More than 6,000 officials have been held accountable and handed over more than double the number of accountability files in the first round、Surface rectification、Pretending to be rectified",so,This place must not be able to escape the "turning arrow" shot by the central environmental protection inspector。truly,Because the problems found in the first round of central environmental protection inspectors were "perfunctory rectification."、Surface rectification、Pretending to be rectified",10 provinces and autonomous regions, including Hebei, have held 6,219 people accountable,610 persons were administratively and criminally detained,74"perfunctory rectification、Surface rectification、pretending to rectify" typical cases were publicly exposed。 As of Oct. 23,Hebei and other 10 provinces and regions "look back" inspectors have all been made public。The reporter of "Legal Daily" is from the Central Environmental Protection Inspectorate's Office(Hereinafter referred to as the Office of the Inspectorate)Understood,Although "looking back" found quite a few problems,There are even problems that are of a bad nature,But,The central environmental protection inspectors fully recognized the overall rectification of the 10 provinces and regions。The relevant person in charge of the Supervision Office told the "Legal Daily" reporter,"More than twice as many accountability files were handed over than in the first round of inspections"。 The reporter of "Legal Daily" noted,10The main leaders of the provincial and regional party committees and governments, as well as the provinces(district)Member of the Standing Committee of the CPC Central Committee、The executive meeting of the government attaches unprecedented importance to ecological and environmental protection issues。 For the problems of too strict supervision and environmental protection "back-up" in the society,The person in charge and relevant experts also responded。The person in charge of the Inspectorate Office pointed out,The central environmental protection inspectors are mainly to check those who "do not do things.",Disorderly officers and false officers".。As for the "back to the pot" theory,Experts say,In some places, the economic downturn is not directly related to environmental inspectors。He thinks,The pot that should not be carried by environmental protection must not be carried。 Environmental issues have been put on the table of provincial governments Some provincial party committees have not studied environmental protection work for two consecutive years;Some provinces have held meetings to convey more on environmental protection,Less research deployment,There are many slogans,Lack of implementation。2016The first round of central environmental inspections conducted in 2017 found that,It is not an isolated phenomenon that the issue of ecological and environmental protection is not ranked at the provincial level。 Two years,The Central Environmental Protection Inspectorate has not only achieved a review of 31 provinces(district、city)Full coverage of inspectors,And,Through the Central Environmental Protection Inspectorate,At the provincial level, especially at the provincial level(city、district)Party committees and governments attach more importance to ecological and environmental protection than at any other time in history。 June-July this year,The Central Environmental Protection Inspectorate launched a "retrospective" inspection of 10 provinces and autonomous regions including Hebei Province。Feedback from inspectors through "looking back".,The reporter of "Legal Daily" noted,At the level of provincial party committees and governments,The issue of ecological and environmental protection has realized the process of changing roles from supporting roles to protagonists。 From the first round of inspectors to the "look back" inspectors,Whether it's a kick-off meeting or a feedback session,Provinces(district、city)clerk、province(mayor、chairman)I will definitely show up at the venue,And that's not all,The top party and government leaders in these localities also personally presided over the meetings,Make a mobilization report,Make a statement on the inspector's opinion。 2016years,Standing Committee of Hebei Provincial Party Committee、The Standing Committee of the Provincial Government has studied and deployed 32 and 22 inspections of ecological environmental protection and supervision and rectification work respectively,The main leaders of the provincial party committee and the provincial government gave 683 instructions。2016Since July,Standing Committee of Henan Provincial Party Committee、The secretary's symposium covered 11 and 4 ecological and environmental protection issues respectively;The Standing Committee of the Provincial Government has covered 18 issues of ecological and environmental protection。2016Since the Central Environmental Protection Inspectorate,The main party and government leaders of the Inner Mongolia Autonomous Region have issued more than 130 instructions on ecological and environmental protection。2017Since June,The Ningxia Hui Autonomous Region has convened the Standing Committee of the Autonomous Regional Party Committee 31 times、Standing meetings and thematic meetings of the government,Study and solve the problems faced by the inspectors in the rectification work。 