship, when we got hired, there were around 50 documents that we needed to train to before we obtained access to our Product Lifecycle Management platform, Windchill. These documents ranged from Work Instructions to Standard Operating Procedures. After these were completed, we would periodically receive notifications to train to some documents again, meaning they were updated. It did not matter if the update was big or small, if a change affected that instruction/procedure, all affected departments needed to retrain.

A factor that I saw that was tied to Quality Control was an incident of an engineering finding a non-conformity of the product dimensions in certain batches that were created by a specific machine. An investigation was launched and the calibration of the production machine was fixed. This was found with routine batch testing where calipers were used to determine if the measurement of a specific part of the device was within the accepted range.

 
Posted : 09/10/2022 7:44 pm
(@ag2265)
Posts: 70
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My experience with Quality Assurance and Quality Control, similar to @hmara, can date back to my Capstone Project from last year. We were responsible for creating a biomedical device that can support the freezing of biopolymer solutions from -196 to -20 degrees Celsius. For this project I, along with my team had to address QA and QC throughout the development, building, and testing for the device. There were two documents that we drafted throughout the creation of the device in which each document referred to QA/QC. As @yroberts mentioned earlier as well as Professor Simon during the lecture, QA is process oriented while QC is product oriented and so a requirements document was drafted to address QA while a test plan was drafted for QC. The Requirements Document outlined exactly how the device was to be built with the exact parts and dimensions. It gave specific requirements for the device and was created to ensure that our device could be replicated. Additionally, the document assured that theoretically all the parts we were using were compatible with each other and could foster a biological environment. On the other hand, the test plan was drafted to assess how well the building of the device followed the requirements document. Furthermore, the test plan made sure that each measurement of the device met the tolerances that were outlined in the document and that all the different aspects of the device were working individually as well as synchronously. 

 
Posted : 09/10/2022 10:37 pm
 an83
(@an83)
Posts: 39
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In the realm of medical device projects, both Quality Control (QC) and Quality Assurance (QA) play pivotal roles. QC, being product-oriented, predominantly involves inspections of the product's quality, ensuring that results align with expectations. It primarily dwells in the domain of controlling quality rather than guaranteeing it. Conversely, QA, which is process-oriented, assures that operations are executed correctly and in the appropriate manner. This dichotomy stems from QC's focus on low/mid-level employee operations and QA's emphasis on the strategic involvement of high-level employees. Two paramount factors influencing QA are management commitment and risk management. Management commitment underscores the essential role of top-tier leadership in championing quality. Through dedicated resource allocation, establishing quality-centric objectives, and nurturing a quality-driven culture, management paves the way for effective QA. On the other hand, risk management entails a comprehensive approach to identifying, assessing, and mitigating potential threats to the device's safety and efficacy, ensuring vigilant monitoring throughout the project lifecycle. In translating these factors into actionable strategies, a suite of tools and techniques come into play. Regular quality audits, for instance, serve as a rigorous check on adherence to quality norms and help pinpoint areas ripe for enhancement. Process mapping visually delineates the steps constituting production and quality processes, spotlighting areas of inefficiency. For QC, the use of control charts helps track quality variations over time, while statistical tools like standard deviation and variance gauge data variability. Further, the comparison of means aids in assessing process effectiveness, and the fishbone diagram offers insights into the root causes of quality discrepancies. Together, these tools and factors weave a comprehensive framework for maintaining impeccable quality in medical device projects.

 
Posted : 01/10/2023 11:21 am
(@andrew684)
Posts: 39
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Quality assurance and quality control serve different purposes within the medical device field, where each complements the other. My background is in quality control, not in medical devices, but in lab testing, which is the hands-on experience of testing the raw materials that go into these products, whether they become medical devices or other products. One of the factors is that the testing of the materials, whether they are raw, in-process, or final, becomes constant because we want to create this feedback loop in creating a product that conforms to what we are creating. Other factors involving quality control are the calibration of equipment and knowing that the equipment you are using is measuring correctly in order to carry out a test for a material. These factors in this feedback loop influence the quality of the medical device project, which is developed by quality assurance. The factor of quality assurance is the fact that there needs to be continuous improvement by reviewing documents so that quality can perform its function on the product. Quality assurance is the factor where this continuous improvement of documents, systems, and processes, among others, influences their work, and some tools include diagrams in order to quantify their work, such as pareto, fishbone, control charts, etc.

 
Posted : 01/10/2023 6:23 pm
(@archishak)
Posts: 66
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Quality assurance (QA) and quality control (QC) are crucial aspects of medical device development. 2 factors that influence QA are regulatory compliance, ensuring that the device is compliant with regulations and standards, and documentation/training, adequately documenting the process and providing training to employees. A tool/technique that can support regulatory compliance and documentation is using management software that can track and monitor regulatory changes and ensure that the medical device is compliant, as well as create and store proper documentation of the processes taking place. 2 factors that influence QC are testing/inspection, where the manufacturer would conduct rigorous tests during the development stage and identify/rectify any issues, and statistical process control (SPC), where manufacturers would monitor and analyze data to detect any deviations in the data from the quality parameters that have been established. A tool/technique that can help with testing/inspection is using test management tools that can plan, execute, and track the testing parameters implemented. A tool/technique that can help with SPC is using statistical software and data analytical tools that can help collect and analyze the data so that the user can identify any patterns or outliers in the collected data set and compare it to the established quality parameters. 

 
Posted : 06/10/2023 9:26 am
(@hayderk)
Posts: 33
Eminent Member
 

In my experience I've had experience with more so quality control than assurance. Things I've done include work orders, inspections, testing, etc... I've created, revised, and seen executions of work instructions so that would be my small experience into quality assurance, but mostly I'd say its control. Other aspects like learning Minitab to do statistical tests such as R&Rs, SPCs, or doing DOEs are additional aspects of QC. Like the initial post had stated, the role of QC vs QA is determined by mid vs high level inputs. I think in terms of documenting OQs and PQs can constitute in the ends of QA because your identifying optimal parameters for quality purposes and efficiency after the IQ. The takeaway is that QC is object oriented, on the basis of testing things physicals to see if they meet a standard while QA is the planning that creates these parameters for the QC. 

 
Posted : 08/10/2023 4:30 pm
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