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. 應(yīng)根據(jù)行業(yè)標(biāo)準(zhǔn)進(jìn)行FMEA（失效模式和效果分析）。設(shè)計(jì)和過程 FMEA 是生活文件需要更新基于工程變更或報(bào)告不合格。應(yīng)該咨詢足夠數(shù)據(jù)源來有效FMEA部署。
FMEA's documents should: FMEA 的文檔應(yīng)︰
a) Be under document control. a）能控制文檔。
b) Contain: Failure Modes, effects b）包含︰失效模式，影響
c) Quantify the risk(s) c）量化風(fēng)險(xiǎn)
d) Define thresholds for action planning. d）定義閾值的行動(dòng)規(guī)劃。
e) Indicate residual risk(s) after completion of improvement actions. e）表明改進(jìn)行動(dòng)完成后的殘余風(fēng)險(xiǎn)。
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. 經(jīng)營者執(zhí)行關(guān)鍵任務(wù)應(yīng)該有正確的權(quán)限來執(zhí)行他們的工作。他們必須有足夠的教育、培訓(xùn)和經(jīng)驗(yàn)。已知的關(guān)鍵任務(wù)。繼任計(jì)劃關(guān)鍵人員已經(jīng)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足夠數(shù)量應(yīng)該是人的可用的勝任這項(xiàng)工作，實(shí)現(xiàn)計(jì)劃的數(shù)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: 它是重要的經(jīng)營者的工作經(jīng)驗(yàn)記錄。產(chǎn)品和過程的訓(xùn)練狀態(tài)應(yīng)該在工作場所，讓操作者決定是否需要額外的資歷隨時(shí)可用。如果使用了"技能矩陣"他們應(yīng)表明︰
- Operators (ID) and the jobs/operations they are qualified for符(ID)和他們有資格做作業(yè)/行動(dòng)
- Expiring dates過期日期
- Experience status of operators (in training, untrained, skilled, trainer) -經(jīng)驗(yàn)操作員（培訓(xùn)，未經(jīng)訓(xùn)，技術(shù)熟練，教練） 的狀態(tài)
- Document control (doc number, approvals) -文檔控制 （doc 號批準(zhǔn)）
- Record retention of obsolete documentation-記錄保留過時(shí)的文件
- Reference to the ruling procedures in the Quality Management System-對質(zhì)量管理體系中的裁決程序的引用
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"能夠產(chǎn)生部分之前-條件部分和生產(chǎn)過程需要由生產(chǎn)函數(shù)接受通過核查和地方適用的驗(yàn)證。
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生產(chǎn)的零件和成品都在其生命周期中工程更改。這必須是一個(gè)控制的過程，考慮到︰生產(chǎn)階段、病情嚴(yán)重程度的變化，成本的變化，跟蹤能力，在適用的情況
P03.01 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions. 組織應(yīng)規(guī)劃并進(jìn)行生產(chǎn)和控制的條件下提供服務(wù)。
Controlled conditions shall include, as applicable, 控的條件應(yīng)包括，如適用，
a) the availability of information that describes the characteristics of the product, a）描述產(chǎn)品特性的信息的可用性
b) the availability of work instructions, as necessary, )必要時(shí)，獲得作業(yè)指導(dǎo)書，
c) the use of suitable equipment, c)使用適當(dāng)?shù)脑O(shè)備，
d) the availability and use of monitoring and measuring equipment, d）可用性和使用監(jiān)視和測量設(shè)備，
e) the implementation of monitoring and measurement, and）實(shí)施監(jiān)視和測量，和
f) the implementation of product release, delivery and post-delivery activities f）產(chǎn)品的放行、交付和交付后活動(dòng)的實(shí)施