INVESTIGATION REPORT
Oil Leakage from Compression Machine During Tablet Compression
Manufacturing Location: AABBCC
Product Name: AABBCC
Batch Number: PGH/T/25-002
Incident Date: DD/MM/YYYY
Department: Production—Compression
Document Type: Deviation Investigation Report
Incident description: Oil leakage was observed from the tablet compression machine during the manufacturing of Batch No. PGH/T/25-002. The incident was investigated to determine the cause of leakage, assess the potential impact on product quality, and establish corrective and preventive actions.
1. Objective
The objective of this investigation is to identify the root cause of oil leakage from the compression machine during the manufacturing of Product AABBCC, Batch No. PGH/T/25-002.
The investigation aims to:
- Determine the source and cause of oil leakage.
- Investigate the incident using the 6M Ishikawa method.
- Assess the potential impact on product quality, equipment performance, and patient safety.
- Determine whether tablets, granules, or product-contact surfaces were exposed to leaked oil.
- Define corrective and preventive actions to prevent recurrence.
- Ensure that the compression machine is fit for use before production resumes.
2. Scope
This investigation covers oil leakage observed from the compression machine during the compression stage of Batch No. PGH/T/25-002 at XXYYZZ, AABBCC.
The scope includes:
- Inspection of the compression machine and the point of oil leakage.
- Examination of seals, gaskets, lubrication lines, fittings, and associated components.
- Review of machine maintenance and lubrication records.
- Review of the batch manufacturing record and compression activity.
- Assessment of the possibility of oil contamination of the product.
- Evaluation of the six potential cause categories: Man, Machine, Material, Method, Measurement, and Mother Nature (Environment).
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Key Parameter of the Below Page:
| INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION |
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Key Parameter of the Below Page:
INVESTIGATION REPORT FOR OIL LEAKAGE FROM COMPRESSION MACHINE DURING TABLET COMPRESSION
Find below pages for the complete report
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
Click the link to download the word file copy of this document: https://pharmaguidehub.com/product/investigation-report-for-oil-leakage-from-compression-machine-during-tablet-compression/
