软件可追溯性管理规范

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软件可追溯性管理规范 / Software Traceability Management Specification

文件编号: HKJY/MS-13 / Document No.: HKJY/MS-13
版本号: A/0 / Version No.: A/0
编制： / Compiled by:
审核： / Reviewed by:
批准： / Approved by:
日期： / Date:

XX有限公司 / XX Co., Ltd.

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1. 目的 / Purpose

本规范旨在规范软件开发过程中的可追溯性管理，确保软件需求、设计、编码、测试和风险管理之间的关系正确、一致、完整和准确。通过本规范的实施，确保软件开发过程中各阶段的文档和活动能够被有效追溯和审查，从而提升软件质量、降低风险，符合公司和行业相关法规的要求。

This specification aims to standardize traceability management in the software development process, ensuring that the relationships between software requirements, design, coding, testing, and risk management are correct, consistent, complete, and accurate. By implementing this specification, we ensure that the documentation and activities at each stage of the software development process can be effectively traced and reviewed, thereby improving software quality, reducing risks, and complying with company and industry regulations.

2. 适用范围 / Scope

本规范适用于所有软件生命周期过程中涉及的可追溯性管理，包括但不限于软件需求分析、软件设计、测试、风险管理等阶段。

This specification applies to all traceability management involved in the software lifecycle process, including but not limited to software requirements analysis, software design, testing, and risk management stages.

3. 术语和定义 / Terms and Definitions

软件可追溯性分析 / Software Traceability Analysis：指追踪和分析软件需求、设计、编码、测试及风险管理之间的关系，确保各项内容的正确性、一致性、完整性和准确性。
需求追踪矩阵 / Requirements Traceability Matrix (RTM)：一个表格，用于记录需求规格说明书（SRS）与产品需求（PRS）、风险评估报告（RISK）之间的映射关系，确保需求和风险管理的对应关系可追溯。
设计追踪矩阵 / Design Traceability Matrix (DTM)：一个表格，用于记录软件设计与需求、风险控制、源代码的对应关系，确保设计与风险管理及编码的对应关系可追溯。
测试追踪矩阵 / Test Traceability Matrix (TTM)：一个表格，用于记录测试用例与设计、系统测试与需求、系统测试与风险管理的对应关系，确保测试的完整性和正确性。
用户测试追踪矩阵 / User Test Traceability Matrix (UTTM)：一个表格，用于记录用户测试与产品需求、用户测试与风险管理的对应关系，确保用户测试与需求和风险的追溯性。
Software Traceability Analysis: Tracing and analyzing the relationships between software requirements, design, coding, testing, and risk management to ensure the correctness, consistency, completeness, and accuracy of each element.
Requirements Traceability Matrix (RTM): A table used to map the relationships between the Software Requirements Specification (SRS) and Product Requirements Specification (PRS), Risk Assessment Report (RISK), ensuring that the relationships between requirements and risk management are traceable.
Design Traceability Matrix (DTM): A table used to map the relationships between software design, requirements, risk controls, and source code, ensuring that the relationships between design, risk management, and coding are traceable.
Test Traceability Matrix (TTM): A table used to map the relationships between test cases and design, system testing and requirements, system testing and risk management, ensuring the completeness and correctness of testing.
User Test Traceability Matrix (UTTM): A table used to map the relationships between user testing and product requirements, user testing and risk management, ensuring the traceability of user testing to requirements and risks.

4. 职责与权限 / Responsibilities and Authorities

4.1 开发部 / Development Department

在软件生命周期各阶段执行软件可追溯性分析，确保文档和活动能够有效追溯和审查。
负责软件设计和编码。
负责软件的测试工作，包括单元测试、集成测试和系统测试。
编写和维护《软件可追溯性分析报告》和《追踪矩阵》（RTM、DTM、TTM、UTTM）。
Perform software traceability analysis at each stage of the software lifecycle to ensure that documents and activities can be effectively traced and reviewed.
Responsible for software design and coding.
Responsible for software testing, including unit testing, integration testing, and system testing.
Compile and maintain the Software Traceability Analysis Report and Traceability Matrices (RTM, DTM, TTM, UTTM).

4.2 质量保证部 / Quality Assurance Department

监督项目进展，确保开发过程符合相关质量标准。
跟踪问题的解决，确保最终产品的质量。
参与项目进展评审，但不涉及研发逻辑审核。
Monitor project progress to ensure that the development process meets relevant quality standards.
Track the resolution of issues to ensure the quality of the final product.
Participate in project progress reviews but do not involve in reviewing the development logic.

4.3 产品部 / Product Department

收集和整理需求，确保需求的完整性和准确性。
组织进行验收测试和临床测试，确保测试的全面性和符合用户需求。
在需求分析阶段与风险管理组和开发部合作，进行需求的可追溯性分析。
Collect and organize requirements to ensure completeness and accuracy.
Organize acceptance testing and clinical testing to ensure comprehensive testing that meets user needs.
Collaborate with the Risk Management Group and Development Department during the requirements analysis stage to conduct requirements traceability analysis.

4.4 项目管理部 / Project Management Department

审核测试文档，确保测试覆盖率和正确性。
协调各部门工作，确保项目进度和质量。
参与各阶段的可追溯性分析评审，确保追溯性矩阵的准确性。
Review testing documents to ensure test coverage and correctness.
Coordinate the work of various departments to ensure project progress and quality.
Participate in traceability analysis reviews at each stage to ensure the accuracy of the traceability matrices.

