Where the results of a process cannot be fully verified by subsequent inspection and testing, the process shall be validated with a high degree of assurance and approved according to established procedures.

However, validation is only the beginning of this requirement. Validated processes must also be controlled and monitored; a requirement generally referred to as continuous process monitoring.

Analyzing a control chart to identify special cause variation can be facilitated by using an Ishikawa diagram

Outline

• Discuss continuous process monitoring requirements.
• Identify continuous process monitoring techniques.
• Choose the correct control chart for the type of data.
• Interpret control charts to identify special cause variation.