When must a documented onsite audit occur?

Master the Preventive Controls Qualified Individual (PCQI) Exam for the FSMA. Discover the exam format, exam expectations, and expert tips. Prepare effectively with our extensive resources.

Multiple Choice

When must a documented onsite audit occur?

Explanation:
The key idea is that verification of a supplier’s controls must be established before you rely on and use their material. An onsite audit is a direct, documented check of the supplier’s processes and controls, and you need that assurance in place prior to using the raw material in your own production. Waiting until after initial verification or inspecting only after receipt doesn’t provide the preventive assurance you need before handling the material, and fixed quarterly timing isn’t required for every supplier. So the onsite audit should occur before you use the raw material, with the audit documented for records.

The key idea is that verification of a supplier’s controls must be established before you rely on and use their material. An onsite audit is a direct, documented check of the supplier’s processes and controls, and you need that assurance in place prior to using the raw material in your own production. Waiting until after initial verification or inspecting only after receipt doesn’t provide the preventive assurance you need before handling the material, and fixed quarterly timing isn’t required for every supplier. So the onsite audit should occur before you use the raw material, with the audit documented for records.

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