4.5 风险管理小组 / Risk Management Group

参与需求分析和设计阶段的可追溯性分析，确保风险得到识别和控制。
提供风险评估报告，协助各部门制定风险控制措施。
Participate in traceability analysis during the requirements analysis and design stages to ensure risks are identified and controlled.
Provide risk assessment reports and assist various departments in developing risk control measures.

5. 内容及流程 / Content and Process

5.1 软件需求分析可追溯性分析 / Software Requirements Analysis Traceability Analysis

工作内容 / Work Content：
- 产品部负责收集和整理需求。
- 产品部与风险管理小组和开发部合作进行需求的可追溯性分析。
- 确保需求内容的正确性、一致性、完整性和准确性。
- 使用《需求追踪矩阵》（RTM），记录需求与产品需求、需求与风险分析的对应关系。
- The Product Department is responsible for collecting and organizing requirements.
- The Product Department collaborates with the Risk Management Group and Development Department to conduct requirements traceability analysis.
- Ensure the correctness, consistency, completeness, and accuracy of requirements content.
- Use the Requirements Traceability Matrix (RTM) to record the relationships between requirements and product requirements, requirements and risk analysis.
产出 / Output：
- 《需求追踪矩阵》 / Requirements Traceability Matrix (RTM)

5.2 软件设计可追溯性分析 / Software Design Traceability Analysis

工作内容 / Work Content：
- 开发部负责软件设计工作。
- 项目管理部负责协调设计工作。
- 开发部与产品部和风险管理小组合作进行设计的可追溯性分析。
- 确保设计方案符合软件需求和风险控制要求。
- 使用《设计追踪矩阵》（DTM），记录设计与需求、设计与风险控制的对应关系。
- The Development Department is responsible for software design.
- The Project Management Department coordinates design work.
- The Development Department collaborates with the Product Department and Risk Management Group to conduct design traceability analysis.
- Ensure the design scheme meets software requirements and risk control requirements.
- Use the Design Traceability Matrix (DTM) to record the relationships between design and requirements, design and risk controls.
产出 / Output：
- 《设计追踪矩阵》 / Design Traceability Matrix (DTM)

5.3 软件编码可追溯性分析 / Software Coding Traceability Analysis

工作内容 / Work Content：
- 开发部负责软件编码工作。
- 确保源代码与设计文档、源代码与单元测试用例的对应关系。
- 使用《设计追踪矩阵》（DTM），记录源代码与设计文档的对应关系。
- The Development Department is responsible for software coding.
- Ensure the relationships between source code and design documents, source code and unit test cases.
- Use the Design Traceability Matrix (DTM) to record the relationships between source code and design documents.
产出 / Output：
- 《设计追踪矩阵》 / Design Traceability Matrix (DTM)

5.4 软件测试可追溯性分析 / Software Testing Traceability Analysis

工作内容 / Work Content：
- 开发部的测试组负责测试工作。
- 项目管理部审核测试文档。
- 确保测试用例与设计文档、系统测试与软件需求、系统测试与风险管理之间的关系。
- 使用《测试追踪矩阵》（TTM），记录测试用例与设计、系统测试与需求、系统测试与风险管理的对应关系。
- The testing team of the Development Department is responsible for testing.
- The Project Management Department reviews testing documents.
- Ensure the relationships between test cases and design documents, system testing and software requirements, system testing and risk management.
- Use the Test Traceability Matrix (TTM) to record the relationships between test cases and design, system testing and requirements, system testing and risk management.
产出 / Output：
- 《测试追踪矩阵》 / Test Traceability Matrix (TTM)

5.5 用户测试可追溯性分析 / User Testing Traceability Analysis

工作内容 / Work Content：
- 产品部组织用户测试工作。
- 分析用户测试与产品需求、用户测试与风险管理之间的关系。
- 使用《用户测试追踪矩阵》（UTTM），记录用户测试与产品需求、用户测试与风险管理的对应关系。
- The Product Department organizes user testing.
- Analyze the relationships between user testing and product requirements, user testing and risk management.
- Use the User Test Traceability Matrix (UTTM) to record the relationships between user testing and product requirements, user testing and risk management.
产出 / Output：
- 《用户测试追踪矩阵》 / User Test Traceability Matrix (UTTM)

5.6 可追溯性分析报告 / Traceability Analysis Report

工作内容 / Work Content：
- 各阶段产生的可追溯性分析记录汇总，由开发部编写综合的《软件可追溯性分析报告》。
- 进行内部评审，确保各阶段的可追溯性分析完整和准确。
- 项目管理部审核《追踪矩阵》，确保每个环节的更新和准确性。
- Summarize the traceability analysis records generated at each stage, and the Development Department compiles a comprehensive Software Traceability Analysis Report.
- Conduct internal reviews to ensure the completeness and accuracy of traceability analysis at each stage.
- The Project Management Department reviews the Traceability Matrices to ensure updates and accuracy at each stage.
产出 / Output：
- 《软件可追溯性分析报告》 / Software Traceability Analysis Report
- 《软件可追溯性分析评审记录表》 / Software Traceability Analysis Review Record
- 《需求追踪矩阵》 / Requirements Traceability Matrix (RTM)
- 《设计追踪矩阵》 / Design Traceability Matrix (DTM)
- 《测试追踪矩阵》 / Test Traceability Matrix (TTM)
- 《用户测试追踪矩阵》 / User Test Traceability Matrix (UTTM)

