Glossary / Lexicon

Deutsch: Menschliches Versagen / Español: Error humano / Português: Erro humano / Français: Erreur humaine / Italiano: Errore umano

Human error in quality management refers to mistakes or unintended actions by individuals that can lead to deviations from established processes, procedures, or quality standards. These errors can affect the quality of products or services, leading to defects, inefficiencies, or non-compliance with regulations.

Description

In the quality management context, human error is recognised as one of the leading causes of defects, process failures, and operational inefficiencies. It can occur at any stage of production, from design and manufacturing to inspection, service delivery, or management oversight. Common forms of human error include:

• Slip: A failure to carry out a known action, such as incorrectly entering data.
• Lapse: Forgetting to perform a step in a procedure.
• Mistake: Making incorrect decisions due to lack of knowledge or training.
• Violation: Deliberately bypassing a process or ignoring procedures, often due to perceived pressure or time constraints.

Human errors can have significant consequences in industries like healthcare, aerospace, pharmaceuticals, and manufacturing, where the quality and safety of products and services are critical. To minimise these risks, quality management systems (QMS) implement processes aimed at reducing the likelihood of human error through:

• Training and competency development: Ensuring employees have the necessary skills and knowledge.
• Standard Operating Procedures (SOPs): Establishing clear guidelines and protocols to follow.
• Automation: Reducing manual tasks prone to error by automating repetitive or complex processes.
• Error-proofing (Poka-Yoke): Implementing mechanisms in the system that make it difficult or impossible for mistakes to occur.

Historically, human error has been recognised as a central factor in quality management failures. The evolution of quality systems, such as Total Quality Management (TQM) and Lean manufacturing, includes strategies designed to reduce or eliminate human error by focusing on continuous improvement and enhancing operational processes.

Application Areas

• Manufacturing: Errors in assembly, incorrect measurements, or using the wrong materials can lead to product defects.
• Healthcare: Human error can manifest in incorrect diagnoses, wrong medication dosages, or procedural errors, impacting patient safety.
• Aerospace: Mistakes in aircraft maintenance or design can have catastrophic consequences, making error reduction critical.
• IT and Software: Coding errors or misconfigured systems can lead to software bugs or security vulnerabilities.
• Pharmaceuticals: Errors in drug formulation, packaging, or labelling can result in unsafe products reaching the market.

Well-Known Examples

• Chernobyl disaster (1986): Human error in following safety protocols contributed significantly to the nuclear plant accident.
• Therac-25 incidents (1985–1987): A combination of software bugs and operator error resulted in patients receiving fatal radiation overdoses.
• Toyota recall (2010): Manufacturing errors, coupled with lapses in communication, led to millions of cars being recalled due to safety concerns over unintended acceleration.

Treatment and Risks

Human error can never be fully eliminated, but its risks can be mitigated. The following strategies are key in managing and reducing human error:

• Training and Education: Ongoing training ensures employees are well-versed in procedures and can avoid mistakes. This also includes raising awareness about the importance of following established processes.
• Process Improvement: Continuous monitoring and improving procedures through approaches like Six Sigma or Lean can help identify steps prone to human error and address them.
• Error-proofing systems: Implementing controls like Poka-Yoke techniques helps prevent mistakes by design. For example, jigs or fixtures in manufacturing processes ensure that components are assembled correctly.
• Automation: By automating repetitive or complex tasks, the chance for human error is significantly reduced.

Risks from human error include:

• Product defects: Errors during production can lead to defective products that do not meet quality standards, resulting in recalls or rework.
• Non-compliance: Regulatory violations can occur if processes are not followed correctly, leading to fines or legal issues.
• Safety hazards: In industries like healthcare, aerospace, and pharmaceuticals, human error can result in severe safety risks, potentially causing harm to users or patients.

Similar Terms

• Process deviation: A broader term that includes both human error and mechanical or system failures leading to deviations from standard operating procedures.
• Operational failure: A failure in executing planned processes or operations, which may be due to human error, equipment failure, or poor planning.
• Systemic error: Errors that arise from flaws in the process or system design, often leading to repeated mistakes unless corrected.

Summary

In the quality management context, human error represents mistakes made by individuals that can impact the consistency, safety, and compliance of products or services. While human error is a natural part of any operational system, it can be mitigated through strategies like training, error-proofing, and automation. Reducing human error is essential in maintaining high-quality standards, particularly in industries where safety and regulatory compliance are critical.

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Weblinks

• maritime-glossary.com: 'Human Error' in the maritime-glossary.com
• information-lexikon.de: 'Menschliches Versagen' in the information-lexikon.de (German)

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