2017Since the second half of the year,The main leaders of the Heilongjiang Provincial Party Committee and the Provincial Government have successively issued 143 instructions on the work of supervision, rectification and ecological environmental protection。Jiangsu Province has convened a total of 21 meetings of the Standing Committee of the Provincial Party Committee、The Standing Committee of the Provincial Government has held 24 meetings、There were 11 special meetings of the provincial government,Study and deploy the rectification work of the central environmental protection inspectors。2017years,The Standing Committee of the Jiangxi Provincial Party Committee has been held for 9 times、The Standing Committee of the Government has studied the construction of ecological civilization and ecological and environmental protection work for eight times,The main leaders of the party and government have issued more than 70 instructions on ecological environmental protection and supervision and rectification work,He has gone deep into Jiujiang many times、On-site supervision in Ganzhou and other places。 2016Since November,Guangdong Province has convened the Standing Committee of the Provincial Party Committee 13 times、20 standing meetings of the provincial government、The provincial government held 27 special meetings to study and deploy the rectification work of environmental protection inspectors。Leaders of Guangxi Autonomous Region have conducted more than 80 in-depth on-site investigations。2016years since the Inspector,Yunnan Province convened 12 meetings of the Standing Committee of the Party Committee、24The Standing Committee of the sub-government will study Xi Jinping Thought on Ecological Civilization、Research and deploy ecological and environmental protection work。 From two years of not studying environmental protection work to such intensive meetings and deployments,Make instructions,Go to the site to supervise。Undoubtedly,Ecological and environmental issues, which were not ranked by provincial-level party committees and governments, have been put on the table of local party and government leaders。 According to the Inspector's Office,This year, the 53 typical cases made public during the "retrospective" inspector's stationing,Relevant localities have taken the initiative to hold 513 people accountable,thereinto,There are 17 department-level cadres,There are 132 cadres at the department level。And there is no decision of the provincial party committee and government behind this,I am afraid that so many people will also be held accountable,In particular, there are 17 department-level cadres among them。 10Provincial and regional rectification has been affirmed but there are differences Does the provincial party committee and government attach so much importance to it that there is no problem of ecological and environmental damage at the local level??The problems found by the central environmental protection inspectors are not all rectified in place?Judging from the "looking back" inspector opinions fed back by the central environmental protection inspectors to 10 provinces and regions,Apparently not exactly。Take a closer look at the inspector feedback reports from 10 provinces and regions,It's not hard to see,10It is true that the rectification of the provinces and regions is not completely in place,Some of the problems of fraud are still very prominent,And there are obvious differences from place to place。This can also be seen from the central environmental protection inspector's evaluation of the rectification of 10 provinces and regions。 10May 18th,Zhu Zhixin, head of the first environmental protection inspection team of the central government, gave feedback to Hebei Province on the general evaluation of Hebei Province's rectification:"Significant progress and results have been achieved。Guangdong Province and Jiangsu Province are also commented upon。Central Environmental Protection Inspectorate for Henan Province、The evaluation of Inner Mongolia and Ningxia Autonomous Region is::"Important progress and results have been made in the rectification work。The evaluation of Heilongjiang Province is that "the rectification work has made certain progress and results";to Jiangxi Province、Guangxi Autonomous Region and Yunnan Province were assessed as "positive progress and results"。 According to the "Legal Daily" reporter learned from the Inspectorate's Office,10On the whole, the rectification and reform of the provinces and regions is good,But there are real differences。"Hebei、Guangdong and Jiangsu provinces have made great efforts to rectify and reform。The person in charge of the Inspectorate said,Especially Hebei Province and Guangdong Province,"Hebei Province is a pilot province for central environmental protection inspection,After the Central Environmental Protection Inspectorate,Hebei Province has achieved remarkable results in air pollution control,It really deserves to be affirmed。The person in charge said,The same is true for Guangdong Province,In some places, water pollution control, especially the treatment of black and odorous water bodies, is still far from the target required by the state,But Guangdong Province is really invested in real governance。 "There are indeed some provinces(district)The rectification action is slow,In some provinces, there are many problems with fraud,Some places think that the rectification has been done very well."。