Strahinja Stojanovic IATF 16949 puts great emphasis on the compliance with requirements of the standard itself, as well as customer-specific requirements. It expands upon ISO 9001 regarding internal audits by providing more requirements for an internal audit program and adding requirements for quality management system audits, manufacturing process audits and product audits.
Considering the complexity of the QMS (Quality Management System) based on IATF 16949, and the complexity of the automotive industry, the standard has divided internal audits into three categories with specific requirements and different scopes, as well as specific sets of competencies necessary to conduct them.
Quality Management System Audit
The Quality Management System Audit is what can be considered a classic internal audit. The purpose of this audit is to determine the level of compliance of the QMS with the standard and customer-specific quality management system requirements for effective implementation. The entire scope of the quality management system must be covered within a three-year calendar period and an annual internal audit program should be developed.
The process approach is a mandatory tool for determining compliance. For more information, see: Five Main Steps in an IATF 16949:2016 Internal Audit.
Manufacturing Process Audit
The purpose of the manufacturing process audit is to determine effectiveness and efficiency of the manufacturing process. The standard requires this type of audit to cover all manufacturing processes within a three-year calendar period. Considering that, in many cases, the manufacturing process begins and ends with customer-specific requirements, the approach to conducting the audit is often defined by the customer. In cases when there are no customer-specific requirements for the audit process, the organization itself needs to define the approach.
A process-based audit means:
- The organization needs to define the Audit Plan that refers to key processes, instead of just the elements of the standard
- The auditors need to check performance. This is linked to common metrics for the organization and suppliers
- The auditors should use the checklist to make sure the audit is thoroughly conducted and have checked all of the required items
- The auditors should use the organization’s procedure for conducting the audit
The manufacturing process audit includes a check to ensure effective implementation of process risk analysis (such as FMEA), control plan and associated documents.
Product Audit
Products are the ultimate result of the organization’s processes. The ability to manufacture products which are compliant with customer and organizational requirements is what QMS is all about. We don’t need to discuss how important the product quality is for the automotive industry. Just remember that, in most cases, 80% of the parts installed in the car are not produced by the car manufacturer, but by suppliers. Such great dependence on the suppliers requires thorough audits of the product quality, not only by the company that assembles all the parts, but also by the parts suppliers themselves.
The products need to be audited using customer-specific requirements at appropriate stages of production and delivery. This allows an organization to verify conformity to their specified requirements. Where not defined by the customers, the organization itself needs to define an approach to be used during the product audit.
Why it has to be done this way
At first glance, the internal audit probably looks like an annoying expense. However, internal audits enable you to discover problems (i.e. nonconformities) that would otherwise stay hidden and cause harm to your business. Let’s be realistic – it is human nature to make mistakes, so it’s impossible to have a perfect system. It is possible, though, to have a system that improves itself and learns from its mistakes.
In a QMS audit process, it is important to make sure you do not miss anything important, such as auditor knowledge and proper audit planning. Keeping this in mind, using a proven method to set up your process can help to greatly simplify implementation. You can use the Internal Audit process to focus on process improvement instead of just maintaining compliance. By doing this, the company can get more value out of the audits. Process improvement is one of the key elements of an IATF 16949 Quality Management System, so it should be one of the main motivators of a company that wants a strong QMS. Process improvement not only helps with efficiency, but saves time and money in the process. If used properly, the Internal Audit, can be one of the biggest contributors toward QMS improvement instead of being a “necessary evil.”
Get your free IATF 16949:2016 Implementation Diagram to prepare your QMS for the audit.
