FAQs_2017 PDR Prcoess_10132017
高维缺失数据处理包hdImpute的说明说明书

Package‘hdImpute’August7,2023Type PackageTitle A Batch Process for High Dimensional ImputationVersion0.2.1BugReports https:///pdwaggoner/hdImpute/issuesMaintainer Philip Waggoner<*************************>Description A correlation-based batch process for fast,accurate imputation forhigh dimensional missing data problems via chained random forests.See Waggoner(2023)<doi:10.1007/s00180-023-01325-9>for more on'hdImpute',Stekhoven and Bühlmann(2012)<doi:10.1093/bioinformatics/btr597>for more on'missForest', and Mayer(2022)<https:///mayer79/missRanger>for more on'missRanger'. License MIT+file LICENSEEncoding UTF-8Imports missRanger,plyr,purrr,magrittr,tibble,dplyr,tidyselect,tidyr,cliSuggests testthat(>=3.0.0),knitr,rmarkdown,usethis,missForest,tidyverseVignetteBuilder knitrRoxygenNote7.2.3Config/testthat/edition3URL https:///pdwaggoner/hdImputeNeedsCompilation noAuthor Philip Waggoner[aut,cre]Repository CRANDate/Publication2023-08-0721:20:02UTCR topics documented:check_feature_na (2)check_row_na (2)12check_row_na feature_cor (3)flatten_mat (4)hdImpute (4)impute_batches (5)mad (6)Index8 check_feature_na Find features with(specified amount of)missingnessDescriptionFind features with(specified amount of)missingnessUsagecheck_feature_na(data,threshold)Argumentsdata A data frame or tibble.threshold Missingness threshold in a given column/feature as a proportion bounded be-tween0and1.Default set to sensitive level at1e-04.ValueA vector of column/feature names that contain missingness greater than threshold.Examples##Not run:check_feature_na(data=any_data_frame,threshold=1e-04)##End(Not run)check_row_na Find number of and which rows contain any missingnessDescriptionFind number of and which rows contain any missingnessUsagecheck_row_na(data,which)feature_cor3Argumentsdata A data frame or tibble.which Logical.Should a list be returned with the row numbers corresponding to each row with missingness?Default set to FALSE.ValueEither an integer value corresponding to the number of rows in data with any missingness(if which =FALSE),or a tibble containing:1)number of rows in data with any missingness,and2)a list of which rows/row numbers contain missingness(if which=TRUE).Examples##Not run:check_row_na(data=any_data_frame,which=FALSE)##End(Not run)feature_cor High dimensional imputation via batch processed chained randomforests Build correlation matrixDescriptionHigh dimensional imputation via batch processed chained random forests Build correlation matrixUsagefeature_cor(data,return_cor)Argumentsdata A data frame or tibble.return_cor Logical.Should the correlation matrix be printed?Default set to FALSE.ValueA cross-feature correlation matrixReferencesWaggoner,P.D.(2023).A batch process for high dimensional putational Statistics, 1-22.doi:<10.1007/s00180-023-01325-9>van Buuren S,Groothuis-Oudshoorn K(2011)."mice:Multivariate Imputation by Chained Equa-tions in R."Journal of Statistical Software,45(3),1-67.doi:<10.18637/jss.v045.i03>4hdImputeExamples##Not run:feature_cor(data=data,return_cor=FALSE)##End(Not run)flatten_mat Flatten and arrange cor matrix to be dfDescriptionFlatten and arrange cor matrix to be dfUsageflatten_mat(cor_mat,return_mat)Argumentscor_mat A correlation matrix output from running feature_cor()return_mat Logical.Should theflattened matrix be printed?Default set to FALSE.ValueA vector of correlation-based ranked featuresExamples##Not run:flatten_mat(cor_mat=cor_mat,return_mat=FALSE)##End(Not run)hdImpute Complete hdImpute process:correlation matrix,flatten,rank,createbatches,impute,joinDescriptionComplete hdImpute process:correlation matrix,flatten,rank,create batches,impute,joinUsagehdImpute(data,batch,pmm_k,n_trees,seed,save)impute_batches5Argumentsdata Original data frame or tibble(with missing values)batch Numeric.Batch size.pmm_k Integer.Number of neighbors considered in imputation.Default set at5.n_trees Integer.Number of trees used in imputation.Default set at15.seed Integer.Seed to be set for reproducibility.save Should the list of individual imputed batches be saved as.rdsfile to working directory?Default set to FALSE.DetailsStep1.group data by dividing the row_number()by batch size(batch,number of batches set by user)using integer division.Step2.pass through group_split()to return a list.Step3.impute each batch individually and time.Step4.generate completed(unlisted/joined)imputed data frame ValueA completed,imputed data setReferencesWaggoner,P.D.(2023).A batch process for high dimensional putational Statistics, 1-22.doi:<10.1007/s00180-023-01325-9>Stekhoven,D.J.,&Bühlmann,P.