The person in charge noted,Although the inspection team's evaluation of the rectification of the Ningxia Autonomous Region is not "the highest level",But he thinks,After the arrival of Secretary Shi Taifeng of Ningxia Autonomous Region,The central environmental protection inspectors have been very strict in rectifying the problems found。The person in charge said,The ecological environment of the Ningxia Autonomous Region has become much better than before 2016。 From the first round of central environmental protection inspectors to "looking back" inspectors,The central environmental protection inspectors are raising the awareness of the ecological environment of local party and government leaders at all levels,The role played in promoting the improvement of local ecological quality has attracted worldwide attention,Particularly to inaction、The level of accountability for slow and chaotic officials is unprecedented。Because of this,The central environmental protection inspectors have indeed moved the "cheese" of some local people。thereupon,Accusing the central environmental inspectorate of being too harsh,Let the voice of the central environmental protection inspector take the blame again。 on this,The person in charge of the Supervision Office told the reporter of the "Legal Daily" that he said,There is a principle that the Central Environmental Inspectorate will grasp when inspecting:"As long as this place really works,It's really promoting pollution control,so,Even if the environmental factors such as water vapor in this place do not meet the targets set by the state for the time being,The central environmental inspectors will not hold on to it,They will not raise it as a problem to the local party committee and government when giving feedback。Instead, praise will be given to these places。The person in charge noted,Water bodies in some parts of Guangdong Province are very polluted,Especially Shenzhen and Dongguan,But,These two places are really invested in the treatment of black and odorous water bodies,True governance,"In 2017 alone, more than 30 billion were spent,Thousands of kilometers of sewerage networks have been built。The person in charge said,Although at present, some black and odorous water bodies in these cities have not yet reached the standard,But,"They did,Some have already worked,The water doesn't smell anymore,We want to be praised。He stressed,The central environmental protection inspector checked that he was not working、Fake work、Messy work。 Some localities are trying to let environmental protection, especially environmental protection inspectors, "take the blame" on the problem,The expert told the "Legal Daily" reporter,The Ningxia Autonomous Region Economic and Information Commission tried to shirk responsibility by "taking the blame" for environmental protection、Interference decision-making is a case in point。 6May 15th,The Economic and Information Commission of Ningxia Autonomous Region reported at the 10th executive meeting of the autonomous regional government,The whole area was shut down due to environmental protection、There are 106 limited production enterprises,It will affect the growth rate of the whole region by 4 percentage points。The results of the "looking back" inspection team on the field were yes,106In enterprises that stop and limit production,In fact, 52 households were affected by market fluctuations,Although the remaining 54 enterprises have the reasons for stopping production and limiting production due to the battle against air pollution,But upon further verification,It is mainly due to market reasons。 As specified,Whether it is the central environmental protection inspector or the "looking back" inspector,After the feedback ends,It is necessary to simultaneously hand over to the local party committees and governments the issue of investigating responsibility for ecological and environmental damage。"In the first round of inspectors,More than 10 accountability files are usually handed over,At most times, it even reaches 20。However, this time, the 'retrospective' inspector only handed over 66 accountability issues at the same time。An average of one province(district)That's 6 to 7,More than twice as many accountability issues as in the first round of inspector handovers。The person in charge of the Inspectorate said,The 10 provinces and autonomous regions that have "looked back" have indeed done a good job of rectification and reform,This is also the main reason for the significant reduction in the number of accountability files transferred。 For the problem of not being in place to rectify the problems found in the "retrospective".,The person in charge noted,The Central Environmental Protection Inspectorate will take a letter of notification as appropriate、Notification、Interviews、special supervision and other measures,Hold on to the problem、Keep an eye on it,to supervise the actual effectiveness of rectification,Win the trust of the people。 source：Legal Daily reporter Xu Jianronghttp://www.legaldaily.com.cn/index_article/content/2018-10/25/content_7675651.htm Statements：This number is reprinted、share、statement、Views remain neutral，The purpose is only to convey more information，The copyright belongs to the original author。If the copyright of the work is involved，Please contact us，We will remove the content as soon as possible! ...

