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Karen Immanuel replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 6 years, 6 months ago
The quality policies usually come off as a burden because they are usually at every step of the medical device development evaluating and cutting things short and asking for steps to be redone until it passes it correctly. Quality just seems annoying to any innovation from the perspective of other departments, especially the R&D. But in the quality’s perspective, they feel like they hold the responsibility of any potential failure in the market and not the R&D because quality is the one that let the product fly under the radar. The quality department also sees that there is a tremendous trust given from the customers who buy and use these products and that the customers must in return be given the best device with minimal to no failure. The quality is also the department that must deal with auditors and external evaluations of practices and processes. The quality department has a huge responsibility and carries the fate of the company after products are released and therefore they must be fully respected and cooperated with. Time and money shouldn’t be seen as a burden in quality but rather it should be seen as a good investment.