(2012).MissForest—non-parametric missing value imputation for mixed-type data.Bioinformatics,28(1),112-118.doi:<10.1093/bioinformatics/btr597> Examples##Not run:impute_batches(data=data,batch=2,pmm_k=5,n_trees=15,seed=123,save=FALSE)##End(Not run)impute_batches Impute batches and return completed data frameDescriptionImpute batches and return completed data frameUsageimpute_batches(data,features,batch,pmm_k,n_trees,seed,save)6mad Argumentsdata Original data frame or tibble(with missing values)features Correlation-based vector of ranked features output from running flatten_mat() batch Numeric.Batch size.pmm_k Integer.Number of neighbors considered in imputation.Default at5.n_trees Integer.Number of trees used in imputation.Default at15.seed Integer.Seed to be set for reproducibility.save Should the list of individual imputed batches be saved as.rdsfile to working directory?Default set to FALSE.DetailsStep1.group data by dividing the row_number()by batch size(batch,number of batches set by user)using integer division.Step2.pass through group_split()to return a list.Step3.impute each batch individually and time.Step4.generate completed(unlisted/joined)imputed data frame ValueA completed,imputed data setReferencesWaggoner,P.D.(2023).A batch process for high dimensional putational Statistics, 1-22.doi:<10.1007/s00180-023-01325-9>Stekhoven,D.J.,&Bühlmann,P.(2012).MissForest—non-parametric missing value imputation for mixed-type data.Bioinformatics,28(1),112-118.doi:<10.1093/bioinformatics/btr597> Examples##Not run:impute_batches(data=data,features=flat_mat,batch=2,pmm_k=5,n_trees=15,seed=123,save=FALSE)##End(Not run)mad Compute variable-wise mean absolute differences(MAD)betweenoriginal and imputed dataframes.DescriptionCompute variable-wise mean absolute differences(MAD)between original and imputed dataframes.mad7Usagemad(original,imputed,round)Argumentsoriginal A data frame or tibble with original values.imputed A data frame or tibble that has been imputed/completed.round Integer.Number of places to round MAD scores.Default set to3.Value‘mad_scores‘as‘p‘x2tibble.One row for each variable in original,from1to‘p‘.Two columns:first is variable names(‘var‘)and second is associated MAD score(‘mad‘)as percentages for each variable.Examples##Not run:mad(original=original_data,imputed=imputed_data,round=3)##End(Not run)Indexcheck_feature_na,2check_row_na,2feature_cor,3flatten_mat,4hdImpute,4impute_batches,5mad,68。
国军标2017版质量管理体系过程清单-参考

1.供方交货准时率100%;2.进料检验合格率≥98%
5
生产和服务提供过程
生产部
1《生产计划控制程序》2《生产控制程序》3《产品标识和可追溯性控制程序》
4《顾客财产控制程序》5《产品搬运包装防护与交付控制程序》
过程绩效指标:
1.制程合格率≥93%;2.每月产品一次交验合格率95%;3.生产计划完成率100%;4顾客财产完好率100%
2
市场开发与营销过程
供销部
1《产品和服务要求控制程序》2《顾Leabharlann 满意控制程序》过程绩效指标:
1.合同履约率100%;2.顾客抱怨结案率100%;3.顾客满意度≥90%
3
产品设计开发与工艺开发过程
品技部
1《设计和开发控制程序》
过程绩效指标:1.样品试制及时率100%
4
采购过程
供销部
1《供应商评价与选择控制程序》2《采购控制程序》
8
人力资源管理过程
行政部
1《人力资源和培训控制程序》
过程绩效指标:1.培训计划按期完成率100%;
9
文件管理过程
行政部
1《文件控制程序》2《记录控制程序》
过程绩效指标:
1.文件发放及时率100%;2.文件抽查合格率100%;
审核组确认:日期:
质量管理体系过程清单
过程基本信息(受审核方填写)
审核组填写
序号
过程名称
主责部门
相关文件/过程绩效指标
涉及标准条款
是否为核心过程
过程类型
1
体系管理过程
管理层
1《风险和机遇控制程序》2《内部审核控制程序》3《管理评审控制程序》4《数据分析与评价控制程序》5《不合格及纠正措施控制程序》
GMP培训课件 性能确认

PQ概述-1
EU GMP附录15确认和验证
PQ should include, but not be limited to the following:
PQ 应该包括以下内容,但不仅限于此:
(a) tests, using production materials, qualified substitutes or simulated product, that have been developed from knowledge of the process and the facilities, systems or e根q据ui生pm产e工n艺t;、系统和设备的相关知识制定性能确认方案,使用正常 生产
I 认 、 运 行 确 认 、
性能确认,在此 意义上,确认是 验证的一部分。
財角认和验证的范围和程度应当经过风险评估来福定。; E3 公 ----------------------
确认的四个阶段
性能确认
(Performance Qualification )
运行确认
(Operational Qualification)
辅助系统
蘭于生产设备,性能确认指通、 过系 统联动试车的方法,考察 工艺设备 运行的可靠性、主要 运行参数的稳 定性和运行结果 重现性的一系列活 动。故其实 际意义即指模拟生产。 一般情
J兄下,模拟生产至少应重复3次。
生产设备
Part 2
*
PQ相关基础知识
PQ与调试,确认和验证的关系
6
PQ前需要解决的几个问题
qualification of the equipment and utilities and (2) process
PatientSafe 移动成熟度模型说明书

The PatientSafe Mobile MaturityModel for Healthcare®A FRAMEWORK FOR CLINICAL MOBILITY ASSESSMENT AND PLANNINGIntroductionOver the past six years, healthcare has seen a dramatic increase in the volumeof mobile and smartphone devices inuse in hospitals by staff and patients alike. The sweeping transition to and adoption of these devices gives rise toa high impact trend shaping the mobile-enabled transformation of the healthcare enterprise: The emergence of Clinical Communication & Collaboration (CC&C) as an indispensable product category for the modern health system1.As health systems start to look beyond their EHRs for further value at thepoint-of-care to improve quality and productivity, CC&C solutions offer an intuitive path, leveraging the power of mobile experiences to help care teams achieve better outcomes while improving the experience of care. With the aid of smartphone-enabled applications, we can