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"，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。 Special Process Process Control Analysis Non-conforming materials submitted in 2014：Non-conformity cause analysis：The company does not have a good understanding of standard learning，The field is controlled by experience，Process parameters were not developed as required；Non-compliance with corrective actions：Modification of "Extrusion Process Operating Regulations"，Increase extrusion、Aging process parameters；The aging treatment, heating temperature and holding time are specified。 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，Enterprises should comply with GB/T Read More …
