First: Qualification of the person in charge of quality and safety
The person in charge of quality and safety is one of the core positions in an enterprise, whose duty is to manage the quality and safety work of the enterprise, ensure that the products and services of the enterprise comply with national laws and regulations and relevant standards, and safeguard the rights and safety of consumers. Therefore, enterprises must establish the position of quality and safety officer by the law, otherwise, it will be illegal. To ensure the legitimacy and ability of the person in charge of quality and safety, the enterprise shall employ and appoint a person with relevant professional knowledge, knowledge of laws and regulations, working experience, and ability to perform the duties to take up the position.
Enterprises have not set up the person in charge of quality and safety, or enterprises set up the person in charge of quality and safety does not meet the required conditions of service or does not have the appropriate ability to perform their duties, by the supervision and management of cosmetic regulations Article 61, paragraph 1, paragraph 2 of the provisions of the penalties. — “Enterprises to implement the main responsibility for the supervision and management of cosmetic quality and safety regulations” Article 28.
1, What are the differences with the old version of Article 105:
a; Professional knowledge: the abolition of the mandatory requirements for college education, emphasizing the study of cosmetics-related professional knowledge, mastery, and application capabilities.
b; Regulatory knowledge: requires familiarity with laws and regulations, mandatory national standards, and technical specifications, emphasizing the mastery of regulations and the ability to implement them on the ground.
c; work experience: increased from 3 years to 5 years, emphasizing the matching work experience with the position and the ability to perform.
2, on cosmetics-related professional knowledge:
a; Regarding specialized knowledge, is a college degree still required? What kind of study and training background can be recognized? Can relevant titles replace academic qualifications? It is still unclear and needs to wait for further official notification.
b; For the time being, a higher education degree certificate is still the most effective proof of professional knowledge. In addition, there are cases where the submission of professional qualifications related to cosmetics passed the audit. Specifically need to consult the local drug regulatory authorities.
3, on the production or quality management experience:
a; Experience in the production or quality management of drugs, medical devices, and special foods can be regarded as experience in the production or quality and safety management of cosmetics. –Based on the “State Drug Administration Comprehensive Department on cosmetics quality and safety of the person in charge of the relevant issues of the reply letter
b; The above special food refers to health food, special medical use formula food and infant formula food, etc. — Based on “Pharmacovigilance Policy Quick Look (Issue 34) Clarifying the Issues of Recognizing the Practicing Conditions of the Person in Charge of Cosmetic Quality and Safety”.
Evidence to prove
a; Authorization letter (or appointment letter) of the person in charge of quality and safety.
b; Certificate of education or title of the person in charge of quality and safety.
c; Resume of the person in charge of quality and safety, proof of work.
d; Participate in cosmetic quality and safety-related professional knowledge or regulatory training certificates or supporting information.
Second: the person in charge of quality and safety performance capabilities
The person in charge of quality and safety should have with the cosmetics quality and safety management of the corresponding ability to perform their duties, including the application of professional knowledge, the application of legal knowledge, organizational and coordination skills, risk research and judgment capabilities, and other cosmetic quality and safety management capabilities should have. — According to “Enterprises to implement the main responsibility for the supervision and management of cosmetic quality and safety regulations”
a; Application of professional knowledge: with cosmetics quality and safety-related professional knowledge, and be able to apply in the quality and safety management work.
b; Legal knowledge application ability: familiar with and able to ensure that the enterprise quality and safety management work in line with laws and regulations.
c; Organizational and Coordination Ability: Have the leadership ability to organize the implementation of a quality and safety responsibility system, and be able to effectively organize and coordinate the quality and safety-related departments to carry out the work.
d; Risk assessment capabilities: able to accurately identify and judge the product quality risks that may arise from the production and operation activities of the enterprise, and put forward countermeasures.
e; Other cosmetics quality and safety management capabilities should have.