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  • hc255 replied to the topic Relation of Quality with other department. in the forum Quality Control and Quality Assurance 8 years, 2 months ago

    Ways to abide to procedure for all departments can be to collaboratively implement a procedure which all voices partake in the creation of such procedure. That way, upper management involved can hear each others opinions and reach a consensus. Quality and regulatory compliance should have the final say as the goal for medical devices is to be safe and effective which is to be achieved through the compliance of standards within processes and procedures. A department has to abide by procedure or FDA will notice and issue problematic statements and fines. It should be in everyone’s mind to keep FDA content with all decisions made in the company to avoid the company from have external auditors, companies, fines, closure, etc. Furthermore, the document control personnel within quality say what changes are allowed to be made and what needs to be changed so if procedure is not being followed, nothing will get done until it is corrected.