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Speaker's Notes

Identify method to routine assess the effectiveness of the SOPs. This assessment should verify that key elements of a sound and effective SOP are in place. These include:

- What process is to be controlled
- How the processis to be controlled
- Who is responsible for ensuring the process is done correctly
- When will the process be conducted and at what times will monitoring . occur.
Why it is important to the operation to conduct the process as specified in the . SOP

This assessment could be based on an internal review, regulatory inspection results, or third party evaluation