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。
相关理论及文献综述
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 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。
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。
认证审核理论依据标准
认证审核与企业过程管理绩效案例分析
GB/T19001-2016标准8.5.1将需要确认的过程并入受控，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.。
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"，It does not meet the requirements of clause 7.5.1 of GB/T 19001-2008 standard。
20152 non-conformity reports were issued for annual supervision and audit，thereinto：The on-site aging furnace is being aged and kept warm for 6063T5 products，6The temperature of each area is displayed separately：158℃、172℃、183℃、174℃、193℃、188℃、216℃；4The insulation temperature of each zone does not meet the requirements of 190 °C ± 5 °C required by the "Extrusion Process Operation Regulations".，It also does not meet the requirements of clause 7.5.1 of GB/T 19001-2008 standard。
The above two audits found non-conformity，On the surface, the problem is different，It is not a product of the same grade，And one is process planning，One is process control，However, the essence is "aging treatment" process control，"Timeliness" is a special process，Changes that affect the intrinsic quality characteristics of the product。
2015The year is the second supervision and audit of the quality management system，Combined with the first supervision and audit of the environmental and occupational health and safety management system，The audit team consists of team leaders, 4 auditors (1 of whom is an intern)，The level auditors are all professional auditors，Have professional audit capabilities，And the audit team leader has a basic understanding of the production process of the enterprise。2015On September 18, he had professional communication with the members of the group at the audit preparation meeting，At the same time, it is reminded that the audit process should focus on tracking the effectiveness of corrective actions that did not meet the requirements of the previous year：extrusion、Review and extrusion of suitability of aging process indicators、Aging process execution and control。
During the on-site audit，Professional auditors on the key processes of production：extrusion、aging、oxidation、spray coating、electrophoresis, etc，Sampling inspections were carried out according to the method of process audit，Relevant documents and records were consulted，And the focus is on extrusion、Process documentation for aging furnaces，The production workshop provides the "Extrusion Process Operating Regulations"，File to extrusion temperature、Transmission speed、The aging treatment, heating temperature and holding time are specified；Follow-up review and confirmation of the specified process parameters，The company offers a "squeeze."、Validation form of aging process"，Confirm that the device meets the requirements，Personnel are trained，Process stability"，For devices、personnel、What is the basis for the process to meet the requirements?，Unable to provide relevant evidentiary materials。The team leader communicated with the relevant person in charge of the enterprise，Understand the actual situation at which the process parameters were determined。According to the head of the enterprise：The temperature of the extrusion process of the aluminum alloy profile、Transmission speed，The temperature of each section of the aging furnace，Warming、The time to keep warm，The production team has been debugged many times，Finalized process specifications。The audit team also asked the production team to provide the temperature of the multiple commissioning processes、Recording of the time and hardness test results。For the site, no evidence was provided to the professional auditor，The squad leader explained，According to the different requirements of customers for product performance，Frequent adjustments to the production process，It's all recorded in a small notebook，Not controlled within the scope of the management system，What is controlled is the "squeezing."、Validation form of aging process"。
The results of the analysis can be seen，Enterprises because of the lack of understanding of the requirements of the standard，Exclude valid process capability validation from the management system。If the audit process cannot be tracked in depth and continuously，It will lead to the failure to collect evidence，The management system of certification audit and the actual process management of the enterprise are "two skins"，Helping companies establish a quality management system for sustainable improvement has become an empty phrase。
