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IATF16949认证要求修订认可解释SI12-13

IATF16949认证要求修订认可解释SI12-5.1.1.2 Process effectiveness and efficiency过程有效性和效率

Top management shall review the product realization processes effectiveness and efficiency of the quality management system and support processes to evaluate and improve their effectiveness and efficiency the organization’s quality management system. The results of the process review activities shall be included as input to the management review (see Section 9.3.2.1.).

高层管理人员应审查 产品实现过程和质量管理体系的有效性和效率并支持过程以评估和提高组织质量管理体系的有效性和效率 。过程审查活动的结果应作为管理审查的输入(见第9.3.2.1节)。

Rationale for change改变原理:
Clarified that not every process requires an efficiency measure. The organization needs to determine which processes require efficiency measures within their quality management system. Additionally, the organization’s problem-solving processes need to have an effectiveness review conducted by the organization’s management.

阐明并不是每个过程都需要效率测度。组织需要确定在他们的质量管理体系中哪些过程需要效率测度。此外,组织的问题解决过程需要由组织的管理人员进行有效性审查。

IATF16949认证要求修订认可解释SI13-9.3.2.1 Management review inputs – supplemental管理评审输入-补充

Input to management review shall include:
a) cost of poor quality (cost of internal and external nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency for product realization processes, as applicable;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001, Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment.

管理评审的输入应包括:
a) 不良质量成本 (内部和外部不符合的成本);
b) 过程有效性的测量;
c) 产品实现过程的过程效率测度, 如适用;
d) 产品符合性;
e) 对变更现有业务和新设施或新产品的制造可行性进行评估(见第7.1.3.1节);;
f) 客户满意度(见ISO 9001,第9.1.2节);;
g) 根据维护目标审查绩效;
h) 保修绩效 (如适用);
i) 审查客户记分卡 (如适用);
j) 通过风险分析(如FMEA)识别潜在的现场故障;
k) 实际现场故障及其对安全或环境的影响。

Rationale for change改变原理:
Clarified that not every process requires an efficiency measure. The organization needs to determine which processes require efficiency measures within their quality management system.

阐明并不是每个过程都需要效率测度。组织需要确定在他们的质量管理体系中哪些过程需要效率测度。

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