Deciding what Processes need Control and Monitoring - 820.70

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R McKiernan

#1
How do you decide what process needs control and monitoring. Is it better to monitor on batch to batch or over a period of time. What defines these requirements?
 
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#2
Re: Process control and monitoring 820.70

How do you decide what process needs control and monitoring. Is it better to monitor on batch to batch or over a period of time. What defines these requirements?
The product realization process outputs defines this.

The short answer is:

- depends on the risk analysis of the product and process (for example FMEA, Fault tree)
- the cost of implementing process control
 
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