System management method based on quality management system

Abstract

The invention discloses a system management method based on a quality management system, and relates to the technical field of quality management auditing, and the method comprises the following steps: generating an auditing authentication system based on a quality management system standard, the auditing authentication system comprises a plurality of auditing modules, and each auditing module corresponds to an auditing theme; based on the enterprise product production process condition, the enterprise product production process is divided into a plurality of process links, the process links comprise key processes and auxiliary processes, and the auxiliary processes are auxiliary machining processes of the key processes; and the auditing and authenticating personnel associates the process links of the target enterprise product based on the auditing theme corresponding to the auditing module, and obtains the process links associated with auditing and authenticating corresponding to each auditing module and the number of the process links. Based on the characteristics and requirements of different enterprises, each auditing module and process link in the auditing system are associated, selected and adjusted, so that the actual situation of the enterprise is ensured, and systematic distributed auditing is realized.

Description

Technical Field

[0001] The present invention relates to the technical field of quality management auditing, and in particular to a system management method based on a quality management system. Background Art

[0002] The ISO9001 standard is an international quality management system certification standard, and its main function is to improve the quality management process of an enterprise. During the system audit, the system certification body assigns an audit team to conduct a document review and on-site audit of the applied quality system. The purpose of the document review is mainly to review whether the provisions of the quality manual submitted by the applicant meet the requirements of the applied quality assurance standards. Only when the document review is passed can the on-site audit be carried out. The main purpose of the on-site audit is to collect objective evidence to check and assess whether the operation of the quality system is consistent with the provisions of the quality manual, confirm the extent to which it meets the requirements of the quality assurance standards, give an audit conclusion, and submit an audit report to the system certification body. For certification bodies, this standard is generally used to audit customers. At present, the audit method generally implemented by certification bodies is to implement certification audit activities based on the existing departments of the organization. The auditors prepare plans and then go to the enterprise site to audit and implement them according to the plans. The current method has the advantage of high flexibility. Different auditors can prepare relevant plans on their own and implement audits according to the plans.

[0003] However, auditors prepare their own plans. Due to the differences in the levels of auditors, plans are often unreasonable and not systematic from the beginning, and standard clauses are often missing. During the audit process, plans are arranged but the audit inspections are not implemented. The coverage and comprehensiveness of the audit and certification cannot be ensured, which affects the accuracy and effectiveness of the audit results. Summary of the invention

[0004] The purpose of the present invention is to provide a quality management system based on the management method to solve the above-mentioned deficiencies in the prior art.

[0005] In order to achieve the above object, the present invention provides the following technical solution: a system management method based on a quality management system, comprising the following steps:

[0006] Step S1: Generate an audit and certification system based on the quality management system standard, wherein the audit and certification system includes multiple audit modules, each audit module corresponds to an audit subject;

[0007] Step S2: Based on the production process of the enterprise's products, the production process of the enterprise's products is divided into multiple process links, and the process links include key processes and auxiliary processes, wherein the auxiliary processes are auxiliary processing processes of the key processes;

[0008] Step S3: The audit and certification personnel associate the target enterprise's product process links based on the audit subject corresponding to the audit module, obtain the process links and the number of process links corresponding to each audit module, and integrate them to obtain the audit data set;

[0009] Step S4: Perform an audit scope coverage assessment analysis based on the audit data set, calculate and obtain the audit scope coverage coefficient, and perform a threshold determination analysis on the audit coverage coefficient;

[0010] Step S5: Evaluate and analyze the comprehensiveness of the process audit based on the audit data set, calculate and obtain the comprehensive audit index of the process, and perform threshold determination analysis on the comprehensive audit index;

[0011] Step S6: The target enterprise fills in and uploads the data information records of each process link based on the audit process link associated with each audit module. The audit module audits based on the uploaded data records and outputs the audit certification results.

[0012] As a further description of the above technical solution: the audit data set includes: {(H1, G1), (H2, G2), (H3, G3)..(Hn, Gn)}, where Hn represents the nth audit module, and Gn represents the number of process links associated with the nth audit module.

