🐟 Fishbone Tool of Investigation in Pharmaceuticals

📌 What is It?

• A cause-and-effect diagram shaped like a fish skeleton.

• “Head” = problem statement (e.g., OOS result, contamination, deviation).

• “Bones” = major categories of potential causes.

• Helps investigation teams visualize, categorize, and analyze possible root causes systematically.

🧾 Common Categories in Pharmaceutical Investigations

Typically adapted into 6M model (can vary):

1. Man (Personnel)

   • Inadequate training or knowledge.

   • Human error (improper gowning, sampling mistakes).

   • Non-compliance with SOPs.

2. Machine (Equipment)

   • Equipment malfunction, improper calibration.

   • Poor preventive maintenance.

   • Design not suitable for cleaning.

3. Method (Procedures/SOPs)

   • Inadequate or unclear SOPs.

   • Not followed as written.

   • Lack of proper validation.

4. Material (Raw & Packaging)

   • Poor quality of raw materials or excipients.

   • Incorrect labeling or dispensing.

   • Supplier-related variability.

5. Measurement (Testing & Data Integrity)

   • Analytical method errors.

   • Incorrect instrument settings.

   • Data integrity lapses.

6. Mother Nature (Environment)

   • Environmental contamination (microbial, dust).

   • Temperature/humidity excursions.

   • Poor cleanroom classification or monitoring.

🔍 Steps in Using Fishbone for Investigation

1. Define the problem clearly (e.g., “High bioburden in water sample” or “Tablet hardness out of spec”).

2. Brainstorm possible causes under each category.

3. Populate the fishbone diagram with identified causes.

4. Analyze which causes are most likely using data, trend analysis, and evidence.

5. Identify the root cause(s) and link them to CAPA actions.

✅ Benefits in Pharma Investigations

• Encourages team-based brainstorming.

• Provides a structured and visual approach to RCA.

• Ensures no potential cause is overlooked.

• Strengthens compliance with FDA/ICH Q10 expectations for scientific investigation.

📌 Example Use Cases in Pharma

• OOS result in HPLC assay.

• Repeated microbial contamination in cleanroom.

• Packaging mix-up investigation.

• Equipment breakdowns affecting batch yield.

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