The heart of any effective Quality Management System (QMS), regardless of the system model, is the Corrective and Preventive Action System. If you are in FDA-regulated industry, the CA/PA system is the key quality system element under the FDA’s “Quality Systems Inspection Techniques” (QSIT) approach to auditing Medical Device Quality Management Systems.
Manufacturers of Human Cellular and Tissue-Based Products (HCT/Ps) are required to establish and maintain a “quality program” that is “appropriate” for the specific HCT/Ps manufactured and the manufacturing steps performed. As defined in the Current Good Tissue Practice (cGTP) regulations “appropriateness” of the quality program is defined by the systems ability to detect and correct quality problems: repetitive, systemic, and critical.
The purpose of the CA/PA system is to “collect information, analyze information, identify and investigate product and quality issues, and take appropriate and effective corrective and/or preventive action to prevent recurrence of a problem.”
-FDA’s Guide to Inspections of Quality Systems (August, 1999)
Jim Colyn & Associates Quality Consulting can help you establish and maintain an effective and appropriate multi-tiered CA/PA system, including development of the following SOPs and forms…or software:
- Documentation and Investigation of Deviations
- Control of Nonconforming Materials and Product
- Failure Investigation – Root Cause Analysis
- Corrective and Preventive Action