[0013] As a further description of the above technical solution: In step 4, the audit scope coverage assessment management analysis is performed based on the audit data set, the audit scope coverage coefficient is calculated, and the threshold determination analysis of the audit coverage coefficient is performed specifically including the following steps:

[0014] S4.1: Retrieve the key processes and auxiliary processes in the production process of the enterprise's products, integrate and calculate to obtain the theoretical audit coverage parameter Fa;

[0015] S4.2: Based on the audit data set, associate the key processes and auxiliary processes in the production process of the enterprise's products, obtain the key processes and auxiliary processes that have not been audited and certified by the audit module, and integrate and calculate to obtain the actual audit coverage parameter Fb;

[0016] S4.3: Calculate the audit coverage coefficient K based on the theoretical audit coverage parameter Fa and the actual audit coverage parameter Fb, where

[0017] S4.4: Set the audit scope coverage coefficient threshold Ke, and compare the audit scope coverage coefficient K with the audit scope coverage coefficient preset Ke;

[0018] S4.5: When K<Ke, the process returns to step S3. The audit and certification personnel re-associate the target enterprise's product process links based on the audit subject corresponding to the audit module. When K≥Ke, the process goes to step S4.

[0019] As a further description of the above technical solution: Retrieving the key processes and auxiliary processes in the production process of the enterprise's products, integrating and calculating to obtain the theoretical audit coverage parameter Fa specifically includes the following steps:

[0020] Integrate the auxiliary processes, and obtain an auxiliary process set by integrating the auxiliary processes corresponding to the same key process;

[0021] The theoretical audit coverage parameter Fa is obtained by summing up the number of key processes and the number of auxiliary process sets.

[0022] As a further description of the above technical solution: obtaining the key processes and auxiliary processes of the audit-uncertified modules, and integrating and calculating to obtain the actual audit coverage parameter Fb specifically includes the following steps:

[0023] Obtain the number of key processes that have not been audited by the audit module and mark them as key process range parameter P;

[0024] Collect the auxiliary processes that have not been reviewed by the audit module, and obtain the number j of auxiliary processes in the auxiliary process set corresponding to the current auxiliary process, and calculate the current auxiliary process range parameter f, where

[0025]

[0026] Repeat the calculation of the range parameters of all other auxiliary processes that have not been audited by the audited module and sum them up to obtain the overall auxiliary process range parameter F;

[0027] Subtract the key process unaudited coverage parameter P and the auxiliary process unaudited coverage parameter F from the theoretical audit coverage parameter Fa to obtain the actual audit coverage parameter Fb.

[0028] As a further description of the above technical solution: Step 3 also includes: counting the key processes and auxiliary processes that have not been audited and certified by the audited modules, and integrating and displaying the key processes and auxiliary processes that have not been audited and certified by the audited modules.

[0029] As a further description of the above technical solution: Based on the audit data set, the comprehensiveness of the process link audit is evaluated and analyzed, and the comprehensiveness audit index of the process link is calculated and obtained, which specifically includes the following steps:

[0030] Collect the key processes of the audit module and calculate the comprehensive audit index Qz of the key processes;

[0031] Collect the auxiliary processes of the audit module for related audit and certification, and calculate the comprehensive audit index Qf of the auxiliary processes;

[0032] The comprehensive audit index Qg of the process link is obtained by summing up the comprehensive audit index Qz of the key process and the comprehensive audit index Qf of the auxiliary process.

[0033] As a further description of the above technical solution: the key process of the collection and audit module associated audit and certification and the auxiliary process of the collection and audit module associated audit and certification are specifically:

[0034] The number of process links associated with the audit module is divided to obtain Gn∈(Xn,Yn), where Xn+Yn=Gn, Xn represents the number of key processes associated with the audit of the nth audit module, and Yn represents the number of auxiliary processes associated with the audit of the nth audit module.

[0035] As a further description of the above technical solution: the calculation formula of the comprehensive audit index Qz of the key process is:

[0036]

[0037] The calculation formula of the comprehensive audit index Qf of the auxiliary process is:

[0038]

[0039] Where Xn represents the number of key processes audited by the nth audit module, Yn represents the number of auxiliary processes audited by the nth audit module, and μ z , μ f are weight coefficients, where μ z >μ f >0.

