Human Errors In Pharmaceutical analysis: How to identify and minimize

Human error in pharmaceutical analysis refers to personnel mistakes that can compromise product quality, patient safety, and regulatory compliance. These errors usually arise from systemic factors—such as unclear procedures, poor communication, insufficient training, or equipment issues—rather than individual fault alone.

Human Error Case Study: Real-Life Incident from a Pharmaceutical Laboratory

Background

Early in my career, I was employed at a reputed pharmaceutical company in Delhi. One day, a routine chemical analysis required the use of ammonia solution. The laboratory attendant was instructed to retrieve the solution from storage.

Incident Description

The ammonia solution had been stored in an uncontrolled temperature area, where it was exposed to high ambient temperatures for an extended period. When the attendant opened the bottle, the pressurised ammonia vapour rapidly expanded, causing the solution to splash forcefully onto his face and body.

The attendant immediately lost consciousness due to inhalation and chemical burns. He was rushed to the hospital and remained under medical care for several weeks.

Root Cause Analysis

• Immediate cause: Opening a container with pressurised ammonia stored under improper conditions.
• Contributing factors:
  • Lack of temperature-controlled storage for volatile chemicals
  • Inadequate hazard awareness and training
  • Absence of clear SOPs for handling temperature-sensitive materials
  • No use of appropriate personal protective equipment (PPE)

Impact

• Severe injury to the employee
• Work disruption and safety incident reporting
• Reputational risk to the company
• Regulatory non-compliance due to unsafe storage practices

Lessons Learned

• Human error was not the true root cause; it was the result of systemic failures such as a lack of training, improper storage conditions, and the absence of risk controls.
• All volatile chemicals must be stored in temperature-controlled areas as per their Material Safety Data Sheet (MSDS).
• Proper SOPs and safety training must be provided to all laboratory personnel.
• Use of PPE (goggles, gloves, lab coat, face shield) is mandatory when handling hazardous substances.
• Risk assessments and periodic safety audits should be standard practice.

Preventive and Corrective Actions

• Implement temperature-controlled chemical storage.
• Revise and train staff on SOPs for chemical handling.
• Provide mandatory hazard communication and emergency response training.
• Ensure availability and use of proper PPE.
• Conduct regular safety drills and audits.

Key Takeaway:
Labelling the incident simply as “human error” would not have solved the problem. Addressing the underlying system weaknesses — storage conditions, training, and controls — is what truly prevents recurrence and protects personnel.

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1. What are Human Errors?

Human error in pharmaceutical analysis refers to mistakes or deviations from standard procedures caused by human actions (either intentional or unintentional) during the testing, measurement, or documentation of pharmaceutical products.

These errors can affect the accuracy, precision, reliability, and compliance of analytical results, which are critical in ensuring product quality and patient safety.

2. What are the different types of Human Errors in Pharmaceutical Analysis?

Human errors in pharmaceutical analysis can be categorised in several ways:

A. Based on the Nature of Error

1. Slips and Lapses (Unintentional Errors)
   • It occurs when the person knows the correct procedure but fails to execute it properly.
   • Examples: Misreading a label, skipping a step, pressing the wrong button on an instrument.
2. Mistakes (Knowledge or Rule-based Errors)
   • It occurs when the person lacks adequate knowledge or applies the wrong procedure.
   • Examples: Using the wrong calculation formula, preparing the wrong concentration, misinterpreting an SOP.
3. Deliberate Violations
   • Intentional deviation from standard procedures, often due to time pressure or overconfidence.
   • Examples: Not calibrating equipment before use, skipping replicate tests.

B. Based on Analytical Process Stage

1. Sampling Errors
   • Incorrect collection, handling, or labelling of samples.
   • Example: Collecting an insufficient sample volume.
2. Sample Preparation Errors
   • Inaccurate weighing, dilution mistakes, and contamination.
   • Example: Using the wrong solvent or incorrect pipetting.
3. Instrumental or Operational Errors
   • Failure to calibrate, incorrect parameter settings, or poor maintenance.
   • Example: Not equilibrating the HPLC column properly.
4. Calculation & Data Handling Errors
   • Arithmetic mistakes, transcription errors, or using outdated versions of calculation sheets.
   • Example: Wrong unit conversion or decimal misplacement.
5. Documentation Errors
   • Incomplete, incorrect, or inconsistent recording of results.
   • Example: Missing signatures, wrong batch number.