Notice of the State Drug Administration on the suspension and rectification of Tianjin Vivadentai Biotechnology Co., Ltd. (No. 104 of 2018) Recently，The State Drug Administration organized an unannounced inspection of Tianjin Vivadentai Biotechnology Co., Ltd。Checking，The following deficiencies were found in the company's quality management system： One、In terms of organization and personnel, the company appointed a management representative on May 1, 2017，However, the actual work is sales and research and development，The company has not taken steps to raise awareness among employees of the requirements of the quality management system，It does not comply with the "Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Specification") in which the management representative is responsible for the establishment、Implement and maintain a quality management system，Report on the operation of the quality management system and the need for improvement，Improve employee compliance with regulations、Requirements for the awareness of regulations and customer requirements。 Two、In terms of equipment, the company is not equipped with equipment to detect X-ray blocking items，Testing has not been commissioned，Enterprises that do not comply with the "Specification" shall be equipped with inspection instruments and equipment that are compatible with the product inspection requirements，The main inspection instruments and equipment shall have clear requirements for operating procedures。 Three、In terms of design and development, the output data of the company's product design and development does not include the product formula，The following performance index requirements in the product technical requirements are not included：X-ray blocking、Tensile bond strength、Shear bond strength、Composition and percentage，The design and development output of enterprises that do not comply with the "Specification" shall meet the input requirements，Procurement is included、Information required for production and service、requirements for product technical requirements, etc。 Four、Production management (1) Enterprise process flow chart (SC-SOP-01，Edition B/2017) stipulates the process as follows:：Raw material procurement, inspection, material breaking, lathe processing, polishing, curing, cleaning, inspection, packaging, warehousing，The company changed the actual production process to lathe processing - material breaking，Failure to compile material cutting process regulations and work instructions，Spot check production records (JL-7.5-03, fiberglass piles，Specification and model VIVAdental-V3, production batch number 180608) changed the production process as:：Wash - cure，Enterprises that do not comply with the "Specification" shall prepare production process regulations、Work instructions, etc，Clarify the requirements of key processes and special processes。 (2) Spot check the production records of enterprises (JL-7.5-03，Fiberglass piles，Specification model VIVAdental-V3, production lot number 180608)，The batch quantity is not recorded、Process parameters、Main equipment，Each batch (Taiwan) of products that do not comply with the "Specification" shall have production records，and meet the requirements of traceability。 Five、In terms of quality control, the following performance indicators in the registered product technical requirements are not covered by the company's product inspection procedures：Flexural performance、Flexural modulus of elasticity、X-ray blocking properties、Tensile bond strength、Shear bond strength、Composition and percentage，Enterprises that do not comply with the "Specification" shall formulate product inspection procedures according to the mandatory standards and the technical requirements of the products that have been registered or recorded，And the requirements for issuing corresponding inspection reports or certificates。 Tianjin Vivadentai Biotechnology Co., Ltd. has confirmed the deficiencies in its quality management system。The above behavior of the enterprise did not comply with the relevant provisions of the Good Manufacturing Practice for Medical Devices，There are serious deficiencies in the production quality management system，The State Drug Administration instructed the Tianjin Municipal Commission for Market and Quality Supervision to order the enterprise to immediately suspend production for rectification in accordance with the law，For those involved in violation of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council) and relevant laws and regulations，Handle it seriously in accordance with the law。At the same time, the Tianjin Municipal Market and Quality Supervision and Administration Commission was instructed to require the enterprise to assess product safety risks，It may lead to potential safety hazards，It should be in accordance with the provisions of the "Administrative Measures for the Recall of Medical Devices" (Order No. 29 of the State Food and Drug Administration).，Product recall。 Production can only be resumed after the enterprise completes all project rectification and is qualified by the Tianjin Market and Quality Supervision and Administration Commission。 Notice is hereby given。 State Food and Drug Administration October 18, 2018 Notice of the State Drug Administration on the Suspension of Production and Rectification of Nanjing Yigao Microwave System Engineering Co., Ltd. (No. 105 of 2018) Recently，The State Drug Administration organized an unannounced inspection of Nanjing Yigao Microwave System Engineering Co., Ltd。