QM Knowledge: Quality Management Audits

Once we have invested money in a product, we expect it to fulfill its purpose and that we can rely on it. What is an expectation on the part of the customer means work on the part of the manufacturer: in order to meet customer expectations, quality must be assured. To this end, certain processes are defined or even specified by standard and management systems. To confirm the fulfillment of defined requirements, audits are a useful tool. Read here what exactly an audit is and what forms it takes:

• Definition
• Forms of the audit
• Audit procedure
• Areas of application

The audit is a review to determine whether guidelines, requirements or even processes in a company meet the required standards. These standards can be either self-developed or nationally or internationally prescribed standards. According to DIN EN ISO 9000, an audit is a "systematic and objective investigation to determine the degree of fulfillment of agreed requirements".

In quality management, there are various forms of audit, each of which can be used to uncover potential for improvement and confirm the effectiveness of the management system. One criterion by which audits can be differentiated is the party performing the audit:

Only the company itself is involved in an internal audit. It is usually carried out by a trained employee who asks colleagues from other departments about the processes. Internal audits are primarily used for self-assessment and promote communication on how to make processes in the company even more efficient.

Two parties are involved in a supplier audit: a supplier and a customer or alternatively a party commissioned by a customer. In some industries, such as the automotive industry, it is common for customers to audit their suppliers prior to collaboration in order to check their suitability for collaboration.

External audits are carried out by independent certification bodies, so that a third, external party is involved. Based on samples, the auditor assesses the extent to which standards such as ISO 9001 for quality management are met. The aim is to obtain official certification and thus demonstrate to customers, for example, that management systems are mastered in accordance with international standards.

Another criterion for distinguishing audits is the respective topic, which divides audits into the following forms, for example:

A product audit is usually part of the production control plan and is carried out preventively. It goes beyond product quality and also looks at the processes that take place around the product.

In a process audit, processes and procedures within a company can be examined with regard to systematic errors that can result in deviations.

Process audit vs. procedure audit? Depending on the definition, the terms process and procedure audit can be used synonymously. A distinction between the two terms usually refers only to the process steps to be audited: while a process audit potentially refers to the entirety of an organization's processes, a procedure audit tends to look at individual workflows.

System audits pursue the goal of checking the entire management system of a company for conformity to standards. The audit is usually based on quality management standards such as ISO 9001.

ISO 19011 serves as a guideline for auditing management systems. In general, it can be stated that an audit requires an appropriately qualified auditor. Depending on the form of the audit, this can be an employee of a company or an external auditor. During the audit, the auditor then asks questions to various people within the company who can provide information on the respective topic. The auditor discusses with the participants whether the processes in day-to-day business correspond to the original definition and which weaknesses, if any, need to be identified. The audit concludes with documented results that can be built upon further.

Audits are of particular interest in the area of quality management. However, the relevance of audits is also growing in other areas of the company – for example, in the areas of environment, energy or occupational health and safety. Current developments such as the setting of sustainability targets or legal requirements such as the Supply Chain Act make it necessary to deal with a wide range of audit topics within the scope of an audit or even to remain marketable through certification audits. In this way, audits can be used on the one hand to check actual conditions and compliance with objectives, and on the other hand to eliminate general problems or identify the need for improvement.