3. How to Identify Human Errors?

Detecting human errors early is crucial to avoid release of inaccurate analytical results. Methods include:

• Review of Analytical Records — checking raw data, calculations, logbooks, and chromatograms.
• Cross-verification — independent verification of critical steps and results by a second analyst.
• Trend Analysis — monitoring recurring deviations, out-of-specification (OOS), or out-of-trend (OOT) results.
• Deviation and Root Cause Investigation — using tools like:
  • Fishbone diagram (Ishikawa)
  • 5 Whys Technique
  • FMEA (Failure Mode and Effects Analysis)
• Audit and Self-inspection — periodic internal checks to detect compliance gaps.

4. How to Minimise / Prevent Human Errors?

To reduce or eliminate human errors, pharmaceutical laboratories adopt Good Laboratory Practices (GLP) and Quality Systems. Key measures:

A. Training and Competency

• Regular training and assessment of analysts on SOPs, instrument operation, calculations, and documentation.
• Competency-based qualifications for complex procedures.

B. Clear and Practical SOPs

• SOPs should be:
  • Clear and unambiguous
  • Easy to follow
  • Periodically reviewed and updated.

C. Automation and Technology

• Use of automated or semi-automated systems to reduce manual steps.
• Electronic systems for calculations and data handling (e.g., LIMS).

D. Double-check / Peer Review

• Independent verification of critical steps such as weighing, calculations, and result entry.

E. Proper Work Environment

• Adequate lighting, ventilation, and ergonomics.
• Minimising distractions and interruptions.

F. Error Reporting Culture

• Encourage staff to report errors without fear of punishment.
• Focus on system improvement, not individual blame.

G. Periodic Audits and CAPA

• Routine internal audits.
• Implementation of Corrective and Preventive Actions (CAPA) based on error trend analysis.

5. Summary Table: Human Error

Expert Tips:
Human errors in pharmaceutical analysis can’t be fully eliminated, but they can be minimised through training, robust SOPs, automated systems, and a strong quality culture. Identifying and addressing these errors promptly ensures the reliability of analytical results and compliance with regulatory requirements.

FAQs on Human Error: Human Errors in Pharmaceutical Analysis

5. What types of human errors commonly occur in pharmaceutical analysis?

• Sampling errors
• Sample preparation errors
• Instrument operation errors
• Calculation and transcription errors
• Documentation errors

6. How can human errors be identified in pharmaceutical analysis?

• Reviewing analytical records and raw data
• Cross-checking results by a second analyst
• Trend analysis of deviations and OOS results
• Audits and self-inspections
• Root cause investigations (e.g., 5 Whys, Fishbone)

7. What tools are used to investigate human errors?

• 5 Whys technique
• Ishikawa (Fishbone) diagram
• Failure Mode and Effects Analysis (FMEA)
• Human error trend analysis
• Deviation investigation forms

8. What is the difference between a human error and a system error?

• Human error: Mistake made by a person due to inattention, lack of skill, or poor judgment.
• System error: Fault in the process, equipment, or environment that sets up conditions for error.
  Most human errors are linked to weak systems rather than individuals.

9. What preventive measures can minimize human errors?

• Well-written, clear SOPs
• Regular training and competency checks
• Peer review and double-checking
• Automation of critical steps
• Creating a no-blame reporting culture

10. What role does documentation play in preventing human errors?

Accurate and complete documentation ensures traceability, helps detect errors early, supports regulatory compliance, and provides data for investigations and CAPA.

11. How are human errors addressed during regulatory inspections?

Inspectors check for error trends, investigations, CAPA implementation, training records, and the robustness of quality systems. Poor error handling can lead to regulatory observations or warnings.

12. Is human error a valid root cause?

No — “human error” alone is not a valid root cause.

It’s only a symptom. A proper root cause analysis must identify why the error occurred (e.g., unclear SOP, inadequate training, poor system design, or lack of controls). Simply stating “human error” doesn’t prevent recurrence.

Further Reading:

• Human errors and their prevention in healthcare – PMC