DOXPUB 09-0189-SOP

Summary:

Provides a guideline for determining appropriate sampling plans used to assess the quality of product and production related materials. Applicable to final product and subassemblies manufactured by for clinical and commercial uses. Also applies to parts purchased from outside vendors and used in manufacturing processes and final kit assemblies. Covers general principles, sampling plan determination, material characteristics, acceptance history, cost, and regulated sampling requirements. Includes provisions for compliance with ISO TR 8550, ISO 2859-1, ISO 3534, and ANSI/ASQC S2.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality Assurance operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel