1. Why should a quality management system be established?
The basic function of quality management system is to help laboratories continuously provide data and reports that meet the requirements, improve competitiveness and enhance customer satisfaction.
(1) The laboratory needs a quality management system to continuously provide customers with satisfactory services. The quality management system method encourages laboratories to analyze customer requirements, specifies the realization process of testing/calibration and related support processes that meet customer requirements, and keeps them under control. Quality management system can provide a framework for continuous improvement, thus increasing the chances of satisfaction of customers and other interested parties.
(2) Quality management system is also the need of customers. Customers can evaluate the ability of the laboratory through the quality management system and choose satisfactory suppliers.
2. What are the responsibilities of the top management, technical management and quality supervisor of the laboratory?
Generally speaking, the top management, technical management and quality supervisor constitute the top management of the laboratory. Top management is usually defined as: leading the laboratory to implement the relevant policies of superiors and conveying the importance of meeting laws, regulations, norms and customer requirements; Preside over the planning and establishment of the quality management system (including changes), that is, determine the organizational structure and management structure, and implement the quality management system review; Formulate quality policies and objectives, approve quality manuals and issue quality commitments; Appoint key position managers and key position agents; Ensure that the resources required for testing/calibration are obtained. For example, the CEO in the quality system and the executive management in the management review are the top managers.
Accreditation criteria 4. 1.5h) and i) respectively explain the roles of technical management and quality supervisor: "Technical management is fully responsible for technical operation and resources needed to ensure the quality of laboratory operation"; "Designate a person as the quality supervisor, regardless of other existing responsibilities, and give him the responsibility and right to ensure the implementation and conformity of the quality system at any time. The quality supervisor should have direct access to the top management who decides the policies and resources of the laboratory.
It is generally believed that the technical management is responsible for analyzing and judging the possible problems in the detection/calibration technology, finally confirming the calibration/detection method, and providing and allocating the technical resources needed to ensure the quality of the detection/calibration work. In other words, the technical management should be responsible for the procurement of supplies, reagents and consumables that affect the quality of testing/calibration.
The quality supervisor is responsible for the management of internal audit and quality activities, such as the disposal of laboratory personnel who do not comply with the quality manual or procedure documents during the system operation, and the management of internal auditors. Generally speaking, technical management ensures the quality of testing/calibration from the effectiveness by handling and mastering professional technical problems; The quality supervisor ensures the quality of inspection/calibration from the perspective of continuous improvement through the operation and maintenance of the quality management system.
3. Who is responsible for implementing the corrective measures?
There may be several different plans to correct nonconformities, which will involve many different elements (processes) and departments. The formulation and implementation of corrective measures must involve many elements (processes) and departments if the laboratory wants to fundamentally eliminate a nonconformity. The department head is responsible for the implementation of corrective measures, and the technical management or quality supervisor is responsible for verifying the effectiveness of corrective measures.
As an element, corrective measures should clarify the responsibility of a department and be implemented by the department that produces nonconforming products. ISO/IEC 17025 mentioned two kinds of nonconforming work. One is called nonconforming product, that is, the data in the laboratory is unqualified, so it is necessary to evaluate the effectiveness of the implementation of such unqualified corrective measures, which is generally better to be carried out by technical management; As far as the quality management system is concerned, unqualified products are called unqualified items, and the effectiveness of the implementation of such unqualified corrective measures should also be evaluated, which is generally better carried out by the quality supervisor.
4. Should the quality supervisor take the leadership responsibility for testing/calibration quality?
From the top manager of the laboratory to every staff member, although their responsibilities are different, they all bear the responsibility of quality management, and the quality of their work may directly or indirectly affect the results of testing/calibration. The accreditation criteria make it clear that the responsibility of the quality supervisor lies in "ensuring the implementation and conformity of the quality system at any time", that is, the quality supervisor is the person who is fully responsible for the operation of the quality system, not the person who is responsible for the quality inspection/calibration. It needs to be clearly defined in the quality manual and procedure documents, instead of simply thinking that the quality supervisor is the person who is responsible for the quality inspection/calibration. All the management requirements in the recognized standards cannot be regarded as the responsibility of the quality supervisor.
