1, the degree to which the organization's quality policy and quality objectives have been achieved;
2. The product quality is stable, meets the requirements and is improved;
3. Continuously improve the satisfaction of customers and other interested parties in the organization;
4, continuous quality improvement mechanism has been formed.
Secondly, we have to solve an existing understanding problem, that is, the relationship between quality management system requirements and product quality requirements. "O9000" standard is the requirement of quality management system. This requirement is universal and applies to all kinds of industries or economic sectors, providing all kinds of products, including hardware, software, services or process materials, as well as organizations of all sizes. However, each organization takes different measures to meet the requirements of quality management system standards. Therefore, every organization should establish a quality management system according to its own specific conditions. Product requirements are embodied in technical specifications, product standards and specifications, contract agreements and laws and regulations. For every organization, product requirements and quality management system requirements are indispensable, can not replace each other, can only complement each other. The quality of products must fully meet the needs of customers, and the requirement of quality management system is the requirement of the organization's ability to provide qualified products, which is finally confirmed by continuously providing products that customers are satisfied with. Therefore, the product quality meets the requirements first, and the quality management system requirements are a supplement to the product requirements. Customers buy products, not systems. When customers buy products, they need to confirm that their quality management system meets the requirements of quality management system standards, and their purpose is still to ensure that the products purchased by customers can fully meet the specified requirements. Never exaggerate the role of the quality management system, and don't think that as long as the quality management system is established, the product quality will naturally meet the requirements. How to improve the effectiveness of quality management system is expounded from two aspects:
Based on more than two years of on-site audit experience and understanding of standards, the following opinions are put forward:
1. Establish a quality policy and quality objectives suitable for the organization;
The quality policy is consistent with the business purpose, adapts to the product requirements, embodies the commitment to customers and continuous improvement, and can provide a framework for the goal. Therefore, the quality policy should not be an empty slogan, but should be determined according to the organization's products, customer positioning and expected product quality level. Quality objectives should be formulated within the framework provided by the quality policy. In order to ensure the realization of organizational quality objectives, relevant functions and levels should determine their own quality objectives according to the requirements of organizational quality objectives and implement them in the activities of all employees. From the perspective of reflecting the commitment to customers, quality objectives can often be related to product performance, such as product service life, maintenance supportability, timeliness of service and so on. It can also be implemented in the quality of product realization process, such as product qualification rate, warranty waiting time, service waiting time, etc. From the perspective of continuous improvement, the goal may be related to customer satisfaction. Quality objectives should be measurable, and the quality objectives of relevant functions and levels should be quantified as much as possible, so as to compare the implementation results and make continuous improvement. Quality policy and quality objectives are not embellishments of quality management system, and the realization of quality policy and quality objectives is an important evidence of the suitability, sufficiency and effectiveness of quality management system.
2. Establish quality information management process:
In the 2000 edition of ISO900 1 standard, Article 8.4 stipulates: "The organization shall determine, collect and analyze appropriate data to confirm the suitability and effectiveness of the quality management system, and evaluate the aspects that can continuously improve the effectiveness of the quality management system. ..... Data analysis shall provide the following information:
A) customer satisfaction;
B) meet the product requirements;
C) Characteristics and trends of processes and products;
D) suppliers.
The purpose of establishing quality information management process is to evaluate the completion of quality objectives (including various indicators) and determine the areas that need improvement. The management process of quality information includes the name, record, transmission, statistics, analysis, reporting methods and related responsibilities of quality information. The organization should establish a set of statistical reports, regularly check and assess the completion of quality indicators at all levels and functional departments, and promote and motivate employees to keep forging ahead in order to achieve quality objectives. We should make full use of statistical tools to summarize and analyze a large amount of quality information, find out the main problems (including potential problems), and put forward suggestions and requirements for improvement.
3, improve the internal quality system audit
An organization should not only actively carry out internal quality system audit, but also carry out quality audit of products and key processes according to its own specific conditions. By analyzing the data accumulated in monthly product quality audit and process quality audit, we can verify the fluctuation of product quality and process quality, and whether the quality management system has been effectively implemented.
It is necessary to improve the practice of internal quality system audit. At present, the practice of most institutions is basically the same as certification audit, that is, part-time internal auditors focus on a few days a year to conduct a comprehensive audit of system elements and departments involved. The disadvantages of this approach are: firstly, internal audit is regarded as a temporary work, not an important and daily work, which cannot attract the due attention of leaders and employees at all levels; Second, all internal auditors are part-time and only do audit work for a few days a year. They have little audit experience and are not skilled, so it is difficult to improve their audit ability and the effectiveness of audit results is poor. It is understood that enterprises in developed countries in Europe and America rarely adopt centralized internal quality system audit, but mostly adopt decentralized audit. The characteristics of decentralized audit are as follows:
(1) Set full-time personnel to be responsible for internal quality system audit and statistical analysis of quality information.
