E15.02 Effective FMEA
FMEA's (Failure Mode and Effect Analysis) should be performed according industry standards.
Both Design and Process FMEA's are living documents that need to be updated based on engineering changes or reported non-conformities. Sufficient data sources should be consulted to come to effective FMEA deployment. 应根据行业标准进行FMEA（失效模式和效果分析）。设计和过程 FMEA 是生活文件需要更新基于工程变更或报告不合格。应该咨询足够数据源来有效FMEA部署。
FMEA's documents should: FMEA 的文档应︰
a) Be under document control. a）能控制文档。
b) Contain: Failure Modes, effects b）包含︰失效模式，影响
c) Quantify the risk(s) c）量化风险
d) Define thresholds for action planning. d）定义阈值的行动规划。
e) Indicate residual risk(s) after completion of improvement actions. e）表明改进行动完成后的残余风险。
P01.01 Competence for key personnel
Operators who perform key tasks should have the right competences to perform their job. They must have sufficient education, training and experience. Key tasks are known. Succession plans for key personnel are in place. 经营者执行关键任务应该有正确的权限来执行他们的工作。他们必须有足够的教育、培训和经验。已知的关键任务。继任计划关键人员已经到位。
P01.03 Sufficient number of qualified people is available
Sufficient number of people should be available, qualified for the job, to realize the planned quantities足够数量应该是人的可用的胜任这项工作，实现计划的数量
P01.05 Skilled workforce
It is important that work experience of operators is documented. The training status for products and processes should be readily available at the workplace to let the operator decide if additional qualifications are needed. If "Skill Matrixes" are used they should show: 它是重要的经营者的工作经验记录。产品和过程的训练状态应该在工作场所，让操作者决定是否需要额外的资历随时可用。如果使用了"技能矩阵"他们应表明︰
- Operators (ID) and the jobs/operations they are qualified for符(ID)和他们有资格做作业/行动
- Expiring dates过期日期
- Experience status of operators (in training, untrained, skilled, trainer) -经验操作员（培训，未经训，技术熟练，教练） 的状态
- Document control (doc number, approvals) -文档控制 （doc 号批准）
- Record retention of obsolete documentation-记录保留过时的文件
- Reference to the ruling procedures in the Quality Management System-对质量管理体系中的裁决程序的引用
P02.02 Product/Processes changes are approved prior production.
Before parts can be produced under "series"-conditions both parts and the production process need to be accepted by the production function by means of verification and where applicable validation. 下"系列"能够产生部分之前-条件部分和生产过程需要由生产函数接受通过核查和地方适用的验证。
P02.03 Engineering Change Process
Production parts and products are subject to engineering changes during their life cycle. This must be a controlled process, taking into account: production phase, severity of the change, cost of change, trace ability where applicable生产的零件和成品都在其生命周期中工程更改。这必须是一个控制的过程，考虑到︰生产阶段、病情严重程度的变化，成本的变化，跟踪能力，在适用的情况
P03.01 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions. 组织应规划并进行生产和控制的条件下提供服务。
Controlled conditions shall include, as applicable, 控的条件应包括，如适用，
a) the availability of information that describes the characteristics of the product, a）描述产品特性的信息的可用性
b) the availability of work instructions, as necessary, )必要时，获得作业指导书，
c) the use of suitable equipment, c)使用适当的设备，
d) the availability and use of monitoring and measuring equipment, d）可用性和使用监视和测量设备，
e) the implementation of monitoring and measurement, and）实施监视和测量，和
f) the implementation of product release, delivery and post-delivery activities f）产品的放行、交付和交付后活动的实施