now seamlessly connect the extended care team across inpatient and outpatient settings on a real-time basis. This level of connectivity can deliver significant value such as improving the timeliness of care, and patient, care team and clinical context consistency across hand-offs.However, successful adoption and useof mobile technologies in the healthcare industry still faces significant challenges. Fragmentation continues to be the norm across infrastructure, devices, integration points, applications, and clinical workflows. In fact, frontline users of mobile devices and applications are already experiencing an increase in workflow fragmentation. A recent HIMSS Analytics study noted that the average clinician has to navigate at least five different devices and application modalities in order to communicate and collaborate with the rest of the care team throughout their shift2.High levels of fragmentation and the general lack of a comprehensive mobility strategy hinders the industry’s progress toward sustainable mobility investments and ushering the clinical communication and collaboration category forward. As health system IT and clinical organizations respond to the rapidly evolving trendsin both CC&C and app-enabled patient engagement, we are observing the need for a clear framework for assessing an organization’s mobile maturity. This framework can inform a cohesive clinical communication and collaboration strategy that aligns the appropriate people, processes, and technologies to deliver an optimized mobile experience for staff and patients alike. Therefore, we are proposing this inaugural version of the PatientSafe Mobile Maturity Model for Healthcare®to help our colleagues and customers organize strategic and operational planning for a successful mobility journey.The Natural Evolution of Mobile AdoptionLike many technologies, mobility adoption in healthcare has followed three successive phases: Phase I:A d hoc reaction to individual painpoints via point solutionsPhase 2:C ollective awareness of thefragmentation consequences of thesepoint solutions and migration towardsintegrated platformsPhase 3:C larity on the need for an integratedstrategy, supported by repeatableprocesses and the ability to monitor andmanage towards intended outcomes.In the past five years, mobile adoption has predominantly been in the ad hoc reaction phase in which our industry has seen the rapid rise of and resulting tremendous fragmentation caused by single purpose apps that clutter mobile device user’s home screens and create further context switching tax as users must navigate multiple apps to carry out their workflows. In the past two years, we have seen the industry begin a concerted effortto seek a true platform approach to mobility solutions. Thought leaders in our space are shifting to clinical communication platforms that encompass more than simple secured messaging, and advance toward integrated voice, alerts, and most importantly, true EMR integrated workflows via a single unified app that can deliver a fundamentally streamlined user experience.Although there are pockets of excellenceand promise, as a whole, our industry isstill far from repeatable processes and true predictable outcomes management ofmobile technologies. The PatientSafe Mobile Maturity Model for Healthcare® should serve as a navigation framework and strategy map to help health systems achieve the highest level of mobile technology adoption success broadly, but especially in the context of clinical communication and collaboration investments.The Six Key Capabilities in the PatientSafe Mobile Maturity ModelThe PatientSafe Mobile Maturity Model for Healthcare reflects an organization’s focus and capabilities in each of six key categories. These six dimensions must be carefully assessed to fully understand an organization’s current state and path forward to optimal mobility adoption and performance. The significant inter-dependencies between these components must also be considered during both strategy development and program planning.1. Outcomes Management:Outcomes definition, monitoring, and ongoing optimization are key criteria for a mature approach to mobility. In combination, all five preceding dimensions will set a foundation for better outcomes. However, it is only by defining the financial, operational and clinical performance desired from mobile technologies at the outset that health care organizations can achieve optimal return from their mobility program investments.Outcomes definition, monitoring, and improvement is the criteria to be considered in conjunction with workflow design. Without the right workflows, the right level of adoption, and the right