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A Example of Product Investigation and Root Cause Analysis and its Report Preparation

Deviation from any process in pharmaceuticals can lead to a matter of investigation and root cause analysis. the manufacturer or responsible person shall be followed the following steps to do an investigation and root cause analysis by using corrective and preventive action.

Root Cause Analysis ; a tree with roots structure

1. Investigation/ Title for Root Cause Analysis:

Start with the product’s name and what was the observation. for eg. the weight of good tablets which is destroyed during the compression stage but not recorded in batch records.

2. Investigation Team

There shall be a team involved in the investigation with name, department, and designation.

3. Behind the scene for even investigation

Use the 5 WHYs technique for investigation and root cause analysis.

          Questions

          Detailed information

Who descover it?

Name of Concerened Person

What Product? and extent of problem and batch details.

eg. Quantity of good tablets destroyed in batch no.

When? when did it happen with the date and time?

Date with shift

Where? Location (building line and equipment etc.) process stage?

for eg. compression cubicle (machine ID., name, location, and block) during the destruction of rejected tablets at end of the batch. 

Which? which characteristics changed over time? is there a turning point? is there a step-change in occurrence?

for eg. during the destruction of rejected tablets, (QUANTITY) of good tablets are destroyed by mistake.

How? How was it destroyed? what was going on at that time? what change occurs? Is the full team available?

it is detected during a discussion with (concerned person name) and (officer name) after the completion of batch

Sign/Date

4. Investigation requirements

Product Name

Strenth

Batch no.

Batch Size

Mfg. Date

Exp. Date

Market

Stage

Area

A. Gather the information GEMBA

  • Write the details of the information like product manufacture location, machine name, batch start date and time, officer, and batch size.
  • calculate the no. of good tablets compressed and the remaining quantity of good tablets destroyed, and others destroyed, then a further match with BMR Records. proceed with an investigation if found any variation.
  • Further, write the details about the name of the officer and operation activity (date and start time). during operation how much quantity was destroyed and who checked and verified by as per label affix? write the observation and fault or gap details.

5. Define

A. Problem statement: (wt. of tablets in kg) which is destroyed during the compression stage but not recorded in batch records with batch no. mention.

B. Process mapping: line clearance- machine setting-startup- compression operation-destruction of rejected tablets- reconciliation- Review BMR.

6. Measure:

Write about what is to be measured if not then do NA.

7. Analysis for Root Cause:

Analysis of the reported event is done with why-why analysis.

WHY: why quantity? of good tablets destroyed

Ans: quantity? of tablets separated for the sample are taken destruction along with rejected tablets of the batch.

WHY: Why good tablets are taken along with rejected tablets for destruction?

Ans: After completion of the operation good tablets and rejected tablets were in a cubicle. due to the small number of good tablets, these tablets are taken with rejected tablets for destruction by the concerned person’s name. the person destroyed the tablets by putting water in them inside the wash area and transfer to ETP (Effluent Treatment Plant) for further disposal.

7.a. Potential root cause based on the assessment performed:

Potential root cause based on the assessment performed from the BMR review and discussion with the concerned officer, it is observed that after the completion of the operation good tablets were separated for sampling as well as rejected tablets were kept in a cubicle. quantity of rejected tablets was checked by a concerned officer and QA officer. during the transfer of rejected tablets for destruction production officer took the good tablets along with rejected ones and destroyed the tablets by mistake.

8. Impact assessment:

  • The batch closed as per the destruction record and reconciliation done
  • The stock adjustment will be done for WIP of (quantity of tablets).

9. Improve and control (CAPA):

Awareness training regarding the event shall be imparted to all officers.

10. Conclusion for Root Cause Analysis:

To conclude the investigation includes the summary in short likes; at the end of the operation concerned officer destroyed the good tablets kept in the sample along with rejects generated during the operation, and the mistaken quantity of these tablets is not recorded in BMR.

The stock adjustment will be done for WIP of (quantity of tablets).

Note: Include the formate no for root cause analysis.

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