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GB/T 43253.1-2023 PDF in English


GB/T 43253.1-2023 (GB/T43253.1-2023, GBT 43253.1-2023, GBT43253.1-2023)
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GB/T 43253.1-2023: PDF in English (GBT 43253.1-2023)

GB/T 43253.1-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 43.040
CCS T 35
Road vehicles - Functional safety audit and assessment
method - Part 1: General requirements
ISSUED ON: NOVEMBER 27, 2023
IMPLEMENTED ON: NOVEMBER 27, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 7
4 General requirements ... 8
4.1 General... 8
4.2 How to use this document ... 8
5 Audit and assessment management requirements ... 9
5.1 Organizational culture requirements ... 9
5.2 Qualification requirements for audit and assessment personnel ... 9
5.3 Input requirements for audits and assessments ... 10
5.4 Audit and assessment process requirements ... 11
6 Technical requirements for audit and assessment ... 16
6.1 Functional safety management ... 16
6.2 Concept phase and system level ... 23
6.3 Software level ... 23
6.4 Hardware level ... 23
6.5 Production, operation, service, decommissioning ... 23
6.6 Support process ... 27
6.7 Vehicle safety integrity level-oriented and safety-oriented analysis ... 38
Appendix A (Informative) Examples of audit and assessment report ... 44
A.1 Overview of Functional Safety Audit and Assessment ... 44
A.2 Audit and assessment summary ... 46
Appendix B (Informative) Functional safety management ... 47
B.1 Audit and assessment of overall safety management ... 47
B.2 Project-related safety management audit and assessment ... 51
B.3 Safety management audit and assessment of production, operation, service,
decommissioning ... 59
Appendix C (Informative) Production, operation, service, decommissioning ... 61
Appendix D (Informative) Support process ... 67
Appendix E (Informative) Automotive safety integrity level-oriented and safety
analysis-oriented analysis ... 94
Road vehicles - Functional safety audit and assessment
method - Part 1: General requirements
1 Scope
This document stipulates the general process, implementation methods, requirements
for functional safety audit and assessment.
This document applies to safety-related systems containing one or more
electrical/electronic (E/E) systems, which are developed in accordance with GB/T
34590.1 ~ 34590.12-2022 and installed on mass-produced road vehicles other than
mopeds.
This document does not apply to specific electrical/electronic (E/E) systems on special
purpose vehicles, for example, vehicle systems designed for disabled drivers.
2 Normative references
The contents of the following documents constitute essential provisions of this
document through normative references in the text. Among them, for dated reference
documents, only the version corresponding to the date applies to this document; for
undated reference documents, the latest version (including all amendments) applies to
this document.
GB/T 34590.1 ~ 34590.12-2022 Road vehicles - Functional safety
GB/T 43253.2-2023 Road vehicles - Functional safety audit and assessment method
- Part 2: Concept phase and system level
GB/T 43253.3-2023 Road vehicles - Functional safety audit and assessment method
- Part 3: Software level
GB/T 43253.4-2023 Road vehicles - Functional safety audit and assessment method
- Part 4: Hardware level
3 Terms and definitions
The terms and definitions defined in GB/T 34590.1-2022 apply to this document.
Note 3: For the inspection items of different ASIL levels, instructions are given in the inspection
item list; if there is no other explanation, the inspection items in this document are applicable
to the four levels of ASILA, B, C, D.
5 Audit and assessment management requirements
5.1 Organizational culture requirements
Relevant organizations that conduct audits and assessments shall establish a safety
culture that ensures effective implementation of audits and assessments. A good safety
culture can include:
a) Implement a clear, traceable, controlled functional safety audit and assessment
process in each development phase (for example: conceptual level development
phase, system level development phase, software level development phase,
hardware level development phase, etc.), production, operation, service,
decommissioning phases and management process;
b) Clarify the duties and responsibilities of audit and assessment personnel; fully
empower them with decision-making rights;
c) Develop a capability improvement plan for audit and assessment personnel;
implement capability improvement according to the plan;
d) Appoint employees with audit and assessment capabilities to conduct audit and
assessment activities. See 5.2 for personnel qualification requirements;
e) Develop clear incentives (such as rewards and punishments) to promote the
effective implementation of audits and assessments;
f) It shall establish, implement, maintain a continuously improved audit and
assessment process, to discover weak links that may lead to safety violations and
improve audit and assessment efficiency.
Note: Improvements can include the audit and assessment process, the number and time points
of audit and assessment throughout the life cycle, phased audit and assessment, splitting of audit
and assessment content, personnel allocation, etc.
5.2 Qualification requirements for audit and assessment personnel
The organization shall designate audit and assessment personnel in accordance with the
independence requirements in Table 1 of GB/T 34590.2-2022. Auditors and assessors
can come from within the company, customers or third-party companies.