Checking，The following deficiencies were found in the company's quality management system： One、In terms of equipment, material weighing is not equipped with suitable weighing equipment，Such as in warehouse 1，The transformer material is placed in a dense manner without packaging，Some of the transformer insulation was scratched，Detection of the number of stainless steel bars in and out of the warehouse，Managers say that the weighing method is used to determine this，During verification, it was found that the stainless steel strip was sagging to the ground，Cannot be weighed accurately，Enterprises that do not comply with the "Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Specification") shall be equipped with appropriate measuring instruments，The measuring range and accuracy of the measuring instrument shall meet the requirements of use，Measuring instruments shall be marked with the validity period of their calibration，Requirements for keeping appropriate records。 Two、In terms of design and development, the power output of the bipolar coagulation mode of the high-frequency surgical system of the enterprise has changed from 0-120W to 0-80W，Failure to provide confirmed design change materials，It does not meet the requirements of the Code that enterprises should identify and keep records of changes in design and development。 Three、Production management: On-site verification of high-frequency electrosurgical unit (No. 16121506)，The company failed to provide relevant production inspection records，Not traceable，Each batch (Taiwan) of products that do not comply with the "Specification" shall have production records，and meet the requirements of traceability。 Four、In terms of quality control, the company failed to formulate factory inspection procedures and inspections in strict accordance with the national mandatory standards，GB9706.4 requires a high-frequency leakage current to test the load resistance of 200 ohms，Test resistance 200 ohms，Line spacing 50cm，The load resistance for the operator is 400 ohms，Test resistance 200 ohms，Line spacing 25cm for testing，Spot check cable withstand voltage test during the production process，The operating procedure requires 10s to 1000V，Hold for 1min；Actually 20s to 1000V，Keep it for 40s，In the finished product inspection，The high-frequency leakage current test requires 10s to 1000V，Hold for 1min，Actually in 18s it rises to 4000V，Hold for 42s，Enterprises that do not comply with the "Specification" shall formulate product inspection procedures according to the mandatory standards and the technical requirements of the products that have been registered or recorded，And the requirements for issuing the corresponding inspection report or certificate。 Nanjing Yigao Microwave System Engineering Co., Ltd. has confirmed the defects in its quality management system。The above behavior of the enterprise did not comply with the relevant provisions of the Good Manufacturing Practice for Medical Devices，There are serious deficiencies in the production quality management system，The State Drug Administration instructed the Jiangsu Provincial Food and Drug Administration to order the enterprise to immediately stop production and rectify in accordance with the law，For those involved in violation of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council) and relevant laws and regulations，Handle it seriously in accordance with the law。At the same time, the Jiangsu Provincial Food and Drug Administration was instructed to require the company to assess product safety risks，It may lead to potential safety hazards，It should be in accordance with the provisions of the "Administrative Measures for the Recall of Medical Devices" (Order No. 29 of the State Food and Drug Administration).，Product recall。 Production can only be resumed after the enterprise completes all project rectification and is qualified by the Jiangsu Provincial Food and Drug Administration。 Notice is hereby given。 NMPA October 18, 2018 ...

GB/T 19001-2016/ISO 9001：2015"Quality Management System Requirements" since its issuance，For new additions and changes to the standard，Each certification body organizes discussions with relevant professionals，At the same time, the content of the original standard is compared，to enhance understanding and unify understanding。Here, the author focuses on GB/T 19001-2016/ISO 9001：2015Standard 8.5.1f) "When the output cannot be verified by subsequent monitoring or measurement."，Confirm and periodically reconfirm the ability to realize the process planning of product and service provision".，This process is often referred to as a special process。 For every production enterprise，Planning and control processes in operation，should be recognized、Determine the special processes in the production process。Because special processes are the key processes that affect the intrinsic quality characteristics of the product，Hence how to control the special process，Whether or not to confirm the process capability，How to confirm the process capability，and the timing of confirmation、methods, etc，Affects the ability of process results to meet requirements，It plays an important role in achieving product quality goals。This article is based on this background，This paper attempts to explore the role of certification audit in improving the performance of process management。 