integration points, no clear outcomes can be achieved with a mobile program. In a comprehensive mobility program, outcomes are measured by both clinical and IT performance.As health systems progress from ad hoc approaches to an integrated mobile platform strategy, all six capabilities must be considered and examined in terms of their interdependency.A successful mobility program is never ashort-term project. Rather, it is an ongoing, continuous pursuit to be guided by clear vision, comprehensive strategy, and a disciplined framework. Evaluating each of the six dimensions will be helpful for all organizations as they determine their short, medium, andlong-term mobility goals. Mobile transformation requires health systems to shift from ad-hoc solutions to strategic planning.2. Workflow Design:Workflow consideration includes the type of communication, documentation, coordination, and execution tasks across each user persona on the extended care team. Advanced organizations include patients & their families in care team planning. Organizations in the early stages of mobile maturity often put workflow as a late-stage consideration orin-production learning. Organizations in advanced stages of mobile maturity prefer to start with workflow design for cross-enterprise teams - more than just one group of users.3. Integration Planning:Integration planning encompasses the tools, mechanisms, protocols, and standards through which structured data from source systems are processed and routed to the various applications on the mobile device of choice. The degree to which integration is planned and managed vs. ad hoc and reactive increases as organizations advance upward through the stages of mobile maturity in our model.4. Application Selection:The sheer volume and variety of mobile applications available in the healthcare settingcan be overwhelming. An organization’s mobile maturity also depends on the degree to which consideration of end user experience influences application selection - inadvertent degradation and accidental fragmentation vs. careful considerations of streamlined, enhanced workflows.5. Mobile Device Management:An organization’s maturity in the selection of mobile devices evolves as they progress from ad hoc adoption to a more planful platform strategy. Mobile device choice is a key consideration driving mobile adoption, and includes smartphone hardware manufacturer (Apple, Samsung, Zebra, etc.), OS developer, and versions(e.g. iOS 12.x, Android Jellybean, TC51 16.04).6. Infrastructure Management:Through the lens of mobile adoption, infrastructure considerations include wireless networks, telephony systems, data center and hosting environments, security standards, and enterprise database infrastructure. The expertise, process sophistication, and key technology requirements increase as new use cases are brought into the mobile-enabled ecosystem.The 5 Stages of Mobile Maturity Organizations generally progress from a fragmented, reactive approach to a moremanaged and scalable mobility program. Along this progression, they discover what the people, process, and technology requirements are in each of the six aforementioned capabilities. The following provides a short description and key characteristics of each stage in the PatientSafe Mobile Maturity Model progressing upward from immature Stage 0 to full maturity in Stage 4.Depending on the scale and evolution of an organization, it may simultaneously be in multiple stages of maturity due to historical investment or the nature of organizational decision making (centralized vs. distributed/localized). It is important to recognize that a detailed assessment of each of the six capabilities will determine the optimal transition path to higher stages of maturity in this model. Regardless of where anorganization is today across each of the six capabilities, implementing the best practices demonstrated in Stage 4 will facilitate a more rapid evolution to mobile maturity and desired outcomes. The fundamental paradigm shift to an outcomes-focused mobility strategy will help healthcare organizations overcome the challenges of the past, and chart a path to tangible results – improving quality, safety, productivity, and satisfaction.Develop a Mobility Program Charter — A common frame for organizing people, processes and technologies.The Five Stages of MaturityWhat you may find in organizations operating at this stageThe design and implementation approach to mobility remains reactive in organizations at Stage 0. Typical status across all six capabilities may look similar to the following.Infrastructure Management• 3 or more PBX systems• 2 or more Wi-Fi network standards• 2.5 Ghz