Monday, May 6, 2013

Using Risk Assessment as Part of an Early Formative Evaluation


Introduction

Formative evaluation is an essential component of the third phase of design-based research as the learning solution is tested and refined.  This evaluation involved the intended facilitators of the e-learning course (including the project sponsor and researcher) and learning consultant to examine the alpha version in order to achieve these goals: 


  • Optimize the learning environment before course is released for pilot
  • Conduct a sequential walkthrough of entire working version of course
  • Identify potential issues with learning materials (e.g., activities, instructions)
  • Achieve consensus on expectations for learning activities (e.g., acceptable/non-acceptable results)
  • Begin to develop a reference guide for facilitators
  • Identify significant risks and ways to control and mitigate them. 
It was the last goal in the list above that involved risk assessment that is described here. 

Risk assessment
Background on risk assessment and risk management
Risk assessment and risk management are used in almost every industry and profession to make data-supported, proactive decisions on how to best use resources to prevent the occurrence of unwanted events, and should they occur, to protect the assets of value in the environment. Despite the usefulness of risk assessment in enabling potentially problematic events to be articulated and then possibly accommodated, such assessments are only rarely performed in planning e-learning environments. Nevertheless, such risks do exist. While e-learning environments have inherent (and easily predicted) risks related to data security, data loss and technology failure, more subtle risks related to learning activities and assessment can create critical obstacles for students engaged in e-learning.  These risks are compounded when e-learners in different countries and different cultures must collaborate online. 
Risk assessment is defined as the “overall process of risk identification, risk analysis, and risk evaluation” (ISO, 2009). In performing a risk assessment, one seeks answers to five basic questions (Kaplan & Garrick, 1981):
1)     What can go wrong?
2)     How bad can it get?
3)     How could it happen?
4)     How likely is it to happen?
5)     Should we try to do something about this?
With answers to these questions, one can then move into risk management where three other questions are asked (Haimes, 1991):
1)     What can be done to control, mitigate or prepare for this unwanted event?
2)     What are the best options given the circumstances?
3)     What other risks or issues might the selected option(s) create?
These questions are asked in a series of phases using a variety of well-defined methods and tools to document the process and results.  Figure 1 shows a model of a typical risk assessment and risk management process.


Figure 1. The typical process for risk assessment and risk management (Vesper, 2006)

Risk assessment can be performed using a variety of tools (such as those illustrated in the right column of Figure 1). Some tools are very basic and may be informal, for example, simply asking “what if…” questions. Other tools, like fault tree analysis (FTA) and failure mode effects analysis (FMEA) are highly structured and well-defined (Stamatis,2003; Vesely, Goldberg, Roberts & Haasl, 1981). Certain tools are optimized to help identify hazards – hazard analysis or hierarchical holographic modeling – while others like hazard analysis and critical control points go through the entire risk assessment and risk management process (Vesper, 2006). 
There is limited literature on risk assessment in relation to formative evaluation. Lynch and Roecker (2007) recommended that risk assessment be used as part of an evaluation and presented a simple form to collect data to be used in the assessment. Similarly, Benson and Brack (2010), in their planning guide for online learning and assessment, noted that an important administrative function in planning online assessment was the completion of a risk assessment of: 1) student support factors (such as access and equity issues), 2) technical issues (such as access to hardware and software, bandwidth, etc.), 3) authentication (such as cheating, collusion, plagiarism, etc.), and 4) consideration of the instructor’s administrative skills (such as ability to use software, manage online grading, copyright, etc.). However, no model or framework of risk assessment appeared to exist that provided guidelines for the assessment of a complex online authentic learning environment involving a community of learners. In the next section, we describe the design and development of such a framework.