[0040] As a further description of the above technical solution: the threshold determination analysis of the comprehensive review index specifically includes the following steps:

[0041] Set the comprehensive audit index threshold Qe;

[0042] Compare the comprehensive audit index Qg of the process link with the surface audit index threshold Qe;

[0043] When Qg<Qe, the process returns to step S3, and the audit and certification personnel re-associate the target enterprise's product process links based on the audit subject corresponding to the audit module. When Qg≥Qe, the process proceeds to step S4.

[0044] In the above technical scheme, the present invention provides a system management method based on a quality management system, which realizes the association, selection and adjustment of each audit module and process link in the audit system based on the characteristics and needs of different enterprises, so as to ensure the actual situation of the using enterprise and realize systematic distributed audit. Secondly, the audit scope coverage evaluation and analysis are performed based on the audit data set, and the comprehensiveness of the process link audit is evaluated and analyzed based on the audit data set, so as to realize the evaluation of the audit coverage and the evaluation of the process link comprehensiveness audit index, so as to improve the audit coverage system and the comprehensiveness of the audit of each process link, and improve the accuracy and effectiveness of the audit results. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0046] Figure 1 A flowchart of a quality management system management method based on an embodiment of the present invention is provided. DETAILED DESCRIPTION

[0047] The following will describe the embodiments of the present invention with reference to the accompanying drawings and preferred embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be understood that the preferred embodiments are only for illustrating the present invention, not for limiting the scope of protection of the present invention.

[0048] It should be noted that the illustrations provided in the following embodiments are only schematic illustrations of the basic concept of the present invention. Although the drawings only show components related to the present invention and are not drawn according to the number, shape and size of components in actual implementation, the type, quantity and proportion of each component in actual implementation may be changed arbitrarily, and the component layout may also be more complicated.

[0049] See also Figure 1 The embodiment of the present invention provides a technical solution: a system management method based on a quality management system, comprising the following steps:

[0050] Step S1: Generate an audit and certification system based on the quality management system standard, wherein the audit and certification system includes multiple audit modules, and each audit module corresponds to an audit subject; specifically, according to the requirements of the ISO9001 standard, formulate detailed inspection and audit items to ensure that each key element is fully reviewed, and then generate an audit and certification system based on the inspection and audit items, wherein the audit and certification system has multiple audit modules, and each audit module corresponds to an audit subject. Optionally, if the audit subject is environmental noise, each audit module has an audit rule, so as to realize the audit of the uploaded data information based on its corresponding audit subject and output the result;

[0051] Step S2: Based on the production process of the enterprise's products, the production process of the enterprise's products is divided into multiple process links, and the process links include key processes and auxiliary processes, wherein the auxiliary processes are auxiliary processing processes of the key processes;

[0052] Step S3: The audit and certification personnel associate the target enterprise's product process links based on the audit theme corresponding to the audit module, obtain the process links and the number of process links corresponding to each audit module for associated audit and certification, and integrate them to obtain the audit data set; that is, based on the characteristics and needs of different enterprises, the audit modules and process links in the audit system are associated, selected and adjusted to ensure the actual situation of the using enterprise and realize systematic distributed audit. Furthermore, in step S3, the key processes and auxiliary processes that have not been associated with the audit module for audit and certification are counted, and the key processes and auxiliary processes that have not been associated with the audit module for audit and certification are integrated and displayed. Auditors can intuitively understand which process links have not been associated with audit, which is convenient for audit and certification personnel to review;

[0053] Step S4: Perform audit scope coverage assessment and analysis based on the audit data set, calculate the audit scope coverage coefficient, and perform threshold determination analysis on the audit coverage coefficient; by calculating the audit scope coverage coefficient and performing determination analysis, the audit coverage can be evaluated, which is convenient for improving the audit coverage system and improving the accuracy and effectiveness of the audit results.