6. 流程图 / Flowchart

无 / None

7. 相关文件及记录 / Related Documents and Records

7.1 相关联的文件 / Related Documents

无 / None

7.2 本文件产生的质量记录 / Quality Records Generated by This Document

7.2.1 《软件可追溯性分析报告》 HKJY/MS-13-001 / Software Traceability Analysis Report HKJY/MS-13-001
7.2.2 《软件可追溯性分析评审记录表》 HKJY/MS-13-002 / Software Traceability Analysis Review Record HKJY/MS-13-002
7.2.3 《需求追踪矩阵》 HKJY/MS-13-004 / Requirements Traceability Matrix HKJY/MS-13-004
7.2.4 《设计追踪矩阵》 HKJY/MS-13-005 / Design Traceability Matrix HKJY/MS-13-005
7.2.5 《测试追踪矩阵》 HKJY/MS-13-006 / Test Traceability Matrix HKJY/MS-13-006
7.2.6 《用户测试追踪矩阵》 HKJY/MS-13-007 / User Test Traceability Matrix HKJY/MS-13-007

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附录 / Appendix

需求追踪矩阵模板 / Requirements Traceability Matrix Template

文件编号: HKJY/MS-13-004 版本号: A/0 / Document No.: HKJY/MS-13-004 Version No.: A/0
编制单位: XX有限公司 / Compiled by: XX Co., Ltd.
日期: [填写日期 / Fill Date]

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需求追踪矩阵 / Requirements Traceability Matrix (RTM)

需求编号	需求描述	产品需求编号	风险编号	更新日期	备注
SRS-001	实现高分辨率医学影像处理功能	PRS-001	RISK-001	2024-08-05	初始创建
SRS-002	支持多种图像格式	PRS-002	RISK-002	2024-08-10	添加需求

Requirement No.	Requirement Description	Product Requirement No.	Risk No.	Update Date	Remarks
SRS-001	Implement high-resolution medical imaging processing function	PRS-001	RISK-001	2024-08-05	Initial creation
SRS-002	Support multiple image formats	PRS-002	RISK-002	2024-08-10	Requirement added

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设计追踪矩阵模板 / Design Traceability Matrix Template

文件编号: HKJY/MS-13-005 版本号: A/0 / Document No.: HKJY/MS-13-005 Version No.: A/0
编制单位: XX有限公司 / Compiled by: XX Co., Ltd.
日期: [填写日期 / Fill Date]

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设计追踪矩阵 / Design Traceability Matrix (DTM)

设计编号	设计描述	需求编号	风险控制编号	源代码模块编号	更新日期	备注
DS-001	图像处理模块设计	SRS-001	RISK-001-CTRL	CODE-001	2024-08-05	初始创建
DS-002	图像格式支持模块设计	SRS-002	RISK-002-CTRL	CODE-002	2024-08-10	添加设计

Design No.	Design Description	Requirement No.	Risk Control No.	Source Code Module No.	Update Date	Remarks
DS-001	Image processing module design	SRS-001	RISK-001-CTRL	CODE-001	2024-08-05	Initial creation
DS-002	Image format support module design	SRS-002	RISK-002-CTRL	CODE-002	2024-08-10	Design added

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测试追踪矩阵模板 / Test Traceability Matrix Template

文件编号: HKJY/MS-13-006 版本号: A/0 / Document No.: HKJY/MS-13-006 Version No.: A/0
编制单位: XX有限公司 / Compiled by: XX Co., Ltd.
日期: [填写日期 / Fill Date]

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测试追踪矩阵 / Test Traceability Matrix (TTM)

测试用例编号	测试用例描述	设计编号	系统测试编号	风险管理编号	更新日期	备注
TC-001	图像处理模块单元测试	DS-001	SYS-001	RISK-001-CTRL	2024-08-05	初始创建
TC-002	图像格式支持模块单元测试	DS-002	SYS-002	RISK-002-CTRL	2024-08-10	添加测试

Test Case No.	Test Case Description	Design No.	System Test No.	Risk Management No.	Update Date	Remarks
TC-001	Image processing module unit test	DS-001	SYS-001	RISK-001-CTRL	2024-08-05	Initial creation
TC-002	Image format support module unit test	DS-002	SYS-002	RISK-002-CTRL	2024-08-10	Test added

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用户测试追踪矩阵模板 / User Test Traceability Matrix Template

文件编号: HKJY/MS-13-007 版本号: A/0 / Document No.: HKJY/MS-13-007 Version No.: A/0
编制单位: XX有限公司 / Compiled by: XX Co., Ltd.
日期: [填写日期 / Fill Date]

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用户测试追踪矩阵 / User Test Traceability Matrix (UTTM)

用户测试编号	用户测试描述	产品需求编号	风险管理编号	更新日期	备注
UT-001	图像处理模块用户测试	PRS-001	RISK-001-CTRL	2024-08-05	初始创建
UT-002	图像格式支持模块用户测试	PRS-002	RISK-002-CTRL	2024-08-10	添加用户测试

User Test No.	User Test Description	Product Requirement No.	Risk Management No.	Update Date	Remarks
UT-001	Image processing module user test	PRS-001	RISK-001-CTRL	2024-08-05	Initial creation
UT-002	Image format support module user test	PRS-002	RISK-002-CTRL	2024-08-10	User test added

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软件可追溯性分析报告模板 / Software Traceability Analysis Report Template