network• W i-Fi security standards refresh was conducted more than three years ago• L ast Wi-Fi coverage assessment was conducted more than 2 years agoMobile Device Management• 3 or more types of mobile devices in use by the care team• Pagers are still used in high volume• L egacy VoIP handsets are the standard communications device of choice• W orkstations on wheels are used for clinical documentation• B YOD smartphone deployment is conducted without Mobile Device Management (MDM) strategy or support• Mobile device security risks and exposure exist Integration Planning• Integration is ad hoc• N o integration of patient, care team or clinical context in smartphone apps• A lerts are not consistently available on all mobile devicesApplication Selection• L ack of or limited use of smartphone apps for care team collaboration and clinical documentationWorkflow Design• N o consideration of workflow designor integration in mobile device and application selection• U sers generally dissatisfied aboutmobile technology’s ability to helpthem execute workflowsOutcomes Management• N o consideration of measurable financial, operational, or clinical outcome targets for mobile technology investmentsWhat you may find in organizations operating at this stageThe organization’s approach to mobility remains “bottoms-up” with an IT bias towards technical infrastructure and devices. There is minimal clinical input on workflow design and user experience.Infrastructure Management• PBX consolidation planned or in-progress• Both 2.5Ghz and 5Ghz Wi-Fi networks in place • S upporting across K/V/R, with latest security standards• W i-Fi coverage map has been re-assessed within the last yearMobile Device Management• T here is a concerted IT-led initiative underway to consolidate device footprint• T he organization is seeking a single smartphone device for their shared device strategy Integration Planning• Integration is ad hoc• N o integration of patient, care team or clinical context in smartphone apps• A lerts are not consistently available on all mobile devices Application Selection• O nce device selection is final, mindset is “We can support any and all apps.”• N o serious forethought about how application strategy impacts device strategy and vice versaWorkflow Design• N o consideration of workflow designor integration in mobile device and application selection• U sers are excited about the upcoming smartphone initiative, but thorough workflow design remains elusive Outcomes Management• N o consideration of measurable financial, operational, or clinical outcome targets for mobile technology investmentsWhat you may find in organizations operating at this stageThe organization’s design and implementation approach to mobility remains “bottoms-up” with IT bias towards technical infrastructure and little clinical input on workflow design and user experience.Infrastructure Management• PBX consolidation planned or in-progress • Both 2.5Ghz and 5Ghz Wi-Fi networks in place • S upporting across K/V/R, with latest security standards• W i-Fi coverage map has been re-assessed within the last yearMobile Device Management• Device consolidation efforts are complete • Beginning broader use of smartphone devices Integration Planning• S ome integration of alerts and notifications to smartphones• S till challenges by a high volume of alerts and alert fatigue Application Selection• P roliferation of single purpose apps— the “app tool belt”• M ultiple users have access to mobile apps, but data and context exchange between apps isn’t consideredWorkflow Design• A pplication proliferation results in workflow fragmentation and unintended consequences at point of care• User experience friction increases• U ser desire for workflow integration andre-design increasesOutcomes Management• N o consideration of measurable financial, operational, or clinical outcomes targetsfor mobile technology investmentsWhat you may find in organizations operating at this stageInfrastructure Management• O n-going optimization of infrastructure to reflect design criteria• A dditional support processes determined through workflow and outcomes discussions Mobile Device Management• Device consolidation efforts are complete • T he organization’s device choice is determined and optimized through clear definition of both workflow and application use cases Integration Planning• I ntentional, planned data flow from source systems and monitors to mobile apps on smartphones.• I ntegration data flow is mapped carefully• Defined workflow and application use cases Application Selection• C onsolidation of disparate applications has eliminated the app tool belt.