Audit and assessment personnel shall have skill levels, abilities, qualifications that
match their responsibilities; at least have training and professional activity experience
in the following knowledge areas:
a) Quality system process;
b) The requirements specified in GB/T 34590.1 ~ 34590.12-2022;
c) The functional safety audit and assessment requirements specified in this
document;
d) As an observer, participate in the audit and assessment process;
e) Have relevant engineering experience in the subject being assessed or similar
products.
5.3 Input requirements for audits and assessments
5.3.1 Inputs to audits and assessments
Inputs to the audit and assessment shall include the following:
a) Description of the purpose of audit and assessment;
b) Functional safety work results to be inspected;
c) Audit and assessment plan (may be included in the safety plan);
d) Product safety issues or list of issues (if applicable);
e) Audit and assessment process;
f) Audit and assessment supporting materials (if applicable).
Other supporting materials shall be provided by the audited and assessed party,
according to the requirements of the auditing and assessment party.
The work products that are the subject of audit and assessment shall have a maturity
level, that matches the phase of audit and assessment being conducted.
Note: The definition of maturity is defined by the audit and assessment party and the audited
and assessed party during the audit and assessment plan.
5.3.2 Authorization for audits and assessments
Audit and assessment parties shall have the necessary authority to support the scope of
the audit and assessment.
5.4.2.1 Audit and assessment phase
Audit and assessment can consist of 4 phases:
a) Preparation phase;
b) Audit and assessment process phases;
c) Audit and assessment report phase;
d) Problem improvement and confirmation phase (if applicable).
5.4.2.2 Preparatory phase requirements
At least the following activities shall be carried out during the preparation phase.
a) Ensure that audit and assessment personnel meet the qualification requirements
for audit and assessment personnel in 5.2.
b) Plan the time and resources required to implement audits and assessments.
c) Develop an audit and assessment plan, which shall at least include the following:
1) With appropriate management support, determine the roles of audit and
assessment team members and assign specific responsibilities;
2) Determine the scope of audit and assessment;
3) Determine the passing criteria for audit and assessment;
4) Preliminarily develop an agenda for the audit and assessment meeting.
d) Develop an audit and assessment checklist, which is required for audit and
assessment. See Chapter 6 for the checklist.
e) Develop a record list of audit and assessment results (including a safety issue
management list).
5.4.2.3 Audit and assessment process requirements
Figure 3 shows the process of the audit and assessment phases.
c) The audit and assessment party will audit the work results based on the checklist
in this document and engineering experience; record the safety issues discovered
in the form of a list of issues defined in the preparation phase. For the technical
requirements for audit and assessment at each phase, please refer to Chapter 6
Technical requirements for audit and assessment.
d) The audit and assessment party raises the issues found to the party being audited
and assessed. If the party being audited and assessed accepts the issue, the issue
will be included in the issue management list. However, if the party being audited
and assessed does not accept the issue, relevant arguments can be provided to
support the re-judgment of the audit and assessment party. When the two parties
cannot reach an agreement, it shall be based on the dispute resolution mechanism
established by both parties;
Example: The dispute resolution mechanism can be based on the opinions of auditors and
evaluators, OR it can be escalated to higher-level personnel from both parties for decision-
making.
e) When all issues have been discussed, the audit and assessment party freezes the
safety issue management list.
f) The party being audited and assessed shall formulate problem-solving measures,
responsible persons, completion date and other information, in accordance with
the audit and assessment plan and related processes.
g) The audit and assessment party will give the conclusion of this audit and
assessment, based on the passing judgment criteria in the audit and assessment
plan. If accepted, make plans for the next audit and assessment or end all audits
and assessments. If accepted conditionally, define a problem confirmation
mechanism (which can be to re-conduct the audit and assessment, or to confirm
that the problem has been closed normally in other ways). If rejected, it shall carry
out sufficient corrective activities and replan the audit and assessment.
Table 1 specifies the passing criteria for functional safety audits and assessments.
i) Details and results of audits and assessments.
j) Archiving requirements for audit and assessment evidence (if applicable).
See Appendix A for examples of audit and assessment reports.
5.4.2.5 Requirements for problem improvement phase
The party being audited and assessed improves and implements problem-handling
measures, based on the problem list and time plan.
The party being audited and assessed shall rectify safety issues, based on the
conclusions of the audit and assessment report; submit the rectification results to the
auditing and assessment party for confirmation.
The audit and assessment party shall revise the audit and assessment report, based on
the rectification results of safety issues.
6 Technical requirements for audit and assessment
6.1 Functional safety management
6.1.1 Objectives
The goal of this chapter is to audit and assess functional safety management documents,
to check whether their content meets the definition and needs of functional safety
development.
6.1.2 Inputs to audits and assessments
The development process and corresponding input materials, that need to be audited
and assessed in functional safety management, mainly include the following contents
(can be tailored according to the scope of audit and assessment).
a) Overall safety management:
1) Functional safety rules and process flow;
2) Evidence of competency management;
3) Evidence of quality management system;
4) Report of identified safety anomalies (if applicable).
b) Item-related safety management:
1) Impact analysis at the relevant item level;
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.