DOXPUB 09-0217-SOP

Summary:

Provides a system for identifying and tracking major Quality Improvement Projects (QIP). Applies to existing or new corrective action projects that will require substantial company resources and/or time to complete. Includes provisions for project identification and assignment, project plan development, project approval, tracking and status, project completion and documentation requirements.

Included Sections:

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

Included Attachments/Appendices:

Quality Improvement Project Description Form, Example of Completed Description Form

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
• Regulatory Affiars Managers