[0054] Step S5: Evaluate and analyze the comprehensiveness of the process link audit based on the audit data set, calculate and obtain the comprehensive audit index of the process link, and perform threshold determination analysis on the comprehensive audit index; by calculating the comprehensive audit index of the process link, the comprehensive audit index of the process link is evaluated, which is convenient for improving the comprehensiveness of the audit of each process link, and further improving the accuracy and effectiveness of the audit results.

[0055] Step S6: The target enterprise fills in and uploads the data information records of each process link based on the audit process link associated with each audit module. The audit module audits based on the uploaded data records and outputs the audit certification results.

[0056] The audit data set includes: {(H1, G1), (H2, G2), (H3, G3)...(Hn, Gn)}, where Hn represents the nth audit module, Gn represents the number of process links associated with the nth audit module, and the number of process links Gn is the sum of the number of key processes and the number of auxiliary processes. The number of process links associated with the audit module is divided to obtain Gn∈(Xn, Yn), where Xn+Yn=Gn, Xn represents the number of key processes associated with the nth audit module, and Yn represents the number of auxiliary processes associated with the nth audit module.

[0057] Furthermore, in step 4, the audit scope coverage assessment management analysis is performed based on the audit data set, the audit scope coverage coefficient is calculated, and the threshold determination analysis of the audit coverage coefficient is performed, which specifically includes the following steps:

[0058] S4.1: Retrieve the key processes and auxiliary processes in the production process of the enterprise's products, integrate and calculate to obtain the theoretical audit coverage parameter Fa;

[0059] Among them, the key processes and auxiliary processes in the production process of the enterprise's products are retrieved, and the integrated calculation is performed to obtain the theoretical audit coverage parameter Fa, which specifically includes: integrating the auxiliary processes, integrating the auxiliary processes corresponding to the same key process to obtain an auxiliary process set; summing the number of key processes and the number of auxiliary process sets to obtain the theoretical audit coverage parameter Fa.

[0060] S4.2: Based on the audit data set, associate the key processes and auxiliary processes in the production process of the enterprise's products, obtain the key processes and auxiliary processes that have not been audited and certified by the audit module, and integrate and calculate to obtain the actual audit coverage parameter Fb;

[0061] The following steps are used to obtain the key processes and auxiliary processes associated with the audited modules that have not been audited, and to integrate and calculate the actual audit coverage parameter Fb:

[0062] Obtain the number of key processes that have not been audited by the audit module and mark them as key process range parameter P;

[0063] Collect the auxiliary processes that have not been reviewed by the audit module, and obtain the number j of auxiliary processes in the auxiliary process set corresponding to the current auxiliary process, and calculate the current auxiliary process range parameter f, where

[0064]

[0065] Repeat the calculation of the range parameters of all other auxiliary processes that have not been audited by the audited module and sum them up to obtain the overall auxiliary process range parameter F;

[0066] Subtract the key process unaudited coverage parameter P and the auxiliary process unaudited coverage parameter F from the theoretical audit coverage parameter Fa to obtain the actual audit coverage parameter Fb.

[0067] S4.3: Calculate the audit coverage coefficient K based on the theoretical audit coverage parameter Fa and the actual audit coverage parameter Fb, where

[0068] S4.4: Set the audit scope coverage coefficient threshold Ke, and compare the audit scope coverage coefficient K with the audit scope coverage coefficient preset Ke;

[0069] S4.5: When K<Ke, the process returns to step S3. The audit and certification personnel re-associate the target enterprise's product process links based on the audit subject corresponding to the audit module. When K≥Ke, the process goes to step S4.

[0070] When calculating the audit coverage parameters, the number of workpiece processes is calculated independently, and the auxiliary processes are associated with the overall number in the corresponding auxiliary process set for proportional calculation. Finally, the actual audit coverage parameters are obtained through integration to avoid the deviation of the audit coverage parameters caused by the difference in quantity between key processes and auxiliary processes, and to improve the accuracy of the evaluation of the comprehensive audit index of the process link.

