2019 HPRCT Conference

The purpose of this talk will be to describe Biogen’s journey of integrating Human Performance principles into the investigation process in the biotechnology industry; from initially walking in the footsteps of the “Old View,” to blazing a new path based on the “New View.” This presentation will describe the path taken by Biogen starting in 2015 with an overemphasis on “human error” to a systematic approach in investigations. Advancing to a systematic approach led to identifying causes at the organizational level as opposed to only uncovering causes at the local level. In addition to the above, organizational analysis presented challenges to the biotech industry, which led to confusion about the application of Human Performance principles into the investigation process. The state of investigations at Biogen in 2019 is quite different from 2015. The integration of the systems approach, use of multi-causal causal analysis methods, delineation of local and organizational factors, evaluation of extent of condition and cause, and learning teams have defined excellence in investigations and established a framework for resilience.

Purpose: To encourage participants to view their current training and operating experience (OPEX) programs through a different lens. This session looks to provide a fresh perspective in reshaping and/or strengthening some common defenses (flawed or not) used throughout many high-risk industries; Training and OPEX. We’ll explore the question “Does your training and OPEX program provide enough impact to help your workforce store and retrieve the operational information they need in order to conduct their job more safely, effectively and productively?” The brain is like a massive haystack, capable of storing billions of pieces of information (needles). In and of itself, this is pretty impressive. However, it’s easily argued that the ability to retrieve the correct needle and pin an un-wanted event to the board of “Not Today”, is equally impressive. From the available research, we know the cognitive ability one uses to encode, store and retrieve information is directly related to the emotional connection an individual has to that information. This session looks to enhance your existing training program by discussing some of the available psychological and cognitive tools you can implement to change your stereotypical training session from “boring” to “memorable”. Summary: Today we are inundated with information coming at us in all directions. Getting your work force to effectively store and retrieve the information required to perform their job at a higher level may often be a daunting task. Oliver Wendel Holmes said, “A person must get a thing before they can forget it”. So how do we help them “get it”? Using some of the fundamentals of cognitive psychology discussed by Dr. Fischer (Florida International University) and Dr. Geiselman (UCLA), and current research from developmental molecular biologist, John Medina, we’ll look at some strategies one can use to help strengthen existing training programs and make them more memorable and operationally effective. Mark Spitz once said, “We all love to win, but how many people love to train?”. We’ll also take a look at some memory techniques used by Grandmaster of Memory, Kevin Horsley. During this session, participants will discover how a drift in training practices and operational excellence led to the unfortunate events of the USS McCain (DDG-56) and USS Fitzgerald (DDG-62), culminating in well over $500M in U.S. property damage and the immeasurable costs associated with the death of 17 sailors.

In 2014 there were very few people at our contract pharmaceutical sterile filling site who believed that effective investigations would be the key to unlocking the performance potential of our site. Support for investigation processes is a regulatory requirement in the pharmaceutical industry, and our level of support was sufficient to meet the requirement, but quality had to drive and pull teams to meet the standard. Today our site and culture are different. Our investigations are considered “best in class” in our contract manufacturing network and we have received this feedback from FDA, ANVISA, Russian Ministry of Health, EMEA, and other regulatory authorities. Leading the team that drove these improvements has been the highlight of my career and our success can be attributed to deep cultural support more than any other factor. This support was challenging to generate and has even been withdrawn at times.   We faced multiple complex problems generating and maintaining buy in to do investigations well even though our process was obviously improved. From 2014-2018 we have had double digit year on year reduction in deviations. We have had investigation cycle time decrease from over 150 days to less than 30 while improving the quality. We have gone from identifying causes in <50% of deviations to 98%. We have gone from human errors being assigned as the cause in 75% of deviations to <10%.  We also went from 30 average days to close back up to 70 and then back down again. We had to identify the causes of shifting support and put processes in place to prevent them in the future. My hope is that others can benefit if I share some very challenging problems and our solutions.  
• How do you get organizational leaders excited support for investigations?
• How do you ensure that stakeholders in each investigation are engaged, honest, and effective?
• How do you motivate a team that has to solve the hardest problems the company faces?
• How do you promote a culture where ownership and accountability?
• How do you recover from the support that led to your success being withdrawn?
• How do you complete investigations quickly without compromising the content?
• How do you facilitate operators and technical teams in finding the most efficient solutions?
• How do you translate quality metrics to financial ones?

It is a complicated and challenging task to get teams excited about investigations. If you love investigating, you are just a little bit of a unique snowflake! It is also so rewarding and satisfying to part of a quality centered organization that embraces change and data driven solutions. Our experience can be used in any industry or environment, because once the case for quality is made in an effective way, support and engagement is the natural response.

In an effort to increase the effectiveness of learning from failure, in certain situations, we have found that combining aspects of a traditional RCA with a learning team can provide more thorough understanding of failures.  The breakout session will briefly cover the methodologies used, how the investigations are conducted, followed by a an example.  We are interested in a dialogue with other practitioners to improve our methodology.

he Dutch railway sector consists of several Train Companies, but only one major Maintenance and Traffic control Company named ProRail. ProRail collaborates with a limited number of certified engineering companies and certified contractors, when it comes to the installation and maintenance of the Railway safety systems. ProRail realized at a certain point that, although each company was trying to enhance their own safety culture, the safety culture on a sectoral level was suffering from fragmentation, competitive obstacles, and a severe lack of sectoral learning. ProRail then decided to launch a three year, sector wide HRO program in order to accomplish a level 4 proactive safety culture on the sectoral level. Apollo13 was having a key facilitating and advisory role in this program. One of the key success factors of the approach was creating a change platform instead of a change program. In the change platform all relevant parties (ProRail, engineering companies and contractors) were represented; they were also owners of the program. Thus the program focused on ‘horizontal organizing’ and transformational change. The members of the Change platform decided which activities were to be launched an how to proceed. Key intervention domains were:

• enhancing collective learning ability
• improving communication and interaction ability
• strengthen change and development capacity
• enhance ability to act. It worked out into a very successful program.

In this breakout session we will inform you about the HRO intervention strategy we used, the specific factors which contributed to the success of the program, the several lessons learned and above all the typical ‘new’ struggles related to horizontal organizing.

In 2016 the Royal Schiphol Group started its journey developing a proactive safety culture. Schiphol uses the HRO perspective to frame the word ‘proactive’ in one of its corporate strategy targets ‘to achieve a proactive safety culture (maturity level HRO4) by 2020.´ For Schiphol ‘proactive’ means: [a] notice weak signals of potential risks earlier, [b] acting faster and with more resilience in managing unexpected events and [c] search for underexposed or subconscious patterns of behavior to prevent repeating incidents. To give the implementation of ´proactive´ a boost the program Schiphol4Safety (S4S) was drafted. After three years, the program will end and leave it to the business to further a proactive safety culture. In 2020, Schiphol will assess the achievements. In this presentation Maryse Schermerhorn, senior Safety Culture Expert at Schiphol, will give an overview of how HRO was used in the design and execution of this journey including the applied methods and tools. Using concrete examples and videos, she will show how Schiphol uses HRO as a source of inspiration for proactive thinking and doing and as an instrument to crack resistance to change and learning.