caption: the process in which documents are required to be written
exif: {"Image DocumentName": "Definition of a QM PlanA written document that describes the systems in place to implement the quality management program.", "Image ImageDescription": "Written documentation of how programs and banks fulfill QM requirements. Description of the QM systems. Implementation plan. Direction for carrying out the overall QM program. The definition of a QM Plan is a written document that describes the systems in place to implement the quality management program. QM Plans serve as written documentation of how programs and banks fulfill QM requirements. For inspection purposes, the QM Plan provides a foundation for inspectors to understand how the QM program functions. More importantly, for operational purposes, QM Plans enable programs and banks to put their ideas on paper and thoroughly plan out how the QM program will function in an efficient, effective manner to ensure high quality cellular therapy products and patient care. To adequately address all requirements of a QM Program, all of those requirements must be in the plan. QM Plans basically include descriptions of the QM systems in place. This is a common source of confusion for programs and banks. The Standards contain a large amount of requirements for inclusion in the QM Plans, so it is easy to become overwhelmed and believe that the QM Plan is intended to be a voluminous and intimidating document. This is not the intent! QM Plans can actually be as brief as you wish. More information regarding what must be included will be provided later in this presentation. The key is to ensure that there is at least a description of all of the required elements so that your program or bank has a framework for implementing the QM program. That is what a QM Plan is \u2013 an implementation plan. The QM Plan may be difficult to establish, but once it is finished, it should be a helpful tool for your program and bank to assist with implementing the QM program. For example, when you are ready to begin your audits or validation studies, the QM Plan should be a good reference tool to help you know what to assess, when to do the assessment, and how. Finally, the QM Plan provides direction for carrying out the overall QM program. As many of you are probably aware of at this point, a QM program is not a linear process, but a circular one. A qualification or validation may show results that require continuous improvement. An adverse reaction necessitates the need for reporting. By documenting what to do in these situations, your program and bank can be confident that all necessary steps are completed.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}