Getting started
Before starting a risk assessment, what is being assessed must be clearly defined. This can be done by a written description, flowchart, or diagram (ICH, 2005).  For this project, the scope of the risk assessment include the:  
  • e-learning application
  • Technological infrastructure enabling the use of the application
  • All participants in the course (including the learners and the facilitators/mentors)
One other important but often overlooked element is clearly defining the “risk question” – the question that the risk assessment is meant to answer (Vesper, 2006). This is consistent with one of Reeves and Hedberg’s (2003) key reasons for doing a formative evaluation – answering questions that can be used to make decisions about development. 
Examples of risk questions include:
1.    What are the IT/technology risks associated with this e-learning project?
2.    What are the risks related to the community of learners due to inappropriate communication?
3.    What are all the risks that could arise when using this e-learning program?
As can be seen in these examples, risk questions can define the scope of the risk assessment from very narrow (Risk question 2) to very wide (Risk question 3). Often, the risk question drives the selection of the method the risk assessment team selects.  A preliminary risk assessment that asks, “What if...” could be used with Risk questions 1 and 2; hierarchical holographic modeling (HHM) and risk ranking and filtering are appropriate for identifying and assessing risks in a large, complex system (Haimes, Kaplan &Lambert, 2002) such as those that would be examined in answering Risk question 3. 

Identifying hazards
Two important definitions to distinguish between are hazard – the source of harm – and risk – the combination of the likelihood of the occurrence of the unwanted event resulting in the harm and the impact of that harm (ICH, 2005). When starting a risk assessment, one first needs to identify the hazards. There are different ways to identify hazards. A frequently used method is to simply brainstorm what could go wrong. Other tools, like hierarchical holographic modeling (Haimes, et al., 2002) can be used to first create “success scenarios” from which risk scenarios and specific risks can be identified. 
In this formative evaluation, the evaluation team first brainstormed what would be necessary for a successful e-learning Pharmaceutical Cold Chain Management Course (e-PCCMC).  The team then identified actions, events, or situations – the hazards – that could prevent or interfere with e-PCCMC. The list was then condensed based on those hazards that were considered most relevant, and then discussed further using a preliminary risk assessment tool. 

Determining the risks
A preliminary risk assessment (PRA) can be used early on in a project when minimal information is available, or as a screening tool to identify risks that need to be examined more critically using other tools, such as fault tree analysis or failure mode effects analysis (Vesper, 2006). For the purposes of this evaluation, the researcher felt that the PRA would provide an appropriate level of detail. 
For each of the hazards, specific questions were asked to help determine the risk. These included:
1.   What are the potential negative impacts to the learners and the desired course outcomes?  Answers to this question provided examples of the consequences, or harm should the hazard be expressed.
2.   What could cause this unwanted event to occur?  Here, the team identified how the hazard could be expressed.
With this information summarized using a matrix (see Figure 2), the team estimated the likelihood that the hazard would be expressed resulting in the harm, using a scale of low-medium-high (1-2-3) (Column 5). In a similar way, the impact was estimated, again using a scale of low-medium-high (1-2-3) (Column 6). Multiplying these two numbers resulted in a risk score – the higher the number the more risk being present (Column 7). 
The last step of risk assessment is risk evaluation:  deciding on the risks that need to be reduced (Column 8). Generally, these are the high or medium risks that are “treated” through control and mitigation.  Other, low-level risks might be addressed as well if the benefit outweighs the risk-reduction cost. 

Reducing the risks through “treatment”
Risk treatment (ISO, 2009) involves two key concepts:  control and mitigation. Control is aimed at preventing the unwanted event from occurring in the first place; the focus is on reducing the likelihood by targeting the root and contributing causes. Mitigation assumes the unwanted event will occur but aims at protecting the “thing of value” (CSA, 2002). For example, one cannot totally prevent a server crash at a hosting site, but one can take protective measures should that happen. Whenever possible, multiple risk treatment approaches should be taken that have a “layering” of the control and mitigation actions. These are tied to the different causes or mechanisms that were identified. These layers result in a more robust solution should the hazard be expressed.
For each of the risks that were identified, the team identified a risk treatment plan.  In some cases, it was providing information, for example, recommending browsers that were tested (and what browsers are not recommended).  Another example of an identified risk was certain governments not allowing access to a video website.  A mitigation plan was established to pre-make DVDs and send them by DHL courier to course participants when requested by them.  (This actually occurred – actually occurred at the start of the pilot course.  A participant could not access the VIMEO or back-up sites, so the treatment plan – sending a pre-made DVD to him via DHL – was executed.) 

