Cleaning correctly means putting some limitations on our operations based upon what we validate — we have to limit our dirty hold time, limit our clean hold time, limit our campaign length, limit what products can be produced on specific equipment, and the like. These rules need to be implemented in a way that they are mistake-proof for operators. Nevertheless, good internal auditing will verify that compliance with these limitations has been observed. When these limitations are violated, it will be important to verify that the right actions are taken—whether that means that deviations are issued, that re-cleaning occurs, or both!
