Human error in the pharmaceutical industry results in costly rework, lost product, and lost time to more drastic consequences that increase the risk to patients, consumers, employees, and operations. Human error reduction methods and risk management techniques are highly sought after and utilized to optimize operations, increase profits, and minimize safety hazards. This presentation distinguishes human error reduction from a person-centered and a systems-based approach in the pharmaceutical industry. The research constructs a theoretical framework of a novel approach from literature research and information gained through interviews with subject matter experts. Furthermore, the research focuses on managerial implications with this new approach and emphasizes the importance of leadership’s involvement through the Bhopal Disaster, which was the world’s worst industrial accident.

1. A Systems-Based Leadership
Approach to Human Error in
the Pharmaceutical Industry
Ashley B. Turner

2. OUTLINE
• Research Motivation
• Introduction
• Theoretical Background
• Case Study
• Managerial Implications
• Limitations
• Future Research

3. RESEARCH
MOTIVATION
• 80% of all failure incidents or defects in manufacturing are
attributed to human error (Barron, 1988).
• Product recalls represent the worst case scenario.
• The highest recorded number of pharmaceutical product recalls
(40%) occurred during 2013 and 2014 (FDA, 2017).
• According to a study by the American Society for Quality (August
2003), each product recall costs an organization, on average, more
than $8 million.

4. INTRODUCTION
• Human error is an unintentional action or decision
(Assael & Kakosimos, 2010).
• Human errors in the pharmaceutical industry have
direct and indirect costs (i.e. product recalls,
increased risk to patients, hazards to employees
increased regulatory action, bad PR, and lost
revenue).
• Human errors affect the entire logistics chain at three
distinct levels: 1) patients and consumers, 2)
physicians, hospitals, and factory workers, and 3)
pharmaceutical companies.

5. LITERATURE
REVIEW
Person-Centered
Approach
• Focuses on unsafe acts by an
individual.
• When an adverse event occurs, the
question is “Who made the mistake?”
• Enforces countermeasures to reduce
unwanted variability in human
behavior and punitive actions , such as
retraining, firing, litigation, and
blaming.
• ‘Bad things happen to bad people’
Systems-based
Approach
• Focuses on system defenses.
• When an adverse event occurs, the
question becomes “Why did the
defense fail?”
• Believes that we cannot change
the human condition because
humans are naturally prone to
error, but we can change the
conditions under which humans
work.

6. Systems-based Leadership Approach
• Expands beyond systems-based approach concept
• Focuses on leadership's role and ethics in decision making with long-
term implications.
• When an adverse event occurs, the question is "Where did leadership
fail?"
• Believes in "Leading by Example“.
• Fosters a 'Collaborative Community' approach.
• Relies heavily on automation, electronic documentation, and social
media technologies to adapt in a fast-paced technologically advance
work environment.
CONCEPTUAL
FRAMEWORK

7. CONCEPTUAL
FRAMEWORK
Systems-based Leadership Approach Model

8. CASE STUDY
In 1984 the Union Carbide gas leak and explosion in Bhopal, India
became the worst industrial accident in world history as a toxic gas
called methyl isocyanate leaked from the pesticide plant and killed
3,787 people and injured hundreds (Jahangiri et al., 2016).

9. System Errors
Selected Latent Failures Origins Selected Latent Failures Origins
Locating a high risk plant
close to a densely populated
area.
Government/Management
Safety measures not
upgraded when plant
switched to large scale
storage of MIC.
Management
Poor emphasis on system
safety. No safety
improvements after adverse
audits.
Management
Heavy reliance on
inexperienced operators and
supervisors.
Management
No improvements in safety
measures, despite six prior
accidents.
Government/Management
Factory inspector’s warning
on washing MIC lines
neglected.
Management
Storing 10 times more methyl
isocyanate (MIC) than was
needed daily.
Management
Failure to release telex
message on MIC treatment.
Management
Poor evacuation methods. Government/Management

10. Operator Errors
Selected Latent
Failures
Origins
Selected Latent
Failures
Origins
Reduction in operating and
maintenance staff.
Management
Not operating warning siren
until leak became severe.
Management
Using a non-trained
superintendent for the MIC
plant.
Management
Switching off siren
immediately after starting
it.
Management
Re-pressurizing the tank
when it failed to get
pressurized once.
Management/Operator
Failure to recognize the
pressure rise was abnormal.
Management/Operator
Issuing orders for washing
when MIC tank failed to re-
pressurize.
Management/Operator
Failure to use empty MIC
tank to release pressure.
Management/Operator

11. Hardware Errors
Selected Latent
Failures
Origins
Selected Latent
Failures
Origins
Insufficient scrubber
capacity.
Design
Iron pipelines were used for
transporting MIC.
Management
Refrigeration plant not
operational.
Management/Maintenance
A manual mechanism for
switching off scrubber.
Design/Management
No automatic sensors to
warn of temperature
increase.
Design/Management
No regular cleaning of pipes
and values.
Management/Maintenance
Pressure and temperature
indicators did not work.
Management/Maintenance
No online monitor for MIC
tanks.
Design
Insufficient gas masks
available.
Management
No indicator for monitoring
position of values in control
room.
Design
Flare tower was
disconnected.
Management/Maintenance
Pressure monitor under
reading by 30 Psig.
Design
Vent gas scrubber was in
inactive mode.
Management

12. MANAGERIAL IMPLICATIONS
• Social Media Technologies
– Increase workplace safety and build organizational safety cultures (Baird, 2015).
– Provide collaborative communities between risk management and frontline
operators to interact in real time.
– Promote increased knowledge sharing between departments to address recurring
errors and solutions.
– Allow immediate access to internal and external networks to inform employees of
potential risks and consumers of recalls in products.
– Create a shared and undiluted vision of safety with interactive media platforms.
– Increase awareness of a no-blame culture through honest and open social
sharing.
– Empower frontline operators to voice concerns about system designs and
improvements for long-term benefits in error reduction.

