System Audit | Process Audit | Product Audit | Relationship

What is System Audit?

System Audit focus on the comprehensiveness and effectiveness of fundamental procedures against specified management standard and customer-specific requirements to determine the quality capability of the QM system.

There are various quality management system standards like VDA 6.1, IATF 16949, ISO 9001, and AS 9100, etc. VDA 6.1 is the German automotive industry standard which is equivalent to IATF 16949 standard.

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What is Process Audit?

Process Audit focuses on the product quality and the associated processes to determine the quality capability of selected products and product groups and their processes. Assess whether there exists a potential risk that nonconforming products can escape to the customer.

The objective of process audit is to determine the production capability to deliver products and services to satisfy the customer requirements in terms of safety, quality, and quantity.

The process audit is an examination to determine the process’s effectiveness and efficiency using standard operating procedures(SOPs), control plan, work instructions, process quality check sheet(PQCS), and customer-specific required approaches, and ensuring the output achieves its intended purpose.

Manufacturing Process Audit requirement as per IATF 16949 clause no. 9.2.2.3

• Audit all manufacturing processes over each three-year calendar period.
• Audited on all shifts for effective control of process and product quality, i.e., process audit must cover all shifts e.g. day and night shifts both.
• Using customer-specific required approaches, else determine the approach to be used i.e., all the customer-specific requirements must be included in the process audit.
• The relevant documents like PFC, process risk analysis (such as PFMEA), control plan, SOPs, and associated documents must be referred for effective process audit.

What is Product Audit?

Product audit focuses on checking product complies with the specification by assessing the quality characteristics of finished products or semi-finished products.

Product audit is an action to verify or validate the output of product characteristics in each stage of manufacturing processes with respect to actual design requirements.

It covers all the manufacturing stages, starting from receiving raw materials to the final finished product, including packaging and labeling. Any deviation during product audit indicates a weakness in manufacturing processes.

Quality documents like a process flow chart, control plan, quality plan, or quality inspection standard, etc., are used for conducting the audit.

It is very important to remember that the measuring instruments and gauges must be calibrated which are to be used for checking the product characteristics like length, width, height, and, diameter, etc.

Product audit requirement as per IATF 16949 clause no. 9.2.2.4

The organization shall audit products using customer-specific necessary approaches at all relevant stages of production and delivery to ensure adherence to specified requirements. Where not defined by the client, the company shall define the approach to be used.

Relationship between System, Process, and Product Audit

Process audit and product audit are an integral part of the system audit. All three audits are interrelated with each other. All are equally important but the viewpoint is different. So, never underestimate any audit. 

The organization establishes the quality management system and the effectiveness of established QMS is ensured by the system audit.

A robust process audit is carried out within the established quality management system to determine the quality capability of the products and their processes. Product quality depends on the process quality. Any weakness in the manufacturing process may lead to poor product quality.