• B road movement toward a one- or two-app platform approach that can satisfy both communications and workflow needs Workflow Design• C ross-functional workflow needs between providers, clinicians, allied health team, ancillary staff, and patient/family are mapped out and understood• W orkflow mapping is used to examineand drive application, device, and infrastructure decisionsOutcomes Management• S ome discussion of outcomes and how they maps to workflow (and vice versa) take place • U nable to achieve consistent results due to earlier decisions made about infrastructure, devices, and integration that now need to be untangledWhat you may find in organizations operating at this stageInfrastructure Management• O ptimized voice, network, and clinical applications infrastructure that supports a large volume of mobile interactions• C onnectivity characterized by high availability, great roaming characteristics, little to no latency Mobile Device Management• T he right device chosen and deployed for the right setting: shared devices for inpatient, BYOD for physician and ambulatory Integration Planning• O ptimized and consolidatedintegration strategy• W orkflow-to-data flow mapped across the enterprise vs. siloed and departmental Application Selection• C onsolidation of disparate applications has eliminated the app tool belt• B road movement toward a one- or two-app platform approach that can satisfy both communications and workflow needs Workflow• C ross-functional workflow needs between providers, clinicians, allied health team, ancillary staff, and patient/family are mapped out and understood• W orkflow mapping is used to examineand drive application, device, and infrastructure decisionsOutcomes Management• D esired outcomes metrics attributable to mobile initiatives are well defined• Results are monitored on a continuous basis • P redictable and consistent achievement of outcomes has been establishedConclusion — Future Evolution of the PatientSafe Mobile Maturity ModelThe rise of mobile technologies and applications brings an unprecedented opportunity to the healthcare landscape for providers, clinicians, and patients to engage in new care experiences that can be significantly simpler and more effective than those of the past. This trend enables health systems to significantly improve the efficiency and productivity of point-of-care workflows and coordination across the care team. Research organizations such as Gartner have long seen the promise of Real-Time Healthcare Systems — in which context, data, and actions come together ina real-time, dynamic fashion, centered around the patient’s needs to help deliver high quality and effective care. Gartner also sees that mobile investments and their complementary technologies can create new channels to collaborate on care that are vital to coordinate transitions of care within today’s complex, often disjointed, care delivery system3.T o build the real-time healthcare system of the future, healthcare organizations are beginning to invest more deeply and strategically in mobile technologies. As such, we believe the industry needs to collaborate on a strategic framework to help health system leadership consider and plan mobility investments with greater purpose, clarity, and structure.This first version of the PatientSafe Mobile Maturity Model for Healthcare® seeks to create a referenceable that enables assessment of any institution’s current state of mobile investmentand organizational capability. Most importantly, it should help structure and define a mobility vision and strategy that guides the creation of a clear and cogent roadmap for decision making across infrastructure, device planning, integrations, application selection, and workflow design, toward complete outcomes management. This paper serves as the inaugural edition of the PatientSafe Mobile Maturity Model for Healthcare. We invite collaboration from healthcare research organizations, health systems, and vendors to further refine and evolve the Model.References1. Gartner 2018 Market Guide for Clinical Communication and Collaboration2. The State of Clinical Communication and Workflow: A HIMSS Analytics Benchmark Survey3. Gartner 2018 Strategic Roadmap to the Real-Time Health System。
ISO TS 22163-2017必须建立22个强制的过程

ISO TS 22163-2017必须建立22个强制的过程ISO/TS :2017标准规定企业必须建立22个强制性过程,其中包括:1.风险管理(6.1.3-1)2.预算管理(计划、批准和控制)(7.1.1.1-1)3.监视和测量资源的验证或校准(7.1.5.3-2)4.能力管理(7.2.1-1)5.成文信息的控制(7.5.3.3-1)6.外包过程的策划(8.1.1-1)7.投标管理(8.1.2-1)8.项目管理(8.1.3-1)9.配置(技术状态)管理(8.1.4-1)10.变更管理(8.1.5-1)11.合同评审(管理产品和服务的要求)(8.2.5-1)12.设计和开发过程(8.3.1-1)13.外部提供的过程、产品和服务(8.4.1.1-2)14.生产和服务的提供(8.5.1.1-1)15.特殊过程的管理(8.5.1.2-1)16.交付后的活动(8.5.5.1-1)17.不合格输出的控制(8.7.3-1)18.管理RAM/LCC活动(8.8-1)19.首件检验(FAI)(8.9-1)20.废置/老化管理(所供应的产品和备件的可用性)(8.10-1)21.内部审核(9.2.3-1)22.不符合和纠正措施(10.2.3-1)此外,ISO/TS :2017标准要求企业必须测量10个KPIs,包括:a) 顾客满意b) 对顾客的按时交付OTDc) 顾客提出的不合格d) 内部不合格e) 外部供方的不合格f) 外部供方的按时交付g) 质量缺陷成本h) 项目成本i) 需求管理过程(8.2.5)j) 设计和开发过程(8.3)此外,还应该测量7个KPIs,包括:a) 顾客投诉及所提不合格的反应时间b) 生产能力包括预测(包括为制造和设施安装)c) 问题解决时间,如开口项;d) FAIe) 生产设备停机时间;稼动率f) 内部审核过程(见9.2);。