文件编号: HKJY/MS-13-001-01 版本号: A/0 / Document No.: HKJY/MS-13-001-01 Version No.: A/0
编制单位: XX有限公司 / Compiled by: XX Co., Ltd.
日期: [填写日期 / Fill Date]

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软件可追溯性分析报告 / Software Traceability Analysis Report

项目名称：新型医疗影像软件开发 / Project Name: New Medical Imaging Software Development

编制人：张三 / Compiled by: Zhang San

审核人：李四 / Reviewed by: Li Si

批准人：王五 / Approved by: Wang Wu

日期：2024-08-25 / Date: 2024-08-25

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1. 引言 / Introduction

本报告总结了新型医疗影像软件开发项目中各阶段的可追溯性分析情况，旨在确保需求、设计、编码、测试和风险管理之间的关系正确、一致、完整和准确。

This report summarizes the traceability analysis at each stage of the new medical imaging software development project, aiming to ensure that the relationships between requirements, design, coding, testing, and risk management are correct, consistent, complete, and accurate.

2. 可追溯性分析概述 / Traceability Analysis Overview

需求分析阶段 / Requirements Analysis Stage：记录了需求与产品需求、风险文档的对应关系，确保需求内容的正确性和完整性。
设计阶段 / Design Stage：记录了需求与设计文档及风险文档的对应关系，确保设计方案符合需求。
编码阶段 / Coding Stage：记录了设计文档与源代码模块的对应关系，确保代码实现与设计要求一致。
测试阶段 / Testing Stage：记录了测试用例与设计文档、系统测试与需求、系统测试与风险管理的对应关系，确保测试覆盖全面，内容正确。
用户测试阶段 / User Testing Stage：记录了用户测试与产品需求、风险管理的对应关系，确保测试内容符合实际需求和风险控制。
Requirements Analysis Stage: Recorded the relationships between requirements, product requirements, and risk documents, ensuring the correctness and completeness of the requirements content.
Design Stage: Recorded the relationships between requirements, design documents, and risk documents, ensuring the design scheme meets the requirements.
Coding Stage: Recorded the relationships between design documents and source code modules, ensuring the code implementation is consistent with the design requirements.
Testing Stage: Recorded the relationships between test cases and design documents, system testing and requirements, system testing and risk management, ensuring comprehensive test coverage and correctness.
User Testing Stage: Recorded the relationships between user testing and product requirements, risk management, ensuring the test content meets actual needs and risk controls.

3. 追踪矩阵 / Traceability Matrices

需求追踪矩阵 / Requirements Traceability Matrix (RTM)
设计追踪矩阵 / Design Traceability Matrix (DTM)
测试追踪矩阵 / Test Traceability Matrix (TTM)
用户测试追踪矩阵 / User Test Traceability Matrix (UTTM)

4. 分析结果和问题 / Analysis Results and Issues

需求分析阶段 / Requirements Analysis Stage：
- 需求与产品需求、风险文档对应关系正确。
- 风险评估中识别出图像处理延迟风险，并制定了初步缓解措施。
设计阶段 / Design Stage：
- 设计方案与需求一致，记录完整。
- 识别出接口定义问题，已安排修改。
编码阶段 / Coding Stage：
- 代码实现与设计文档一致，逻辑清晰。
- 部分接口定义与设计文档不一致，已安排整改。
测试阶段 / Testing Stage：
- 测试用例覆盖全面，测试结果符合预期。
- 补充了部分测试用例，确保覆盖所有边界条件。
用户测试阶段 / User Testing Stage：
- 用户测试内容符合产品需求和风险管理的要求。
- 用户反馈表明系统性能良好，但存在潜在改进空间。
Requirements Analysis Stage:
- The relationships between requirements, product requirements, and risk documents are correct.
- Identified image processing delay risk during risk assessment and developed initial mitigation measures.
Design Stage:
- The design scheme is consistent with the requirements, and the records are complete.
- Identified interface definition issues and arranged modifications.
Coding Stage:
- The code implementation is consistent with the design documents, and the logic is clear.
- Some interface definitions are inconsistent with the design documents and have been arranged for rectification.
Testing Stage:
- The test cases cover comprehensively, and the test results meet expectations.
- Added some test cases to ensure all boundary conditions are covered.
User Testing Stage:
- The user test content meets the product requirements and risk management needs.
- User feedback indicates good system performance, with potential areas for improvement.

5. 结论和建议 / Conclusions and Recommendations

总体可追溯性分析结果良好，各阶段的文档和活动均能有效追溯。
建议进一步加强接口定义、风险评估和用户反馈的记录和追溯。
The overall traceability analysis results are good, and the documents and activities at each stage can be effectively traced.
It is recommended to further strengthen the recording and traceability of interface definitions, risk assessments, and user feedback.

