You have just been hired by a start-up Biologics company as the Sr. Director of the Quality Management System (QMS) and one of the many tasks you will do in your new role is establish an Audit Program. What is a QMS? What is the difference between a QMS, QA and QC? In which area does Quality Audit typically belong? How did the field of Quality Assurance emerge? List 3 functions/things within a Quality Management System (QMS) that can be done to ensure quality. Using the ASQ concepts, explain what is required to establish an effective Quality Audit Program/Department. There should be 8 sections to your answer. please include the following: the overall goal of an audit to the organization (as per ASQ) include who audits are primarily performed for (as per ASQ) 2 places where Auditing Department resources can come from at least 1 example of a continuous improvement at least 1 statement about cost, risk or opportunity in relation to continuous improvement (text is critical) at least 1 thing that can impact the long-term planning of an audit program at least 1 way that an Audit program can be evaluated

You have just been hired by a start-up Biologics company as the Sr. Director of the Quality Management System (QMS) and one of the many tasks you will do in your new role is establish an Audit Program. What is a QMS? What is the difference between a QMS,





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