Basic knowledge of CNAs | how to rectify the use of approval marks beyond the scope

Date：2022-05-16 15:34:51Views：879

Since 2009, China National Accreditation Commission for conformity assessment (CNAs) has carried out special supervision over laboratories and inspection institutions (hereinafter referred to as laboratories), and also organized a large number of complaint investigations during this period. Since 2014, CNAs has continuously issued 8 issues of typical cases of problems found in the laboratory through special supervision and complaint investigation, which has had a good warning effect on the accredited laboratory.

In order to further improve the quality awareness and management level of accredited laboratories, CNAs Secretariat selected some typical cases with outstanding rectification work and obvious improvement effect from the laboratories under special supervision and complaint investigation, so as to promote mutual reference and common improvement among accredited laboratories.

It is hoped that the majority of accredited laboratories can fully realize the importance of learning and mastering accreditation rules and other accreditation requirements, correctly understand the purpose and role of non routine supervision such as CNAs special supervision and complaint investigation, learn from and learn from the good experience and practices of other institutions, continuously improve quality awareness, technical ability and management level, and make greater contributions to the healthy development of the industry and the "high-quality" development of the country.

Use of approval marks beyond the scope (some items exceed the limited scope)

1. Problem overview

In March 2021, a complaint investigation was conducted on a motor vehicle testing laboratory, and it was found that some items in two inspection reports exceeded the scope of approval, but the report contained CNAs approval mark and approval status statement.

2. Rectification measures

The laboratory analyzed the causes and took the following corrective and preventive measures:

(1) Clear requirements, conduct comprehensive investigation, and immediately start the report modification procedure. The laboratory organized the testing, review and approval personnel of the project to discuss, sort out and accurately grasp the scope of recognition ability, and comprehensively investigated the reports of such problems after the re evaluation of certificate renewal in 2018 (this review gives the limited scope of the above project ability), with a total of 12 reports; At the same time, revise the inspection report template of the project and refine various requirements; Subsequently, the laboratory completed the recycling of the old report and the renewal of the new report according to the report modification procedure.

(2) Use the management platform to convey the latest recognition information in time. In view of the characteristics that the laboratory accreditation ability involves many technical fields, product types, method standards, projects / parameters and frequent changes and expansion, the laboratory establishes a special workflow and uses the company's management platform to timely and accurately convey the latest and effective accreditation results.

(3) Strengthen contract risk review and achieve correct detection. Based on risk thinking, for specific types of business (the annual frequency is not high, which may cause social concern or other significant impact), the contract review department is required to carry out targeted review, identify business risks and quality risks, formulate risk prevention measures, and supervise the whole process of testing.

(4) Improve the management system, effectively monitor and achieve dynamic prevention. On the basis of "two ends, one end and three reviews" (verification review of new capability testing methods, review of testing business contracts and review of quality system management), plan and implement internal quality monitoring activities for key quality risks based on process control methods to ensure the effectiveness of testing results, so as to achieve dynamic prevention of quality risks.

(5) Consolidate the detection ability, digital management and achieve fine control. Continue to upgrade the functions of the laboratory esr-cnas special information data system, and align the relevant elements of the recognized detection ability in the CNAs structured system, from the original single standard controlled novelty search, to further expand the functions of recognized items and parameter analysis, business center and functional laboratory alignment, operation SOP preparation, equipment technical index confirmation, personnel ability authorization and so on, so as to achieve fine control.

(6) Optimize the authenticity inspection of the report and achieve self prevention. Combined with the scope of recognition, the system combs the business types of industry management and market demand and the corresponding report template. At the same time, it upgrades the electronic anti-counterfeiting systems such as watermark, encryption and cross seal of the report management system, connects with the query system of the national certification and Accreditation Commission, and also uses the company's official micro platform to establish the query and screening functions such as key information, release status and unexpected modification of the detection report, so as to check the authenticity of the report.

3. Institutional change and development

After this complaint investigation, through practical rectification activities, the laboratory not only effectively identified and controlled risks, but also transformed them into opportunities for improving quality and efficiency, which promoted the healthy development of the laboratory.

(1) The quality awareness of all staff was further improved. The laboratory has established a company level, department level and employee level quality improvement hierarchical control mode, and established a solid quality bottom line thinking and risk prevention awareness. Through the monthly quality special bulletin, the company tracks and analyzes the quality of the laboratory in various links such as quality control, qualification and report, and takes it as the assessment input. Each department has established a "quality management working group", held monthly regular meetings, carried out tracking and spot checks on various quality activities, timely publicized and implemented the new documents and requirements recognized and qualified by CNAs, conveyed the new trends of the company's internal and external quality, and improved the effectiveness of quality work. The majority of employees get feedback on their work quality through rectification work and regular department meetings, know the quality status of their department, effectively control the quality risk and improve their quality work ability.

(2) The means of digital informatization were further strengthened. "Civil air defense is not as good as technical defense". In combination with the company's digital transformation strategy, the laboratory gives full play to the application and guarantee advantages of digital and information means in laboratory business and quality work, basically realizes the systematization of capacity construction, the process of capacity acceptance and the sharing of data and information, and truly realizes the opening of all mobile terminals (among which the standard and SOP documents support mobile terminal access), recognition ability, standard analysis Real time tracking of quality control activities and timely anti-counterfeiting of test reports, so as to further improve the quality level and professional ability.