Factory Audits & Quality Inspections During & Post COVID-19: On-site Supplier Audits + Remote Participations by International Buyers (Ⅲ) (Continued from the last issue) A QMS audit consists of an audit of complete terms according to the IATF16949:2016 standard and a process audit on products that are within the scope of factory's certification.
An audit on the manufacturing process is a process quality audit which focuses on the inspection of selected processes of all processes to evaluate the effectiveness of process control. Process quality audit is the key of internal quality audit. Its purpose is to verify whether the factors affecting the production process and their control methods meet the requirements of process control and process capability, so as to spot the existing problems in time and take corrective or preventive measures to ensure that the process quality is in a stable and controlled state. For suppliers who have passed IATF16949 certifications but their product manufacturing process has many unstable factors and abnormal quality control points, we will arrange process audits, focusing on the complete audit on identified process characteristics.
The audit of the process is to audit the control plan prepared by the supplier for the type of products purchased by the customer. The audit focuses on the identified product and process characteristics, taking into considerations the audit experience of the auditor.
Product audit is a management tool for an independent evaluation of products from the perspective of customers, so as to avoid product or goods defects. In addition, product audit also shows the potential for continuous improvement. The listed product characteristics will be inspected during product audit (e.g. consistence with parts list, product size, material, functionality, reliability, packaging, identification), so are the customer expectations in a specific status (e.g. after packaging, new state, after use, etc.). A product audit can objectively evaluate product quality characteristics, obtain product quality information, and determine the product quality level, in order to take timely corrective and preventive actions on issues discovered in the audit and further improve the quality system and product quality. When analysis show the qualities of products provided by suppliers are unstable or different types of quality complaints are frequently raised by customers, we will arrange product audits to focus on the identified product characteristics.
The method of product audit depends on the type of products purchased by the customer, combined with the customer's performance evaluation of the supplier for the selected products to be audited. The audit focuses mainly on overall product testing, quality characteristics testing, performance testing, full-size inspection, reliability testing, etc.
▌Audit frequency
Audit frequency generally refers to how often the suppliers already in the approved supplier list should be audited. The recommended frequency of the second party audit (including audits of QMS, process and product) is to complete a full audit cycle every two years (see the chart below). Specifically, the QMS audit is to be conducted once every 24 months, the process audit once every 12 months, and product audit also once every 12 months. If the supplier has major quality complaints against it, emergency events, or risks in its operation environment, an immediate second party audit is necessary.
For the process audit and product audit, we will prepare audit plans appropriate to the customer's product requirements according to the quality performance evaluation of the purchased products, the process characteristics and the product characteristics. (To be continued) |