IATF 16949升级策划案和数据检查表

IATF 16949 Upgrade Planner and Delta Checklist

IATF 16949升级策划案和数据检查表

Reference Document

Question / Requirement

(Name / Rev. Level)

OR Records

问题/要求参考文件（名称/版本）或者记录Evidence of determination of Understanding the Organization and

its Context(4.1)

确定理解本组织及其背景的证据（4.1）

Evidence of determination of Interested Parties and their

requirements (4.2)

相关方的确定及其要求的证据（4.2）

Evidence that scope of the QMS includes applicable remote support

functions and customer specific requirements. Also, if product

design is excluded, has justification been documented in QMS? (4.3)

QMS的范围包括适用的外部支持功能和顾客特定要求的证据。 此外，

如果排除产品设计，是否在QMS中记录了正当理由？ （4.3）

QMS Documentation (7.5.1):

Examples:

- Process map (or equivalent)

- Process descriptions & interactions

- Quality Policy

- Quality Objectives

- Planning of changes

- Other Documentation (as appropriate)

Includes 4.4, 5.2.1, 6.2 and 6.3

QMS文档（7.5.1）：

例子：

- 过程图（或同等）

- 过程描述和交互

- 质量方针

- 质量目标

- 更改的策划

- 其他文件（如适用）

包括4.4，5.2.1，6.2和6.3

Product Safety (4.4.1.2): Evidence that a documented process is

implemented related to the management of product-safety related

products and manufacturing processes. Note - cannot be “NA”.

产品安全（4.4.1.2）：有证据说明已实施文件化的与产品安全相关产

品和制造过程的管理过程。 注意 - 不能为“NA”。

Evidence of Leadership and Commitment (5.1)

领导和承诺的证据（5.1）

Evidence of Corporate responsibility policies, defined and

implemented. (5.1.1.1)

企业责任政策的定义和实施的证据。 （5.1.1.1）

Evidence that Process Owners are identified for all QMS processes

including support processes. (5.1.1.3)

为所有QMS过程（包括支持过程）确定过程所有者的证据。

（5.1.1.3）

Organization Roles, responsibilities and authorities (5.3.1) are

assigned and documented.

组织岗位，职责和权限（5.3.1）被分配和记录。

问题/要求参考文件（名称/版本）或者记录Evidence of Risk-Based Thinking and evidence of Actions to

Address Risks and Opportunities (6.1). Risk analysis to include

appropriate inputs and is documented. (6.1.2.1)

基于风险的思维证据和解决风险和机遇的行动证据（6.1）。 风险分析

包括适当的输入，并形成文件。 （6.1.2.1）

Evidence that a Preventive action process exists which lessens the

impact of negative effects of risk. (6.1.2.2)

存在预防性行动过程以减少风险的负面影响的证据。 （6.1.2.2）

Evidence that expanded Contingency planning has occurred

(6.1.2.3)

有应急计划（6.1.2.3）

Evidence that expanded Plant, facility and equipment planning has

occurred including risk analysis and manufacturing feasibility including

capacity planning (7.1.3.1)

有工厂、设施、设备的规划，包括风险分析和制造可行性，以及产能

规划（7.1.3.1）

Evidence that expanded expectations regarding Calibration/

verification records have been met. (7.1.5.2.1)

对校准/验证记录的期望获得满足的证据。 （7.1.5.2.1）

Evidence of Organizational Knowledge (7.1.6) management.

组织知识（7.1.6）管理的证据。

Evidence that Internal Auditors competency requirements are

captured within the QMS and implemented. (7.2.3)

内审员能力要求在质量管理体系中得到体现和实施的证据。 （7.2.3）

Evidence that Second party Auditor competency requirements are

satisfied. (7.2.4)

二方审核员能力要求在质量管理体系中得到体现和实施的证据

（7.2.4）

Evidence that documentation is available related to Employee

awareness , Motivation and empowerment (7.3.1 & 7.3.2)