5. In the detection/calibration activities, what customer information should the laboratory personnel bear the confidentiality responsibility?
Certification standard 4. 1.5 requires that the laboratory "has policies and procedures to protect the confidential information and ownership of customers".
The secrets that need to be protected during the experiment include not only the information carried by the product and the technical data provided by the customer for situation evaluation or prototype experiment, such as process flow, design drawings, technical basis, appearance design, technical specifications of the product, technical progress information of new products (such as patented technology), information submitted by the customer, but also the testing/calibration data and results given by the laboratory, as well as other information that the customer's competitors may use. At the same time, on-site inspection may also come into contact with customers' advanced management methods, technical equipment and other related information, and inspectors are also obliged to keep it confidential. In order to do a good job of confidentiality, when necessary, the laboratory can sign a confidentiality agreement with customers to clarify the scope and responsibility of confidentiality.
When the inspection/calibration work is subcontracted to other laboratories, the subcontractor shall be required to keep confidential and supervise the inspection/calibration work of the subcontractor in a confidential manner.
6. What is the laboratory of the second-level legal person?
The second-level enterprise laboratory usually means that the laboratory undertaking testing/calibration is not an independent legal person, but a part of the parent organization (first-level legal person). Although it has approval documents, its own name and organizational structure, and sometimes even financial funds can be independently accounted for, it cannot independently bear legal responsibilities (such as compensation liability and tort liability), and the superior organization still has to bear legal consequences for the agreements signed with foreign countries.
7. How to draw an organization chart?
Organization chart is divided into external organization chart and internal organization chart.
The external organization chart focuses on the interface with external organizations, and the secondary legal person needs to describe its position in the parent organization and its relationship with other structures in the parent organization; A first-class legal person can describe the administrative department at a higher level and the institution with business guidance relationship. A first-class legal person usually does not need to provide an external organization chart in the manual. The internal organization chart should truly reflect the internal settings of the organization, including the composition and division of labor of the top management, the establishment of various management departments and professional departments, the establishment of non-permanent institutions and their respective positions, functions and relationships in the laboratory. The advantages of internal organizational structure and external organizational structure can also be shown in a picture.
The leadership relationship in the organization chart is stable. It should be noted here that although the professional department and the management department are parallel in administrative level, they can sometimes be above the professional department in the organization chart because of the organization, coordination and service functions of the management department. The management department can indicate the relationship with the professional department with solid lines and arrows. Non-permanent institutions can be represented by dotted boxes and connected with the person in charge of the top management by dotted lines. For laboratories with secondary legal persons, when other departments outside the laboratory provide technical support and supply, they can be connected by dotted lines.
In the organization charts provided by some international organizations and foreign testing/calibration laboratories, there are some cases: there is no arrow between the upper and lower levels; There is no extraordinary organization; There is no simple description of the function or accusation in the box; The management department and the professional department are parallel, and they also accept the leadership of the top management of the laboratory and so on.
8. What resources can the laboratory allocate?
The available resources of the laboratory include financial resources, equipment resources, facilities resources, environmental resources, organizational resources, human resources, technical resources, method resources, information resources, suppliers and collaborators and the availability of natural resources.
9. How to ensure the fairness of quality activities in secondary corporate laboratories?
Because the second-level legal person itself cannot bear legal responsibility independently, it is different from the first-level legal person laboratory in ensuring the fairness of quality activities. To this end, it is usually stipulated as follows:
(1) The top management of the superior organization authorizes the laboratory to carry out testing/calibration activities, and promises to bear legal responsibility for it.