13. MANAGERIAL
IMPLICATIONS
• Electronic Documentation Management Systems (EDMS)
– Free up office floor space and do not require purchasing filing cabinets.
– Improve operational efficiency
• Reduces potential for human errors that can lead to low product quality and even
product recalls.
• Improves tracking of non-conformant product to gain a better understanding of
rework costs.
• A digital system is searchable much faster than a manual one.
– Adhere to compliance standards easier.
• Enhanced information capabilities speed up review times.
• Allows access to compliance results to quickly identify any
production anomalies and to take immediate corrective action.
– Increase readiness for new regulations.
• Aids in conducting more efficient product recalls, and
shortens containment response.

14. MANAGERIAL IMPLICATIONS
• Automation
– Improves operational efficiency
• Reduction in production time
• Increase in accuracy and repeatability
• Higher volume production
• Less human error
• Less costs
• Increases profitability
– Increases safety
• Fewer employees means less safety issues.
– According to the U.S. Department of Labor’s Occupational Safety and Health
Administration businesses spend $170 billion a year on costs associated with occupational injuries and
illnesses (Ceraolo, 2015).
• Automating the handling of products will naturally help reduce the human contact equation
and reduce incidents of contamination.

15. Social Media
LIMITATIONS
• Social media platforms are publicly
available, but require maintenance from
personnel.
–SOLUTION: Consider whether the
benefits outweigh the costs as each
organization has different needs.
• Companies are afraid to utilize social
media technologies because open
communication and information
sharing break down organizational
hierarchies.
–SOLUTION: Embrace change.
• Potentially results in lost productivity,
if employees are continually updating
their profiles, which causes distractions
from work.
–SOLUTION: Social media policy stating
regulations and expectations.
EDMS and Automation
LIMITATIONS
• EDMS (web-based) systems
– Will have occasional connectivity issues
and may be unavailable at times due to
network issues.
– Can also be slow to use, especially as
more and more data is stored within
them.
– Are vulnerable to hackers.
– Require a technological change and a
cultural change.
– Large initial investment and continued
maintenance
– SOLUTION: Plan carefully.
• Automation
– Robots are expensive.
– SOLUTION: Initial investment is worth
the long-term benefits.
– Still requires human interface.

16. FUTURE RESEARCH
• Real-world case study comparison of pharmaceutical
manufacturing companies (small, medium, and large)
that utilize two main approaches to human error
reduction.
• Monitor a pharmaceutical organization that is
making a change from a person-centered approach to
a systems-based approach.
• Implementation of systems-based leadership
approach in these pharmaceutical manufacturing
organization case studies.
– Implementation of social media technologies, electronic
documentation, and automation.

17. REFERENCES
• 4 reasons paperless operation improves manufacturing quality. (2017). Industry Week, Retrieved from
https://ezproxy.wilkes.edu/login?url=https://search-proquest-
com.ezproxy.wilkes.edu/docview/1903495832?accountid=62703
• Alshidiq, A. (2017, August 10). Innovative paperless manufacturing in the pharmaceutical industry. Retrieved
September 27, 2017, from https://www.ceasiamag.com/2017/08/paperless-manufacturing-pharmaceutical/
• Assael, M. J., & Kakosimos, K. E. (2010). Fires, explosions, and toxic gas dispersions: effects calculation and risk
analysis. CRC Press.
• Baird, S. (2015, July 01). 4 Ways to Use Social Media to Keep Workers Safe. Retrieved November 28, 2017, from
http://wp.hsepress.com/2015/06/4-ways-to-use-social-media-to-keep-workers-safe/
• Baron, RG., (1988). Human Factors in the Process Industries. Human Factors and Decision Making: Their Influence
on Safety and Reliability, Symposium for the Safety and Reliability Society. ed. Sayers, BA. (pp.1-9).
• Beware the dangers of product mislabeling. (2013, June 12). Retrieved October 8, 2017, from
http://www.kallik.com/news/beware-the-dangers-of-product-mislabelling/
• Ceraolo, B. (2015, March 24). Improving Manufacturing Product Quality with Flexible Automation & Software.
Retrieved November 30, 2017, from
http://www.supplychain247.com/article/improving_product_quality_with_flexible_automation_software/omron_a
dept_technologies
• Disaster and scandal in India. (2017). Retrieved November 16, 2017, from http://chemicalsdisasters.over-
blog.com/article-disaster-and-scandal-in-india-61384562.html
• Jahangiri, M., Hoboubi, N., Rostamabadi, A., Keshavarzi, S., & Hosseini, A. A. (2016). Human Error Analysis in a
Permit to Work System: A Case Study in a Chemical Plant. Safety and Health at Work, 7(1), 6–11.
http://doi.org/10.1016/j.shaw.2015.06.002
• Reason, J. (1992). Human error. New York, N. Y: Cambridge University Press.
• Reason, J. (2000). Human error: models and management. BMJ : British Medical Journal, 320(7237), 768–770.

18. THANK YOU!
ANY QUESTIONS?
Ashley B. Turner (ashley.carpenter@wilkes.edu)
Wilkes University