签字 / Signature：

编制人 / Compiled by：_________

审核人 / Reviewed by：_________

批准人 / Approved by：_________

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软件可追溯性分析评审记录表模板 / Software Traceability Analysis Review Record Template

文件编号: HKJY/MS-13-002 版本号: A/0 / Document No.: HKJY/MS-13-002 Version No.: A/0
编制单位: XX有限公司 / Compiled by: XX Co., Ltd.
日期: [填写日期 / Fill Date]

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软件可追溯性分析评审记录表 / Software Traceability Analysis Review Record

产品名称：__________________________ / Product Name: __________________________

型号规格：__________________________ / Model Specifications: __________________________

发布版本：__________________________ / Release Version: __________________________

完整版本：__________________________ / Full Version: __________________________

评审内容 / Review Content：

软件需求分析可追溯性 / Software Requirements Analysis Traceability
风险分析可追溯性 / Risk Analysis Traceability
软件设计可追溯性 / Software Design Traceability
软件编码可追溯性 / Software Coding Traceability
软件测试可追溯性 / Software Testing Traceability
用户测试可追溯性 / User Testing Traceability
可追溯性分析报告 / Traceability Analysis Report

评审会签 / Review Sign-off：

评审人	部门	签名	日期
张三	开发部
李四	项目管理部
王五	产品部
赵六	质量保证部
钱七	风险管理小组

Reviewer	Department	Signature	Date
Zhang San	Development Department
Li Si	Project Management Department
Wang Wu	Product Department
Zhao Liu	Quality Assurance Department
Qian Qi	Risk Management Group

—

通过简化需求追踪矩阵中的内容，并仅追踪从需求规格说明书（SRS）到风险评估报告（RISK）、功能规格说明书（FS）、设计规格说明书（DS）再到验证测试计划（VRTP）的追踪，可以更清晰地管理和追踪各阶段的活动和文档。同时，明确了各阶段的工作内容和产出文档，便于管理和审查。

By simplifying the content of the Requirements Traceability Matrix and only tracking from the Software Requirements Specification (SRS) to the Risk Assessment Report (RISK), Functional Specification (FS), Design Specification (DS), and Verification Test Plan (VRTP), the activities and documents at each stage can be managed and traced more clearly. At the same time, the work content and output documents at each stage are clarified, making management and review easier.

admin

上面是瀑布模型的可追溯性管理，如果是V模型，使用下面的规范。

软件可追溯性管理规范 / Software Traceability Management Specification

文件编号: HKJY/MS-13 / Document No.: HKJY/MS-13
版本号: A/0 / Version No.: A/0
编制： / Compiled by:
审核： / Reviewed by:
批准： / Approved by:
日期： / Date:

XX有限公司 / XX Co., Ltd.

—

1. 目的 / Purpose

2. 适用范围 / Scope

本规范适用于所有软件生命周期过程中涉及的可追溯性管理，包括但不限于软件需求分析、软件设计、测试、风险管理等阶段。

3. 术语和定义 / Terms and Definitions

产品需求规格说明书 / Product Requirements Specification (PRS): 由产品部门输出，详细描述产品总体需求，包括功能需求、性能指标、用户需求和市场需求。
软件系统需求规格说明书 / Software System Requirements Specification (SRS): 由项目管理部指定人输出，从PRS中提炼出与软件相关的系统级需求，包括软件功能、性能、接口和限制。
子系统需求规格说明书 / Subsystem Requirements Specification (SSRS): 由开发人员输出，进一步分解SRS，定义每个子系统的功能和设计约束。
功能规格说明书 / Functional Specification (FS): 详细描述软件功能的文档。
设计规格说明书 / Design Specification (DS): 详细描述软件设计的文档。
验证测试计划 / Verification Test Plan (VRTP): 记录测试计划并验证需求的实现情况和风险的控制效果。
验证验证报告 / Verification Validation Report (VVR): 记录验证测试结果，并总结验证测试的发现与结论。
需求追踪矩阵 / Requirements Traceability Matrix (RTM)：一个表格，用于记录PRS、SRS、SSRS与风险评估报告（RISK）、功能规格说明书（FS）、设计规格说明书（DS）及验证测试计划（VRTP）之间的映射关系，确保各阶段的活动和文档可以相互追溯。
Product Requirements Specification (PRS): Output by the Product Department, detailing the overall product requirements, including functional requirements, performance metrics, user needs, and market demands.
Software System Requirements Specification (SRS): Output by a designated person in the Project Management Department, extracting system-level requirements related to software from the PRS, including software functions, performance, interfaces, and constraints.
Subsystem Requirements Specification (SSRS): Output by the Development Team, further breaking down the SRS into subsystem functions and design constraints.
Functional Specification (FS): A document that details the software functionality.
Design Specification (DS): A document that details the software design.
Verification Test Plan (VRTP): A document that records the test plan and verifies the fulfillment of requirements and the effectiveness of risk controls.
Verification Validation Report (VVR): A document that records the results of verification testing and summarizes the findings and conclusions of the verification process.
Requirements Traceability Matrix (RTM): A table used to map the relationships between PRS, SRS, SSRS, the Risk Assessment Report (RISK), Functional Specification (FS), Design Specification (DS), and Verification Test Plan (VRTP), ensuring that activities and documents at each stage can be traced to each other.

—

4. 职责与权限 / Responsibilities and Authorities

4.1 开发部 / Development Department

在软件生命周期各阶段执行软件可追溯性分析，确保文档和活动能够有效追溯和审查。
负责编写《子系统需求规格说明书（SSRS）》，并基于此进行软件设计和编码，编写《功能规格说明书（FS）》、《设计规格说明书（DS）》。
负责软件的测试工作，包括单元测试、集成测试和系统测试，编写《验证测试计划（VRTP）》和《验证验证报告（VVR）》。
编写和维护《软件可追溯性分析报告》和《需求追踪矩阵（RTM）》。
Perform software traceability analysis at each stage of the software lifecycle to ensure that documents and activities can be effectively traced and reviewed.
Responsible for compiling the Subsystem Requirements Specification (SSRS) and based on it, conducting software design and coding, including the compilation of the Functional Specification (FS) and Design Specification (DS).
Responsible for software testing, including unit testing, integration testing, and system testing, and the compilation of the Verification Test Plan (VRTP) and Verification Validation Report (VVR).
Compile and maintain the Software Traceability Analysis Report and Requirements Traceability Matrix (RTM).