Figure 2. A section of a risk assessment performed using Preliminary Risk Assessment (PRA) worksheet

Monitoring and review
The identified risks were addressed through control and mitigation, however, team members intended to review the assessment at the end of the pilot course to see if the control and mitigation actions were effective and if the likelihood and impact were correctly estimated. Additionally, monitoring was implemented as an ongoing effort to determine if anything that changed that could affect the assessment.  Another aspect of monitoring is to identify any other risks that were not previously identified. 
A formal review of the risk assessment and risk management plan will be performed when the pilot course is completed.  In terms of monitoring, the design team realized two weeks into the course that there was going to be a seasonal time change (from “standard time” to “daylight savings time”) occurring at two different points during the course.  To mitigate the impact, a notice was sent to all participants alerting them to the change.  This event will be included in the listing of risks to be compiled for the next offering of the course.






This is an excerpt from a dissertation chapter from James Vesper. Professors Thomas Reeves and Jan Herrington have contributed to it.


Sunday, May 5, 2013

EPELA e-Pharmaceutical Cold Chain Management course goes to Berlin, Germany

Dr Umit Kartoglu will be presenting the "behind the computer" story of e-pharmaceutical cold chain management course development and will make a demonstration on how it works to participants of the IQPC's 6th Annual Cold Chain Conference in Berlin. The keynote speech will take place at Novotel Berlin Am Tiergartern on Monday 13 May 2013 at 12:00.

http://www.cool-chain-conference.com/


How to fit a bus into a computer screen?

Dr Umit Kartoglu presented the anatomy of the e-Pharmaceutical Cold Chain management course design to WHO colleagues on Wednesday 27 March 2013. On Monday 8 April, a second presentation was organized for those who missed the first presentation.


Authentic Learning Goes to the Next Level – WHO launches EPELA e-learning course

19 February 2013, Gainesville, Georgia, USA (photo: Umit Kartoglu)
From left to right: Kevin O'Donnell, James Vesper, Andrew Garnett and Thomas Reeves
We rendezvoused at Atlanta’s Hartsfield Airport, piled into the rented SUV, and drove through the rainy Georgia night to Gainesville — five weary travellers. We entered the sprawling rented house on Lake Lanier that would serve as our group’s office, home, restaurant, and laundromat for the next four days. We uncorked a bottle of red wine and raised a glass in camaraderie, each secretly wishing for success in the launch of a new and unique chapter in online learning. We gathered to work out the few remaining kinks and put the finishing touches on the World Health Organization’s inaugural EPELA authentic e-learning course on pharmaceutical cold chain management, a virtual-world extension of the WHO/PDA Pharmaceutical Cold Chain Management on Wheels Course in Turkey.

This revolutionary ‘Authentic’ e-learning experience, two years in the making, is the brainchild of Dr. Umit Kartoglu, Ph.D., M.D. and scientist, and the coordinator for Global Learning Opportunities for Vaccine Quality at WHO headquarters in Geneva, Switzerland. Umit invited me, along with principal course architects Jim Vesper, a widely respected expert in risk management and founder and president of LearningPlus Inc., in Rochester, NY, and Tom Reeves, Ph.D., and professor emeritus of Learning, Design and Technology at University of Georgia, in Athens, and a pioneer in interactive learning programs, to make final preparations for the course launch. The fifth colleague at our rural hide-away was Andrew Garnett, a London-based architect-writer-intellectual, and member of the team that developed the WHO/UNICEF Effective Vaccine Management initiative.  Joining us by videoconference from Istanbul were graphics designer, illustrator and animator Gokhan Gurses, and a small team of software engineers.

We spent most of the next four days dissecting and correcting a myriad of physical, electronic and technical aspects of the course and plotted an elaborate risk assessment matrix to address any and all “unforeseen” circumstances that might arise, by plastering dozens of hand-written Post-It notes across the surface of the sliding glass doors in the great room of the lake house that led to the balcony overlooking a dreary Lake Lanier below. In the end we felt confident we had mediated any likely scenarios that might arise that could throw a wrench into the launch.

The course successfully launched worldwide at 00:00 GMT on Monday, March 4th, as planned. This was no sooner accomplished than we realized that when the course schedule was defined and distributed to the first “class,” we forgot to account for the change to Daylight Savings Time (which occurs on different days throughout the world during the month of March). This is critical considering groups convene for the course tasks at specific times. Crisis averted.

