It can be seen from the figure that the structure of the quality system file is usually depicted in the shape of a pyramid, which means that the lower the organization level, the higher the complexity and detail of the file. The scale of the
quality system mainly depends on the size of the organization, the complexity of the process, and the level of training received by the employees.
Quality Manual
Quality Manual generally includes or involves:
-The highest leader of the enterprise signs a document to declare the company's quality policy, including the obligations assumed for the quality of products or services;
-The organizational structure chart of the enterprise and stipulates the responsibilities and authority of the main management department;
-The description of the established management functions to ensure compliance with all relevant elements of the selected standard, including reference procedures or other documents that clarify how each employee carries out their respective work;
-In some way, the auditor can enable the auditor to verify that the verification manual is written according to the requirements of each element of the standard. This can be achieved by writing each chapter according to the number of standard elements;
-There is evidence that the documented quality system is the company's directive document, and all employees of the company must comply with it, and those who need a quality manual have a controlled version of the manual;
-There are procedures for file control and version control, and ensure that the manual is regularly revised and reflects the actual status of the company.
Typical quality manuals generally give a general description of the quality system, and this description should be concise and concise. The quality manual should be a key to the entire quality system, and should be able to pass the structure and purpose of the quality system to:
-customer
-employee
-competent authority
-competent authority
-Certification Agency
Program
We recommend that the program adopt a predefined format, so that the title of each paragraph can be used as a checklist and can ensure the standardization of all programs in the system. The program can adopt the following title structure:
-Scope and applicable areas
-Responsibility permissions
-Program
-Modify and change
-Purpose and scope of activity
-What to do, Who makes
-When, where, how to do
-What kind of materials, equipment and files are needed
-How to control and record
-Reference file
To avoid the program becoming cumbersome due to too much information, you can use the homework instructions to describe the details separately.
Assignment Instructions
program is used to describe when, what to do, and who will do it, while homework instructions are used to describe how to do it. This method can avoid the program being too cumbersome. When certain details must be specified in documents, they can be used in the form of work instructions. It must be noted that the quality system should describe the work details only when the manager needs to track it.
standard requires that if quality cannot be guaranteed without an operation instruction, an operation instruction should be formulated to explain in detail how to carry out the work. There are usually two types of work instructions:
(1) Work instructions related to the system
and other supplementary programs provide detailed guidance on how to conduct specific control, inspection or test, or how to process materials or form files. The homework instruction book should clearly, accurately and in detail explain the work content, and from this point of view, it helps train new employees.
Some are standard work instructions, and they have become part of the filed quality system, so they should be controlled like program files.
(2) Work instructions related to the contract
These include drawings, material lists, resume cards, special inspections, tests, and processing or packaging instructions. These documents convert the specific requirements in the contract into work files. All of the above documents need to be controlled.
In the quality system containing programs and work instructions, the program is called a secondary document file, the work instructions are called a third-level file, and the manual is called a first-level file.
program files and work instructions can make work tasks clearly understand and execute, and can also ensure the continuity of work in the event of personnel changes.
Quality Plan
The purpose of the quality plan is to make arrangements for the implementation of a certain production process or project quality assurance activities. Quality plans usually refer to some contents of the quality manual or quality system that is suitable for the specific product or project or contract.
Quality Plan focuses on providing customers with specific services in related products, projects or contracts. Therefore, the quality plan selects the quality system document section directly related to the required services. Quality planning is widely used in project management and is also used in certain products of the enterprise.
Other plans
ISO9000 series standards require that certain activities should be planned or should be included in the system's plans, two of which are quality review, education and training. These two plans are integral parts of the system and should meet the requirements of document control. These plans should be updated regularly (for example once a year) and should reflect the time period in which the company conducts training and audits. Once the plan is formulated, it should be implemented, otherwise it should be deemed to be inconsistent.
Specification
mentions specifications, which are generally related to the vocabulary of the files they use, such as production specifications, test specifications, procurement specifications, etc. Their requirements can be expressed in the form of drawings, details, values and tolerances, to clarify working methods and standards, and as the basis for compliance inspection.
ISO9000 series standards only indirectly mention the needs of specifications. In the elements of procurement, process control, inspection and testing, all activities are required to ensure that they meet the specified requirements. For this purpose, the quality system must include procurement specifications, finished product specifications and semi-finished product specifications in some cases.
quality record
quality record provides an objective basis for the degree of completion of quality requirements, or proves the effectiveness of the operation of quality system elements.
quality records are usually divided into contract-related records, products or services-related records, and quality system operation records. Generally, various records are stipulated in writing in relevant procedural documents. For example:
-What records should be saved;
-Who is responsible for filling in these records;
-How to issue a copy of the record;
-Where is the record saved, how to save, and how long to save it;
-How to confirm the authenticity and accuracy of the record.
The following issues should be paid attention to when controlling quality records:
-Does the relevant products or services be indicated in the record;
-Does the record be collected according to regulations and stored for easy review and prevention of damage and loss;
-Whether the record is filled out before the work is carried out or the work is completed long after the work is completed;
-Whether the record is true, complete and reliable, whether it has been modified without authorization to cover up the defects;
-Whether the modifications in all records and records are signed and confirmed by the responsible person and the date is indicated.
records can be in various forms, such as paper, film, tape, floppy disk, , and photos, but no matter which form is adopted, it must be implemented in accordance with the above regulations.
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