The audit team further observed the actual control of the process on site，It was found that the aging furnace was undergoing aging insulation of 6063T5 products，7The temperature of each area is displayed separately：158℃、172℃、183℃、174℃、193℃、188℃、216℃，The insulation temperature of 5 of the zones did not meet the requirements of 190°C ±5°C。The purpose of aging treatment of aluminum alloy profiles is to eliminate the internal stress of the workpiece，Stabilize tissue and size，improve mechanical properties, etc，Manual aging processing，The allowable deviation of the heating temperature of aluminum alloy solution treatment is only 5°C，So，Poor control may affect the quality of product performance。The audit team communicated with the supervisor of the auditee，A non-compliance report was issued for this。In the process of discussion and communication with management representatives，The two sides also held full discussions on this issue，Representatives of business managers recognized，Aging treatment of the heating process、Maintain temperature、Holding time is the main reason affecting the performance and quality of aluminum alloy profiles。
At the last meeting, the head of the audit team put forward requirements for non-compliance rectification，The difference between corrective and corrective actions is explained，Emphasis is placed on starting with "people."、machine、material、law、ring、and other aspects to analyze and find the cause of the temperature difference，Develop corrective actions for the cause，Ensure the effectiveness of improvements，It is also required to provide evidence of the hardness index inspection of the batch of products together with the rectification materials。
on this，The management representatives of the enterprise attach great importance to it，The production department is clearly required to organize the extrusion workshop，The quality inspection department cooperates with the cause analysis of the non-conformity，Implement corrections、Corrective Actions。On October 14, 2015, the company submitted a non-compliant closure material：The hardness test record of this batch of products，The results are qualified；Non-conformance rectification report。
Cause analysis：The production department organized personnel to inspect the aging furnace and the temperature gauge，Search through several aspects，Finally, it was found that the temperature display of 7 areas of the large aging furnace was inconsistent，The main reason is that there are 6 areas where the thermocouples are loose and not in place，This results in a discrepancy between the measured temperature and the actual temperature。
Corrective Actions：Production maintenance personnel repair thermocouples in all 7 areas，After resetting the thermocouple that is not in place，After many observations and data tracking，The actual temperature measured is consistent with the specified temperature of the process。
Verification of effectiveness：Display photo of the actual temperature measured during the heating process and holding process of aging furnace 6063T5 (October 14, 2015)；Tracking record of the data after the thermocouple reset of the aging furnace and evidence of passing the hardness test (tracking data from September 23 to September 28, 2015.)，and the test data on October 14)。
The results of the analysis can be seen，企业应按照GB/T 19001-2016/ISO 9001：2015标准8.5.1f）要求，与生产工艺和过程实际结合，策划特殊过程确认和再确认的时机、method，按策划对特殊过程的设备状态、工艺指标进行定期确认，将质量管理体系融入生产经营管理过程，为认证审核提供可信的证据，从而使认证认可能够通过传递信任机制，对提高产品及服务质量提升发挥引领作用。
2016January 6，审核组长进一步跟踪了不符合整改后续的持续有效性，企业提供信息：2015年9~12月工业材出厂合格率98.7%，比1~8月份96.8%提高1.9%；9~12月产量6815.279吨，退货87.9吨，退货率1.3%； 2015year、2014年产销量、质量、退货等数据，其中2015年产销量17905.46吨，比2014年多销3415吨；出厂不合格品退货回炉率：2015年为26.1%，2014年为42%；2015年产销量大而退货回炉率却低于2014年。
分析结果进一步阐明，企业对于不符合整改结合实际，从“人、machine、material、law、ring、测”各方面进行分析，必要时采取统计技术，找到问题的主要原因，针对原因采取措施才能防止问题的再次发生。审核组对于企业的整改材料，应以有效证据为依据，以真正引导企业解决问题为目的，强化企业对认证审核的认识和信任，充分发挥认证审核对企业提升过程管理绩效的作用。
针对这次的不符合整改，企业召开了专题会议，对GB/T 19001标准的实际应用展开了讨论，进一步理解特殊过程要求；从2014年认证审核对挤压、时效保温工艺规定不符合的整改，到2015年认证审核现场工艺控制不符合的整改，进行了全面分析，并以此为契机举一反三，对挤压、氧化过程设备、温控仪表都进行了检查，并对工艺指标进行了评审和确认。
The results of the analysis can be seen，认证审核促进了企业对过程管理的重视，从而提高了过程管理的绩效。
2014年开展的中国企业ISO 9001认证有效性调查表明，我国获证企业的质量满意度高达98%。presently，全国通过质量管理体系认证的企业只占全国企业总量不到2%，因此充分发挥认证认可的服务效能，提高认证审核的技术水平，促进企业产品质量和过程管理绩效提升，对于认证事业的持续发展将起到积极重要的作用。
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