What is Authentic Learning?

Authentic learning is a learn-by-doing concept where course participants become ‘cognitive apprentices’ to the experts, engaged in realistic tasks and complex collaborative activities that encourage the creation of enriched mental models of the constructs and procedures related to, in this case, vaccine regulation, production, distribution, and storage.

The name given by WHO for this revolutionary method for online learning is, in Latin: Extensio et Progressio Authentic e-Learning, or EPELA, for short. Unlike most electronic courses where participants read through the material, slide show or video presentation, and complete some on-line assessment based on memorization skills (or lack thereof), EPELA incorporates a significant amount of “imagineering,” a custom platform of content designed by various experts and learning professionals in collaboration with creative directors, cinematographers, graphic artists, and software developers from around the world. From the moment participants sign-in, the course becomes a very immersive experience, a virtual reality.

During the past five years, Dr. Kartoglu has been leading groups composed of 15 participants and three mentors through the length and breadth of the cold chain in Turkey. In both the public and private sectors, institutions have hosted the learners and allowed them an “all-access pass” of the real life of the cold chain. The award-winning “bus course,” as it is frequently called, has proven a notably intense and successful learning experience. (I have served as mentor on the course in 2010 and 2012 and will do so again this June.) However, a week-long course requires an enormous amount of planning and resources, which has limited the course to once a year. With the demand growing, Dr. Kartoglu has been challenged to find ways to provide a similar learning experience for cold chain practitioners around the world and was committed to create a unique, technology-supported learning experience where people could learn with and from each other and where real-life situations and case studies could be used to develop expertise.

The resulting on-line experience is remarkably similar to the actual bus course, but without the fumes and kebabs. All the major facilities of the real-life experience are visited, including: a wholesaler, a public hospital, a regional healthcare storage facility, a primary healthcare clinic, a commercial pharmacy distributor, and a retail pharmacy. Each “visit” includes a facility tour video, 360° photographs, extensive video and document “libraries” on everything from basic thermodynamics to storage facility design to risk management. Participants from around the world engaged in the course are grouped (by time zones) and also work independently on a host of exercises. There are discussion groups and everyone is encouraged to keep an online diary of their travels. Mentors closely monitor the progress of each individual over the 11-week course, providing personalized feedback and support via e-mail, Skype, and group conferencing by phone. The culmination of the course addresses a real-life (authentic) task involving the immunization supply chain in Albania — where the participants are required to create a solution that would be of a real public health benefit based on their course learnings.

Some of the advantages of the EPELA e-learning course — other than the obvious monetary savings associated with travelling — are that it supports a learning environment that even the best traditional face-to-face courses can’t match. EPELA enhances collaborative, cooperative and individualized learning in ways that traditional e-courses do not allow, and this is well recognized among educational experts as vital aspects of effective learning and professional development. EPELA is a state-of-the-art process enriched with learning assessments — not tests — that allow personalization of learning with the needs of individual learners. The course also ensures a consistent delivery of the same learning opportunities to all participants, an important advantage in regulatory environments such as pharmaceuticals.

Development of the WHO EPELA e-learning course was driven by an aspiration to provide a high-quality education program that will help to ensure that time-temperature sensitive drug products are safe, pure, and effective. To that end, I believe the EPELA e-Pharmaceutical Cold Chain Management Course will prove a resounding success and a teaching model for others to follow in the future. Additional courses are already under development by Dr. Kartoglu, including e-VVM Based Vaccine Management and e-GCP Inspection.

The course is free (!) to eligible public sector applicants. Eligible private sector applicants pay $3,500 USD. That’s quite a bargain. To learn more about this ground-breaking learning experience or to review eligibility requirements for application, go to www.epela.net Perhaps we’ll meet on the virtual bus!

By Kevin O'Donnell - published in Contract Pharma and Clutchcargo



Wednesday, May 1, 2013

New e-learning design: Global Learning Opportunities for Vaccine Quality (GLO/VQ) has gone virtual



Over a period of five years, learning groups composed of fifteen participants and three mentors have traveled along the route of the cold chain in Turkey.  Public and private institutions hosted the learners and allowed them to experience the real life of the cold chain.