4.2 质量保证部 / Quality Assurance Department

监督项目进展，确保开发过程符合相关质量标准。
记录并跟踪发现的问题，确保问题得到及时解决。
Supervise project progress to ensure that the development process meets relevant quality standards.
Record and track identified issues to ensure timely resolution.

4.3 产品部 / Product Department

收集和整理需求，编写《产品需求规格说明书（PRS）》，确保需求的完整性和准确性。
组织进行验收测试和临床测试，确保测试的全面性和符合用户需求。
在需求分析阶段与风险管理组和开发部合作，进行需求的可追溯性分析。
Collect and organize requirements, compiling the Product Requirements Specification (PRS), ensuring completeness and accuracy.
Organize acceptance testing and clinical testing to ensure comprehensive testing that meets user needs.
Collaborate with the Risk Management Group and Development Department during the requirements analysis stage to conduct requirements traceability analysis.

4.4 项目管理部 / Project Management Department

协调各部门工作，确保项目进度和质量。
输出《软件系统需求规格说明书（SRS）》，确保系统需求与产品需求一致。
参与各阶段的可追溯性分析评审，确保追溯性矩阵的正确性。
Coordinate the work of various departments to ensure project progress and quality.
Output the Software System Requirements Specification (SRS), ensuring that system requirements align with product requirements.
Participate in traceability analysis reviews at each stage to ensure the correctness of the traceability matrix.

4.5 风险管理小组 / Risk Management Group

参与需求分析和设计阶段的可追溯性分析，确保风险得到识别和控制。
提供风险评估报告（RISK），协助各部门制定风险控制措施。
Participate in traceability analysis during the requirements analysis and design stages to ensure risks are identified and controlled.
Provide the Risk Assessment Report (RISK) and assist various departments in developing risk control measures.

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5. 内容及流程 / Content and Process

5.1 软件需求分析可追溯性分析 / Software Requirements Analysis Traceability Analysis

任务 / Task：
- 产品部负责收集和整理需求，编写《产品需求规格说明书（PRS）》。
- 基于PRS，开发《系统需求规格说明书（SRS）》和《软件需求规格说明书（SRS）》，并使用相同的需求ID。
- 风险管理小组基于SRS进行风险评估，生成《风险评估报告（RISK）》。
- 更新《需求追踪矩阵（RTM）》，记录需求与风险文档的对应关系。
- The Product Department is responsible for collecting and organizing requirements and compiling the Product Requirements Specification (PRS).
- Based on the PRS, develop the System Requirements Specification (SRS) and Subsystem Requirements Specification (SSRS), using the same requirement ID.
- The Risk Management Group conducts risk assessments based on the SRS and generates the Risk Assessment Report (RISK).
- Update the Requirements Traceability Matrix (RTM) to record the relationships between requirements and risk documents.
产出 / Output：
- 《产品需求规格说明书（PRS）》 / Product Requirements Specification (PRS)
- 《系统需求规格说明书（SRS）》 / System Requirements Specification (SRS)
- 《子系统需求规格说明书（SSRS）》 / Subsystem Requirements Specification (SSRS)
- 《风险评估报告（RISK）》 / Risk Assessment Report (RISK)
- 《需求追踪矩阵（RTM）》 / Requirements Traceability Matrix (RTM)

5.2 软件设计可追溯性分析 / Software Design Traceability Analysis

任务 / Task：
- 开发部根据SSRS编写《功能规格说明书（FS）》和《设计规格说明书（DS）》。
- 在设计过程中，制定《验证测试计划（VRTP）》。
- 风险管理小组继续评估设计过程中的风险，并将结果纳入《需求追踪矩阵（RTM）》。
- 更新RTM，记录设计文档与需求和风险评估报告的对应关系。
- The Development Department compiles the Functional Specification (FS) and Design Specification (DS) based on the SSRS.
- During the design process, the Verification Test Plan (VRTP) is developed.
- The Risk Management Group continues to assess the risks during the design process and incorporates the results into the Requirements Traceability Matrix (RTM).
- Update the RTM to record the relationships between design documents, requirements, and the Risk Assessment Report.
产出 / Output：
- 《功能规格说明书（FS）》 / Functional Specification (FS)
- 《设计规格说明书（DS）》 / Design Specification (DS)
- 《验证测试计划（VRTP）》 / Verification Test Plan (VRTP)
- 《需求追踪矩阵（RTM）》 / Requirements Traceability Matrix (RTM)

5.3 实现（编码）阶段的可追溯性分析 / Implementation (Coding) Phase Traceability Analysis

任务 / Task：
- 开发部根据设计规格说明书（DS）进行编码，生成代码模块。
- 记录代码模块ID，并与设计规格中的模块进行对应。
- 更新RTM，以反映代码与设计规格的对应关系。
- The Development Department performs coding based on the Design Specification (DS) and generates code modules.
- Record the code module IDs and map them to the modules in the Design Specification.
- Update the RTM to reflect the relationships between the code and design specifications.
产出 / Output：
- 代码模块及其对应的ID / Code modules and their corresponding IDs
- 《需求追踪矩阵（RTM）》 / Requirements Traceability Matrix (RTM)

