API Spec Q1第九版增补二发布，2019年6月1日起开始执行

 

Addendum 2

增补2

Page 3, the following definition shall be added:

3.1.22

supply chain

Suppliers and associated sub-supplier(s) required for product realization.

第3页，增加以下定义：

3.1.22

供应链 产品实现所需的供应商和相关子供应商。

Page 11, Section 5.4.3, bullet d) shall be replaced with the following:

d) include identification of, or reference to, products, components and/or activities

deemed critical to the design;

第11页，5.4.3章节，d)部分被替换为：

d) 包括对设计至关重要的产品、部件和/或活动的识别或引用；

Page 11, Section 5.4.3, the NOTE shall be replaced with the following:

NOTE Identification of criticality of products, components, and/or activities can be

maintained outside of the design and development process.

第11页，5.4.3章节，注释部分被替换为：

注：对产品、部件和/或活动的关键性的识别可在设计与开发过程之外加以保持。

Page 12, Section 5.6.1.1 shall be replaced with the following:

The organization shall maintain a documented procedure to ensure that purchased products,

components or activities conform to specified requirements.

The procedure shall address:

a) identification of critical products, components or activities;

b) initial evaluation and selection of suppliers based on their ability to supply products

components or activities in accordance with the organization‘s requirements (see 5.6.1.2 and

5.6.1.3);

c) type and extent of control applied to the supply chain for critical products, components or

activities;

NOTE Section 5.6.1.6 contains additional requirements for outsourced activities.

d) criteria, scope, frequency, and methods for reassessment of suppliers; and

e) maintaining a list of approved suppliers and scope of approval.

第12页，5.6.1.1章节被替换为：

组织应保持文件化的程序，以确保采购产品、部件或活动符合规定的要求。

程序应：

a) 对关键产品、部件或活动的识别；

b) 对供方的初次评审和选择基于其依据组织要求提供产品、部件或活动的能力（见5.6.1.2和

5.6.1.3）；

c) 基于产品、部件或活动的重要性对供应链采取的控制的类型和程度；

d) 重新评审供方的准则、范围、频率和方法；

e) 保持合格供方名单和批准的供货范围。

Pages 12 and 13, Section 5.6.1.2 shall be replaced with the following:

For purchase of critical products, components or activities, the initial evaluation of suppliers by

the organization shall be site-specific for each supplier and shall include the following:

a) verification that the supplier’s quality management system conforms to the quality system

requirements specified for suppliers by the organization;

b) verification of the type and extent of control applied by the supplier, internally and to their

supply chain, in order to meet the organization’s requirements; and

c) assessment of the supplier to ensure its capability to meet the organization’s specified

requirements by one or more of the following:

1) performing an on-site evaluation of relevant activities, or

2) performing first article (see 3.1.11) inspection to ensure conformance to stated

requirements, or

3) identifying how the supplied product, component or activity conforms to stated

requirements when limited by proprietary, legal, and/or contractual arrangements.

第12和13页，5.6.1.2章节被替换为：

对于关键产品、部件或活动的采购，组织对供方的初次评审应针对每个供应商具体确定，

应包括如下内容：

a） 验证供方的质量管理体系符合组织规定的供方的质量体系的要求

b）验证供应商内部和供应链中应用的控制类型和程度，以满足组织的要求;

c） 通过以下一点或几点评估供方，确保其有能力满足组织的采购要求：

1) 对相关活动实施现场评审；或

2) 实施首件检验（见3.1.11），确保符合规定的要求；或

3) 在专利、法律法规和/或合同条款限制时，确定所供产品、部件或活动如何满足规定的

要求。

Page 13, Section 5.6.1.3, bullet c) shall be replaced with the following:

c) assessment of the product or component upon delivery, or activity upon completion.

第13页，章节5.6.1.3，c）部分被替换为：

c) 评估交付的产品或部件，或完成的活动。

Page 13, Section 5.6.1.4, shall be replaced with the following:

The organization shall determine the supplier reevaluation frequency based on supplier risk and

supplier quality performance.

For the reevaluation of suppliers of critical products, components or activities, the requirements of

5.6.1.2 shall apply.

For the reevaluation of suppliers of noncritical products, components or activities, the

requirements of 5.6.1.3 shall apply.

第13页，章节5.6.1.4被替换为：

组织应根据供应商风险和供应商质量表现确定供应商复评频率。

对关键产品、部件或活动的供方的复评要求按5.6.1.2执行。

对非关键产品、部件或活动的供方的复评要求按5.6.1.3执行。

Page 13, Section 5.6.1.6, the following note shall be added after the first paragraph:

NOTE See 5.7.1.5 for requirements when a process requiring validation is outsourced within

the supply chain.