与员工意识，激励和授权有关的文件的可获得性（7.3.1和7.3.2）

Evidence that a document was created to cross reference coverage of

applicable customer specific requirements within QMS. (7.5.1.1d)

有书面的文件在QMS内交叉参考适用的顾客特定要求。 （7.5.1.1d）

Evidence that expanded manufacturing feasibility analysis

requirements are being met. (8.2.3.1.3)

制造可行性分析要求被满足的证据。 （8.2.3.1.3）

The design and development process (applies to product and

manufacturing process design) shall be documented. (8.3.1.1)

设计和开发过程（适用于产品和制造过程设计）应形成文件。

（8.3.1.1）

Evidence that the expanded criteria for design and development

planning has been incorporated within the organizations approach

(8.3.2.1)

设计和开发策划的准则已纳入组织方法（8.3.2.1）

Evidence that the organization utilizes an appropriate process for

quality assurance related to products with internally developed

embedded software. (8.3.2.3)

组织利用适当的过程对带有内部开发的嵌入式软件的产品进行质量保

证的证据。 （8.3.2.3）

问题/要求参考文件（名称/版本）或者记录Evidence that the expanded criteria for product design inputs has

been incorporated within the organizations approach (8.3.3.1)

产品设计输入的准则已融入组织的过程的证据（8.3.3.1）

Evidence that the expanded criteria for manufacturing process

design inputs has been incorporated within the organizations

approach (8.3.3.2)

制造过程设计输入的准则已融入组织的过程的证据（8.3.3.2）

Evidence that the process for managing special characteristics has

been documented and implemented. (8.3.3.3)

特殊特性管理过程已形成文件并和实施的证据。 （8.3.3.3）

Evidence that the expanded criteria for design and development

outputs has been incorporated within the organizations approach

(8.3.5.1)

设计和开发输出准则已融入组织的方法（8.3.5.1）

Evidence that the expanded criteria for manufacturing process

design outputs has been incorporated within the organizations

approach (8.3.5.2)

制造过程设计输出已融入组织的方法（8.3.5.2）

Evidence that the expanded criteria for managing design and

development changes has been incorporated within the

organizations approach (8.3.6)

设计和开发更改的管理准则已纳入组织方法的证据（8.3.6）

Evidence that a documented supplier selection process has been

defined and implemented. (8.4.1.2)

已经确定并实施了文件化的供应商选择过程的证据。 （8.4.1.2）

Evidence that a documented process for outsource process control

has been defined and implemented. (8.4.2.1) (What are the

outsourced processes and how are they controlled?)

已经定义和实施了外包过程控制的文件化过程的证据。 （8.4.2.1）

（什么是外包过程，它们是如何控制的？）

Evidence that a documented process for meeting statutory and

regulatory requirements has been defined and implemented.

(8.4.2.2)

已经确定并实施了符合法律法规要求的书面过程的证据。 （8.4.2.2）

Evidence that the organization requires suppliers of embedded

software to implement and maintain a process for software quality

assurance for their products. (8.4.2.3.1)

组织要求嵌入式软件供应商实施和维护其产品的质量保证过程的证据

。 （8.4.2.3.1）

Evidence that the process for supplier monitoring has been

documented. (8.4.2.4)

供应商监控过程已形成文件的证据。 （8.4.2.4）

Evidence that the organization utilizes an appropriate second party

audit approach within its supplier management process. (8.4.2.4.1)

组织在其供应商管理过程中采用适当的第二方审核方法的证据。

（8.4.2.4.1）

Evidence that supplier development activities and expectations are

determined based on performance and risk. (8.4.2.5)

基于绩效和风险确定供应商开发活动和预期的证据。 （8.4.2.5）

Is there evidence that key information is being cascaded down the

supply chain to point of manufacture (8.4.3.1)

是否有证据表明关键信息是从供应链级联到制造点（8.4.3.1）

问题/要求参考文件（名称/版本）或者记录Evidence that the expanded criteria for control of production and

service provision has been incorporated within the organizations

approach (8.5.1).

