Improve quality, learn English - TS16949 (VIII)
4.2.2 Quality manual
In the grand framework of quality management, the quality manual plays a crucial role. It is necessary for an organization to carefully compile and properly maintain the quality manual, which is like the core map of the quality management system, guiding the quality direction of the entire organization.
First, the quality manual should cover the scope of the quality management system. The definition of this scope is not arbitrary. It needs to precisely clarify all aspects involved in the system. Among them, the details and rationality of any deletions should be explained in detail. Why are there deletions? It may be due to factors such as the organization's business characteristics, product types, or specific operating environment, which make some standard clauses inapplicable in actual operations. However, such deletions must not be baseless and must have sufficient and reasonable reasons. For example, an enterprise focusing on the production of specific components has a business process that has nothing to do with some general service links. Then, relevant clauses can be reasonably deleted from the quality management system, and the reasons should be clearly stated in the quality manual to ensure the pertinence and effectiveness of the entire system.
Secondly, the quality manual shall present the documented procedures prepared for the quality management system or make references to these procedures. These procedure documents are the specific operational guidelines for quality management, which stipulate the processes, methods and requirements of various tasks. By presenting or referencing the procedure documents, the quality manual provides a set of rules for the entire quality management system. For example, in the product inspection procedure, the inspection steps, inspection standards and requirements for inspection records are clearly defined. The quality manual can directly list the names and contents of these procedure documents or point to these documents by way of reference, facilitating relevant personnel to consult and follow them.
Finally, the quality manual needs to describe the interactions between the processes of the quality management system. The quality management system is a complex system composed of multiple processes that are interrelated and influence each other. The coordinated operation among various processes is directly related to the performance of the entire system. For example, there are close connections between the production process and the quality inspection process, as well as between the design and development process and the procurement process. The quality manual should clearly describe how these processes interact. For instance, a problem in a certain link of the production process may affect the quality inspection results, and how the decisions made in the design and development stage will affect the selection of purchased materials. By describing the interactions between processes, it helps the organization to comprehensively understand the operating mechanism of the quality management system, identify potential problems and improvement opportunities.
4.2.3 Control of documents
In the quality management system, document control is a crucial link to ensure the effective operation of the system. All documents required by the quality management system must be strictly controlled, as these documents are the basis and norms for the organization's various tasks. As a special form of documents, records should be specifically controlled in accordance with the requirements of 4.2.4. Records can reflect the actual operation of the organization and provide important information for quality traceability, data analysis and continuous improvement.
To achieve effective control of documents, the organization shall prepare documented procedures and clearly specify the control requirements in the following aspects.
I. Before a document is issued, it must be approved to ensure that the document is adequate and appropriate. The approval process is a strict control over the quality of the document. Relevant reviewers should conduct a comprehensive review from aspects such as the completeness and accuracy of the document's content and its applicability to actual work. For example, before a process document is issued, it needs to be reviewed by process engineers, quality management personnel, etc., to ensure that the process parameters in the document are reasonable, the operation steps are feasible, and it can meet the product quality requirements. Only the approved documents can be officially issued and put into use.
II. Review and update the documents when necessary and approve them again. With the development of the organization, changes in business, and alterations in the external environment, the documents may gradually become unsuitable for actual needs. Therefore, the documents should be reviewed regularly or irregularly. For example, when the product standards are updated, the relevant process documents, inspection documents, etc. need to be adjusted accordingly. If it is determined that the documents need to be updated after the review, they should be modified according to the prescribed procedures and approved again to ensure that the documents always maintain the latest effectiveness.
III. Ensure that changes to documents and their current revision status are identified. Documents may undergo multiple changes during use, and each change must be clearly recorded and marked. The change status and current state of the document can be identified through methods such as version numbers and revision dates. In this way, relevant personnel can clearly know whether the document is the latest version when using it, avoiding incorrect operations caused by using outdated versions of the documents.
IV. It is necessary to ensure that relevant versions of applicable documents can be obtained at the points of use. The ultimate purpose of documents is to serve practical work. Therefore, it is necessary to ensure that the correct versions of documents can be obtained in a timely manner at all points of use. For example, the latest work instructions should be provided at the operation posts in the production workshop, and the latest inspection standard documents should be placed in the quality inspection room. Effective distribution of documents can be achieved through methods such as document distribution management and electronic document sharing to ensure that users can easily obtain the required documents.
V. It is necessary to ensure that the documents remain clear and easy to identify. The clarity and identifiability of documents directly affect their usage effectiveness. Whether they are paper documents or electronic documents, the content should be clear and legible, and the format should be standardized and unified. Appropriate annotations and explanations can be made for important content to facilitate reading and understanding. For example, in drawing documents, key dimensions and technical requirements should be marked; in program documents, complex processes should be presented in a graphical way.
VI. It is necessary to ensure that external documents are identified and their distribution is controlled. External documents may include laws and regulations, industry standards, customer requirements, etc. These documents have an important impact on the organization's quality management system. The organization should identify and classify external documents, and clarify their scope of application and usage requirements. At the same time, it is necessary to control their distribution to ensure that relevant departments and personnel can obtain the necessary external documents in a timely manner. For example, when the state issues new environmental protection regulations, the organization should promptly identify the impact of these regulations on its own production process and convey relevant content to departments such as production and quality.