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1. link.springer.com › chapter › 10Clinical Workflow Analysis, Process Redesign, and Quality ...

   link.springer.com › chapter › 10

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   Apr 20, 2022 · Appraise the value of process re-engineering and its application to improve health care processes; Describe quality improvement tools available for use in clinical settings; Discuss the role of workflow in clinical decision making, design, and implementations of health IT and organizational design.

2. elsmar.com › elsmarqualityforum › threadsDefine "Rework" Under Medical Device Standards

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   Nov 12, 2010 · Rework: A process that adds, removes, or replaces parts to create an item with a changed bill of materials. The configuration of the inbound device or sub-assembly changes to a different configuration when it leaves the process.

3. link.springer.com › chapter › 10Clinical Workflow Analysis, Process Redesign, and Quality ...

   link.springer.com › chapter › 10

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   Characterize, evaluate, and refine clinical processes. Understand how business processes influence health care delivery and the flow of data among the major domains of the health system. Apply methods of workflow analysis. Appraise quality improvement and re-engineering principles and practices.

   • Author: Mustafa Ozkaynak, Kim M. Unertl, Sharon A. Johnson, Juliana J. Brixey, Saira N. Haque

   • Publish Year: 2016

4. emmainternational.com › rework-vs-nonconformanceRework vs. Nonconformance - EMMA International

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   Mar 6, 2024 · Rework in the context of medical devices refers to the process of correcting or modifying a device that does not meet specified requirements. It involves identifying defects or deviations from established standards and taking corrective action to rectify them.

5. www.ncbi.nlm.nih.gov › pmc › articlesHow to specify healthcare process improvements ...

   www.ncbi.nlm.nih.gov › pmc › articles

   May 11, 2021 · Background. Practical methods for facilitating process improvement are needed to support high quality, safe care. How best to specify (identify and define) process improvements – the changes that need to be made in a healthcare process – remains a key question.

   • Author: Jan W. van der Scheer, Matthew Woodward, Akbar Ansari, Tim Draycott, Tim Draycott, Cathy Winter, Gra...
   • DOI: 10.1186/s12874-021-01288-9

   • Publish Year: 2021
   • Publication: BMC Med Res Methodol. 2021; 21: 103.

6. medtechintelligence.com › column › fail-documentFail to Document Rework and Bad Things Happen—Ask FDA

   medtechintelligence.com › column › fail-document

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   Jul 27, 2017 · From an FDA perspective, their concerns are pretty basic: (a) script a written procedure for rework, (b) document when rework has occurred in the device history record (DHR), and (c) identify potential adverse influences the rework may have on the finished device (in writing of course).

7. People also ask

   What does rework mean on a medical device?

   • Look at From MIL-STD-1520C, Corrective Action and Disposition System for Nonconforming Material On medical device standards (Basically ISo 13485), rework is applied only to the finished non-conforming product and means bringing the prodict back into full conformity so it can be sent to the customer as new.

   Define "Rework" Under Medical Device Standards - The Elsmar Cove

   elsmar.com/elsmarqualityforum/threads/define-rework-under-medical-device-standards.44651/

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   Is rework a necessary evil for medical device establishments?

   • Rework is a necessary evil for medical device establishments. As finished devices become increasingly more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.

   Rework of Nonconforming Product Must Be Documented

   medtechintelligence.com/column/rework-of-nonconforming-product-must-be-documented/

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   Is rework an approved process?

   • Rework is not an approved process, period end if story. If you didn't have a non-conformance you wouldn't have rework. But, you cannot have a non-conformance because there is all kinds of bad things associated with that. Rework: A process that adds, removes, or replaces parts to create an item with a changed bill of materials.

   Define "Rework" Under Medical Device Standards - The Elsmar Cove

   elsmar.com/elsmarqualityforum/threads/define-rework-under-medical-device-standards.44651/

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   What does rework mean?

   • On medical device standards (Basically ISo 13485), rework is applied only to the finished non-conforming product and means bringing the prodict back into full conformity so it can be sent to the customer as new. We recently had a periodic re-assessment during which rework became a discussion topic and eventually an OFI.

   Define "Rework" Under Medical Device Standards - The Elsmar Cove

   elsmar.com/elsmarqualityforum/threads/define-rework-under-medical-device-standards.44651/

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   What is workflow and process redesign?

   • Workflow and process redesign efforts, which seek to create the structure and processes that improve performance, build an understanding of the relationship between process and outcomes, and thus support quality assessment and improvement.

   Clinical Workflow Analysis, Process Redesign, and Quality ... - Springer

   link.springer.com/chapter/10.1007/978-3-319-22753-5_7

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   Is rework a safety hazard?

   • Rework falls into the same category. Simply stated, if rework is performed on a nonconforming product, the FDA wants to ensure that the reworked product is just as robust as the product that is not reworked. You see, there is always the potential for rework to adversely influence the safety and efficacy of a finished medical device.

   Rework of Nonconforming Product Must Be Documented

   medtechintelligence.com/column/rework-of-nonconforming-product-must-be-documented/

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8. medtechintelligence.com › column › rework-ofRework of Nonconforming Product Must Be Documented

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   Apr 28, 2015 · Rework is a necessary evil for medical device establishments. As finished devices become increasingly more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.