Nothing Stands Still - Pharmaceutical cold chain management on wheels 2008 from EPELA on Vimeo.

The WHO-PDA Pharmaceutical Cold Chain management on Wheels course has proven a notably intense and successful if not unique learning experience.  However,  a week-long course required an enormous amount of planning and resources – the reason why only one such course a year has been possible to arrange.  With the demand growing, we have been challenged to find ways to provide a similar learning experience for the cold chain practitioners around the world.

With the goal of increasing access to efficient learning opportunities, the course design team was put together in late 2010.  Besides providing an important and useful content, the design team was committed to create a unique technology-supported learning experience where people could learn with and from each other and where real-life situations and study cases could be used to develop expertise.  The team also wanted to include aspects of “authentic learning” where the learners could address real, ill-defined problems and create solutions that would be of a real public health benefit.

25 September 2010, Antalya, Turkey (photo: Hakan Gonendik)
Design team (from left to right) Umit Kartoglu, Thomas Reeves, James Vesper, and Gokhan Gurses discussing the course objectives

The e-Pharmaceutical Cold Chain Management course is the result of the work of the talented and dedicated design team, including instructional designers, illustrators, filmmakers, software engineers, programmers, content experts, and formative evaluators who spent literally thousands of hours on this project.  Their motivation was driven by an aspiration to create a high-quality learning programme that will help to assure using time-temperature sensitive products that are safe, pure, and effective.

The platform EPELA (Extensio et Progressio: Authentic e-Learning) provides all necessary tools to participants.  EPELA e-learning promotes collaborative learning which is now well recognized as the vital aspects of effective learning and professional development.  EPELA e-learning enhances quality and outcomes of the courses offered.  As good as the other courses are, EPELA e-learning provides unique affordances for supporting learning that even best traditional face-to-face courses cannot match.

The EPELA e-learning platform can be visited at www.epela.net.  You can also explore the very first example of this authentic e-learning course e-Pharmaceutical Cold Chain Management course at http://epela.net/epela_web/introduction.html.  The course takes participants inside an enhanced, robust mental model of a pharmaceutical cold chain.  For 11 weeks, we travel with participants virtually from one location to another, through different levels of the supply chain.  In addition to the virtual visits to facilities, we offer short illustrated videos and critical reference materials.  Authentic tasks are arranged mainly as group activities to promote collaborative learning and enhanced with peer-review.  The course site offers participants tools to help to easily connect with other participants, discuss and produce as a team.  Mentors provide timely feedback to all participants whenever necessary and are always ready to assist them whenever participants need them.  Following 7 weeks of virtual visits to facilities, participants are introduced as a group to a real client so that together with their peers they could analyze, repot and give recommendations to the client regarding the client’s operation of the time and temperature sensitive pharmaceutical products.

Although developed to support the authentic context of the e-Pharmaceutical Cold Chain Management course, we make all short video-lectures and limited number of documents publicly available (more documents are available for course participants as well as facility tour videos, 360 degree spherical and cylindrical photography of the facilities and authentic task videos).

Both WHO and EPELA encourage others to widely use the videos and embed them in other web sites.  The following videos are now available publicly (http://epela.net/epela_web/video_library.html):

Documents, records and record management by James Vesper


Documents, records and records management - James Vesper from EPELA on Vimeo.

James Vesper reviews the critical aspects of documents, records and record management.  Documents like procedures, protocols, methods, and specifications provide instructions so people can perform tasks and make decisions safely, effectively, compliantly, and consistently.  Records, such as batch manufacturing records, cleaning logs, and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were (hopefully) made in keeping with procedures and GMP expectations.  Reports, another type of documentation, provide specific information on a particular topic (like an investigation or one aspect of product development) in a formal, standardized way.

Exploitation of stability data to reach the unreached by Umit Kartoglu
Umit Kartoglu presents the critical aspect of exploitation of stability data to reach the unreached through overview of studies taking vaccines beyond the 8oC, all published in peer-review journals as well as a new concept of cool water packs by the WHO and Vaccine Vial Monitors.  As he indicates that vaccines have become more stable and there is a clear prospect of increased or even complete heat stability, and concludes that in these circumstances the dogmatic approach to the cold chain causes resources to be wasted and places unnecessary restrictions on field operations.