[0071] Based on the audit data set, the comprehensiveness of the process audit is evaluated and analyzed, and the calculation of the comprehensive audit index of the process includes the following steps:

[0072] Collect the key processes of the audit module and calculate the comprehensive audit index Qz of the key processes;

[0073] Collect the auxiliary processes of the audit module for related audit and certification, and calculate the comprehensive audit index Qf of the auxiliary processes;

[0074] The comprehensive audit index Qg of the process link is obtained by summing up the comprehensive audit index Qz of the key process and the comprehensive audit index Qf of the auxiliary process.

[0075] The key processes of the collection and audit module-related audit and certification and the auxiliary processes of the collection and audit module-related audit and certification are as follows:

[0076] The number of process links associated with the audit module is divided to obtain Gn∈(Xn,Yn), where Xn+Yn=Gn, Xn represents the number of key processes associated with the audit of the nth audit module, and Yn represents the number of auxiliary processes associated with the audit of the nth audit module.

[0077] The calculation formula of the comprehensive audit index Qz of the key process is:

[0078]

[0079] The calculation formula of the comprehensive audit index Qf of the auxiliary process is:

[0080]

[0081] Where Xn represents the number of key processes audited by the nth audit module, Yn represents the number of auxiliary processes audited by the nth audit module, and μ z , μ f are weight coefficients, where μ z >μ f >0. Among them, μ z , μ f The value of μ is preset by those skilled in the art. z , μ f The size of the weight coefficient is to quantify each data to obtain a specific value for easy subsequent comparison.

[0082] The threshold determination analysis of the comprehensive review index specifically includes the following steps:

[0083] Set the comprehensive audit index threshold Qe;

[0084] Compare the comprehensive audit index Qg of the process link with the surface audit index threshold Qe;

[0085] When Qg<Qe, the process returns to step S3, and the audit and certification personnel re-associate the target enterprise's product process links based on the audit subject corresponding to the audit module. When Qg≥Qe, the process proceeds to step S4.

[0086] It should be noted here that when calculating the comprehensive audit index of the process link, the process links are classified into key processes and auxiliary processes, and the comprehensive audit index of the key processes and the comprehensive audit index of the auxiliary processes are comprehensively considered to improve the accuracy of the calculation of the comprehensive audit index of the process link, thereby improving the accuracy of the evaluation of the comprehensive audit index of the process link.

[0087] The above description is only by way of illustration of certain exemplary embodiments of the present invention. It is undoubted that those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the above drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A system management method based on a quality management system, characterized in that: The following steps are involved: Step S1: Generate an audit and certification system based on the quality management system standard, wherein the audit and certification system includes multiple audit modules, each audit module corresponds to an audit subject; Step S2: Based on the production process of the enterprise's products, the production process of the enterprise's products is divided into multiple process links, and the process links include key processes and auxiliary processes, wherein the auxiliary processes are auxiliary processing processes of the key processes; Step S3: The audit and certification personnel associate the target enterprise's product process links based on the audit subject corresponding to the audit module, obtain the process links and the number of process links corresponding to each audit module, and integrate them to obtain the audit data set; Step S4: Perform an audit scope coverage assessment analysis based on the audit data set, calculate and obtain the audit scope coverage coefficient, and perform a threshold determination analysis on the audit coverage coefficient; Step S5: Evaluate and analyze the comprehensiveness of the process audit based on the audit data set, calculate and obtain the comprehensive audit index of the process, and perform threshold determination analysis on the comprehensive audit index; Step S6: The target enterprise fills in and uploads the data information records of each process link based on the audit process link associated with each audit module. The audit module audits based on the uploaded data records and outputs the audit certification results.

2. A quality management system management method according to claim 1, characterized in that: The audit data set includes: {(H1, G1), (H2, G2), (H3, G3)..(Hn, Gn)}, where Hn represents the nth audit module, and Gn represents the number of process links associated with the nth audit module.

