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F Deviation Investigation Report

This 4-page deviation investigation report form documents the investigation into deviation XX-XXX. The form includes sections to describe the problem, investigation team members, immediate corrective actions taken, summary of the normal process, investigation and test results, root cause analysis, corrective and preventive actions, impact assessment, conclusions, references, and attachments. The document follows a standard format for deviation investigations at [COMPANY NAME].

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Bilal Abbas
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287 views

F Deviation Investigation Report

This 4-page deviation investigation report form documents the investigation into deviation XX-XXX. The form includes sections to describe the problem, investigation team members, immediate corrective actions taken, summary of the normal process, investigation and test results, root cause analysis, corrective and preventive actions, impact assessment, conclusions, references, and attachments. The document follows a standard format for deviation investigations at [COMPANY NAME].

Uploaded by

Bilal Abbas
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 4

[INSERT COMPANY NAME] Document ID: XXXX

Title: Deviation Investigation Report Form Revision: [INSERT REV]

DEVIATION INVESTIGATION REPORT


Deviation #: XX-XXX

Deviation Title: [Insert Title]

Date: [Date of Investigation]

Author: Date

Name, Title

Approval: Date
Name, Title

Approval: Date
Name, Operation

Approval: Date
Name, Quality Assurance

Page 1 of 4
1. DESCRIPTION OR PROBLEM STATEMENT
 A brief summary of what should normally occur, and what did occur
 Summarize the purpose of the investigation
 Identify the type and classification of the exception (i.e., minor deviation) if applicable
 Describe any unique concerns for this investigation (if applicable)

2. INVESTIATION TEAM MEMBERS


Name Department

3. IMMEDIATE CORRECTIVE ACTION


This section should include any actions taken immediately to correct a situation (i.e. moved material
to Quality Hold, removed equipment from service.)
4. SUMMARY OF OPERATION
 Describe the normal process/operation that is associated with the investigation, such that a
third-party reviewer can understand the process
 Provide a process flow overview (include diagrams, if applicable)
 List relevant technical parameters (if applicable)

Example:
REVIEW OF HISTORICAL TRENDS, RELATED BACKGROUND, OR HISTORY
 Describe whether this is the first occurrence of the event or if it is recurring
 Provide a summary of historical trends/data/information

5. INVESTIGATION AND TEST RESULTS


 List steps/actions performed as part of the investigation
 Include test results (summarize in the text or reference attachments)
 Use this section to report data and facts from the investigation. Do not describe conclusions
here.

Page 2 of 4
6. ROOT CAUSE ANALYSIS
 Discuss all possible causes that were considered and justifications for eliminating or confirming
as a potential root cause. Address the following as applicable to the event:
o Materials
o Methods
o Equipment
o Environment
o Personnel
 Use QA tools
 If the deviation is marked as ‘recurring’, address the recurring cause of the deviation in addition
to the specific instance
 If the root cause cannot be determined, this section should still be used to rule out causes
and/or state why the root cause could not be determined
 Include Root Cause Analysis Conclusions – Based on investigation and results

7. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA)


 Summarize corrective and/or preventative actions taken in response to the root cause analysis,
referencing CAPA numbers when applicable
 These actions may be completed or may be pending at the time of the report
 If there are no CAPAs, provide a justification to explain why corrective/preventive action is not
necessary

8. IMPACT ASSESSMENT
 Describe the impact associated with the deviation (i.e., product, equipment, procedures,
protocols, testing, stability, etc.)
 Describe the impact to other materials that may have been affected (previous or future batches,
related equipment, other samples, etc.)

9. CONCLUSIONS
 Summarize the investigation by providing a brief overview of the investigation, root
cause analysis, CAPA, and impact assessment
 The conclusion should supplement the Introduction by providing a brief overview of all
key points associated with the investigation report

10. REFERENCES (IF APPLICABLE)


Document /Form/ Record Document ID

Page 3 of 4
11. ATTACHMENTS (IF APPLICABLE)
Attachment # Attachment Name

Page 4 of 4

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