Human Error in Pharmaceuticals | Fresh Approaches to Prevention and Control

Human error is still one of the leading contributors to deviations, batch failures and regulatory non-compliance in the pharmaceutical manufacturing sector. While the industry has progressed towards automation and added robust standard operating procedures (SOP’s), it is estimated that human errors still account for roughly 60-80% of all quality incidents reported.

While many times, we simply refer to mistakes as ‘human error', this approach can lead to oversimplification of the issue. The root cause of these issues usually lies deeper with inadequate processes, lack of training, poor communication and a dysfunctional company culture.

To make a true impact on reducing errors; businesses must change their methods from blaming individuals to creating processes that decrease the likelihood for error to occur and create systems that make early detection of errors easier. This article will outline several new, practical methods that can be utilized to identify and mitigate human errors in pharmaceutical environments.

Human Error Related to Pharmaceuticals

Human error within the pharmaceutical manufacturing industry encompasses any actions (intentional or unintentional), decisions or omissions that deviate from the proper procedure. In turn, this introduces the potential for noncompliance or a risk to product quality.
Examples of human error in the pharmaceutical industry include:

• An incorrect label was placed on a batch of product.
• A batch of equipment was not cleaned properly or was not set up properly because of a step that was missed.
• Data was entered incorrectly in a batch processing log.
• Gowning and hygiene rules were not being followed.

The majority of all human errors are a symptom of a greater problem, not a root cause. It is unlikely that retraining or reprimanding individual employees will solve the majority of human error situations because it does not eliminate the underlying systemic failure.

Common Causes for Human Errors

For organizations to effectively deal with human errors they need to understand the reason behind them occurring in the first place.

A) Inadequate or Clarified Procedures

When Standard Operating Procedures (SOPs) are too much complicated, out of date or not clear, they lead to misinterpretation and errors

B) Lack of Appropriate Training and Management of Competence

When training is primarily based on rote learning and not based on developing an understanding of the processes, employees will not be prepared for "real world" deviations

C) Fatigue and Stress

Long hours, shift work and mental overload result in a reduced level of attention and decision making ability, which may negatively affect the accuracy of the task being performed.

D) Poor Workspace Design

Workspace with poor ergonomics, clutter and poor lighting, create a higher risk for operational errors.

E) Ineffective Communications

When there are poor handovers, incomplete information or language barriers there will be a high level of probability that an operational error will occur.

F) Over-Reliance on Human Memory

When a manual system requires a person to remember critical steps, the likelihood of making an error will be extremely high.

The first step toward improvement is to recognize that these causes are systemic - not personal.

Traditional Responses to Human Error - And Why They Fall Short

Historically, many companies have responded to human error with either disciplinary actions or retraining. Unfortunately, this approach treats only the symptom of human error and fails to address the actual root cause(s).
Reasons why this fails:

• Retraining employees will not resolve their employer’s inability to develop good standard operating procedures or confusing systems.
• The use of punitive (i.e., disciplinary) action creates fear among employees and discourages them from reporting errors.
• Recurring errors indicate that the system (not the individual employee) is responsible for the problem.

Regulatory perspective:

FDA and EMA inspectors are placing greater emphasis on companies conducting genuine root cause investigations rather than simply concluding “human error” or “operator error.” The term “human error” or “operator error” without supporting documentation is no longer acceptable in non-conformity reports.

Innovative Ways to Decrease the Chances of Making a Mistake

Currently, the way that pharmaceutical manufacturers are managing human error is using scientifically proven processes. Below are examples of some effective options.

A. Use Human Factors Engineering (HFE)

Human Factors Engineering (HFE) is a discipline that studies the design of systems regarding people and their capabilities and limitations.
How do you apply HFE to your processes?

• Make your procedures and interfaces as simple as possible; do not overload the human brain with too much information.
• Ensure your work spaces are ergonomic (properly designed) for the functions being performed.
• Use the same color codes, labels and visual tools to improve understanding.
• Have controls and instrument displays that look the same.

Example: When using raw materials in different containers, they should have bold, color-coded labels to reduce confusion.

Advantage: An environment that has been created with HFE will be one with low to no errors because the system was designed to eliminate the potential for errors before receiving the input required to initiate a process.

