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  • alexandrabuga replied to the topic Management Responsibility in the forum Quality Systems Management 6 years, 12 months ago

    I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. Corrective and Preventative Actions, iii. Production and Process Controls, iv. Equipment and Facility Controls, v. Records Documents and Change Controls and vi. Material Controls. Therefore there should be regular/clear communication with management between the subsystems and management. We also learned that if companies do not follow the device regulations, if found that the device does not comply, it is considered “adulterated”. This means that the devices and people responsible for this are subject to regulatory action, and could even receive jail time. I these are serious consequences that should not be taken lightly. Therefore, I don’t think management would want have quality suffer to save resources. It could ended up costing them everything in the end if it is not compliant with current regulations. I think they would be happy to discuss to make sure resources are allocated and used efficiently to ensure the development of a quality/compliant device. If resources are really going to be cut, as @thuytienlecao mentions good management would have some plans to address these cases, but if appropriate actions aren’t being taken-I think you would just need to communicate your concerns and solutions to management. Communication is key and QS are important.