(2) If one or two departments audit once a month, all departments and elements involved in the quality system can audit at least once in an audit cycle;
(3) Increase the audit frequency in weak and important areas, arrange two or even three audits in an audit cycle, and urge them to improve;
(4) A full-time person shall be responsible for each audit, and one or two capable part-time internal auditors shall be appointed;
(5) Full-time personnel are responsible for preparing annual rolling audit plans and various audit plans, tracking and verifying nonconformities, and writing audit reports.
The biggest advantages of adopting decentralized audit are: taking internal quality system audit as daily work, having special personnel responsible for it, and making it regular; The total number of audit days is greatly increased compared with centralized audit, which makes the audit more in-depth and detailed; The biggest advantages of decentralized audit by full-time staff are: taking internal quality system audit as daily work, having special personnel in charge, and making it regular; The total number of audit days is greatly increased compared with centralized audit, which makes the audit more in-depth and detailed; Full-time staff have more audit experience, high audit ability and strong sense of responsibility, which greatly improves the effectiveness of audit results.
4. Do a good job in management review:
The purpose of management review is to ensure the continuous suitability, adequacy and effectiveness of the quality management system, which is of great significance to quality management. Doing a good job of management review will promote the continuous improvement of the organization's product quality, performance and quality management system, and the top management of the organization should pay enough attention to doing a good job of management review.
Because management review is a new thing in our country (there was no such concept before the implementation of ISO9000 family standard), many organizations lack foundation and experience on how to do a good job in management review, and many organizations go through the motions to cope with the inspection. In my opinion, to do a good job in management review, we should focus on the following points:
(1) Define the contents of management review:
A, evaluate the internal quality system audit report, focusing on the effectiveness of the results of corrective measures, as well as the problems that need to be studied and solved by the management and the measures taken for weak links;
B, evaluate the handling results of customer complaints, and study measures to prevent future recurrence; Evaluate the changing trend of customer satisfaction;
C. Evaluate the analysis results of product and process quality, and put forward the direction, objectives and requirements for further quality improvement (solving potential quality problems);
D, evaluate the completion of the quality policy and quality objectives, and study solutions for poorly completed projects; Revise the quality policy when necessary;
E. Assess whether the organizational structure and resources meet the needs of current development.
(2) Preparation before management review:
First, the internal quality audit report. Because the internal audit report reflects the conformity and effectiveness of the whole quality management system in an audit cycle, the problems and suggestions that need to be discussed and solved by management review should be clearly put forward;
Customer complaints and satisfaction analysis. Use statistical tools to visually display the number and classification ratio of customer complaints, and put forward suggestions and solutions for projects with more customer complaints compared with the previous review cycle;
C, using statistical tools to summarize and analyze the results of product and process quality audit, explain the changing trend of product and process quality, and put forward matters and suggestions that need to be improved;
D, put forward the analysis data of quality policy and quality objectives, including the reasons, countermeasures and suggestions of unfinished projects;
E. Other issues that need to be submitted to management review for discussion and solution.
(3) Hold a management review meeting and keep records;
(4) Tracking and verifying management review resolutions.
Two, improve the effectiveness of the audit quality of certification bodies
The effectiveness of quality system certification mainly involves the standardization of the operation of quality certification institutions, the auditing ability of certification audit teams and the degree of compliance with the code of conduct, as well as the supervision and management of accredited institutions.
In recent years, China's quality certification has developed rapidly, and the overall quality of certification audit is good, which has been recognized by the society. However, there are still some problems that need attention and solution. The following is to discuss these problems and the countermeasures that should be taken:
1, strengthen the review of quality system documents;
Quality system document audit is an important part of certification audit, which runs through the whole process of audit. Usually, document review is divided into two stages: first, document review, which examines whether the quality system documents meet the standards; The latter stage is conducted in the on-site audit to check whether the quality system documents are practical and operable.
The existing problems are: in the preliminary examination of documents, we often only check the quality manual but not the program documents, and there is no special inspection of the quality system documents in the on-site audit. In this way, there is a quality system document approved by the certification body. In fact, there are still many obvious errors and omissions in the quality system documents of many certified and registered organizations.