Related theories and literature review certification audit "Certification and Accreditation Regulations" pointed out，Certification is the certification of an organization's products by a nationally recognized certification body、serve、The management system complies with the relevant technical specifications、Conformity assessment activities of mandatory requirements or standards of relevant technical specifications。 Audit (GB/T 19000-2016 in 3.13.1)，A system to obtain audit evidence and conduct an objective evaluation to determine the extent to which audit criteria are met、Independent、The process of forming a document。 Accreditation is based on standards and technical specifications，Help enterprises to establish a quality management system for sustainable improvement，And through the transmission of trust mechanism, guide all parties in society to participate in quality co-governance，For products that improve at the micro level、serve、The quality of the project and even the quality of economic development at the macro level，All of them play a role in basic guarantee and leading promotion。 Special Process Special Process (GB/T 19000-2008 4.1 Note 3)：The process of verifying whether a product is qualified or unsatisfactory or uneconomically。 Special Procedures (GJB 1405A-2006 in 4.2)：Intuitive and not easy to spot、The process by which the intrinsic quality characteristics of a product are formed that are not easily or economically measurable。Chemistry is often included、metallurgy、creature、optics、electronic and other processes。In machining，The common ones are casting、forging、weld、Surface treatment、heat treatment, etc。 It can be seen from this，Special processes are inherent。During the implementation of special processes，The intrinsic quality characteristics of the product have changed。Company H as an example in this article is an aluminum alloy profile processing enterprise，Determine "aging processing" as a special process，The author found in combination with the on-site audit，Explain the impact of product quality caused by the uncontrolled process of special processes，Further clarify the importance of certification audits in facilitating enterprise process management、The role of improving process management performance。 Process Management Performance Process management refers to:：Use a set of practical methods、technology and tools to curate、Control and improve the effectiveness of the process、Efficiency and adaptability，Including process planning、Process implementation、There are four parts: process monitoring (inspection) and process improvement (disposal).，That is, the PDCA cycle has four stages。The PDCA cycle is also known as the Deming cycle，It was put forward by Deming, a master of quality management, on the basis of Sheukhart's idea of statistical process control。 The ISO 9001 standard proposes a process-based quality management system，Continuous improvement of the quality management system through the four stages of the PDCA cycle。This paper mainly discusses the special processes involved in the production of enterprises，Further focus on the significant impact of special process management on product quality characteristics，to analyze how enterprises can make good use of GB/T 19001-2016/ISO 9001：2015standard，Identified in accordance with the requirements of 8.5.1f、Confirm the special process，Confirmation of the ability of the special process to meet the requirements，and carry out effective control，Promote the improvement of process management performance。 Performance (GB/T 19000-2016 3.7.8)，Measurable results，Quantitative or qualitative results may be involved。Performance is an indicator that reflects the effectiveness and effectiveness of an organization's operations，It can be measured by a set of indicators，It is influenced by different research objects and different research angles，Scholars also differ in their definitions of organizational performance，But scholars generally agree on one view，It's that performance is a composition, not just a concept。 Peter S. F. Drucker thinks，Effectiveness refers to the ability to do the right thing，That is, setting an appropriate goal and achieving that goal。 Process management performance，It is a combination of a set of evaluation process indicators，It is used to measure the quality of enterprise process control results。In this paper, the classification of process management performance evaluation indicators is mainly process indicators and quality indicators。 Certification audit theory basis standard Understand the requirements of GB/T 19001-2016 standard 8.5.1f) GB/T 19001-2016 standard 8.5.1 control of production and service provision，It is based on GB/T 19001-2008 standard 7.5.1 "Production and service provision process control" and 7.5.2 "Confirmation of production and service provision process".，The requirements have been consolidated and expanded。From the structural design of the standard clauses，GB/T 19001-2016 will be the 2008 version of the standard 7.5.1、7.5.2The Terms are consolidated into Clause 8.5.1，Requires organizations to set controls for product and service provision，combined with the nature of its products and services，Determine what controlled conditions are required in the production and service process，Plan and determine what specific controls to be in place。This clause gives controlled conditions in a) ~ h) 8 aspects，where f) "when the output cannot be verified by subsequent monitoring or measurement."