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1. What function does Standard require the highest supervisor to play in quality management system?
Leading Principle which is one of the Eight Quality Management Principles mainly means that unite the operation direction of organization with the objective of organization and create an inside atmosphere and environment that enable all the staff to participate in realizing the organization's purpose. It mainly embodies in the following aspects:
£¨1£© Establish and maintain the quality policy and quality aim of the organization
£¨2£© Put forward the realization of quality policy and quality aim in mending organization by
strengthening the consciousness, enthusiasm and participating extent of staff
£¨3£© Ensure mending organization pay attention to customers' requirements
£¨4£© Ensure proper process is carried out to meet customers' need and other related aspects, realizing quality aim
£¨5£© Ensure establishing, carrying out and maintain an effective quality management system
in order to realize these quality aims
£¨6£© Ensure obtaining necessary resource
£¨7£© Asses quality management system regularly
£¨8£© Decide the measures related to quality policy and quality purpose
£¨9£© Decide the measures which are used to improve quality management system
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2.What's "Process Method"?
Process Method means identifying and managing the process applied by organization methodically, especially the interaction of these processes. Process is a group of interdependent and interacting activities that transform input to output. Resource is the necessary condition of the process activities. The output of one process will directly become the input of the next process. The basic points of Process Method include£º
£¨1£© Identify the process applied by organization methodically. Process can be large or small,
and a process can be divided into several subprocesses. The quality management system pattern referred by New Standard includes the following four main processes: production accumulating process, resource management process, management activity process and measure, analyze and improve process. These four main processes can be divided into more detailed process according to the realizing condition
£¨2£© Identify each process, including the input, output, activity and resource, concretely
£¨3£© Identify and confirm the interaction among processes. Make sure the relationship of each
process and the relationship between the output of process and the input of the next process and next several processes
£¨4£© Manage process and the interaction of processes. For example, confirm the responsibility,
authority limitation and communication of process activity. It also includes the management of resources that used by process
Applying Process Method can use resource effectively, reduce cost and shorten periodicity. It
can obtain predictable and consistent improvement result, especially can pay attention to and master the improvement chance prioritized order, by controlling activity
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3.What's "continuous improvement"?
Improvement means the activity that carried out to improve the characteristic of product or promote the effectiveness and efficiency of product designing, manufacturing and delivering process. Continuous Improvement is the circulating activity that strengthens the capacity to meet requirement. When the Improvement is gradual and seeks for further improvement actively, it is Continuous Improvement. The object of Continuous Improvement is quality management system. In that progress, it usually finds out the existed problems, points out the causes and leads organization to apply correct measures or defend measures by auditing discovery, auditing conclusion, data analysis management audit and other methods. This continuous and circulating activity is Continuous Improvement.
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4.What's the purpose of continuous improvement?
The purpose of continuously improving quality management system is to promote the validity
and efficiency of organizing quality management system, realize quality policy and quality aim, increase the chance of customers and other related party's satisfaction. Validity is the procedure of completing the planned activity and reaching the planned result. Efficiency is the relationship between the reached result and the resource that used.
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5.Which types of documents are usually applied in quality management system?
¢Ù Quality Manual
It is the document that stipulates organizing quality management system. It provides the consistent
information related to quality management system to internal and external of organization
¢Ú Quality Plan
It is the document that stipulates the person, time, degree and related resource for special program,
product, process and contract. It usually quotes some content or program files from Quality Manual
¢Û Code
If code is related to activity., it may be program file, process code, testing code and so
on. If code is related to product, it may be product code, performance criterion, drawing and so on
¢Ü Guidance
Instruction clarifies the recommended methods or suggested document
¢Ý The Program that Forms Document
¢Þ Work Instruction
¢ß Table
¢à Record
Record can provide document for traceability or provide evidence for verification, prevent measure and rectifying measure
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