Therefore, in order to improve the audit quality, we must first strengthen the audit of quality system documents. In the preliminary review of documents, in addition to reviewing the quality manual, the corresponding program documents should also be checked. On-site audit should also pay attention to the review of quality system documents, especially the access to the third-level documents. The third-level document review is not only an important part of the whole quality system document review, but also a part that directly affects the product quality. Whether it is the document review in the document preliminary review or on-site audit, we should pay attention to the inspection and check of the phenomenon of "copying standards" to ensure that the quality system documents can be combined with the product characteristics of the organization and stipulate appropriate control measures according to the requirements of standards, which is practical and effective.
2. Make full preparations before on-site audit:
An advantage without preparation is not a real advantage. An audit team with audit ability may make serious mistakes in the audit and even fail to achieve the purpose of the audit if it is not fully prepared before the audit. Pre-audit preparation includes activities such as allocating audit resources, determining audit scope, making audit plan and writing audit documents. But the key is to do three things well: make a careful audit plan, give professional guidance and prepare a checklist before the audit. In order to make full preparations, certification bodies should make corresponding provisions and guarantees on the preparation time.
3, strengthen the audit of top managers:
In the current certification audit, the audit of top managers is not enough. Some of them have not been audited, while others are just "talking", "exchanging views" or "reporting". Some people have reported that the current audit is "no trial, no trial by the people." This situation not only deviates from the requirements of the standard, but also shakes the foundation of the quality management system. Therefore, strengthening the audit of top managers is an important measure to deepen the certification audit and improve the effectiveness of the audit. Therefore, the audit of top managers should focus on checking whether the quality policy has been implemented; Whether the quality objectives are appropriate, measurable and being achieved; Whether the responsibilities and authority of all kinds of personnel are clear; Whether the resources are sufficient; Whether the management representative is appropriate and conscientious; Whether the management review is effective. It is necessary not only to know whether the managers take responsibility and enter the "role", but also to know whether the quality management system has a solid foundation, that is, to create conditions to objectively, fairly and accurately evaluate the quality system and promote the improvement and perfection of the quality system.
4. Strengthen the review requirements of product standard internal control standard contracts:
To strengthen the review of product standards, internal control standards and contract requirements, we should focus on the following contents:
(1) Whether to list the international standards, national standards and industry standards that should be implemented as controlled documents. If there are no national standards or industry standards, whether enterprise standards have been formulated as the basis for organizing production;
(2) Whether the internal control standards have been compiled for the existing national standards or industry standards, whether the internal control standards are stricter than the requirements of the national standards or industry standards, and whether they have been implemented;
(3) according to the product standard or contract, check whether the purchased raw materials meet the specified requirements;
(4) Check the process control according to the quality requirements of product standards or contracts on product performance, structure and credibility. Check whether there are corresponding process documents, manufacturing equipment, detection means, monitoring measures, personnel training and suitable environment;
(5) According to product standards, internal control standards or contracts, review the integrity of testing items, the suitability of testing methods, the adequacy of testing equipment and the conformity of testing results;
(6) Check the contract review, design input, design confirmation and finished product inspection according to the contract requirements, and check whether it meets the contract requirements.
5. Check the key working procedures.
The key process generally refers to the process that has a significant impact on product quality or plays a decisive role in the process of product, installation and service, and needs strict control. Due to the particularity of the impact of key processes on product quality, it should be listed as the focus of inspection in process audit, and the input, output, resources and activities should be investigated in depth and in detail. The existing problem is that some auditors are not good at identifying key processes, can't make detailed and in-depth inspections of key processes, and can't even make accurate judgments on the degree of process control. In addition to the contents of general process inspection, the inspection of key processes should focus on the following aspects:
(1) process input, namely key raw materials, parts and related subcontractors;
(2) Necessary process documents or work instructions and corresponding control regulations;
(3) process equipment and process capability;
(4) personnel training, qualification examination and skill evaluation standards;
(5) The setting of quality control points, and whether the process is continuously monitored;
(6) Using statistical techniques to control quality fluctuation;
(7) Check whether the equipment, methods and personnel are appropriate, and implement the first inspection;
(8) Conduct 100% inspection on key features;
(9) The quality records are complete and accurate;
(10) Whether the process output achieves the expected effect, and whether the product and its quality characteristics meet the specified requirements.
In short, the main way to improve the effectiveness of the organization's quality management system is to take external certification audit as the driving mechanism, the information from certification audit and inspection as the driving force for internal quality improvement, and take various improvement measures with a realistic attitude to improve their overall quality and enhance the competitiveness of products in the market; The scientific and fair image of certification bodies is the core of effective certification. The main way to improve the effectiveness of certification audit is to work in strict accordance with standards, norms and procedures, maintain its scientific and fair image, improve the auditor's knowledge level and strengthen supervision.
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