SAE AS 9101D-2010：航空航天与国防质量管理体系审核标准

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"SAE AS 9101D-2010.pdf 是一份由美国SAE（Society of Automotive Engineers）技术标准委员会发布的关于航空、航天和国防组织的质量管理体系审核要求的文档。该标准旨在提升技术与工程科学的发展水平，其使用完全基于自愿原则，用户需自行承担适用性、专利侵权等可能产生的责任。SAE会每五年对这份技术报告进行一次审查，可能进行确认、修订或取消。SAE欢迎书面的反馈和建议。文档的版权归2010年SAE International所有，未经许可，不得以任何形式复制、存储、传播。如需订购文档，可联系SAE提供的电话、传真或电子邮件。" 《SAE AS 9101D-2010》是航空航天行业质量管理的重要参考标准，它详细规定了在设计、开发、生产、安装和服务过程中，质量管理体系的审计要求。这份标准对于确保航空航天产品的质量和安全至关重要，因为它帮助组织建立和维护一套高效的质量管理系统，以满足行业内的严格要求和标准。该标准涵盖了以下关键知识点： 1. **质量管理原则**：SAE AS 9101D遵循ISO 9001的基本原则，包括客户关注、领导力、人员参与、过程方法、系统方法、持续改进、基于事实的决策和关系管理。 2. **审计流程**：标准定义了质量管理体系审核的步骤，包括审计计划、审计团队的组建、审计准备、现场审计活动、审计报告编写、不符合项的处理以及后续行动的跟踪。 3. **审计员资质**：对审核员的专业知识、技能和行为准则进行了规定，确保他们具备足够的能力和独立性来执行有效的质量管理体系审核。 4. **风险管理**：强调了在整个供应链中识别、评估和控制风险的重要性，以防止潜在的质量问题和缺陷。 5. **合规性**：要求组织必须符合所有适用的法规、行业标准和合同要求，以确保产品和服务的合法性和合规性。 6. **持续改进**：鼓励组织通过定期的内部审计和管理评审，不断优化其质量管理体系，以提高效率和有效性。 7. **记录管理**：规定了质量记录的创建、维护、存储和销毁的程序，确保记录的准确性和可追溯性。 8. **供应商管理**：强调了对供应商的质量要求和绩效评估，以确保供应链的稳定性和可靠性。 9. **顾客满意度**：要求组织收集并分析顾客反馈，以了解客户需求和期望，从而改进产品和服务。 10. **纠正和预防措施**：规定了如何对发现的问题采取纠正措施，并防止类似问题的再次发生。通过遵循SAE AS 9101D标准，航空航天组织能够确保其质量管理体系的健全性，提高产品质量，降低风险，并增强客户信任。同时，该标准也促进了组织间的互认，降低了重复审核的成本，提高了行业的整体竞争力。

SAE AS9101D Page 13 of 24

4.2 Common Audit Activities

4.2.1 Audit Planning

[ISO/IEC 17021 clauses 9.1.2 and 9.1.3; ISO 19011 clause 6.4.1]

The audit team shall be appointed before the audit.

The audit planning should take into account:

a) the scope and complexity of the organization's quality management system;

b) the processes of the organization, including their sequence and interactions;

c) the criticality of products and processes, including special processes;

d) product related safety issues (e.g., airworthiness issues, reporting to customer and/or authorities);

e) results of internal audits;

f) previous audit findings;

g) performance measures and trends for quality and OTD;

h) previous management review results;

i) customer satisfaction and complaints log, including feedback requests received by the CB (e.g., items identified

through OASIS feedback process);

j) customer specific, statutory, and regulatory quality management system requirements;

k) performance data available from customers;

l) changes to organization (e.g., structure; facilities; business strategy; processes; technologies; a review of

requirements from new aviation, space, and defense customers); and

m) the audit team member’s required background/experience and desired competencies.

The audit team leader shall use the organization’s customer feedback requests, including those received through OASIS,

to assist with audit planning for surveillance and recertification audits. The audit activities shall be prioritized based upon

performance data for business risks that can impact the customer (i.e., customer concerns, customer special statuses)

and on low performing processes.

As an input into the audit planning process, the audit team leader shall obtain information from the organization regarding

their customers on the proportion of aviation, space, and defense business each customer represents, based on their

approximate percentage of business. The audit team leader shall ensure that the amount of audit time planned on

auditing any one customer’s specific quality management system requirements is consistent (approximately) with the

proportion of aviation, space, and defense business each customer represents (e.g., customer X may only have 20% of

the business so do not spend 80% of the time verifying customer X's specific quality management system requirements).

NOTE: The need to use translators can impact the audit plan/planning and defined audit duration.

