Quality managment system|Kaizhen business (Shanghai) Co., Ltd

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Quality managment system

Cosmetic registrants, record holders, and entrusted production enterprises shall appoint a person in charge of quality and safety who shall undertake corresponding product quality and safety management and product release responsibilities.
1. The person in charge of quality and safety
1.1 Competences of the person in charge of quality and safety: The person in charge of quality and safety should have professional knowledge of cosmetics quality and safety, and have more than 5 years of experience in cosmetics production or quality and safety management.
1.2 Failure to set up a person in charge of quality and safety will face at least the following penalties:
The legal representative or main person in charge, the directly responsible person in charge, and other directly responsible persons of the illegal unit shall be fined at least 1 time but less than 2 times the income received from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities within 5 years .
2. Overview of the quality management system
Cosmetic registrants and recorders should provide an overview of the quality management system

Quality management system overview table (commissioned production)

Module	content or measure (overview)
Recipe source	Does the registrant/filer have formula research and development capabilities:
	□Yes, please briefly describe the minimum requirements for the education background and work experience of the relevant personnel, and the minimum number of people set;
	□No, please briefly describe the source of the product formula and the control measures to ensure the quality of the formula and product quality and safety.
Material purchase	Whether the registrant/filer purchases materials by himself:
	□Yes, please briefly describe the relevant systems for material procurement and supplier management;
	□No, please briefly describe the material procurement method and the corresponding quality and safety control measures.
Production company selection and Management System	Please briefly describe the relevant systems for the selection of production enterprises, including at least: 1. Selection criteria for production enterprises; 2. On-site inspection related systems, including on-site inspection frequency; 3. Elimination and replacement system of production enterprises
	Please check the management system that the manufacturer should have when selecting the manufacturer (multiple choices are possible):
	□Document Management System □Retrospective management system □Supplier selection system □Raw material acceptance system □Equipment Management System □Production process and quality control system	□Product inspection system □Sample management system □Product sales system □Record management system □Quality Complaint System □Product recall system
Product release	Please briefly describe the qualified release standard of the registrant/filer and the relevant system to ensure that the manufacturer implements the product release in accordance with the standard.
Quality management measures independent of the production enterprise	Quality management measures independent of the production enterprise Please briefly describe the quality management measures independent of the manufacturer, including at least: 1. Product file management and quality traceability system; 2. Whether there are regular self-sampling inspections or inspections, inspection scope, inspection frequency, inspection items, etc.; 3. Related systems for sales management.
Quality self-examination and correction	Quality self-inspection and error correction Please briefly describe the self-inspection and error correction system of the enterprise's quality management system, including at least: 1. Traceability, cause analysis and corrective measures of non-conforming products; 2. Enterprise internal audit system and internal audit frequency; 3. Information collection measures and necessary rectification measures for adverse reactions, consumer complaints, unqualified sampling inspections, etc.
other
(Seal of the registrant/filer) year month day

Summary Table of Adverse Reaction Monitoring and Evaluation System (Overseas registrant/filer)

Module	Item	Content or Measures (Overview)
Registrant/Recorder's Measures	Job Responsibilities	Please briefly describe the registrant/recorder’s adverse reaction monitoring and evaluation related job settings, including at least: 1、Relevant institutions and position settings; 2、Basic requirements for relevant personnel.
	Adverse Reaction Monitoring	Please briefly describe the relevant system of the registrant/filer's adverse reaction monitoring, including at least: 1、The overall composition and operation mode of the adverse reaction monitoring system; 2、Please briefly describe all active or passive adverse reaction information collection channels and the frequency of information collection.
	Adverse Reaction Evaluation	Please briefly describe the relevant system of the registrant/filer's adverse reaction evaluation, including at least: 1、The way to complete the adverse reaction evaluation, such as by the registrant/filer or entrusting a relevant professional organization to complete it; 2、Evaluation criteria for adverse reactions; 3、Corresponding treatment measures after adverse reaction evaluation.
Cooperative measures for the domestic responsible person	Job responsibilities	Please briefly describe the situation of the relevant job setting for the adverse reaction monitoring and evaluation of the domestic responsible person, including at least: 1、Relevant institutions and position settings; 2、Basic requirements for relevant personnel.
	Adverse reaction monitoring	Please briefly describe the relevant system of adverse reaction monitoring of the responsible person in China, including at least: 1、The overall composition and operation mode of the adverse reaction monitoring system; 2、Please briefly describe all active or passive adverse reaction information collection channels and the frequency of information collection.
	Adverse Reaction Evaluation	Please briefly describe the relevant system of adverse reaction evaluation of the responsible person in China, including at least: 1、The way to complete the adverse reaction evaluation, such as by the registrant/filer or entrusting a relevant professional organization to complete it; 2、Evaluation criteria for adverse reactions; 3、Corresponding treatment measures after adverse reaction evaluation.
Communication method	Communication mechanism Please briefly describe the mechanisms and measures for information exchange, data sharing, risk linkage and other aspects of adverse reaction monitoring and evaluation by overseas registrants/filers and domestic responsible persons.
(Seal of the registrant/filer) year month day