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. 應根據行業標準進行FMEA（失效模式和效果分析）。設計和過程 FMEA 是生活文件需要更新基于工程變更或報告不合格。應該咨詢足夠數據源來有效FMEA部署。
FMEA's documents should: FMEA 的文檔應︰
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）量化風險
d) Define thresholds for action planning. d）定義閾值的行動規劃。
e) Indicate residual risk(s) after completion of improvement actions. e）表明改進行動完成后的殘余風險。
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. 經營者執行關鍵任務應該有正確的權限來執行他們的工作。他們必須有足夠的教育、培訓和經驗。已知的關鍵任務。繼任計劃關鍵人員已經到位。
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足夠數量應該是人的可用的勝任這項工作，實現計劃的數量
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: 它是重要的經營者的工作經驗記錄。產品和過程的訓練狀態應該在工作場所，讓操作者決定是否需要額外的資歷隨時可用。如果使用了"技能矩陣"他們應表明︰
- Operators (ID) and the jobs/operations they are qualified for符(ID)和他們有資格做作業/行動
- Expiring dates過期日期
- Experience status of operators (in training, untrained, skilled, trainer) -經驗操作員（培訓，未經訓，技術熟練，教練） 的狀態
- Document control (doc number, approvals) -文檔控制 （doc 號批準）
- Record retention of obsolete documentation-記錄保留過時的文件
- Reference to the ruling procedures in the Quality Management System-對質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"能夠產生部分之前-條件部分和生產過程需要由生產函數接受通過核查和地方適用的驗證。
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生產的零件和成品都在其生命周期中工程更改。這必須是一個控制的過程，考慮到︰生產階段、病情嚴重程度的變化，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. 組織應規劃并進行生產和控制的條件下提供服務。
Controlled conditions shall include, as applicable, 控的條件應包括，如適用，
a) the availability of information that describes the characteristics of the product, a）描述產品特性的信息的可用性
b) the availability of work instructions, as necessary, )必要時，獲得作業指導書，
c) the use of suitable equipment, c)使用適當的設備，
d) the availability and use of monitoring and measuring equipment, d）可用性和使用監視和測量設備，
e) the implementation of monitoring and measurement, and）實施監視和測量，和
f) the implementation of product release, delivery and post-delivery activities f）產品的放行、交付和交付后活動的實施