investigation Report Template
This Article contains the Master investigation Report Template which will be useful for the Preparation of Investigation and Harmonize the Investigation Format across the Site which will avoid the variability of contents in each and every investigation reports.
INVESTIGATION REPORT TEMPLATE
Product:
Batch No.:
Event type:
Investigation Number :
-
Details and Description of Event:
<Mention the details of complaint / Deviation / OOS / OOE such as When it was received, complainant details, Product name, Batch number, Manufacturing date, Expiry date, defect nature, details with photographs, etc,.>
2. Background:
<Mention the details of the issue with the back ground information>.
3. Problem statement:
<Mention the identified problem statement>
4. Immediate action taken:
<Mention the immediate action(s) taken to avoid the magnitude of the impact Eg: Production line stopped / Material quarantined / isolated the defective material etc,.>.
5. Criticality (as per initial assessment):
Critical / Major / Minor
<Refer track-wise record and provide the criticality details>.
6. Investigation team members:
Based on the nature of the complaint / deviation, following personnel from cross functional teams were identified as investigation team members to carry out the investigation.
| Sr. No. | Name | Department |
7.Investigation:
The cross functional investigation team had brain storming sessions / GOYA to find out the root cause and details follow.
7.1 Process flow & Point of cause:
< Provide the Process flow of the relevant product manufacturing / packaging / testing / storage & Distribution and Point out the relevant section of cause to be focused to carry out the investigation>
7.2 Investigation tool used:
<Mention the investigation tool used to find out the root cause such as Fish-bone / Ishikawa/ Cause-effect analysis, GOYA / 5M / 5Y’s / Fault tree analysis, etc,.>
7.3 Investigation details:
<Each element involved in the point of cause to be analyzed and evaluated and mention the complete details of investigation such as the areas focused as part of investigation, review of documents, interaction with personnel, Complaint sample verification, Review of facilities, methods and material, review retention samples, stability study verification details, Similar history details and any other relevant information>
7.4 Root cause / Contributory factors (s):
<Mention the probable cause(s) identified from the above investigation, apply the appropriate methodology (eg: 5Y’s) to derive the actual root cause / most probable cause(s). Provide the root cause class and sub-class referring to Track-Wise>.
| Root cause class | Root cause sub-class(es) |
7.5 Impact on other batches / activities / patients / markets:
< Assess the impact of the defect on other areas / products / activities / patients / Markets and provide the details>.
7.6 Criticality (post investigation assessment):
Critical / Major / Minor
<Mention the criticality of the complaint / deviation as an outcome of the investigation with justification>.
7.7 Investigation summary and conclusion:
< Detail the brief summary of investigation with the outcome of areas investigated and identified root cause / Probable causes>.
8. Disposition:
< Provide the batch disposition details such as batch rejection / approve / use for intended purpose / reprocess / repack / destruction / recall /etc,.>.
9. Correction:
<Describe the actions taken to repair, correct the existing discrepancy / defect / undesirable condition>
10. Corrective and Preventive action :
< Mention the identified CAPAs against the each individual Probable cause(s) or root cause>.
| Sr. No. | Reference of root cause / probable cause | Description of action | Responsibility | Target date of completion |
11.Investigation report approval:
| Name | Designation | Department | Signature & Date |
| Prepared by: | |||
| Reviewed by: | |||
| Approved by: | |||
