For manufacturers of Traditional Medicine (OBA), Quasi-Drugs (OK), and Health Supplements (SK) in Indonesia, the term “human error” is often used as a convenient conclusion for production deviations.
However, according to the latest guidance from the BPOM Directorate of Supervision of Traditional Medicines and Health Supplements, treating human error as the “root cause” is a critical mistake that leads to ineffective Corrective and Preventive Actions (CAPA).
Why “Retraining” is No Longer Enough for BPOM Compliance
Historically, when a mistake happened on the production line, the standard response was to blame the operator and schedule “retraining.” BPOM inspectors are now looking deeper. Modern industrial psychology shows that human error is usually a symptom of issues in:
- Unclear SOPs (Standard Operating Procedures)
- Poorly designed workspaces (Ergonomics)
- Unrealistic production targets
- Weak Quality Culture
If your investigation ends at “human error,” your CAPA will likely fail, and the mistake will happen again, putting your BPOM distribution permit (NIE) and brand reputation at risk.
Effective Investigation: The 3 Types of Human Failure
To satisfy BPOM requirements and improve your operations, you must categorize errors to find the real fix:
1. Inadvertent Errors (Unintentional)
- Slips and Lapses: Physical mistakes (like pressing the wrong button) or memory failures (forgetting a checklist step).
- The Fix: Don’t retrain; redesign. Use color-coded buttons, automated reminders, and better ergonomics to “error-proof” the process.
2. Rule-Based & Knowledge-Based Mistakes
- The Problem: The operator followed the plan, but the plan was wrong. They might be using an outdated SOP or lacking the technical depth to handle a complex machine.
- The Fix: Update and simplify documentation. Shift from theoretical training to practical, simulation-based mentoring.
3. Deliberate Violations (Shortcuts)
- The Problem: An operator intentionally skips a step to save time or meet a high quota.
- The Fix: This isn’t an error; it’s a culture issue. Management must address “Quality Culture” by ensuring targets are realistic and enforcing a zero-tolerance policy for shortcuts.
How to Conduct a BPOM-Standard Interview
When a deviation occurs, the investigation interview is your most powerful tool. BPOM recommends:
- Interviewing, not Interrogating: Create a non-threatening environment so staff feel safe telling the truth.
- Focusing on the “Why”: Ask open-ended questions to discover if the SOP was too complex or if the lighting in the room was poor.
- Observing Non-Verbal Cues: Look for patterns of stress that might indicate where a process is too taxing for the human mind.
Secure Your BPOM Compliance
Navigating BPOM requirements for CPOTB (Good Manufacturing Practices for Traditional Medicine) requires more than just submitting forms. It requires a system that withstands inspection.
Product Registration Indonesia helps global and local brands not only secure their registrations but also ensure their quality systems are built to last. We provide:
- SOP & Documentation Review: Ensuring your manuals are clear, compliant, and “human-error resistant.”
- Strategic CAPA Guidance: Helping you move beyond “human error” to build investigations that satisfy BPOM inspectors.
- End-to-End BPOM Support: From initial registration to post-market surveillance.
Stop blaming humans and start fixing systems. Contact us today to ensure your production is compliant, efficient, and ready for the Indonesian market.
