质量管理体系审核技巧

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现场审核

现场审核是使用抽样检查的方法寻找客观证据的过程。

现场审核的原则

坚持以“客观证据”为依据的原则

坚持独立、公正的原则。

坚持“三要三不要”原则

客观证据的收集

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On site audit

On site audit is a process of using sampling inspection to find objective evidence.

Principles of on-site audit

Adhere to the principle of "objective evidence" as the basis

Adhere to the principle of independence and impartiality.

Adhere to the principle of "three demands and three don'ts"

Collection of objective evidence

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现场审核记录

在提问、验证、观察中，审核员应作好记录，记下审核中听到、看到的有用的真实信息，这些记录是审核员提出报告的真凭实据。

审核发现

对所收集到的客观证据应进行整理、分析、筛选，在此基础上得出审核证据与审核发现 。

当发现不合格项时，应与受审核方的代表就不合格项进行确认，双方应力求解决有关事实存在的意见分歧，未能达成一致的意见应予以记录。

面谈技巧

一次成功的面谈，有利于建立融洽关系，消除心理障碍；有助于争取受审核方人员的合作，有助于查明情况，获取需要的客观证据。

在面谈时审核员应掌握的技巧有：

a.得当的提问；

b.要少说，要多听；

c.保持融洽的关系；

d.选择适当的面谈对象。

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On site audit records

During questioning, verification and observation, the auditor shall keep records of useful and true information heard and seen during the audit. These records are the true evidence for the auditor to submit the report.

Audit findings

The collected objective evidence shall be sorted, analyzed and screened, and audit evidence and audit findings shall be obtained on this basis.

When nonconforming items are found, they shall be confirmed with the representative of the auditee. Both parties shall strive to resolve differences of opinion on relevant facts, and the opinions that fail to reach an agreement shall be recorded.

Interview skills

A successful interview is conducive to establishing a harmonious relationship and eliminating psychological barriers; It is helpful to win the cooperation of the auditee's personnel, identify the situation and obtain the necessary objective evidence.

During the interview, the auditor should master the following skills:

a. Proper questions;

b. Speak less and listen more;

c. Maintain a harmonious relationship;

d. Select the appropriate interview object.

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不合格项的含义：

审核所述的不合格项是指“未满足规定的要求”。这里的规定要求主要有：

(1)标准要求(如ISO9001标准要求)。

(2)文件规定(包括质量手册、程序文件、质量记录和质量计划或技术性文件和管理性文件)。

(3)合同规定(与顾客签订的销售合同，与供方签订的采购合同等)。

(4)社会要求(包括法律、法规、法令、条例、规章规则以及环境保护、健康 安全、能源和自然资源的保护等应承担的义务)。

(5)其他规定，如最高管理者的要求，常识性要求(不一定形成文件)。

(6)顾客投诉。

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Meaning of nonconformities:

The nonconformities mentioned in the audit refer to "failure to meet the specified requirements". The requirements here mainly include:

(1) Standard requirements (such as ISO9001 standard requirements).

(2) Document regulations (including quality manual, procedure documents, quality records and quality plans or technical documents and management documents).

(3) Contract provisions (sales contracts signed with customers, purchase contracts signed with suppliers, etc.).

(4) Social requirements (including the obligations to be undertaken by laws, regulations, decrees, ordinances, rules and regulations, as well as environmental protection, health and safety, energy and natural resources protection, etc.).

(5) Other regulations, such as the requirements of top management and common sense requirements (not necessarily documented).

(6) Customer complaints.

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不合格项的分级与评定

内部质量管理体系内部审核可按严重性分成严重不合格、一般不合格、轻微不合格、观察项四级：

(1)严重不合格项

严重不合格通常是指系统性失效或缺陷。主要判断标准有：

①质量管理体系与约定的质量管理体系标准或文件的要求严重不符。如关键的控制程序没有得到贯彻，缺少标准规定的要求等。

②造成系统性失效的不合格(可能需要由多个一般不合格去说明)。如在用测量监控设备大部分未按周期进行校准(检定)，不合格品的处置大部分未按规定要求进行评审和记录等。

③造成区域性失效的不合格(可能需要由多个一般不合格去说明)。如某组织质量管 理体系未 覆盖到应实施的某组织单元或该组织单元根本未按标准要求组织实施，质量管理体系覆盖的所有的产品中有某个产品未按标准进行质量控制等。

④可造成严重后果的不合格项。如压力容器的焊接达不到规定要求，家用电器没有进行绝缘、耐压试验，按错误的图纸进行加工等，这些都直接危及到产品、人身安全，或会给组织带来重大经济损失，严重损害组织声誉。

