Guidelines-of-Working-Instruction.docx

Guidelines of work instructions(WIs)/作业指导书的指导方针
1. Requirements of WI from TS16949/TS16949 关于WI的要求
a) Have documented work instructions, accessible at work stations, for all employees responsible for processes impacting quality. 
组织为所有负责过程操作影响到品质的人员提供形成文件的作业指导书。这些指导书应在工作岗位易于得到。
b) These WI’s shall be derived from sources such as the Quality plan, Control plan and product realization processes 
这些作业指导书文件的制定可参照诸如质量计划、控制计划、产品实现过程等
2. Key explanation points
理解与实施要点
a. WI is the basis for operators’ work. So establishing the standard and workable WI is the important mission for corporation. Avoid the discrepancy from the operator’s work to WI contents, which is helpful for keeping consistent and stable product quality.
作业指导书是现场作业人员的作业依据，因此建立规范的可操作性的作业指导书是组织的一项十分重要工作。切忌作业指导书的内容与作业人员的作业不一致，这不利于形成一致稳定的产品质量。
b. Have work instructions in written form, accessible at work stations, for all operators responsible for processes.
所有过程操作的员工必须有书面作业指导书，这些指导书能在作业现场应容易得到。
c. WI types as below:
作业指导书的形式有：
  1 ）Process work instruction
工序作业指导书；
  2 ）Inspection procedure
检验规程；
  3 ）Flow cards in workshop
车间流程卡；
  4 ）Machine operation manual
机台操作说明书；
  5 ）Test procedure
试验程序；
  6 ）Other documented form
其他文件形式。
d. WI contents included as below:
作业指导书的内容可包括以下内容：
  l ）WI name, number, version, prepared date, revision date and approvals.
作业指导书的名称、编号、版次、制定日期、修订日期和批准；
  2 ）Part name, number and family.
所需的零件名称、零件编号和零件系列；
  3 ）Required tools, gauges and other equipment, its parameter settings.
所需的工具、量具和其他设备, 及其参数设置；
  4 ）The symbol marks for special characteristics(if have)
特殊特性及其符号标识（如果有）;
  5 ）Self-check and cross check contents
自检与互检内容；
  6 ）Reaction plans of abnormal issue points
异常问题点的反应计划；
  7 ）Tools change intervals and set-up instructions
工具更换的周期和设置指令；
  8 ）Relevant engineering and manufacturing standards
有关的工程和制造标准；
  9 ）Visual aids， such as magnifier, microscope etc.
目检辅具, 如放大镜，显微镜等。
 10 ) SPC and other process monitoring requirements
SPC 及其他过程监控要求；
 11 ) Inspection and test instructions with acceptance criteria
检查和测试说明的可接受标准；
 12 ) material identification and disposition instructions
物料存贮标识及分配处理说明；
13 ) operation name and number keyed to the process flow diagram
过程流程图中的操作名称及序号。
14 ) other customer required information
其它客户要求信息
15 ) Relevant safety, Occupational protection, laws and regulations requirement
相关安全、职业防护及法律法规要求
16 ) Relevant ESD requirement
相关ESD 要求
17 ) Operator relevant skill level requirement
作用员相关技能要求

e. Define complete controls for the manufacture of product. Use them for pre-launch and production of end product, sub-assemblies, components and/or materials.
在产品制造过程中，定义完整的控制方法。应用到产品试生产和大量生产，部件装配，元器件或物料的管控当中。
f. Work instructions may be viewed as a subset of your quality plan and may relate to a specific task or activity of your overall product realization process (e.g. setting up a machine; performing an inspection; packaging a product). If you determine that work instructions are needed at specific points in your process, then they must be readily available and relevant i.e. current or right version. Note that work instructions may exist in many forms – narrative; graphical; audio; video; physical display; etc..
作业指导书可看作是控制计划的一部分，与产品实现过程中的相关特殊工作或者活动相关（例如：设置一台机器、执行一项检查、包装一个产品）。如果你确定在制程当中相关特殊点需要作业指导书，那么它们必须准备好并可以用得到，并且是当前的或者正确的版本。 需要注意的是，作业指导书可以以多种形式存在：记述的、图像的、声音的、影像的、实体展现等。
g. In combination, these documents address what has to be made; how much has to be made; when it has to be made; by whom; in what sequence; how it has to be made; what production equipment to use; what measurement and monitoring tools to use ; when to inspect; how much to inspect; what to do if problems arise, etc.  
总体来说，这些文件要求明确需要去做什么，做多少，何时做，谁来做，按什么顺序，怎样做出来，会用到什么设备，会用到什么测量与监控工具，何时检查，检查多少，如果出现问题怎样处理。
h. These documents are dynamic and must be updated for the changes
这些文件是持续更新的，如有变更必须作相应的更新。
j.Þ Production personnel must have timely access to all information relevant to their activities. There may be serious risk to production flow, if such information is unavailable or untimely. 
生产人员必须能够适时的得到所有与他们作业相关的信息。如果这些信息没有或者不能及时得到，那么将会对生产流程产生很大的风险。

3. Control of Documents
文件管控 
a. Control all documents required by your QMS
基于公司质量管理系统的要求，管控所有的文件。
b. Have a documented procedure that defines controls needed to: 
具有一个能够有效管控相关文件的程序文件，需要包含以下几点：
a) Approve the adequacy of documents prior to issue 
在文件发行前需要审批文件的内容结构是否完整有效。
b) Review, update as necessary, and re-approve documents 
必要时需要复查、更新、以及重新批准。
c) Identify changes to documents as well as identify their current revision status 
注明当前文件的变更内容以及版本状态。
d) Make relevant versions of applicable documents available at points of use 
确保已发行的最新版本的文件已放置在相应的工作岗位上。
e) Maintain documents so that they are legible and readily identifiable  
定期维护相关文件，使得它们够清楚明白并且容易理解。
f) Identify documents of external origin and control their distribution 
能够识别清楚外部文件并且很好的管制其派发。
g) Prevent the unintended use of obsolete documents, and apply suitable identification to these documents if they are kept for any purpose.  
对那些由于某些原因需要暂时保留的旧文件，必须做好标识，以防止不小心用错。
4. Control of Records  
相关记录的管控
a) Records are a special type of document. Establish and maintain records as evidence that your QMS conforms to requirements and that your QMS is being operated effectively. 
记录是一种特殊的文件。建立并维护好相关记录，可以证明公司的质量管理系统符合相关要求，并且在有效的运行。
b) Establish a documented procedure that controls how you identify; store; protect; retrieve; retain and dispose of records. 
建立一个程序性文件来管控这些记录文件，怎样去识别、保存、保护、回收、保留及处理它们。
c) Keep the records legible, readily identifiable, retrievable.
记录文件的信息需要很清楚的，容易理解的，且可回收的。