My supplier process audits services

Supplier process audits are performed on specific processes within a supplier’s production operation to verify that comprehensive and systematic controls are in place that will assure the conformance and consistency of the process output.

Process audits are often the only way for a client to establish that a supplier applies adequate controls to special processes. Special processes are manufacturing processes where the quality of the output cannot be determined fully by test or inspection at the end of the process—perhaps because to do so would require destruction of the product. In these cases, additional measures such as process qualification exercises, operator certification, precise procedures, rigorous process monitoring and analysis methods and statistical process control techniques are usually necessary.

What I will do for you

I will carry out an audit in accordance with any specific instructions you provide, but typically I will

• conduct an objective and systematic examination of the documented production process;
• review the process documentation and the monitoring, control and analysis methods applied and investigate the basis on which they are judged to be satisfactory;
• review the results of any approval or qualification exercise performed on the process;
• verify the training and certification records of those personnel involved in the process;
• review the records that are maintained of the process operation, monitoring and control;
• collect evidence—through interviews with personnel, examination of documents, and observation of activities and conditions in the relevant area—of the degree to which the process is being operated in accordance with procedures and specifications.

The overall objective will be to confirm whether the process control methods and documentation are sufficient to assure that product will comply with quality requirements.

I will prepare a report for you using your own forms or report format if available; otherwise I will provide a report to you in my own style and covering the agreed process subjects.