⑤违反法律、法规的不合格项。

(2)一般不合格项

一般不合格项判断标准：

①不是偶然的，明显不符合文件要求的不合格项。如有部分采购合同未进行评审，检验员职责不明确。

②直接影响产品质量的不合格项。如几台检测设备超过校准周期，未按规定进行首检自检。

③造成质量活动失效的不合格项。如质量控制点没有针对关键质量特性或工序支配因素进行控制等。

(3)轻微不合格项

轻微不合格项是指孤立的、偶发性的、并对产品质量无直接影响的问题。如卷宗里有一 张图或一份文件的版次不是最新的，某一份文件没有标明日期，用词不准确，签字不符合要求等。

(4)观察项

对不合格项进行分级，在有些情况下会成为一件困难的事情，因为其界线很难准确划定。这种区分往往取决于审核组长和审核员的经验和技巧。有时候会出现一种类似不合格项的报告称为“观察项”。出现“观察项”的情况主要有：

①证据稍不足，但存在问题，需提醒的事项。

②已发现问题，但尚不能构成不合格，如发展下去就有可能构成为不合格的事项。

③其他需提醒注意的事项。

观察项报告不属于不合格报告，也不列入最后的审核报告中去。“观察项”的设置无疑 为审 核方和受审核方各准备了一个台阶，对于缓解审核气氛会带来好处。使用得法，对内审有积极意义。

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Classification and evaluation of nonconforming items

The internal audit of the internal quality management system can be divided into four levels by severity: serious nonconformity, general nonconformity, minor nonconformity and observation:

(1) Serious nonconformities

Serious nonconformity usually refers to systematic failure or defect. The main criteria are:

① The quality management system is seriously inconsistent with the agreed quality management system standards or documents. For example, the key control procedures are not implemented, and the requirements specified in the standards are lacking.

② Nonconformities that cause systematic failure (may be described by several general nonconformities). For example, most of the measuring and monitoring equipment in use are not calibrated (verified) on a regular basis, and most of the disposal of nonconforming products are not reviewed and recorded as required.

③ Nonconformities that cause regional failure (may be described by several general nonconformities). If the quality management system of an organization does not cover an organizational unit that should be implemented, or the organizational unit does not organize the implementation according to the standard requirements at all, and a product in all products covered by the quality management system does not have quality control according to the standard, etc.

④ Nonconformities that may cause serious consequences. If the welding of pressure vessels fails to meet the specified requirements, household appliances are not subject to insulation and withstand voltage tests, or are processed according to wrong drawings, these will directly endanger the safety of products and people, or cause significant economic losses to the organization, and seriously damage the reputation of the organization.

⑤ Nonconformities violating laws and regulations.

(2) General nonconformities

Judgment criteria for general nonconformities:

① Nonconformities that are not accidental and obviously do not meet the requirements of the document. If some purchase contracts are not reviewed, the responsibilities of inspectors are unclear.

② Nonconformities that directly affect product quality. If several testing equipment exceed the calibration cycle, the first inspection and self inspection are not carried out as required.

③ Nonconformities that cause quality activities to fail. For example, the quality control points did not control the key quality characteristics or process control factors.

(3) Minor nonconformities

Minor nonconformities refer to isolated, sporadic problems that have no direct impact on product quality. For example, there is a picture or a document in the file whose version is not up to date, a document is not dated, the wording is inaccurate, and the signature does not meet the requirements.

(4) Observations

In some cases, grading non conformities will become a difficult thing, because it is difficult to accurately delineate their boundaries. This distinction often depends on the experience and skills of the audit team leader and auditors. Sometimes a report of similar nonconformities is called "observation item". The "observation items" mainly include:

① The evidence is a little insufficient, but there are problems.

② Problems have been found, but they cannot constitute nonconformities. If they continue to develop, they may constitute nonconformities.

③ Other matters needing attention.

The observation report does not belong to the non conformity report, nor is it included in the final audit report. The setting of "observation items" undoubtedly provides a step for the approver and the auditee, and will bring benefits to ease the audit atmosphere. Proper use is of positive significance to internal audit.

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末次会议

现场审核结束后应召开末次会议，内审组长主持，审核组全员和受审核部门相关人员参加并签到。

末次会议的主要内容：

a) 重申审核范围、目的和依据；

b) 审核说明；

c) 宣读不合格项报告；

d) 提出纠正措施要求；

e) 宣读审核意见，说明审核报告发布时间、方式及其它后续要求；

f) 审核总结。

末次会议应有记录，并保存。

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Final meeting

The final meeting shall be held after the on-site audit, presided over by the internal audit team leader, and attended and signed in by all members of the audit team and relevant personnel of the audited department.

Main contents of the closing meeting:

a) Reaffirm the audit scope, purpose and basis;

b) Audit description;

c) Read out the nonconformity report;

d) Put forward requirements for corrective measures;

e) Read out the audit opinions, and explain the time, method and other subsequent requirements of the audit report;

f) Audit summary.

The final meeting shall be recorded and kept.