第13页，章节5.6.1.6, 第一段后应加上以下注释：

注：当要求确认的过程外包给供应链时，参阅5.7.1.5。

Page 14, Section 5.6.2, the following note shall be added at the end of the section:

NOTE Applicable specifications may include or be derived from the customer, API product

specifications, design output, and/or industry standards.

第14页，章节5.6.2，本节末尾应加上以下注释：

注：适用的规范可包括API产品规范、设计输出和/或行业标准，也可来自客户

Page 14, Section 5.6.3, the first paragraph shall be replaced with the following:

The organization shall maintain a documented procedure defining the verification or other

activities necessary for ensuring that purchased products, components or activities meet

specified purchase requirements.

第14页，章节5.6.3，第一段被替换为：

组织应保持验证或其它必要活动的文件化程序，以确保采购产品、部件或活动满足规定的

采购要求。

Page 14, Section 5.6.3, the following shall be inserted after the first paragraph:

For critical products, components or activities, the procedure shall include the following :

a) review of the organization’s required documentation from the supplier; and

b) verification that the applicable versions were used when specifications, drawings, process

requirements, inspection instructions, traceability, and other relevant technical data are

specified per 5.6.2. b).

Additionally for critical products and components, the procedure shall include requirements for the

testing or inspection methods, frequency and responsible party for these activities. The

requirements shall be based on risk associated with supplier product quality.

第14页，章节5.6.3，第一段后插入下列内容：

对于关键产品、部件或活动，程序应包括以下内容：

a） 对组织要求的供应商文件化信息的评审；

b） 当规范、图纸、过程要求、检验说明、可追溯性以及其他相关技术数据在5.6.2. b)中规定时，

验证适用的版本是否被使用。

此外，对于关键产品和部件，程序应包括测试要求或检查方法、频率以及这些活动的责任方。

要求应基于与供应商产品质量相关的风险。

Page 15, Section 5.7.1.5, the last sentence of the first paragraph shall be replaced with the

following:

Where an organization chooses to outsource a process that requires validation, the organization

shall require that the supply chain conform to these requirements (see 5.6.1.6).

第15页，章节5.7.1.5，第一段的最后一句用以下内容替换：

组织如果选择将要求确认的过程外包，应要求供应链符合这些要求（见5.6.1.6）

Page 16, Section 5.7.1.5, the last paragraph shall be replaced with the following:

The organization shall validate those processes identified by the applicable product specification

as requiring validation. If these processes are not identified, or there is no product specification

involved, the processes requiring validation (if applicable to the product) shall include, as a

minimum:

g) nondestructive examination;

h) welding;

i)heat treating; and

j)coating and plating (when identified as critical to product performance by product

specification or the organization).

第16页，章节5.7.1.5，最后一段被替换为：

组织应按要求验证适用的产品规范，确认所识别的过程。如果过程未被识别，或者

不涉及任何产品规范，要求确认的过程至少应包括（产品适用）：

g）无损检测；

h）焊接；

i）热处理；和

j）涂装和电镀（当产品规范或组织认为为对产品性能至关重要时）

Page 20, Section 5.11.2, bullet c) shall be replaced with the following:

c） changes in suppliers of critical products, components or activities (see 5.6.1.1); and/or

第20页，章节5.11.2  c）部分被替换为：

c）关键产品、部件或活动的供方的变更（见5.6.11）；和/或

Page 22, Section 6.4.2, the first sentence of the first paragraph shall be replaced with the

following:

The organization shall maintain a documented procedure to correct nonconformities and to take

corrective actions, both internally and with suppliers, to eliminate the causes of nonconformities in order to minimize the likelihood of its recurrence.

第22页，章节6.4.2，第一段的第一句被替换为：

组织应保持文件化的程序，在内部和供应商内纠正不符合项和采取纠正措施，消除不符合的原因以

尽可能降低其再次出现的可能性。

Page 23, Section 6.4.3, the first sentence of the first paragraph shall be replaced with the following:The organization shall maintain a documented procedure to determine and implement preventive actions, both internally and with suppliers, to eliminate the causes of potential nonconformities in order to minimize the likelihood of their occurrence.

第23页，章节6.4.3，第一段的第一句被替换为：

组织应保持文件化的程序，在内部和供应商内制定和实施预防措施，消除潜在不符合的产生以尽可能降低其再次发生的可能性。