Managing Deviations

Quality can only be manufactured. – This principle is still highly relevant today and is the focus of ISO 22716 on Good Manufacturing Practice (Cosmetic GMP) implemented within the cosmetics industry. While the Cosmetic GMP mainly considers the production processes, established management tools such as process evaluation only play a marginal role. On the other hand, quality management standards such as ISO 9001, which are not industry related, tend to lose focus on the production processes, resulting in a void in the standards. Can applicable and reasonable,individual extensions lead the standard Cosmetic GMP to a practice-oriented quality management system?

Since the mandatory introduction of Good Manufacturing Practice for cosmetics with the European Cosmetics Regulation in 2009, the contents of the ISO 22716 standard have not been revised. Nevertheless, technology and science as well as new products have changed. As a result, we continue to change the interpretation and implementation of the requirements over the years. The focus here is clearly on the issue of technologisation and the related avoidance of negative influences on the cosmetic product at all levels of production.

By using Enterprise Resource Planning (ERP) systems in conjunction with fully automated storage and transport systems, the risk of confusion between materials and products is reduced to a minimum. Software- supported 100% checks in filling and packaging support the classic, sample-based in-process control. CIP systems increase the efficiency and reproducibility of system cleaning. While the manufacturing process is constantly being improved; however, we are observing that management issues have fallen out of focus in many companies that work exclusively according to Cosmetic GMP.

Which supplements?

In our experience, it makes sense to add supplements that avoid deviations and negative influences on the cosmetic product from the beginning of the process. Particularly noteworthy here are supplier and action management. A strict procedure for the selection and regular evaluation of suppliers and their performance can significantly reduce the risk of production downtime and complaints due to material defects. The action management system compensates for the remaining deviations that could not be avoided by Cosmetic GMP actions, recording all deviations occurring in the company, internal and external complaints and the related corrective and preventive actions. This system effectively helps companies to recognize recurring deviations faster and better control the implementation of actions. In this context, a regular evaluation of one’s own performance in the form of a management review can also be helpful for identifying weaknesses and taking targeted actions for improvement.

Target Group

The extension of the good manufacturing practice by selected management tools of ISO 9001 or similar is always useful, if there are no specific customer requirements for further qualifications for a company. It is recommended that these companies approach current developments in the area of quality requirements by means of targeted expansion of Cosmetic GMP.

The International Featured Standard Household and Personal Care (IFS HPC) is particularly interesting as it combines requirements from Cosmetic GMP, ISO 9001 and the HACCP concept.

In recent years, IFS HPC become a binding quality standard for cosmetics manufacturers by the major retail chains. Manufacturing companies should consister in the strategic orientation of manufacturing companies.