B. Using "Error-Proofing" (Poka-Yoke) Methods

"Error-Proofing" (Poka-Yoke) is borrowed from Lean Manufacturing and refers to creating a method to prevent an improper action or to make it readily apparent.
Examples of how this has been implemented in the pharmaceutical business include:

• Using barcodes to verify that the correct material is used before implementing it in the product.
• Automated machine safety devices to prevent mistakes while completing job duties.
• Using RFID tag systems to confirm that a product has been properly cleared from a manufacturing line.
• Using sensor-based systems to ensure that components are properly assembled on products.

Advantage: Small "smart" interventions can be very beneficial because they help eliminate the need to rely on memory and provide relief from repeated errors from people.

C. Human Error Root Cause Analysis (HERCA)

Common root cause analysis tools like the Fishbone Diagram or the 5 Whys frequently conclude with operator error. The HERCA process delves deeper into the reasons why the error of the operator occurred in order to determine the true cause of error earlier in the process. The steps to HERCA are:
- Identify the specific task where the error took place
- Review the environmental (lighting) and systemic (supervision) conditions that contributed to the incident
- Determine whether the error was due to a skills deficit, rule deficit, or knowledge deficit
- Identify systemic improvements that can be implemented (other than retraining) that will eliminate the opportunity for errors in the future

Examples of how a HERCA can provide more accurate identification of the root causes of errors include identifying ambiguous or poorly designed interfaces, unclear procedures, and/or having unrealistic expectations of the operator.

D: Build a Just Culture
A Just Culture balances accountability and learning while striving to create systems to minimize the occurrence of errors, rather than punishing individuals for unintentional mistakes. Key components of a Just Culture include:
1. Human Error: Unintentional mistakes
2. At Risk Behavior: Taking shortcuts due to external constraints imposed by the system
3. Reckless Behavior: Intentional disregard for established policies or procedures

Benefits of a Just Culture:

1. Increased willingness of operators to report near misses and errors
2. Increased ability to learn from an incident instead of hiding it
3. Building trust between management and operators.

In a Just Culture, errors become opportunities for continuous improvement instead of being blamed.

E. Organize Meaningful and Application-Based and Experience-Based Training

The majority of traditional training methods do not adequately prepare employees to navigate real-life complexities; therefore it is more effective to apply experiential training methods which can be learned through:

• Simulations of real-world case studies of deviations.
• Hands-on workshops that demonstrate the impact of mistakes.
• Peer-to-peer coaching/mentoring.
• Micro-learning (short, frequent modules) is used to promote understanding of the important GMP principles without overloading employees

Because viable and real-world applications of Knowledge and Skills are incorporated into a training program, employees retain the information much longer and, therefore, will apply the processes that they have learned in their jobs more effectively.

F. Simplify your Standard Operating Procedures and Documentation.

A great deal of complexity and length in a Standard Operating Procedure usually results in employee skipping steps or misinterpreting instructions.

• A new approach to the above:
• utilize clear and concise language.
• Utilize visuals (flow charts, photos, etc.) Which demonstrate major elements in the process.
• Utilize controls to show what is most important.
• Periodically review and update to show current processes.

When processes are user-friendly, there will be natural compliance.

G. Improving the Work Environment and Managing Workloads

Design/ scheduling of the workplace can have a direct impact on how well people perform their jobs.
To enhance employee's ability to perform:
- Implement shift rotations as a means to combat fatigue
- Use breaks strategically to keep employees alert
- Improve lighting, ventilation and sound control in production areas
- Create ergonomic work stations to help eliminate physical strains on workers
- Create a positive physical and psychological environment to foster concentration and decrease errors.

H. Error Monitoring and Forecasting from a Data-Driven Perspective

By utilizing digital technology and artificial intelligence will allow the organization to measure and predict the trends associated with human error.
Actions to take:
- Utilize systematically developed deviation management systems for error measurement
- Classify errors into type of error, venue type and source of occurrence.
- Conduct trend analysis on errors and discover consistent systemic patterns of errors.
- Utilize predictive analytics or AI to predict where various risk sources will create a repetitive risk.
With this proactive approach, focus will shift from reacting to an event to the prevention of the event.