The written authorization document shall specify the authorization content and validity period, specify the actions that the laboratory can take independently, and state its relative independence in business writing, contract signing and plan management. , and clarify the property distribution rights and disposal rights that it can enjoy, so that the second-level legal person can carry out testing/calibration activities and implement quality management on the premise of partial autonomy, and fulfill the corresponding legal obligations.
(2) Restrain and restrain the relevant departments and personnel in the superior organization to avoid potential conflicts of interest that may be caused by laboratory testing/calibration activities.
The second-level legal person is only a part of the higher-level organization and does not enjoy the right to completely dispose of and distribute people, money and things. In the acquisition of various resources, it has to be controlled by other leaders or departments other than the top managers of the higher-level organizations. When other leaders or other departments in the superior organization put forward some requirements or suggestions that are contrary to fairness, independence and sincerity, the laboratory will worry whether rejecting their requirements will harm its legitimate interests. Therefore, as a superior organization, it is necessary to make some restrictions and constraints on the behavior of other departments and personnel, and form a written document.
(3) The top manager is also the person in charge of the second-level corporate laboratory. The laboratory should be independent of the production, finance, trade and business departments in terms of organizational structure, not subject to its jurisdiction, but subject to the direct leadership of the superior organization.
Sometimes, the top managers of higher institutions may be too busy to take care of the specific work of the laboratory, and it is necessary to set up an executive deputy director to preside over the daily work; The senior manager who is also the head of the second-level enterprise laboratory can ensure the direct contact and effective communication between the daily work manager of the laboratory and the senior manager of the higher-level organization. On the other hand, without high-level attention, all kinds of express provisions may become a mere formality and cannot really play a role. Therefore, the laboratory should accept the direct leadership of the superior organization to facilitate the acquisition of resources and the maintenance of interests.
10. How to design the laboratory organization?
The purpose of organizational design is to coordinate the activities of the laboratory and minimize duplication or conflict. The design organization should consider the customer demand, products, services, environmental changes, business philosophy, objectives, limited resources, division of labor and cooperation, rights and responsibilities and other factors. The organizational design of the laboratory can refer to the following principles:
(1) rational interval principle
The number of leaders at all levels who can effectively manage is limited. Too many people under the jurisdiction are easy to get out of control, and too few tend to be over-controlled.
(2) Ladder principle
The organization should have a clear ownership relationship, and everyone must know who should be responsible and who should be instructed or supervised.
(3) Clarify the business principles
Everyone's work must be specified in advance, so as not to assign work in general.
(4) the principle of rights.
Decisions should be made by people with corresponding decision-making power, so as to avoid people having the final say.
(5) the principle of authorization
Rights must be delegated to subordinates in order to better complete the tasks specified in their posts.
(6) unified command principle
Everyone's work has only one direct leader, so as not to be at a loss.
(seven) the principle of reciprocity of rights and responsibilities.
If a person is in charge of a specific task, he should also have corresponding rights.
Organizational design includes the division of departments and levels, the choice of control scope, the degree of authorization and the clear relationship between power and responsibility. The laboratory can first list the objectives of establishing the organization, then list the work needed to complete the objectives, then integrate the relevant working groups into appropriate departments and posts, and then clarify the relationship between each post and other posts, as well as the responsibilities and authority of departments and posts.
What are the objectives of quality management and total quality management?
Quality management is to ensure that products or services meet the needs of customers and achieve the goal of continuous customer satisfaction through systematic management.
The quality of a product or service is affected by the interaction of various stages. In order to achieve satisfactory quality economically, laboratories should attach importance to the quality of each stage and implement total quality management.
Total quality management refers to the collective efforts made by all employees to improve performance, that is, by organizing Qi Xin at all levels to continuously improve performance, thus enhancing customer satisfaction. TQM emphasizes low-cost, high-efficiency and zero-defect work to meet customer requirements through improving processes, participation of customers and suppliers, teamwork and training. Therefore, customer satisfaction and Excellence are the two major goals and theoretical basis of total quality management.