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Establishing and Implementing a Quality Management Plan.ppt
This slide also contains information from the FACT Quality Management tutorial. It has a lot of information and is worth repeating because it provides an outline of the three main parts to a QM Plan. It is helpful to remember that the requirements listed in the Standards truly serve three main purposes: Structural Requirements, Assessment and Reporting, and Information and Document Control. These elements encompass the actual function of the QM program. Structural Requirements: Dictate who is responsible for the QM program, how the QM program is organized, personnel requirements, and the process for developing and implementing processes, policies, and procedures Assessment and Reporting: Activities that allow measurement of results of the QM program and mechanisms for reporting those results, such as outcome analysis, audits, validations, qualifications, biological product deviations, etc. Information and Document Control: Protection of documents, product and unit tracking, continuous operations when IT fails. * At the time you embark on either creating a new QM Plan or revising an existing one, it is important to put it in perspective. What is the point of the QM Plan – what role does it play, and how important of a piece is it within the overall program? Each program or bank will face external threats outside of its control, which include comorbidities of patients, regulatory and political pressure, faulty manufacturing of supplies, and other types of issues programs and banks deal with. Programs and banks also have inherent internal weaknesses – we all have things that we can work on and improve. This can include communication issues, facility limitations, staff turnover, and other similar issues. The QM Plan is an umbrella document to protect programs and banks from those external threats and internal weaknesses. Since we can expect that we will come across issues that could negatively impact our services and products, we need to plan how we will not only
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