GB/T 39063-2020 English PDF (GBT39063-2020)
GB/T 39063-2020 English PDF (GBT39063-2020)
GB/T 39063-2020: Consumer product recall -- Risk assessment for electronics and electrical appliances
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 13.120; 97.030
Consumer Product Recall - Risk Assessment for
Electronics and Electrical Appliances
ISSUED ON: SEPTEMBER 29, 2020
IMPLEMENTED ON: APRIL 1, 2021
Issued by: State Administration for Market Regulation;
Standardization Administration of the PEOPLE Republic of
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Purpose and Principle ... 7
5 Assessment Procedure ... 8
6 Risk Control ... 22
Appendix A (informative) An Example of Division of Severity of Injuries ... 23 Appendix B (informative) An Example of Estimation Method for Possibility Probability Value ... 25
Appendix C (normative) Risk Level Sensitivity Analysis ... 26
Bibliography ... 27
Consumer Product Recall - Risk Assessment for
Electronics and Electrical Appliances
This Standard specifies the purpose, principle, procedure and risk control measures for the risk assessment of consumer products like electronics and electrical appliances in recall management.
This Standard is applicable to the safety risk assessment of consumer products like electronics and electrical appliances in recall management. Electronics and electrical appliances for children may take this Standard as a reference.
This Standard is inapplicable to information security risk assessment of consumer products like electronics and electrical appliances.
NOTE: in this Standard, consumer products like electronics and electrical appliances are a general term for electronics consumer products and electrical appliances consumer products, which usually include: household appliances, audio and video equipment, wires and cables, lighting electrical appliances, electric power tools, electrical accessories, appliance switches and automatic control equipment, information technology equipment and telecommunication terminal equipment, etc. 2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 27921 Risk Management - Risk Management Techniques
GB/T 34400 Consumer Product Recall - Guidelines for Manufacturers
Assessment Standard of Degree of Human Injury - The Supreme PEOPLE Court of the PEOPLE Republic of China, The Supreme PEOPLE Procuratorate of the PEOPLE Republic of China, The Ministry of Public Security of the PEOPLE Republic of China, the Ministry of National Security, Ministry of Justice of the PEOPLE Republic of China - Notice of the Ministry of Justice  No. 146
---Combination of quantitative and qualitative study
During the assessment, the quantitative study, qualitative study, or a
combination of them may be adopted to provide assessment indicators. When appropriate data is obtained, the assessment indicators shall be quantified as much as possible.
---Give priority to severity of consequences
The determination of risk level is mainly based on the severity of injury caused by the accident and the possibility of the occurrence of injury. When the consequences of injury are extremely severe, even if the possibility of its possible occurrence cannot be accurately estimated, as long as there is a certain possibility, a suggestion shall still be given that it is necessary to take measures to reduce the risk.
5 Assessment Procedure
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
Undertake the fundamental work of assessment. The specific
1) Collection and verification of necessary information;
2) Investigation of relevant accident cases;
3) Technical exchange;
4) Necessary test and preliminary problem analysis
Accept consultation, assist or undertake relevant technical work, such
1) Assist investigators in relevant work;
2) Carry out risk identification;
3) Analyze and assess risks;
4) Submit proposals
184.108.40.206 Requirements for assessment team
220.127.116.11.1 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.
18.104.22.168.2 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. 22.214.171.124 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 126.96.36.199.1 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.
Pi---the probability value of the possible occurrence of the ith factor; n---number of influencing factors of possibility;
i---the ith 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.
188.8.131.52.2 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: ??? S---severe risk;
??? H---high risk;
??? M---moderate risk;
c) Identified hazards;
d) Analysis of risk influencing factors;
e) Assessment result;
f) Related suggestions.
6 Risk Control
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.
Risk Level Sensitivity Analysis
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.