I. Improving the Ability of Senior Management to Supervise and Oversee Employees

Management and senior operators are very important in identifying and preventing errors.
New approaches:
- Create a peer checking system for high-risk operations
- Perform "Line Walks" before starting a batch operation to assure readiness
- Encourage open lines of communication between operators and management.
Through an environment of collective vigilance, early identification of potential lapses will be possible.

Examining Low Labeling Errors through a Combined Effort of Operator and Corporate Support

The company manufactures a line of tablets; however, they faced continuous difficulties in applying labels and subsequent reports indicated that operators were responsible. Due to this report, the company retrained employees.
Despite the retraining, the facility continued to have issues with incorrect label application.
Once the facility started looking deeper into the problem, they conducted a root cause analysis.
The analysis uncovered the following:

• There were many instances of similar labels for different strengths.
• There was a lack of adequate lighting at the labeling and packaging station.
• There was a lack of adequate verification before the operator began setting up the packaging line.

As a result of this analysis, the facility decided to redesign their labels with distinct color branding, improve the lighting in the facilities and automate the barcode scan verification process.

The end result of these improvements was that the facility recorded zero label application errors over the next 12 months.

Key Takeaway: Significant improvement occurs when organizations change from a focus of placing blame on the employee to fixing the processes.

Measurement of Success in Achieving Human Error Reduction

It is vital for an organization to monitor business metrics that reflect both overall human error prevention and overall culture change, including:

• Reduced number of repeat deviations associated with human error.
• Increased number of near-miss reports (indicates an "open" culture).
• Effectiveness ratings of CAPAs.
• Employee engagement scores in company quality initiatives.

An organization must monitor and regularly assess the above metrics to enable continued improvement.

The Future: Human Error Management in a Digital World

As pharmaceutical manufacturing incorporates automated systems and becomes more automated through Industry 4.0, the management of human errors in the pharmaceutical industry will also evolve.
Some anticipated future developments include:

• Digital SOPs that will have step-by-step guided instruction.
• Training via AR for critical operations.
• Smart sensors to verifying errors.
• Utilizing AI-driven analytics to analyze behavior trends and help prevent errors.

While technology provides support to and enhances human judgment and decision making, human judgment is always more important than technology in the decision making process in the pharmaceutical industry, with the intention of simplifying tasks and decreasing chances for error.

It is impossible to fully eliminate human error; however, it can greatly diminish through proper attention to the work processes and the environment in which employees operate. A perfect combination of human factors engineering, Just Culture, simplified working procedures, advanced training methods and data analysis can provide the foundations for pharmaceutical companies to develop better approaches to reducing human error and providing employees with more accountability and responsibility in their work practices.

Ultimately, the focus of minimizing human error is more a matter of designing effective systems rather than providing ongoing training to the individual because effective systems support human performance, develop a culture of accountability and improve an organization's ability to be compliant.

Frequently Asked Questions (FAQs) on Human Errors

Q1. What is human error in pharmaceutical manufacturing?

Answer: Essentially, it would be any unintentional behaviors or omissions performed by a person resulting in a deviation or non-conformance.

Q2. Why does human error occur?

Answer: The cause of a human error in the pharmaceutical industry lies primarily in an organization's system weaknesses; i.e., procedures that are not correctly defined; fatigue; unclear communication; and poor training.

Q3. Can we eliminate human errors?

Answer: No, but it can be minimized through the design of systems and through the implementation of preventive strategies.

Q4. What is a Just Culture?

Answer: It is a management style that encourages accountability through systems, but rewards learning as opposed to punishment.

Q5. How can Human Factors Engineering be useful?

Answer: It is a method for designing systems and equipment to be compatible with the capabilities of the human user and reduce the likelihood of human error.

Q6. What tools are available to use for root cause analysis?

Answer: HERCA, 5 Whys, and Fishbone Diagrams based upon system factors.

Q7. Can the use of training programs reduce human error?

Answer: Using scenario based, hands-on training will allow employees to build their ability to make decisions based upon real-life examples.

Q8. What is the single best long-term solution to human error?

Answer: Creating an organizational culture that promotes continuous improvement through learning and system based prevention of errors.