okIECQQC080000-2017有害物质过程管理体系手册(HSPM)

IECQ QC 080000:2017有害物质过程管理体系手册( HSPM)目录前言1 范围1.1 总则1.2 应用2 规范性引用文件3 术语和定义4 组织环境4.1 理解组织及其环境4.2 理解相关方需求和期望4.3 确定HSPM体系的范围4.4 HSPM体系及其过程4.4.1 总则5 领导作用5.1 领导作用和承诺5.1.1 总则5.1.2 以顾客为关注点5.2 HSF方针5.2.1 制定HSF方针5.2.2 沟通HSF方针5.3 岗位、责任、职责与权限6 策划6.1 应对风险和机遇的措施6.1.1 HSPM体系的策划6.1.2 组织6.2 HSF目标及其实现的策划6.2.1 HSF目标6.2.2 HSF目标的策划6.3 变更的策划7 支持7.1 资源7.1.1 总则7.1.2人员7.1.3 基础设施7.1.4 过程运行环境7.1.5 监视和测量资源7.1.6 组织的知识7.2 能力7.3 意识7.4 沟通7.5 文件化信息7.5.1 总则7.5.2 创建和更新8.1 运行策划和控制8.2 产品和服务的HSF要求8.2.1 顾客沟通8.2.2 产品和服务HSF要求的确定8.2.3 产品和服务要求的评审8.2.4 产品和服务要求的更改8.3 产品和服务的设计开发8.3.1 总则8.3.2 设计和开发策划8.3.3 设计和开发输入8.3.4 设计和开发控制8.3.5 设计和开发输出8.3.6 设计和开发更改8.4 外部提供的过程、产品和服务的控制8.4.1 总则8.4.2 控制类型和程度8.4.3 提供给外部的供方的信息8.5 生产和服务提供8.5.1 生产和服务提供的控制8.5.2 标识和可追溯性8.5.3 顾客或外部供方的财产8.5.4 防护8.5.5 交付后活动8.5.6 更改控制8.6 产品和服务的放行8.7 不合格输出的控制9.0 绩效评价9.1 监视测量分析和评价9.1.1 总则9.1.2 遵顾客满意9.1.3 分析和评价9.2 内部审核9.3 管理评审9.3.1 总则9.3.2 管理评审输入9.3.3 管理评审输出10.0 改进10.1 总则10.2 不合格和纠正措施10.3 持续改进目标11.0 附录11.1 程序文件清单11.2 组织架构11.3 职能分配表11.4 HSF管理体系流程图0.1颁布令为全面提升公司的管理水平,提高产品质量及为确保产品中有害物质符合HSF法律法规及客户要求,本公司按照ISO9001:2015《质量管理体系要求》及IECQ QC080000:2017《有害物质过程管理体系要求》,建立了《管理手册》和相应的及程序文件,作为本公司标准的行动指南.现予以发布,自发布之日起实行,各部门和全体人员皆应遵守文件的要求.本手册由本公司 ISO推行委员会编制,经HSF管理者代表及质量代表 xxx 审查:管理者代表职责:1.确保按照ISO9001:2015/IECQ QC080000:2017标准的要求建立、实施与保持质量及有害物质过程管理体系。
IECQ-QC-080000:2017-第四版标准(中文版)(20200707090009)
有害物质过程管理(HSPM )体系要求刖言本出版物由IECQ管理委员会(MC)制订。
本出版物与包含IECQ HSPM方案程序规则的IECQ 03-5直接相关' 本IECQ国际规范(以下称为国际规范)及其要求源于以下理念:只有有效地融合管理规范,才能实现有害物质减免(HSF)产品和生产过程。
本国际规范是对ISO 9001质量管理体系(QMS )框架的补充,与其协调一致,目的是对过程进行全面、系统、透明的管理和控制,以实现HSF目标。
IECQ QC 080000第四版针对第三版的使用反馈进行修订。
第四版中的变化包括:-与ISO 9001:2015 一致;-采用了ISO附录SL高层结构;-适应全球不断增加的有害物质法规。
如REACH1法规所规定的新增受控物质、变更控制、产品召回,供应链内的信息沟通,以及向ECHA2 通报SVHC3 ;-晌应适用的法律法规义务,强化了成文信息的要求。
如RoHS4指令改写后的要求(如符合性评定、技术文件的编写、自我声明的编制、标志的使用等)现在都可以通过IECQQC 080000来管理。
IECQ QC 080000规定了组织如何建立和实施关键过程来管理其有害物质,而不是强调如何去除和回避产品中的受限物质。
用于识别、控制、量化和报告电工产品或其部件中有害物质(HS)含量的各种过程,必须足够详尽地予以定义和理解,以便让所有相关方确信产品的HSF状态。
这些过程必须适当成文,并以受控和一致的方式执行,从而:-有利于验证适用顾客要求和法规的符合性-可以进行高效且有效的符合性检查-有利于在组织及其供应链得到一致推广-使得符合性和执行方法能够相互协调这样,就能够在世界范围内最大限度地减少产品贸易的技术壁垒。
本IECQ QC 080000第四版从出版之日起替代第三版。
按本版规范进行的IECQ HSPM 认证转换安排在IECQ MC/345A/CD 中有详细规定。
请参考IECQ MC决议2016/22。
process npd成分
process npd成分
Process NPD成分是指对新产品开发过程中使用的原材料和成分进行处理和管
理的方法。
这是一个关键的步骤,以确保最终产品具有所需的特性、品质和性能。
首先,为了确保产品的安全性和有效性,对NPD成分进行严格的筛选和审核
是至关重要的。
这包括对每个成分进行全面的风险评估和安全性评估,以确定其在产品中的适用性。
接下来,在进行新产品开发之前,对NPD成分进行充分的研究和测试是必不
可少的。
这涉及到对成分在所需应用中的相互作用、稳定性和效能进行全面的了解。
通过这些测试,可以确定最佳配方和成分组合,以实现所需的产品性能和特性。
在选择和采购NPD成分时,与可靠和有资质的供应商建立合作关系非常重要。
供应商必须能够提供高质量的原材料,并符合行业的标准和要求。
建立稳定的供应链合作伙伴关系有助于确保成分的持续供应和一致性。
在产品开发过程中,必须确保对NPD成分进行适当的储存和管理。
这包括正
确的储存条件和标识,以确保成分的质量和有效性。
定期的库存管理和盘点是必要的,以确保所有成分的可用性,并防止过期和腐败的问题。
最后,在新产品开发的过程中,持续的监测和评估NPD成分的性能和表现是
关键。
这可以通过进行实地测试、消费者反馈和市场调研来实现。
根据客户和市场需求的变化,必要时对成分进行调整和改进,以确保产品持续具有竞争力。
通过对Process NPD成分进行细致的处理和管理,企业能够确保其新产品的质量、安全性和有效性。
这有助于提高客户满意度,增加市场份额,并实现可持续的业务增长。
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质量体系编写表格COP17-1
1、目的1.1验证公司品质目标的有效及适合性。
1.2 保证ISO9000标准要求有效应用于系统运作。
1.3 提供文件化资料,纠正及改善品质系统。
1.4 指出品质系统的短处及改善机会。
2、概述2.1参与品质系统的部门必须每年接受审核至少两次。
2.2所有审核须由经培训合格之内部审核员执行。
3、职责3.1品质系统代表A.制定及确认内部审核计划B.安排及组织内审行程C.培训及确认内审人员D.保证于内审发现的问题得到记录及让责任人知道,从而跟进改善。
E.总结内审表现,呈交品质管理评审。
3.2内部审核员A.根据ISO9000要求,执行内部审核。
B.用[不符合项报告](NCR)通知被审部门有关问题点C.解释NCR及使责任人承诺改善行动。
3.3 被审部门负责人A.提供足够资源,使内审有效完成B.保证NCR的改善工作完成4、程序4.1年度内审计划4.1.1 年度内审计划由QMR制定及确认发出,并知会所有关系部门负责人,这个计划可因应需要修订。
4.2内审通知书A.根据年度内审计划,QMR审核前发出内审通知书给审核部门负责人。
B.除了年度内审计划,QMR可于认为有需要时,安排额外之特别审核给任何一个部门。
4.3审核的实施4.3.1 委派的内审员须于执行内审前,召开审前会议。
A.解释被审部门负责人,内审的目的及使用时间。
B.解释内审的内容及审核范围。
4.3.2 内审员按照计划到被审部门进行现场审核,内审员根据有关标准化文件(品质手册、程序文件、工作指导书)中的内容,审核该部门运作是否符合要求。
4.3.3 如发现有任何问题,审核员应及时反馈该部门负责人,如有任何误解亦应尽早解决。
4.4内审记录A.内审结果总结于[内审总结报告](IASR)内审期间找出每个不符合项,独立记录于[不符合项报告](NCR)内,NCR的编号依次在[NCR状况记录表]中顺序取出。
B.NCR的结构NCR第一部分(不符合项目)——由内审员制定,由被审部门负责人承认。