3. A quality management system management method according to claim 1, characterized in that: In step 4, the audit scope coverage assessment management analysis is performed based on the audit data set, the audit scope coverage coefficient is calculated, and the threshold determination analysis of the audit coverage coefficient is performed, which specifically includes the following steps: S4.1: Retrieve the key processes and auxiliary processes in the production process of the enterprise's products, integrate and calculate to obtain the theoretical audit coverage parameter Fa; S4.2: Based on the audit data set, associate the key processes and auxiliary processes in the production process of the enterprise's products, obtain the key processes and auxiliary processes that have not been audited and certified by the audit module, and integrate and calculate to obtain the actual audit coverage parameter Fb; S4.3: Calculate the audit coverage coefficient K based on the theoretical audit coverage parameter Fa and the actual audit coverage parameter Fb, where S4.4: Set the audit scope coverage coefficient threshold Ke, and compare the audit scope coverage coefficient K with the audit scope coverage coefficient preset Ke; S4.5: When K<Ke, the process returns to step S3. The audit and certification personnel re-associate the target enterprise's product process links based on the audit subject corresponding to the audit module. When K≥Ke, the process goes to step S4.

4. A quality management system management method according to claim 3, characterized in that: Retrieving the key processes and auxiliary processes in the production process of the enterprise's products, integrating and calculating to obtain the theoretical audit coverage parameter Fa specifically includes the following steps: Integrate the auxiliary processes, and obtain an auxiliary process set by integrating the auxiliary processes corresponding to the same key process; The theoretical audit coverage parameter Fa is obtained by summing up the number of key processes and the number of auxiliary process sets.

5. A quality management system management method according to claim 4, characterized in that: Obtaining the key processes and auxiliary processes associated with the audit certification of the unaudited modules, and integrating and calculating to obtain the actual audit coverage parameter Fb specifically includes the following steps: Obtain the number of key processes that have not been audited by the audit module and mark them as key process range parameter P; Collect the auxiliary processes that have not been reviewed by the audit module, and obtain the number j of auxiliary processes in the auxiliary process set corresponding to the current auxiliary process, and calculate the current auxiliary process range parameter f, where Repeat the calculation of the range parameters of all other auxiliary processes that have not been audited by the audited module and sum them up to obtain the overall auxiliary process range parameter F; Subtract the key process unaudited coverage parameter P and the auxiliary process unaudited coverage parameter F from the theoretical audit coverage parameter Fa to obtain the actual audit coverage parameter Fb.

6. A quality management system management method according to claim 1, characterized in that: The step 3 also includes: counting the key processes and auxiliary processes that have not been audited and certified by the audited modules, and integrating and displaying the key processes and auxiliary processes that have not been audited and certified by the audited modules.

7. A quality management system management method according to claim 2, characterized in that: Based on the audit data set, the comprehensiveness of the process audit is evaluated and analyzed, and the calculation of the comprehensive audit index of the process includes the following steps: Collect the key processes of the audit module and calculate the comprehensive audit index Qz of the key processes; Collect the auxiliary processes of the audit module for related audit and certification, and calculate the comprehensive audit index Qf of the auxiliary processes; The comprehensive audit index Qg of the process link is obtained by summing up the comprehensive audit index Qz of the key process and the comprehensive audit index Qf of the auxiliary process.

8. A quality management system management method according to claim 7, characterized in that: The key processes of the collection and audit module's associated audit and certification and the auxiliary processes of the collection and audit module's associated audit and certification are as follows: The number of process links associated with the audit module is divided to obtain Gn∈(Xn,Yn), where Xn+Yn=Gn, Xn represents the number of key processes associated with the audit of the nth audit module, and Yn represents the number of auxiliary processes associated with the audit of the nth audit module.

9. A quality management system management method according to claim 7, characterized in that: The calculation formula of the comprehensive audit index Qz of the key process is: The calculation formula of the comprehensive audit index Qf of the auxiliary process is: Where Xn represents the number of key processes audited by the nth audit module, Yn represents the number of auxiliary processes audited by the nth audit module, and μ z , μ f are weight coefficients, where μ z >μ f >0.

10. A quality management system management method according to claim 7, characterized in that: The threshold determination analysis of the comprehensive review index specifically includes the following steps: Set the comprehensive audit index threshold Qe; Compare the comprehensive audit index Qg of the process link with the surface audit index threshold Qe; When Qg<Qe, the process returns to step S3, and the audit and certification personnel re-associate the target enterprise's product process links based on the audit subject corresponding to the audit module. When Qg≥Qe, the process proceeds to step S4.

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