The process audit in QMS examines the processes instead of specific things, it determines whether the process is working within established limits. Now we are going to introduce what is process audit, with its purposes, responsibilities, methods, steps, and more.

What is a Process Audit?

The process audit is used to audit whether the product realization process/batch production process meets the product quality requirements, whether the process is controlled and whether it has the ability to meet the requirements. Audit of process/batch production process, including planned and unplanned process audit.

What are the Purposes and Functions of Process Audit?

Standardize the method of a process audit, and evaluate the process quality capability of the company’s products through process audit, so as to verify its effectiveness and continuous improvement.
(1) Investigate the implementation and effect of the process quality control plan, evaluate whether its formulation is practical and how to guide it, and clarify whether to take corrective and corrective measures.
(2) Understand the current situation of process factors, evaluate their control level, study the relationship between factor changes and process quality fluctuations, and clarify how to control process factors more economically and effectively.
(3) Carry out a quality audit on key processes (processes), study the problems existing in enterprise quality control activities, strengthen the management of process (process) quality control points, improve process quality control methods, and point out the direction for improving the effectiveness of quality control activities, increasing the role of prevention and control and enhancing the ability of quality assurance.

Responsibilities of Different Departments in Process Audit

  • Management representative: be responsible for reviewing and approving the annual process audit plan and process audit process plan, appointing the audit team leader, and supervising the implementation of process audit activities.
  • Quality department: prepare process audit plan. Lead the implementation of the company’s process audit. Management of audit-related records.
  • Audit team leader: prepare the process audit process plan according to the approved process audit plan and organize the implementation of the company’s process audit.
  • Auditor: be responsible for implementing the audit according to the requirements of the process audit process plan and recording the audit results. Issue the report of corrective/preventive measures for nonconformities, and track and verify the effectiveness of the implementation of corrective/preventive measures.
  • All departments: actively cooperate with the audit team and formulate corrective/preventive measures for the problems found in the audit.

How to Conduct Process Audit?

Process audits can be divided into planned (for projects) and unplanned (for events) audits.
For the audit of the project, the process audit shall be conducted as early as possible before the determined project boundary point (milestone) (mass production) in the process of project development and planning, so as to find defects and take appropriate measures.
Review of events/problems; For problematic processes, a process audit is required at each stage of the project in order to eliminate defects or to review whether sufficient consideration has been given to key process characteristics.

What are the steps of process audit?
(1) Establish process audit organization.
(2) Formulate a process audit plan.
(3) Carry out process quality audit.
(4) Write the process quality audit report.
(5) Archive the audit plan, audit records, audit reports, and other relevant documents.