Author:Gilligan-SID:9234-GUID:39571924-155.69.4.4

SAE AS9101D Page 14 of 24

4.2.2 On-site Audits

[ISO/IEC 17021 clause 9.1.9]

4.2.2.1 General

Each on-site audit, except for nonconformity follow-up (see clause 4.2.4) and special audits (see clause 4.3.6) shall

include the following, as applicable:

a) a review of the changes to the quality management system, since the last audit;

b) a review of requirements from new aviation, space, and defense customers, since the last audit;

c) a review of customer satisfaction information and requested corrective actions and associated responses;

d) an interview with top management (see clause 4.1.2.2);

e) an audit of the quality management system performance and effectiveness (see clause 4.1.2.3);

f) an audit of the organization’s processes (their performance and effectiveness, see clauses 4.1.2.4 and 4.1.2.5), as

identified in the audit plan (see clause 4.2.1);

g) an audit of the continual improvement of the quality management system (see clause 4.1.2.6);

h) an audit of special processes (see clause 4.2.2.8), as identified in the audit plan (see clause 4.2.1);

i) an audit of follow-up actions from previous audits.

During the audit, the use of relevant audit methods, as described in clause 4.1.2, shall be considered.

NOTE: If there is more than one surveillance audit during a year (e.g., every six months), the activities and items

mentioned above can be spread over these audits.

4.2.2.2 Opening Meeting

[ISO 19011 clause 6.5.1]

The opening meeting shall be conducted by the audit team leader. Attendance to the opening meeting shall be recorded.

In addition to the criteria mentioned in ISO 19011, the following items shall be addressed, as applicable:

a) introduce the participants, purpose, and roles of Accreditation Body (AB), Other Party (OP) assessors, or National

Aviation Authorities (NAAs), if the certification audit is subject to a witness audit activity;

b) confirmation of the status of nonconformities from the previous review or audit; and

c) reconfirmation of any access restrictions for security reasons.

4.2.2.3 Site Tour

The audit team leader may conduct a site tour to address any changes in scope or facilities since the last visit, or to

familiarize audit team members with the organizations’ activities.

Author:Gilligan-SID:9234-GUID:39571924-155.69.4.4

SAE AS9101D Page 15 of 24

4.2.2.4 Audit Conduct

[ISO 19011 clause 6.5.2]

The audit should be conducted through the use of various auditing methods (see clause 4.1.2), as defined by the audit

plan. Furthermore, the audit team should pursue relevant audit trails to assist in the determination of quality management

system conformity and effectiveness.

Objective evidence on audit findings shall be recorded in accordance with clause 4.2.2.5.

4.2.2.5 Identifying and Recording of Audit Findings

[ISO/IEC 17021 clauses 9.2, 9.3, and 9.4; ISO 19011 clause 6.5.5]

The audit team shall record detailed objective evidence (e.g., reviewed procedures, shop orders, training records,

products, verification records). The objective evidence shall be recorded on a standardized form [i.e., OER (see

Appendix A)] or on the CB’s own documentation. In this case, the CB document shall meet the intent of the OER. The

completed form(s) shall be included in the audit records maintained by the CB.

NOTE 1: Population of the OER may start during the Stage 1 audit to record the documents reviewed.

NOTE 2: If clause 7 of the 9100-series standards and its’ sub-clauses are associated with processes that are addressed

by PEARs, the objective evidence is only required to be documented on the PEAR. In such case, the PEAR

number should be referenced in the OER.

In addition to recording conformity/nonconformity, the audit team may identify opportunities for improvement.

The NCR (see Appendix B) shall be used to record nonconformities; each NCR shall contain only one nonconformity.

When nonconformities are identified, the audit team shall categorize the nonconformity as ‘major’ or ’minor’, according to

the definitions provided in this standard. The need for containment in accordance with the organization’s corrective action

process shall be reviewed by the audit team.

Recurrence of the same or similar nonconformity found during consecutive audits at a particular site/location shall be

considered as a failure of the corrective action process (see 9100-series standards clause 8.5.2) and shall result in a

major nonconformity being issued.

NOTE 3: If there is no evidence of non-fulfillment of a requirement, the auditor cannot issue a nonconformity. If the

auditor found evidence of non-fulfillment of a requirement, the auditor determines the nonconformity

classification (major/minor). Soft grading of nonconformities and/or identifying them as an observation,

opportunity for improvement, or recommendation does not benefit the organization, its customers, or the CB.

Furthermore, there is risk that the nonconformity be given a lower priority for correction and/or corrective action

or that no action will be taken, and the conditions will expand and/or continue to exist.

The results of effectiveness shall be recorded on the PEAR (see Appendix C) for each audited product realization

process. The level of effectiveness for each recorded process shall be recorded on the PEAR (statement of effectiveness

level). If the level of effectiveness has been classified as a ‘2’ or a ‘1’, this shall result in a nonconformity being issued

against 9100-series standards clauses 4.1.c and f (see clause 4.2.4).

NOTE 4: At the discretion of the auditing organization, other processes can be recorded on a PEAR.

4.2.2.6 Preparing Audit Conclusions

[ISO/IEC 17021 clauses 9.2.4, 9.3, and 9.4; ISO 19011 clause 6.5.6]

Prior to the closing meeting, the audit team shall identify any changes that may be required to the audit program (e.g.,

scope, audit time or timing, surveillance frequency, audit team competence).

Author:Gilligan-SID:9234-GUID:39571924-155.69.4.4

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