GB/T 39063-2020Consumer product recall - Risk assessment for electronics and electrical appliances (English PDF)

5.1 General Rules

5.1.1 Generally speaking, the assessment is firstly based on the basic normal scenario.

If the assessment result is the highest risk under this situation, usually no further assessment is required. Otherwise, it is necessary to further consider the influence of other factors on the assessment result, such as: the foreseeable abuse, the consumer’s vulnerability and unfavorable operating environment, etc.

NOTE: the normal scenario refers to a reasonable situation of use that does not consider special circumstances. For example, it is assumed that a certain consumer has normal capabilities and certain safety awareness of consumer products; he / she can use consumer products in accordance with instructions and can even normally use consumer products without instructions.

5.1.2 In each link of the assessment of consumer products, necessary assessment

techniques may be selected in accordance with the specific situation. See GB/T 27921 for the assessment techniques.

5.1.3 Generally speaking, the assessment bases on the collected information of

accidents, injuries and accident symptoms of consumer products to diagnose the hazard of the consumer products. In terms of the hazard, various scenarios that might lead to accidents and injuries are speculated. For different scenarios, the severity and possibility of the caused injuries are respectively analyzed; the highest risk level is determined through comprehensive analysis. The basic assessment procedure is shown in Figure 1.

5.2.2 Information inquiry

In terms of a certain consumer product, for the collected safety information, based on the experience and preliminary judgment, if it is considered necessary to conduct an in-depth investigation, investigators shall be arranged to further collect, verify and organize relevant information, including:

a) Basic information

For consumer products to be assessed, basic information shall be collected as much as possible, such as:

---Technical information, such as: product models, main technical parameters, design principles and structures, etc.;

---Relevant laws, regulations and standards;

---Information of relevant historical recall cases.

b) Information of accidents, injuries and accident symptoms

For consumer products to be assessed, relevant information of accidents, injuries and accident symptoms shall be collected as much as possible, such as:

---Situation of accident product, such as: product photos, service life, long- term service environment and maintenance records, etc.;

---Physical evidence on the site of accident, for example, accident consumer products or their fragments, etc.;

---The time, place, environment, site conditions and process of the occurrence of accident, such as: photos, videos and other materials;

---Situation of operators or injured persons, such as: the number of injured persons; the age, gender, physical condition, education level and occupation of the operators and injured persons; the type and severity of injury, medical treatment and rehabilitation, etc.;

---Cause analysis report or expert opinions on accidents, injuries and accident symptoms;

---Information of relevant accidents and injuries obtained through daily collection.

c) Information of scope of consumer products being affected

Information of the scope of consumer products that might have the same

1) Select assessment experts;

2) Organize the execution of assessment

Investigators

Undertake the fundamental work of assessment. The specific responsibilities include:

1) Collection and verification of necessary information;

2) Investigation of relevant accident cases;

3) Technical exchange;

4) Necessary test and preliminary problem analysis

Assessment

Experts

Accept consultation, assist or undertake relevant technical work, such as:

1) Assist investigators in relevant work;

2) Carry out risk identification;

3) Analyze and assess risks;

4) Submit proposals

5.2.4.2 Requirements for assessment team

5.2.4.2.1 When the regulator establishes an assessment team, in principle, the participation of interested parties shall be avoided, especially the manufacturer of the consumer products being assessed. When necessary, the cooperation of interested parties may be coordinated.

5.2.4.2.2 When the manufacturer establishes an assessment team, the assessment team may be composed of experienced management personnel and professional technicians of the enterprise. When the circumstance is relatively complicated, relevant technical experts in the industry may be invited to jointly establish an assessment team.

5.2.4.3 Requirements for experts

The selected assessment experts shall possess disciplinary knowledge, professional skills and experience related to the assessment items. The following should be selected:

---Personnel who are familiar with the safety requirements for relevant electronics and electrical appliances, such as: regulations and standards, etc.;

---Personnel who understand the design principles, functions and performance of relevant consumer products;

---Personnel who understand problems in the use and maintenance of relevant consumer products, and the basic situation of accident history.