，Confirm and periodically review the ability to plan the process of realizing product and service provision"，It is also one of the controlled conditions。Compared with the 2008 version of Standard 7.5.2，It is further emphasized that the process is an integral part of the production and service process，It is a key process that affects the intrinsic quality characteristics of the product，It is necessary to devise specific methods and measures to control them，And in the production process, the process capacity is confirmed and reconfirmed according to the planned arrangement。 GB/T 19001-2008 standard 7.5.2 audit practice The author combines years of audit practice and review of audit materials，It is calculated from the audit data information of 100 production enterprises，Clause 7.5.2 of GB/T 19001-2008 standard，50%of the production enterprises chose to delete，The reason is：The production process of the company's products can be verified by inspection，Processes that do not occur after the product has been used or the problem has become apparent after the service has been delivered。The other 50% did not delete the reviewee of the clause，While identifying and identifying the processes that need to be confirmed in the production process，Guidelines and methodologies for process capability validation are set out in the document，Required when the device、personnel、craft、When there is a change in any conditions such as materials，The process capability should be reconfirmed。But the audit found，80%The auditee above only provides a "Process Capability Qualification" table for the process to be validated at the time of initial certification，After that, the annual audit is "equipment."、personnel、craft、No change in material"，Evidence of process capability confirmation cannot be provided。However, in the actual production process，As customer requirements change、The need for quality upgrades or changes in suppliers，will cause the material、craft、equipment、Changes in any one or more of the personnel。Reasons for this result：First, enterprises do not understand the special process，At the time of quality management system planning，The methods and guidelines for confirming the capability of the process do not correspond to the actual characteristics of the product，Confirmation results do not confirm that the process capability meets the quality characteristics，Therefore, it is believed that "doing such evidence" is only for the purpose of certification，There is no practical point；Second, enterprises have their own methods for confirming process capabilities，Because of the lack of understanding of the requirements of the standard，Therefore, effective process validation is excluded from the management system，As a result, the certification audit cannot be obtained。visible，How can companies incorporate effective controls into their management systems，How can auditors collect effective evidence of enterprise process control during the audit process，It directly affects the awareness and trust of enterprises in certification audits，This affects the role of certification audit on the improvement of enterprise process management performance。 Certification Audit and Enterprise Process Management Performance Case Study GB/T19001-2016 Standard 8.5.1 Incorporates the processes that need to be confirmed into the control，First, inappropriate prunings were avoided，Second, the framework and requirements for identifying guidelines and methods have been removed，It is more conducive to the effective combination of the actual control of the production process and the application of standards。The following is a case study of Company H's 2015 surveillance audit，Take the audit found that the special process (timeliness treatment) control is not in compliance with the situation and rectification as an example，Analyze and discuss the role of certification audit in improving the performance of enterprise process management.。 Company Information Company H was established in May 2003，The registered capital is 100 million yuan，It is a private enterprise engaged in the processing of various aluminum alloy profiles。At present, the company has a total of 14 sets of 500T~2600T and continuous extruders and supporting electrophoresis、oxidation、Spraying (introduction of Gema in Switzerland)、Thermal insulation and energy-saving door and window profile composite production line、Several solar photovoltaic frame deep processing production lines and other supporting facilities，It is able to produce more than 300mm of external circles，An extra-long complex cross-sectional profile with an effective length of 14 meters。At present, the company has an annual output of 1060、6063、6005、6061、6082and other alloys, aluminum alloy profiles of more than 30,000 tons。From 2004 to 2005, the company completed the GB/T 19001 quality management system in two steps、GB/T 24001 Environmental Management System、GB/T 28001 Occupational Health and Safety Management System Certification。 Case Background The company's management manual identifies the determination of extrusion、aging、oxidation、spray coating、Electrophoresis is a special process。 20143 non-conformance reports were issued during the annual supervision and audit，Among them, "the No. 3 furnace on site is aging the product with the profile number TM079 of alloy 6005T5，The "Extrusion Process Operation Procedure" used in the workshop does not extrude the alloy grade、Specification of aging process parameters"，不符合GB/T ...