Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food &amp; Drug Administration

Rappel, Michael J.; Hunter, Nina L.; Alexandrow, April I.; Hair, Kyle O.; Sherman, Rachel E.; Califf, Robert M.

doi:10.1111/cts.12441

Cited by 3 publications

(2 citation statements)

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“…The Lean-based methodologies will only reach its potential when it is based on a logic dominant Root cause focus Drive for root causes, not symptoms, and be objective (cost cutting/lay-offs or improvement of process). Edgeman et al (2005); Rappel et al (2017) Cause-effect actions Perform cause-effect impacts and product design. Grasp the impact of the organization and culture on lean process design and operation.…”

Section: Content Analysismentioning

confidence: 99%

Critical success factors-based taxonomy for Lean Public Management: a systematic review

Caiado

Carocha

Goulart

et al. 2020

Prod.

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Section: Content Analysismentioning

confidence: 99%

Critical success factors-based taxonomy for Lean Public Management: a systematic review

Caiado

Carocha

Goulart

et al. 2020

Prod.

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“…Moreover, several internal process improvement initiatives have taken place at the FDA (Booz Allen Hamilton, 2016; FDA, 2015). That includes streamlining the synchronization and management among the FDA centers involved in the review of combination products (MJ Rappel et al, 2017), and the modernization of the 510(k) pathway (FDA & CDRH, 2019).…”

Section: Relevant Progressmentioning

confidence: 99%

A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

Rojas

Cosler

Santos

2019

Proceedings of the International Symposium on Human Factors and

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As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly focused on HF methods to ensure success from that perspective. However, the development of across-the-board strategies that can address other critical factors is necessary. No previous scientific research has outlined and addressed the problems considering the QSR and the needs of key stakeholders. For that purpose, this effort presents a narrative review of how the HF requirement for medical devices and combination products developed, as well as the issues and the interventions that have taken place to address the bottlenecks. Some essential considerations such as notorious knowledge-based and process-based gaps are discussed. Similarly, because of the demands of a changing QSR, attention is brought to the need to align key stakeholders, namely manufacturers and HF service providers (HFSPs). Also, the development of an industry (HFSPs) maturity assessment tool and future research for that purpose are proposed.

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A retrospective cohort study evaluating the improvement of medical records management based on whole-process control

Chen

2023

THC

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BACKGROUND: Whole-process management is a novel approach widely applied in industry and commerce; however, it is not widely used in the management of medical records in hospitals. OBJECTIVE: The purpose of this study is to investigate the application of whole-process control in the administration of a hospital’s medical records department to achieve refined management of medical records. METHODS: Whole-process control is a management measure that begins with process conception and implementation and includes control over all processes The control group included medical records that were created prior to the implementation of whole-process control, i.e., those created between June 1 and December 31, 2020. The observation group included medical records that were created after the implementation of whole-process control. The behavior of the medical records staff (in terms of medical record collection, sorting, entry, inquiry, and supply) and the final quality of the medical records (the number of grade-A medical records and their front-page quality) were compared between the two groups, and subjective judgments related to staff satisfaction were reviewed. RESULTS: The implementation of whole-process control improved the behavior of the medical records staff. The final quality of the medical records was also improved, as was the job satisfaction of the medical records staff. CONCLUSION: Implementing whole-process control improved the management of medical records and quality of medical records.

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Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration

Cited by 3 publications

References 0 publications

Critical success factors-based taxonomy for Lean Public Management: a systematic review

Critical success factors-based taxonomy for Lean Public Management: a systematic review

A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

A retrospective cohort study evaluating the improvement of medical records management based on whole-process control

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