5.3 Risk Identification

5.3.1 General rules

Analyze the hazards of consumer products in the foreseeable use and foreseeable

5.4.3.3.1

Under a certain scenario of injury, product injury is usually caused by the combined action of multiple factors, or, it may be comprehended as injury caused by various factors in separated steps. For each possibility influencing factor, the probability value of its possible occurrence may be estimated in accordance with the information of historical accidents that have occurred, the overall product quality status, the possible hazardous occurrence scenarios and the actual experience, etc. Multiply the probability values of all the relevant influencing factors to obtain the overall probability value (P). The calculation is shown in Formula (1). See Appendix B for an example of the estimation.

Where,

Pi ---the probability value of the possible occurrence of the i th factor;

n---number of influencing factors of possibility;

i---the i th possibility-influencing factor.

NOTE: “probability of injury” is an estimation of the probability of the possible occurrence of injuries during the entire life cycle of a consumer product. It is not calculated by dividing the number of a few sold products that would cause injuries by the total number of products.

5.4.3.3.2

When the basic data information is insufficient, which leads to the deficiency of sufficient basis or the impossibility of objective estimation of the probability value, the method provided in GB/T 27921 may be taken as a reference; all the existing relevant information may be used to estimate the probability value.

5.5 Risk Assessment

5.5.1 Determination of risk level

On the basis of risk identification and risk analysis, in accordance with the severity level of the occurrence of injuries and the corresponding possibility level of the occurrence, and Figure 3, respectively determine the risk level; in which, the highest level is deemed as the ultimate risk level.

The risk level is divided into 4 levels, which are respectively expressed below:

lambda S---severe risk;

lambda H---high risk;

lambda M---moderate risk;

c) Identified hazards;

d) Analysis of risk influencing factors;

e) Assessment result;

f) Related suggestions.

6.1 Technical Measures of Risk Control

In accordance with the problems found in the assessment process and the proposed suggestions, through technical measures, for example, respectively or simultaneously reducing the severity of injuries and the possibility of the occurrence of injuries, reduce the risks to below the allowable level.

In order to reduce risks, corresponding measures may be taken in the following sequence:

a) Enhance the intrinsic safety of products;

b) Reinforce protective measures;

c) Improve warning instructions.

6.2 Management Measures of Risk Control

There is no necessary connection between risk level and management measures of risk control. Under general circumstances, in accordance with the assessed risk level, corresponding management measures of risk control that should be taken are as follows:

a) When the risk level is “S” and “H”, take measures like recalling or removing products from the market.

b) When the risk level is “M”, comprehensively consider whether it is necessary to take measures like recalling or removing products from the market. When the involved products have hazards with extremely severe consequences, for example, accidental fatalities, even if the probability of the occurrence of these accidents is extremely low, corresponding measures like recalling or removing products from the market also need to be taken.

c) When the risk level is “L”, measures may not be taken.

Appendix C (normative)

Risk Level Sensitivity Analysis

C.1 Overview

Sensitivity analysis is to identify which parameters have greater influence on the assessment result through the analysis of the influence of a certain parameter data change on the input end on the risk level. Hence, its accuracy shall be further ensured.

C.2 Method of Analysis

Generally speaking, the method of adjusting a certain risk factor parameter upwards or downwards by one level (if a certain risk parameter can estimate the maximum value, then, the parameter adopts the maximum value, and no adjustment is needed) is adopted, at this moment:

---If the risk level changes, it means that the obtained risk level is sensitive to the parameter, and its risk level might also be in a critical state, then, it is necessary to re-verify whether valid information is thoroughly adopted in the estimation and assumption of the parameter;

---If the risk level does not change, it means that the obtained risk level is insensitive to the parameter, then, it is unnecessary to re-confirm the parameter, and the estimated value is very likely to be accurate.