GB/T 35253-2017Dividing principles of risk warning on product quality safety (English PDF)

3.1 Hazard

Hazard refers to a potential source that might cause injury. [GB/T 22760-2008, Definition 2.3]

3.2 Injury

Injury refers to damage to human health, property or the environment. [GB/T 28803-2012, Definition 3.3]

3.3 Risk

Risk refers to a comprehensive measurement of injury, including the possibility of the occurrence of injury and the degree of injury. [GB/T 22760-2008, Definition 2.5]

3.4 Risk Analysis

5.1.2 Information collection

Collect product quality safety risk information; clarify information sources and collection channels:

a) Information sources: before the occurrence of a product quality safety incident, information is mainly obtained through sampling inspection of the products; after the occurrence of a product quality safety incident, information is obtained through the collection and analysis of risk product information.

b) Collection channels: product quality safety information found in the process of administrative supervision, such as: supervision and random inspection, testing and certification, quality arbitration, administrative law enforcement and special rectification; product quality safety information provided by relevant parties, such as: news media reports, consumer complaints, notifications from administrative supervision departments, industry organization reports and expert opinions, etc.; product quality safety information obtained from special works, such as: public opinion monitoring, market survey and industry research, etc.

5.1.3 Risk monitoring

Based on the collection of product risk information, formulate risk monitoring schemes; scientifically and reasonably determine risk monitoring items, basis and methods; systematically implement the product quality safety risk monitoring work; identify and verify product quality safety risks; gradually expand the product range of risk monitoring and raise the frequency of monitoring; determine product safety risk factors, which mainly include system risk factor, personnel risk factor, technical risk factor, environmental risk factor, self-discipline factor and management risk factor, etc.

5.1.4 Comprehensive research and judgment

Adopt quantitative-based method and the combination of qualitative and quantitative to comprehensively analyze product quality safety risks. In addition, combine laws, regulations, policies, economy, technology and geographical environment in the research and judgment.

5.1.5 Rating determination

In accordance with the result of analysis, research and judgment, determine the rating of early risk warning and the grade of product quality safety risks.

5.2 Basis Factors

5.2.1 Severity of injuries

The severity of injuries is determined in accordance with the severity of the mainly includes the risk of personnel, animal, surrounding environment and facility hazards caused by certain other potential factors in the normal use or misuse of the product.

5.3 Early-warning Rating Division Methods

5.3.1 Method of risk assessment

Product quality safety risk assessment methods are divided into three types: qualitative, semi-quantitative and quantitative. 8.4 of GB/T 22760-2008 provides specific risk assessment methods.

5.3.2 Method of early-warning rating

In accordance with the size of product quality safety risks, conduct comprehensive analysis through the tolerance of product quality safety risks in different groups of society and different geographical environments; determine the early-warning rating of product quality safety risks suitable for the current region. The early-warning rating of product quality safety risks may adopt the following two methods; other product quality safety and social risk rating methods may also be adopted.

a) Historical case analysis method: based on historical product quality and safety risk incident cases, by comparing historical incident cases, analyzing the severity of consequences that the incident might cause and the scope of impact, perform the early-warning rating.

b) Risk control capability evaluation method: based on the current region's control capability towards specific product quality safety risks, and with reference to the current region's product quality safety risks, perform the early-warning rating.

5.4 Division of Early-warning Rating

Under general circumstances, the product quality safety risk early-warning rating is divided into: Level-I, Level-II, Level-III and Level-IV, which are respectively marked with red, orange, yellow and blue. Among them, Level-I is the highest early-warning rating;

Level-II, Level-III and Level-IV signify gradually decreasing early-warning rating, and the severity of the corresponding risks decreases step-by-step. Generally speaking, when determining the early-warning rating Level-I, Level-II, Level-III and Level-IV of the product quality safety risks, the information channels, through which, the early-warning is issued, might be different, and the response measures taken after the early warning are also different. […]