Quality Risk Management of Alcohol-Based Cosmetics for Hand Sanitizer Eakchai Yaochuang

Abstract

Background: Alcohol-based hand sanitizer cosmetic products play an important role in the COVID-19 pandemic control. However, approximately a haft of the products that available in Thailand markets did not meet standard because of having the contained alcohol less than 70% according to the requirements of the Cosmetic Act B.E. 2558.

Objectives : To track down the risks which alcohol-based hand sanitizer cosmetic products did not meet standards and to suggest recommendations for improving product quality to meet standards.

Methods: This research was a qualitative research. The total population of nine alcohol-based hand sanitizer cosmetic entrepreneurs in Saraburi province were used by assessing the production site with experts and interviewing with a questionnaire. Two samples were randomly selected by conducting in-depth interviews to identify problems, causes, and review production processes that effected on product quality risks with a fish-bone diagram and causal analysis from 4M (Man, Machine, Method, and Material) with a proposed risk management approach.

Results: The results revealed that most of the production sites had 1-5 employees, 66.7% of which had alcohol raw materials stored in the building, the cosmetic mixing container had an average size of 113 litre. The average alcohol mixing was 21 minutes. There were three types of mixing methods: mix all the ingredients and leave it for about 12 hours, then bring the mixture to the gel; mixing other substances together and adding alcohol to mix and the gel-forming type soaked for about 12 hours and then mixed with alcohol. In the mixing-to-packing process, it took around 0.25–16 hours. The Carbomer 940 was used as a gelling agent that accounted for 66.7%. Besides, when looking for risks from manufacturers, it is found that the risk of 4M was the same for three main reasons: (1) Man: lack of correct technique and forgetting to add/incomplete alcohol according to the formula, because there was no record of production process, but the control can be modified by following the notification of the Ministry of Public Health in the part of production recording and in accordance with the master formula; (2) Method: lack of checking the alcohol content due to lack of proper tools/methods, however it can be corrected by using a suitable test kit; and (3) Material: the initial alcohol content was not in accordance with the analysis certificate and the finished product container was not suitable due to non-compliance with the notification of the Ministry of Public Health as for the details of the specifications of raw materials, as well as components including purchasing raw materials from reliable sources.

Conclusions: Risk of the quality of cosmetics containing alcohol for hand sanitizer caused by cosmetic manufacturers who were not strictly at every stage of production, competent staff lack of inspection, and lack of appropriate tools to measure alcohol content in the production process. Therefore, the Thai Food and Drug Administration should develop and communicate risk management knowledge to manufacturers, strictly apply the law, and coordinate the relevant academic units to develop an alcohol measurement kit.