5.4 测试阶段的可追溯性分析 / Testing Phase Traceability Analysis

任务 / Task：
- 开发部根据VRTP执行单元测试、集成测试和系统测试。
- 测试完成后，编写《验证验证报告（VVR）》。
- 更新RTM，记录测试用例与需求和设计规格的对应关系，以及测试用例与VVR的对应关系。
- The Development Department performs unit testing, integration testing, and system testing based on the VRTP.
- After testing, compile the Verification Validation Report (VVR).
- Update the RTM to record the relationships between test cases, requirements, design specifications, and the VVR.
产出 / Output：
- 《验证验证报告（VVR）》 / Verification Validation Report (VVR)
- 《需求追踪矩阵（RTM）》 / Requirements Traceability Matrix (RTM)

5.5 系统测试和验收测试阶段的可追溯性分析 / System Testing and Acceptance Testing Phase Traceability Analysis

任务 / Task：
- 开发部执行系统测试，并确保系统需求和功能需求的全面验证。
- 产品部组织进行验收测试，确保测试结果符合用户需求。
- 完成《验证验证报告（VVR）》，记录系统测试结果并与初始需求进行对比。
- 更新RTM，记录系统测试结果与初始需求和验证测试计划的对应关系。
- The Development Department performs system testing and ensures the comprehensive validation of system requirements and functional requirements.
- The Product Department organizes acceptance testing to ensure the test results meet user needs.
- Complete the Verification Validation Report (VVR) to record system testing results and compare them with the initial requirements.
- Update the RTM to record the relationships between system testing results, initial requirements, and the Verification Test Plan.
产出 / Output：
- 系统测试报告 / System Testing Report
- 《验证验证报告（VVR）》 / Verification Validation Report (VVR)
- 《需求追踪矩阵（RTM）》 / Requirements Traceability Matrix (RTM)

5.6 可追溯性分析报告 / Traceability Analysis Report

任务 / Task：
- 各阶段产生的可追溯性分析记录汇总，由开发部编写综合的《软件可追溯性分析报告》。
- 进行内部评审，确保各阶段的可追溯性分析完整和准确。
- 项目管理部审核《需求追踪矩阵》，确保每个环节的更新和准确性。
- Summarize the traceability analysis records generated at each stage, and the Development Department compiles a comprehensive Software Traceability Analysis Report.
- Conduct internal reviews to ensure the completeness and accuracy of traceability analysis at each stage.
- The Project Management Department reviews the Requirements Traceability Matrix to ensure updates and accuracy at each stage.
产出 / Output：
- 《软件可追溯性分析报告》 / Software Traceability Analysis Report
- 《软件可追溯性分析评审记录表》 / Software Traceability Analysis Review Record
- 《需求追踪矩阵（RTM）》 / Requirements Traceability Matrix (RTM)

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6. 流程图 / Flowchart

无 / None

—

7. 相关文件及记录 / Related Documents and Records

7.1 相关联的文件 / Related Documents

无 / None

7.2 本文件产生的质量记录 / Quality Records Generated by This Document

7.2.1 《软件可追溯性分析报告》 HKJY/MS-13-001 / Software Traceability Analysis Report HKJY/MS-13-001
7.2.2 《软件可追溯性分析评审记录表》 HKJY/MS-13-002 / Software Traceability Analysis Review Record HKJY/MS-13-002
7.2.3 《需求追踪矩阵》 HKJY/MS-13-004 / Requirements Traceability Matrix HKJY/MS-13-004

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附录 / Appendix

需求追踪矩阵模板 / Requirements Traceability Matrix Template

—

需求追踪矩阵 / Requirements Traceability Matrix

需求编号	需求描述	风险编号	PRS/SSRS/SRS编号	FS编号	DS编号	VRTP/VVR编号	更新日期	备注
REQ-001	实现高分辨率医学影像处理功能	RISK-001	REQ-001	FS-001	DS-001	VRTP-001	2024-08-05	初始创建
REQ-002	支持多种图像格式	RISK-002	REQ-002	FS-002	DS-002	VRTP-002	2024-08-10	添加需求

Requirement No.	Requirement Description	Risk No.	PRS/SSRS/SRS No.	FS No.	DS No.	VRTP/VVR No.	Update Date	Remarks
REQ-001	Implement high-resolution medical imaging processing function	RISK-001	REQ-001	FS-001	DS-001	VRTP-001	2024-08-05	Initial creation
REQ-002	Support multiple image formats	RISK-002	REQ-002	FS-002	DS-002	VRTP-002	2024-08-10	Requirement added

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软件可追溯性分析报告模板 / Software Traceability Analysis Report Template

—

软件可追溯性分析报告 / Software Traceability Analysis Report

项目名称：新型医疗影像软件开发 / Project Name: New Medical Imaging Software Development

编制人：张三 / Compiled by: Zhang San

审核人：李四 / Reviewed by: Li Si

批准人：王五 / Approved by: Wang Wu

日期：2024-08-25 / Date: 2024-08-25

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1. 引言 / Introduction

2. 可追溯性分析概述 / Traceability Analysis Overview

需求分析阶段 / Requirements Analysis Stage：记录了需求与风险文档的对应关系，确保需求内容的正确性和完整性。
设计阶段 / Design Stage：记录了需求与设计文档及风险文档的对应关系，确保设计方案符合需求。
编码阶段 / Coding Stage：记录了设计文档与源代码模块的对应关系，确保代码实现与设计要求一致。
测试阶段 / Testing Stage：记录了测试用例与需求文档的对应关系，确保测试覆盖全面，内容正确。
Requirements Analysis Stage: Recorded the relationships between requirements and risk documents, ensuring the correctness and completeness of the requirements content.
Design Stage: Recorded the relationships between requirements, design documents, and risk documents, ensuring the design scheme meets the requirements.
Coding Stage: Recorded the relationships between design documents and source code modules, ensuring the code implementation is consistent with the design requirements.
Testing Stage: Recorded the relationships between test cases and requirements documents, ensuring comprehensive test coverage and correctness.

