DOXPUB 09-0074-SOP

Summary:

Describes sampling plans used in the inspection of purchased materials, subassemblies, final product, and kits. Describes the general methods used to obtain the required samples used in the inspection of purchased materials, subassemblies, final product, and kits. Applies to sampling performed for all materials inspection by Quality Control. Covers general principles, general procedures, chemical requirements, plastic parts requirements, and parts with aseptic handling considerations. Includes provisions for compliance with ISO 2859-1 and ISO 3534-2.

Included Sections:

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

Included Attachments/Appendices:

Sampling Plan for Purchased Parts, Instructions for Choosing An Inspection Level, Acceptable Quality Levels for Sampling Plans

About This Document:

This is not a generic template, it's a 9-page procedure that was actually created and used in the Quality Control 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