Good discussion so far! I would like to add more to HACCP-Hazard Analysis Critical Control Point. HACCP process could be divided as following.

• Conduct a Hazard Analysis.
• Identify Critical Control Points.
• Establish the critical limits of the control.
• Monitor your CCPs.
• Corrective Actions.
• Establish record keeping procedures.
• Verify – Ensure the HACCP System is Working as it’s Supposed to.

Source: http://blog.etq.com/bid/52835/haccp-for-medical-device-and-pharmaceuticals

-Hetal