Written by: Catherine Binuya, Ed.D.

Presentation Overview 

Steve Hopper, founder and principal of Inviscid Consulting, is a subject matter expert and specialist in supply chain operations, warehousing, logistics, and distribution. He answered the questions: what are risks? what can go wrong? and how do we deal with it? He then shared several analytical models to quantify, rank and subsequently mitigate risk.

Takeaways

• FMEA—Failure Mode & Effects Analysis is an objective, systematic, iterative approach to manage and prioritize potential failure modes to mitigate impact. Initially developed by the US military in 1949, with applications in aerospace by NASA and later the automotive industry
  • Note: FMECA—Failure Mode & Effects Criticality Analysis applies probability and statistics to assess FMEA mitigation
• FMEA approach can either be
  • Top-Down—if focus is on operation and/or design
  • Bottom-Up—if focus is on product design
• Anatomy of Operational Risk—Two measures of failure
  • Likelihood: measures realistic possibility of failure (3 levers)
    1. Occurrence
    2. Resulting Harm
    3. Non-detection
  • Impact: measures realistic consequences if failure occurs (3 targets)
    1. Functional Operation
    2. Time (downtime)
    3. Customers’ ability to process services or goods
• Identifying Risk Controls (2 types)
  • Preventative Controls—attempt to filter causal factors to lower or eliminate likelihood of failure
  • Preparedness Controls—attempt to filter failure to lower or eliminate impact
• RPN—Risk Profile Number: assign each identified risk an objective, composite score calculation based on measure of likelihood and impact.

Next Event

Join us at the next PMI Atlanta Architectural, Engineering, & Construction (AEC) Forum on November 8, 2022

Register at www.pmiatlanta.org/events/event-calendar  

Event Pictures   

Written by: Catherine Binuya, Ed.D.

Presentation Overview 

Joshua Crews, AIA, EDAC, serves as Studio Director at Nelson Worldwide. As an expert in project management in architecture, he leverages his expertise in research and Evidence-Based Design (EBD) to collaborate with leading research institutions to develop wellness designs used in the healthcare industry. He presented on the application of functional scenarios and how the design principles of Flexibility and Efficiency influence the outcome of Evidence-Based Design models.

Takeaways

• Evidence-Based Design (EBD) considers the principles of design flexibility and design efficiency to evaluate scales of flexibility
• Eight (8) Steps of EBD: Define, Resource, Interpret, Create, Measure, Monitor, Collect, and Hypothesize
• EBD Flexibility employs Functional Scenarios that seek to provide design solutions for the space between the Start State and the End State by answering the “What if…”
  • The processes bridge the gaps from “what is known” versus “what we think we know” versus “what we don’t know”
    • E.g., The Paimio Sanatorium, designed by Alvar Aalto in 1932, was originally a facility to treat tuberculosis (TB) which was then a public health pandemic. The overall design incorporated what was thought to cure TB, i.e., access to fresh air and sunlight, as evidenced in the construction of the building, outdoor seating area chairs, and ventilation systems. Due to the Paimio Sanatorium’s EBD design flexibility, this was one of the few TB sanatoriums that survived demolition after vaccinations were widely available in the 1950s. The former sanatorium stands today, with a recent remodel in 2014 to convert the building into a pediatric hospital to serve the community. https://www.architectural-review.com/buildings/revisit-aaltos-paimio-sanatorium-continues-to-radiate-a-profound-sense-of-human-empathy
• Three (3) types of Flexibility:
  • Adaptability- no construction, multiple use of a single space
  • Transformability– moveable, able to relocate, responsive/surge capacity
  • Convertibility– construction involved, time considerations
• Five (5) Drivers of Change: Demographics, Patient Mix, Volume, Disaster, Technology *The Unknowns are always a factor in the change process

Next Event

Join us at the next PMI Atlanta Architectural, Engineering, & Construction (AEC) Forum on October 11, 2022

Keynote Presentation: "How to Prevent Risky Business in Supply Chain Facilities" by Stephen (Steve) T. Hopper, PE, Founder & Principal at Inviscid Consulting

Register at www.pmiatlanta.org/events/event-calendar 

Event Pictures

Written by: Rishea Middlebrooks MHI, CAPM

The COVID-19 global pandemic has shown up in every area of our lives, forcing employees to work virtually to support their organizations. Delve into the world of motivational competence in E-Leadership with Abegail Banzon as she presents her qualitative study on building leadership motivational skills that will transcend spaces, virtually and physically!

Presentation Overview 

The presentation illuminated perceived motivational competencies of Information Communication Technology (ICT) for communication amongst project managers in different industries. During this presentation, Abegail discussed five major motivational competencies that prepare project managers to build high-performing virtual teams.

Takeaways

Motivational Competency for Leaders: 

• What is motivational competency?
  • It is the level of commitment, drive and energy a company’s workers bring to the role daily
• Why is motivational competency important for leaders?
  • Employee motivation is key to an organization’s success
• Motivational competencies
  • I – Ability to influence
    • Leading effectively
    • Having forming relationships
  • C – Developing effective communication
    • Cultural awareness
    • Direct/empathetic language
    • Using ICT effectively
  • A – Fostering autonomy and accountability
    • Using task management systems
    • Supporting/encouraging
  • R – Building interpersonal relationships
    • Positive environments
    • Team building
    • Trustworthiness
  • E – Showing empathy
    • Listening
    • Encouraging
    • Service orientation
• E-leadership conceptual framework
  • E-leadership
  • Motivational language theory
  • Media synchronicity
  • High-performing virtual team

Next Event

Join us at the next PMI Atlanta Healthcare and Technology Forum on November 16, 2022

Register at www.pmiatlanta.org/events/event-calendar

Event Pictures

Written by NoriYah Yisrael, MS-PM, PMP, CPPM, FAAPM

Presentation Overview

On August 11, 2022, the Clinical Research (CR) Forum of the PMI Atlanta Chapter hosted the "Tips on Study Start up, Clinical Trial Conduct and Preparing for an FDA Inspection" Special Interest Forum Event as presented by Professor Toks Onabanjo. The purpose of this event was to provide an overview of how to prepare for study start-up, patient data collection, and an FDA inspection and approval to market a new drug in the United States (US).

During this forum, Professor Onabanjo discussed the requisite skills that make for a successful Project Manager within the CR industry. He spoke about the site selection process that begins with the site completing a feasibility questionnaire which includes questions pertaining to the site’s personnel qualifications, capabilities, and patient population.

Once the sponsor and investigative site make a mutual decision for the site to participate in the study, the study start-up process commences. During this phase, sites must submit documentation to the sponsor, as required by governing entities and organizations to include regulatory agencies and institutional review boards. After everything is submitted and approved, the sponsor may conduct an Investigator Meeting and/or a site initiation visit, which are training pre-requisites that must be fulfilled before the site can begin consenting and enrolling patients in the study.

After a study is conducted, the sponsor may analyze and submit the patient study data that it collects from the sites to the Food and Drug Administration (FDA) in a New Drug Application. The FDA then reviews the application and could potentially inspect one or more investigative sites prior to making a formal decision on whether to approve the drug for marketing in the US.

Takeaways

• The sponsor and the investigative site must mutually decide on whether a study is feasible and beneficial for the site to be selected to participate.
• Study Start-Up is a complex process that takes the coordinated efforts of both the sponsor and the site to complete.
• The data collected on participating patients at the investigative sites are analyzed and, if appropriate, packaged for submission to the FDA for US market approval.

Next Event

Join us at the next PMI Atlanta Clinical Research forum on Thursday, November 10, 2022.

Register at www.pmiatlanta.org/events/event-calendar