是否有证据表明生产和服务的控制准则已融入组织的方法（8.5.1）

Evidence that the expanded criteria for control plans has been

incorporated within the organizations approach (8.5.1.1)

控制计划制定准则已纳入组织办法（8.5.1.1）

Evidence that the elevated criteria for Verification of job set-ups has

been incorporated within the organizations approach (8.5.1.3)

作业准备验证已纳入组织的做方法的证据（8.5.1.3）

Evidence that the new requirement of Verification after shutdown

has been implemented. (8.5.1.4)

停机验证的新要求已经实施的证据。 （8.5.1.4）

Evidence that the expanded criteria for Total productive

maintenance has been incorporated within the organizations

approach (8.5.1.5).

设备的总的预期维护已融入组织的方法的证据（8.5.1.5）。

Evidence that the Production scheduling activities include the added

relevant planning information (8.5.1.7)

生产计划活动包括补充策划信息的证据（8.5.1.7）

Evidence of robust identification and traceability practices to

support industry requirements. Includes analysis of requirements and

traceability plans developed based on risk. (8.5.2.1)

强大的标识和可追溯性支持行业要求的证据。 包括基于风险制定的需

求分析和可追溯性计划。 （8.5.2.1）

Evidence that the expanded criteria for control of changes has been

incorporated within the organizations approach (8.5.6.1)

更改控制的准则已融入组织方法的证据（8.5.6.1）

Evidence of implementation related to Temporary change of process

controls within the quality management system (8.5.6.1.1)

在质量管理体系内过程控制的临时变化有关的实施证据（8.5.6.1.1）

Evidence of Statutory and regulatory conformity for externally

provided processes, products and services in country of manufacture

and destination (8.6.5).

制造国和目的地国的外部提供的过程，产品和服务的法律法规合规性

证据（8.6.5）。

Evidence that the expanded criteria for control of reworked product

has been incorporated within the organizations approach (8.7.1.4).

返工产品控制准则已融入组织方法（8.7.1.4）的证据。

Evidence that the expanded criteria for control of repaired product

has been incorporated within the organizations approach (8.7.1.4).

返修产品控制准则已融入组织方法（8.7.1.4）的证据。

Evidence that the expanded criteria for Nonconforming product

disposition has been incorporated within the organizations approach

(8.7.1.7).

不合格产品处置准则已融入组织方法（8.7.1.7）的证据。

Evidence that Customer satisfaction indicators include a focus on

warranty and periodic monitoring (9.1.2.1)

顾客满意度指标包括专注于保修和定期监控的证据（9.1.2.1）

问题/要求参考文件（名称/版本）或者记录Evidence that Analysis and evaluation additional expectations are

being met (9.1.3 & 9.1.3.1)

满足分析和评估额外预期的证据（9.1.3和9.1.3.1）

Evidence that the Internal Audit Programme follows a risk based

approach for the entire organization and has been updated to consider

new specific requirements. (9.2.2)

内审策划基于整个组织的风险分析的方法并已更新以考虑新的特殊要

求的证据。 （9.2.2）

Evidence that the expanded criteria for Management review has

been incorporated within the organizations approach (9.3).

管理评审已融入组织方法（9.3）的证据。

Evidence that the expanded criteria for Problem solving has been

incorporated within the organizations approach (10.2.3).

解决问题准则已融入组织方法（10.2.3）的证据。

Evidence that the expanded criteria for Error proofing application and

control has been incorporated within the organizations approach

(10.2.4).

防错应用和控制准则已融入组织方法（10.2.4）的证据。

Evidence that the new criteria for Warranty management systems

has been incorporated within the organizations approach (10.2.5).

有关保修管理系统的新准则已融入组织方法（10.2.5）的证据。

Evidence that the new criteria for Customer complaints and field

failure analysis (embedded software) has been incorporated within

the organizations approach (10.2.6).

有关顾客投诉和现场失效分析（嵌入式软件）的新准则已融入组织方

法（10.2.6）的证据。

Evidence that Continual Improvement additional expectations are

being met (10.3.1)

持续改进的额外期望得到满足的证据（10.3.1）