OBJECTIVE:

• To establish a procedure for preparation, approval, maintenance, and revision of the organizational chart (organogram) to ensure a clear definition of reporting structure, roles, and responsibilities in compliance with WHO GMP requirements.

 SCOPE:

• This SOP applies to the preparation, control, review, and updating of the organizational chart for all departments including:
  • • Production
    • Quality Assurance
    • Quality Control
    • Warehouse
    • Engineering
    • Regulatory Affairs
    • Human Resources and Administration
    • Finance
    • Marketing

RESPONSIBILITIES:

HR Department:

• Prepare the organizational chart (organogram).
• Update the organogram when there is any structural change in departments or reporting hierarchy.
• Coordinate with department heads to collect updated reporting structure.

Department Heads:

• Verify the accuracy of the departmental reporting structure.
• Inform HR and QA about any changes in departmental structure or reporting lines.

Quality Assurance (QA) Department:

• Review the organogram for GMP compliance and clarity of reporting lines.

Management Representative:

• Review and approve the final organizational chart.
• Ensure the structure supports effective management and GMP compliance.

 DEFINATIONS:

• Organogram: A graphical representation of the organizational structure showing reporting relationships between different designations within the company.

 PROCEDURE:

Preparation of Organogram:

• The HR Department shall prepare the organizational chart showing the reporting hierarchy and departmental structure.
•  The organogram shall include designation titles only and not individual employee names to avoid frequent revisions due to personnel changes.
• The organogram shall clearly show:
• • Management hierarchy
  • Departmental structure
  • Reporting relationships

• The organizational chart shall clearly indicate major departments such as:
  • Top Management
  • Quality Assurance
  • Quality Control
  • Production
  • Warehouse
  • Engineering
  • Regulatory Affairs
  • Human Resources and Administration
  • Marketing
  • Finance

• The prepared organogram shall be reviewed by QA Department and approved by Managing Director.

• The organogram shall be revised when:
  • Major organizational restructuring occurs
  • Creation or removal of departments
  • Change in reporting hierarchy
• Personnel replacement alone shall not require revision, as names are not included in the organogram.
• A separate document titled “Personnel Responsibility List” shall be maintained.
• This document shall be updated whenever personnel changes occur.
• The approved organogram shall be controlled by HR through the document control system.
• The organogram shall be reviewed at least once every three years or whenever major organizational changes occur.

REFERENCES:

• WHO TRS – Good Manufacturing Practices (Personnel section)
• EU GMP Chapter 2 – Personnel
• Company Quality Manual

RECORDS:

REVISION HISTORY.