Measuring Readiness for Compliance: A Gap Analysis Tool to Complete the TIPA Process Assessment Framework

2016 ◽  
pp. 106-116 ◽  
Author(s):  
Michel Picard ◽  
Alain Renault ◽  
Béatrix Barafort ◽  
Stéphane Cortina
Keyword(s):  
Gap Analysis ◽  
Analysis Tool ◽  
Process Assessment ◽  
Assessment Framework

scholarly journals Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis

2019 ◽  
Vol 21 (Supplement_1) ◽  
pp. S133-S144 ◽  
Author(s):  
Micah L Berman ◽  
Allison M Glasser
Keyword(s):  
Systematic Review ◽  
Risk Assessment ◽  
Gap Analysis ◽  
Research Priorities ◽  
Smoking Initiation ◽  
Assessment Framework ◽  
Potential Health ◽  
Wide Range ◽  
Product Standard ◽  
Nicotine Reduction

Abstract Background The US Food and Drug Administration (FDA) is considering reducing nicotine levels in cigarettes to “minimally or non-addictive levels.” However, important research gaps remain, and the FDA must determine when the available research is sufficient to support moving forward. Methods The authors conducted a systematic review of research articles in PubMed relating to nicotine reduction. Building on a review of risk assessment best practices, the authors also developed a risk assessment framework for tobacco regulation and used it to guide a gap analysis of nicotine reduction research. Results The final sample consisted of 78 articles. The majority examined either nicotine dependence on very low nicotine cigarettes (VLNCs) or markers of potential health effects of using VLNCs. One-third of the identified articles reported results from four large randomized controlled trials (RCTs). While these studies report promising results and suggest that a nicotine reduction rule would be a powerful tool to reduce cigarette smoking, our gap analysis suggests that there is a need for studies that better reflect the use and availability of a wide range of tobacco/nicotine products and the potential for dual- or multi-product use. Conclusion The current body of research on nicotine reduction is weighted towards RCTs, which is appropriate for a policy that has not yet been implemented anywhere in the world. The FDA must consider a wide range of factors that may impact a product standard’s public health impact, including those difficult to assess in RCTs, such as a nicotine reduction rule’s impact on smoking initiation and relapse. Implications This systematic review presents a gap analysis based on a risk assessment framework to help identify remaining research priorities to inform FDA’s potential product standard to reduce nicotine levels in cigarettes. Quickly addressing those gaps would support the FDA’s effort to develop a nicotine reduction product standard that will be effective and withstand legal challenges.

Using ArchiMate to model a process assessment framework

2015 ◽  
Author(s):  
Nuno Silva ◽  
Miguel Mira da Silva ◽  
Béatrix Barafort ◽  
Marco Vicente ◽  
Pedro Sousa
Keyword(s):  
Process Assessment ◽  
Assessment Framework

Process Assessment as a Means to Improve Quality in IT Services

2011 ◽  
pp. 168-191
Author(s):  
Stéphane Cortina ◽  
Michel Picard ◽  
Omar Valdés Solórzano ◽  
Alain Renault
Keyword(s):  
Service Management ◽  
Process Assessment ◽  
Improve Quality ◽  
It Services ◽  
Assessment Framework ◽  
Standard Process ◽  
It Service ◽  
The Impact ◽  
Generic Process

The main objective of this chapter is to present how a formal and standard process assessment - thanks to its repeatable approach and its comparable results - can be an invaluable contribution for improving the IT services in a continual way. This chapter introduces ISO/IEC 15504, the international standard for process assessment. As a generic process assessment framework, ISO/IEC 15504 can be used for determining the capability of processes of any domain. The authors of this chapter have applied this framework in the field of IT Service Management. Their works (described below) have enabled to develop the TIPA® methodology, based on ITIL® version 2. The chapter then discusses the impact that assessments can have on the quality of the assessed processes and, as a consequence, on the services supported by these processes. The chapter finishes by presenting an example of the results and the lessons learnt as perceived by adopters of TIPA.

Evaluation and Enhancement of a Comprehensive Controlled Substances Management Process at an Academic Medical Center

2021 ◽  
pp. 089719002110222
Author(s):  
Bailey E Eason ◽  
Tyler A Vest ◽  
Katherine D. Mieure ◽  
Danielle Neal ◽  
Jennifer Tryon
Keyword(s):  
Direct Observation ◽  
Gap Analysis ◽  
Work Group ◽  
Medical Center ◽  
Phase 1 ◽  
Academic Medical Center ◽  
Compliance Rate ◽  
Analysis Tool ◽  
Controlled Substances ◽  
Current State

Purpose: Controlled substances management is highly regulated, and requires institutions to have processes in place to maintain a closed-loop. This study was conducted to comprehensively evaluate the current state of controlled substances management, propose optimization opportunities, and implement steps to align the medication use process (MUP) to a defined desired state. Methods: This evaluation was conducted in 2 phases. In phase 1, the current state of controlled substances management was assessed in order to develop a gap analysis tool and failure mode and effects analysis (FMEA). In phase 2, a work group was assembled to address opportunities within the FMEA. The work group prioritized opportunities using the risk priority number (RPN), and formulated action steps to align processes with the defined desired state. Results: Through the literature evaluation, a desired state, consisting of 86 segments, was defined and compared with a gap analysis tool. Direct observation of the MUP allowed for development of 13 process maps depicting current state. Of the 86 segments, it was determined the study institution had a compliance rate of 62%. The remaining 38% correlated with 55 actionable process opportunities that were included in the FMEA. To date, 31 of the 55 (56%) opportunities have been successfully addressed by the work group. Conclusion: Use of direct observation to formulate a gap analysis tool and FMEA is an effective modality to evaluate controlled substances processes. These tools allow for pharmacy departments to identify and prioritize opportunities to optimize controlled substances management within an academic medication center

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