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Date:

To:

From:

Subject:

We would like to extend our appreciation for the opportunity to conduct an internal audit to
your respective department and its quality operation related processes. Below are the details
concerning the audit:

Audit Period/Time: 16-28 SEPTEMBER 2015 / 0900-1600H

Auditee: ALL DEPARTMENT HEADS / EMPLOYEES

Auditor/s:

Purpose of Audit

Internal Audit will be conducted to determine compliance to Good Manufacturing Practices

Principles and company’s agreement on Quality Management System.

Scope of Audit

The Auditor/s will be focusing on the following areas: Quality, Materials, Production,
Laboratory, Facility and Equipment, Safety and Packaging and Labeling.

 Introductions
 Area Tour
 Audit Proper
 Close Out Meeting

Supporting Documents (To be presented by the Auditee)

As applicable, please provide the following references and discussion materials through the
course of the audit:
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Quality System

• Corrective and Preventive Action Program

• List of approved suppliers and contractors
• Supplier qualification program
• Product complaints and investigation
• Quality Policy
• Control of Non-conforming Products

Material System

• Conformance to client’s specifications

• Material storage and handling
• Receipt and material identification
• Testing and release of materials

Facilities and Equipment System

• Sanitation and housekeeping

• Pest Control Program
• Equipment calibration and preventive maintenance

Safety System

• Personal Protective Equipment

• Fire Extinguishers and Fire Exits
• Chemical Storage and Spill/Leak Control
• Other Safety Practices

Laboratory System

• Quality Control Laboratory Procedure

• Test method, test result for raw materials, in-process product and finished product

Production System

• Manufacturing flow chart

• Artwork storage
• In-process control points
• Documentation and records
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• Batch record used for manufacturing material provided to _______ with corresponding
traceability

Packaging and Labeling System

• Labeling and packaging process and documentation

• Label control and inspection

Audit Report and Response

An audit report will be summarized after the audit period. A meeting will be conducted with all
the Department Head to discuss the root cause and its corresponding corrective and preventive
action. The auditee shall provide response within the agreed completion date.

We are looking forward to any quality and compliance support if necessary. Please do not
hesitate to contact us if you need any additional information or further clarifications regarding
the audit.