3. 需求追踪矩阵 / Requirements Traceability Matrix

需求编号	需求描述	风险编号	PRS/SSRS/SRS编号	FS编号	DS编号	VRTP/VVR编号	更新日期	备注
REQ-001	实现高分辨率医学影像处理功能	RISK-001	REQ-001	FS-001	DS-001	VRTP-001	2024-08-05	初始创建
REQ-002	支持多种图像格式	RISK-002	REQ-002	FS-002	DS-002	VRTP-002	2024-08-10	添加需求

Requirement No.	Requirement Description	Risk No.	PRS/SSRS/SRS No.	FS No.	DS No.	VRTP/VVR No.	Update Date	Remarks
REQ-001	Implement high-resolution medical imaging processing function	RISK-001	REQ-001	FS-001	DS-001	VRTP-001	2024-08-05	Initial creation
REQ-002	Support multiple image formats	RISK-002	REQ-002	FS-002	DS-002	VRTP-002	2024-08-10	Requirement added

4. 分析结果和问题 / Analysis Results and Issues

需求分析阶段 / Requirements Analysis Stage：
- 需求与风险文档对应关系正确。
- 风险评估中识别出图像处理延迟风险，并制定了初步缓解措施。
设计阶段 / Design Stage：
- 设计方案与需求一致，记录完整。
- 识别出接口定义问题，已安排修改。
编码阶段 / Coding Stage：
- 代码实现与设计文档一致，逻辑清晰。
- 部分接口定义与设计文档不一致，已安排整改。
测试阶段 / Testing Stage：
- 测试用例覆盖全面，测试结果符合预期。
- 补充了部分测试用例，确保覆盖所有边界条件。
Requirements Analysis Stage:
- The relationships between requirements and risk documents are correct.
- Identified image processing delay risk during risk assessment and developed initial mitigation measures.
Design Stage:
- The design scheme is consistent with the requirements, and the records are complete.
- Identified interface definition issues and arranged modifications.
Coding Stage:
- The code implementation is consistent with the design documents, and the logic is clear.
- Some interface definitions are inconsistent with the design documents and have been arranged for rectification.
Testing Stage:
- The test cases cover comprehensively, and the test results meet expectations.
- Added some test cases to ensure all boundary conditions are covered.

5. 结论和建议 / Conclusions and Recommendations

总体可追溯性分析结果良好，各阶段的文档和活动均能有效追溯。
建议进一步加强接口定义、风险评估和用户反馈的记录和追溯。
The overall traceability analysis results are good, and the documents and activities at each stage can be effectively traced.
It is recommended to further strengthen the recording and traceability of interface definitions, risk assessments, and user feedback.

签字 / Signature：

编制人 / Compiled by：_________

审核人 / Reviewed by：_________

批准人 / Approved by：_________

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软件可追溯性分析评审记录表模板 / Software Traceability Analysis Review Record Template

—

软件可追溯性分析评审记录表 / Software Traceability Analysis Review Record

产品名称：__________________________ / Product Name: __________________________

型号规格：__________________________ / Model Specifications: __________________________

发布版本：__________________________ / Release Version: __________________________

完整版本：__________________________ / Full Version: __________________________

评审内容 / Review Content：

软件需求分析可追溯性 / Software Requirements Analysis Traceability
风险分析可追溯性 / Risk Analysis Traceability
软件设计可追溯性 / Software Design Traceability
软件测试可追溯性 / Software Testing Traceability
可追溯性分析报告 / Traceability Analysis Report

评审会签 / Review Sign-off：

评审人	部门	签名	日期
张三	开发部
李四	质量保证部
王五	产品部
赵六	项目管理部
钱七	风险管理小组

Reviewer	Department	Signature	Date
Zhang San	Development Department
Li Si	Quality Assurance Department
Wang Wu	Product Department
Zhao Liu	Project Management Department
Qian Qi	Risk Management Group

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通过简化需求追踪矩阵中的内容，并仅追踪从产品需求规格说明书（PRS）到软件系统需求规格说明书（SRS）再到子系统需求规格说明书（SSRS）、风险评估报告（RISK）、功能规格说明书（FS）、设计规格说明书（DS）、验证测试计划（VRTP）和验证验证报告（VVR）的追踪，可以更清晰地管理和追踪各阶段的活动和文档。同时，明确了各阶段的工作内容和产出文档，便于管理和审查。

By simplifying the content of the Requirements Traceability Matrix (RTM) and only tracking from the Product Requirements Specification (PRS) to the Software System Requirements Specification (SRS) to the Subsystem Requirements Specification (SSRS), Risk Assessment Report (RISK), Functional Specification (FS), Design Specification (DS), Verification Test Plan (VRTP), and Verification Validation Report (VVR), the activities and documents at each stage can be managed and traced more clearly. At the same time, the work content and output documents at each stage are clarified, making management and review easier.