Global Perspectives in Regulatory Oversight by Rafik Bishara


Global Perspectives in Regulatory Oversight - Rafik Bishara from EPELA on Vimeo.

Members of the pharmaceutical supply chain have various global requirements to meet during the storage, transport and handling of time and temperature-sensitive products.  Changing product portfolios, requirements for good storage and distribution practices, regulatory expectations, quality management, and risk assessment factors bring many challenges to the handling of drug products.  Rafik Bishara reviews the global perspectives in regulatory oversight on pharmaceutical time and temperature products.

How Best to Use Stability Data for Handling of Time and Temperature Sensitive Products by Claude Ammann


How Best to Use Stability Data for Handling of Time and Temperature Sensitive Products - Claude Ammann from EPELA on Vimeo.

Claude Ammann reviews the importance of understanding regulations related to the stability testing to add value to evaluate temperature excursions.

Introduction to Quality Risk Management by James Vesper


An introduction to quality risk management - James Vesper from EPELA on Vimeo.

Risk management involves a series of activities that are sequenced so that one step informs or shapes those that follow.  James Vesper provides a high-level overview of the entire process.

Last Mile by Umit Kartoglu
Umit Kartoglu reviews the critical last mile between the service point and the end user.  He further discusses the best solutions for storage and transport of products and best practices for temperature monitoring.

Packaging design by Kevin O'Donnell
Kevin O’Donnell reviews the peculiarities of five different packaging technology: Nylon, EPS, EPP, Airliner and VIP.

Risk assessment methods by James Vesper
James Vesper goes into details of methods frequently used in risk assessments and gives first hand advise on when and how best to them: Preliminary risk assessment, failure mode effects analysis and fault tree analysis.

Storage Facility Design: Cold Storage by Andrew Garnett


Storage facility design / Cold storage - Andrew Garnett from EPELA on Vimeo.

Andrew Garnett reviews the cold storage aspects of storage facility design and covers temperature controlled storage areas, order assembly areas and materials handling.

Storage Facility Design: Site and Buildings by Andrew Garnett

Andrew Garnett reviews the storage facility design with a particular emphasis on the site and buildings through analysing the reasons for storing cold chain products, different types and functions of storage facilities, location, access, security, general building design issues.

Thermodynamics by Kevin O'Donnell

Kevin O’Donnell discusses thermodynamics, the basis of heat transfer and how we can use heat energy to our benefit in packaging.

In addition these illustrated video-lectures, EPELA also brings the following videos on technical issues:

Five senses: Vaccine Vial Monitors by World Health Organization
A movie, produced for the 10th year anniversary of the introduction of vaccine vial monitors (VVM).  The movie focuses on how this simple tool expands the horizon of the immunization programme and empowers health workers serving people at the very periphery of the health system.  The theme and the goal are specific but there are scenes, human conditions, different livings for everybody to see and think about them.  Shot in Niger, Vietnam and Indonesia in 2007.

Nothing stands still by World Health Organization
The video of the WHO-PDA Pharmaceutical cold chain management on wheels course conducted during 2-7 June 2008 in Istanbul, Ankara, Konya, Eskisehir and Bursa (1,400 km route) in Turkey.

Now is the time by Project Optimize
This three-minute video examines the growing challenges of maintaining reliable vaccine supply and logistics systems and offers potential solutions toward achieving optimized, efficient systems that reach people with the vaccines they need.

Shake and Tell (video article) by World Health Organization
This is the first ever video of a full-fledged scientific article on the validity of the shake test.  Shake test is the only test available to diagnose whether a freeze-sensitive vaccine has been damaged by freezing.

Step-by-step how to conduct the shake test by World Health Organization
This educational video provides the steps of a standard validated way of performing a shake test and interpreting the results.

WHO and EPELA, with the launch of their second course e-VVM Based Vaccine Management, will make seven more illustrated-lecture videos publicly available in coming months.

Stay tuned… With warmest regards,

Umit Kartoglu
Global Learning Opportunities for Vaccine Quality
Extensio et Progressio: Authentic e-Learning