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FAQs – 2017 Year End Performance Development Review Process10. 2017FOR COLLEAGUES1) I have just started with Shangri-La, am I eligible for the year-end PDR?▪Colleagues who are still under probation during the PDR period are exempt from the review.Colleagues who have completed their probation period before 1st of October are eligible for the review.2) I transferred from a sister property in 2017, who should be my performance appraiser?▪In the event if the transfer is before 1 Oct 2017, the former and current manager of the colleague should discuss and mutually agree on the performance feedback & rating. The current manager is responsible for input of rating in the PDR form▪In the event if the transfer is after 1 Oct 2017, the former manager of the colleague is responsible for the review and input of rating in the PDR form3) If I work at a preopening hotel, do I have to participate in the performance review?▪Yes, colleagues in a pre-opening hotel should join the performance review to complete the PDR form in the TMS / on a paper form.4) When would the Leading Metrics results be released?▪The leading metrics results will be shared with the GM in early Nov. You will receive subsequent communication by your management team.5) When will the PDR form in TMS be available?▪The form will be available in TMS from 16 Oct 2017. Please contact your HR team if you encounter any problem in accessing the forms.6) What if I have questions regarding the TMS / PDR form access?▪You may refer to the technical training guide below, or contact your HR.FOR MANAGERS1)For calibration of L5-2 colleagues at hotel level, do we need to go through all individuals one byone at the meeting?▪The purpose of the calibration meeting is to openly discuss colleagues’ performance to ensure objectivity and transparency. For L5-4 colleagues, the focus could be the review of generalFAQs – 2017 Year End Performance Development Review Process10. 2017rating distribution and single out any individual for discussion as needed. For L3-2 colleagues,the focus could be the higher performance (rating 4 or 5) or lower performance (rating 1 or 2).The team could then browse through rating 3s to decide if any of the assessment should be re-calibrated and modified.2)How should the distribution guideline of performance rating be used?▪The distribution guideline should be used as reference to guide the performance assessment decisions. It should be taken as a recommendation rather than restricted to any fixedpercentage.3)Will there be any by-level descriptors of leadership competencies which could be used to discuss& calibrate performance?▪The existing leadership competencies include general behavioural descriptors which can be used in combination with the performance rating descriptions to discuss & assess the “how” part of performance. Starting in 2018, there will be an enhanced set of leadership competency model including by-level behavioural descriptors.4)We are a smaller hotel and do not have Level 1s in the management team, how should weconduct the calibration meeting?▪The structure of hotel level calibration meeting is to have GM and the ExCom members sitting together to discuss and calibrate performance of colleagues in hotel. Therefore, regardless ofthe job grade of the ExCom members, the calibration meeting should be organized in the same manner with GM as the host, ExCom members as participants to discuss colleagues’performance.5)What if there are disputes between managers and colleagues on PDR rating after it’s submitted toHQ?▪Calibration meeting serves as the forum to discuss and agree on colleagues’ performance rating by the management team. Any changes or disagreements on PDR ratings should be brought up and thoroughly discussed at the meeting. PDR ratings as the outcome of the discussion should be considered as “final” and approved by the management team. When managerscommunicate the ratings to their colleagues, focus of the discussion should be on providingconcrete performance feedback supported by examples. In extenuating cases where acolleague has strong disagreement with the PDR rating, it should be discussed with thecalibration host (e.g. GM) and notify HQ with justifications for exceptional approval.FAQs – 2017 Year End Performance Development Review Process10. 20176)How does PDR rating impact on salary increase and bonus?▪The PDR rating is one of the factors to be considered for salary increase and year-end bonus.It’s our organizational goal to create a greater linkage between the two on the journey inbuilding a high performance organization and eventually tie performance (business andindividual) with rewards in the future.7)What does 2018 performance review look like? Will we continue to use calibration roundtableand balanced scorecard?▪The new elements introduced to 2017 PDR process work as the “practice run” for 2018. From the beginning of 2018, individual goals will be aligned with organizational goals to ensureexpectations are set up front, and individual contribution is tied in with business performanceand organization strategy. The calibration meeting will occur in the end of the year during year-end review. Further details on 2018 performance management approach will be communicated in near future.。