In this age, different emerging technologies are beginning to rapidly change the nature of work. Internet of things(IoT), Artificial intelligence (AI), Machine learning are just a few examples of the new, disruptive technologies that are impacting the jobs in one form or another in a very short period of time.
Now the question is how can you keep up with all these technologies and make the QA process more efficient and more accurate.
Any thoughts?
I think the best way to keep up with the newest technologies would be to just stay up to date through research and following publications and reviews of those new technologies. The more that is known, the better the company will be able to understand and access the risks that come with the technology. Then they'd be able to most effectively and accurately design the QA process.
In my opinion, it would be beneficial for companies to further incorporate emerging technologies such as artificial intelligence and automation to improve on their quality assurance process. Therefore, I believe companies should promote the quality assurance department to investigate and look for ways such technologies can help increase the efficiency and effectiveness of their current procedures. For instance, automation can be used to perform repetitive tasks performed by the quality control department at not only a faster speed, but also on a greater number of samples. For instance, as I said in another forum post for this week, automation can be used to measure the dimensions of a product, which can result in more samples being measured in the same period of time. Furthermore, the incorporation of artificial intelligence can be used to determine the step or process that may cause a product to fail quality standards at an earlier stage of the manufacturing process. As a result, I believe the results obtained by the quality control department using these emerging technologies can then be assessed for effectiveness and efficiency by the quality assurance department as they make changes to further improve their system. Overall, I believe companies can keep up with such technologies by promoting its acceptance and use in the quality assurance and quality control departments.
Using emerging technologies to assist in quality can be a very helpful tool for QA/QC departments. For examples, using AI to perform inspections along the production line can help ensure consistent inspection. This will also help with lean manufacturing because resources will not be wasted on finishing parts that were already identified as defective earlier on the production line. For the medical device industry, improved quality control is especially important. Just as with human inspections, the methods of "smart industry" would need to be validated. However, it is my belief that these new technologies can improve the consistent quality of products.
https://www.ingedata.net/blog/artificial-intelligence-and-quality-control
To go along with your research suggestion, specifically human research is vital to understand the effect of these new technologies on society. Companies in charge of IP within these new technologies must have a robust customer service department that will correctly identify issues reported by their customers. In most cases an equally robust field service repair department is necessary; otherwise an efficienct shipping method in conjunction with service repairs in house.
There are many companies that have already implemented AI in quality management and also product development as well. For example, there is a french company called Pharnext who has recently been able to develop a drug for CMT1a using AI called PXT 3003( https://www.pharnext.com/fr/produits/pxt3003 ). They were able to combine already approved and known drugs to make it into a cocktail drug. By using AI they were able to skip certain clinical steps and save ample amounts of time and money. By researching and finding new technology, one company can effectively decrease the time of the process and in some cases even skip the processes. Also, by showing and proving the effectiveness of these technologies the FDA and/or ISO can change there process accordingly.
Quality Assurance can be made more efficient and accurate by emerging technologies by facilitating more traceability in the methods used to produce medical devices RFID in the supply chain, Computer aided selection test for validation. After market tracking of device functionality in the field can be facilitate by IoT. Blockchain could be used to ensure integrity of supply chain.
I think overall these things tend to all be in support of quality, via traceability and chain of custody traceabillity.
To make the QA process more efficient for newly developing technologies, my approach would not be different, even though some of the tools I would use might be upgraded. One of my first steps would be ensuring that I hired top-notch talent to administer QA and effectively communicate QA priorities company-wide. I would frame my QA process based on two key principles: 1) To do no harm to my prospective customers or patients, like in the oath taken by physicians, and 2) To strive to be the "model" organization/product for my industry by surpassing all required regulatory standards. There are so many effective scientific and statistical tools on the market to help evaluate and synthesize manufacturing or production processes/procedures. Plus, bodies such as the FDA, EPA and OECD are very explicit about their guidelines. Thus, there is just no good reason for even a startup medical device company to be clueless about conceiving and developing an effective QA mechanism. Lastly, it is imperative for companies to cultivate a culture of quality and safety that gets instilled at every level and in every product.
QA has long gone far from being just about bug seeking. Users rely on having the best service turning to any company, and one of the most important QA tasks nowadays is their satisfaction while achieving business outcomes. Incorporation of AI is what updates the QA process to a autonomous software. The impact of AI in software testing can be seen adding value in the present testing efforts by enabling auto-exploring apps on actual devices for making sure that all of the functionalities and user flows work as they are supposed to.
The value of digital transformation with the various technologies such as IIOT, Artificial Intelligence, etc. to the "Quality" of medical devices would have similar impact to other technologies over the last forty years. The ability to communicate and share information of medical devices throughout the product lifecycle gained advantages with the initial introduction of the internet such as email, engineering systems as CAD and manufacturing automation systems to control processes. The new wave of Industry 4.0 can have even larger impact with the ability of medical devices. Think for example of implants such as heart pacemakers with the ability to communicate status wirelessly or the ability of genealogy of medical device components to quickly provide product complaints and investigations (root cause analysis) processes with critical information to resolve quality issues.
QA is derived from FDA and ISO regulation and the company Vision. QA Team should keep an eye around what is happening in the world and what going on inside the company. Communication always help improvement with feedback in the right way between the departments. All these data can be used with software's or AI for analysis and to build a stronger and efficient QA system.
Companies can have a department associated with researching the latest relatable technologies and to keep track of emerging future technologies. Proper research can help the company decide whether a certain technology is needed or not, and what are the risks associated with using it, and how long it will take to train employees on using it properly.
Technology needs proper training, and with each new technology, the company needs to train its employees on how to use it, how it impacts the workplace, the risks associated with it, and what are the benefits of using it. Research is necessary to ensure that the technology being used by the company is useful and understood by the team. The company needs to be on top of the training to ensure that each and every one of the team knows what they are working with and can fix any problems that come their way. Even though technology is there to make our lives easier, it comes with many complications that we need to be aware of. The more knowledge we know about a certain technology, the better the experience will be at the workplace.
Keeping up with new technology such as IoT, AI, and ML not only requires literature reviews and reading more on the emerging fields, but it may also help to hire scientists/engineers familiar in those areas. Many engineers in computational research have used machine learning or artificial intelligence at one point and would be able to help in transforming the QA process more efficiently. Therefore, it may help to simply hire people with these skillsets and hold workshops to update everyone on the recent advances in the field. I find training workshops to be particularly useful when it comes to learning the latest technologies. Additionally, I believe incorporating these "smart" technologies into the QA process is not disruptive, but will rather enhance the medical device industry, as it allows for more objective analyses rather than subjective, better prediction of future failures, and takes a more proactive approach to quality management.
Technology such as AI can be helpful in developing semi or fully automated quality inspections processes. I think it's important to note that these new technologies also have to get validated themselves. Any new technology added to improve quality control also needs to meet inspection requirements.
For example, an AI system is equipped with a sensor to measure a specific dimension of a part. This AI system will also have to be validated to make sure it's consistently measuring the part correctly.
New technology can be extremely useful in a well planned Quality Management System.
I believe that the implementation of emerging technologies into QA could be very useful for companies. It would allow for easier creation of QA procedures and make the overall QA process easier. This would obviously be for more preventative measures. However, one of the key aspects I thought about with this topic was traceability. It was touched upon in the lecture, but I think the ability to be able trace back different parts of a project could be very important. Emerging technologies could make this process much quicker and easier which could make a difference during emergencies. With new technology always coming out, I believe it would be interesting to see how companies implement these technologies to make their QA responsibilities, and overall quality department responsibilities, more efficient.