An interview with our internal auditor

If you want to have a well-working quality management system, you also need a regular review of this system. The most effective method for this is to conduct audits. On this topic, we interviewed Yannic Hallier, Executive Assistant, in his function as internal auditor at myStandards GmbH.

In general, audits check whether norms and standards followed by a company are complied with and whether existing documents are up to date. In addition, potential improvements in existing processes are identified.

Yannic Hallier, who joined our team in March 2020, is the Executive Assistant at myStandards GmbH and is responsible, among other things, for conducting internal audits.

As part of our series of news articles on Quality Management & Reference Materials, we conducted an interview with him.

myStandards: What are audits and what is the role of an auditor?

Yannic Hallier: The term audit comes from the Latin “audire” and means “to hear” or “to listen”. This describes the core idea of audits quite well. During an audit, the auditor listens to the managers and employees of a company. Based on the presentation of the existing processes, the auditor checks whether the company is working according to standard specifications, whether it deviates from them, or whether there is potential for improvement. The auditor leads the discussions and critically examines the processes, always keeping the relevant standards in mind. Finally, the potential for improvements and nonconformities are recorded and summarized in an audit report.

What exactly are nonconformities and how should they be handled by the company?

Nonconformities result from processes or procedures that do not adhere to the standard as a whole or in parts and thus deviate from it. A distinction is made between minor nonconformities and major nonconformities. Minor nonconformities are mistakes, lacks or deviations that do not negatively affect the management, the product quality and the customer satisfaction. Major nonconformities, on the other hand, affect these points or carry a high risk of doing so. The audit report is passed on to the quality management representative, who in turn is responsible for taking corrective actions to eliminate the nonconformities.

How are the corrective actions taken handled afterwards?

The quality management representative is responsible for coordinating and implementing the corrective actions. After the correction, the effectiveness of these actions can be checked in follow-up audits, but is in any case part of the regular management reviews of a company.

“The outcome of the audit can, depending on the audit objectives, indicate the need for corrections, or for corrective actions, or opportunities for improvement. Such actions are usually decided and undertaken by the auditee within an agreed timeframe. […]The completion and effectiveness of these actions should be verified. This verification may be part of a subsequent audit. Outcomes should be reported to the individual managing the audit program and reported to the audit client for management review.”
DIN EN ISO 19011:2018-10, Guidelines for auditing management systems

How did you become an internal auditor with us?

Through my previous job as a quality management representative and safety officer at a certified service provider and manufacturer of medical devices, I gained some experience in the field of quality management and in dealing with standards. In addition, I accompanied the internal and external audits there and learned the approach of the auditors. At myStandards GmbH, I intensively studied DIN EN ISO 17034 and the associated ISO Guides in preparation for the first audits.

How do audit planning and audits work in our company?

First, in cooperation with the quality management representative, I create an audit plan that covers the areas of management system documentation, quality management, management, method development and production. The content of the plan is based on DIN EN ISO 17034 and the timing is coordinated with the management. On the audit days, I first conduct a brief introductory meeting with all parties involved, in which the process is roughly discussed. I then observe and analyze the processes and procedures, and check the associated documents for conformity with the standard. The atmosphere should be relaxed so that the discussions are as open and honest as possible. The interviewees should at no time feel as if they are being set up, but that they can help to improve the processes in the company.

Has the Covid-19 pandemic had an impact on auditing?

Yes, the pandemic has made auditing somewhat more difficult, but at the same time it has created new opportunities. Basically, it is best to conduct the audits on the premises of the company, especially if it is a company with its own production, research, warehouse or similar. This is the only way to look at the processes in day-to-day operations and to audit different employees. Due to the pandemic and the related hygiene measures in the company, this part is done on a smaller scale. Other areas can be audited in remote audits.

What are remote audits and what are their advantages and disadvantages?

Remote audits are audits that are conducted via a video conferencing tool. The biggest disadvantage of a remote audit is that the auditor is not on site in the company and therefore cannot make a walk-through and take anything in hand to get a full impression. Furthermore, the personal character is somewhat lost and only employees who participate in the video conference can be included. However, remote audits are also a great opportunity in today’s world. Auditors can perform audits from anywhere and no longer need to travel. This saves costs and time and protects the environment. In addition, more and more documents and processes are being mapped exclusively digitally, which makes on-site audits unnecessary in many areas.

Our internal auditor, Yannic Hallier, during an on-site audit in the laboratory.

What is the current status of the internal audits at our company?

Based on our audit program, all areas of myStandards GmbH were successfully audited in 2020. Due to the Covid-19 pandemic, most of the audits were conducted remotely. Audits are planned again for this year and have already taken place in part or will take place in the coming months.

The original interview was conducted in german.

More articles from our series on the quality management system: