The quality management system audit is a systematic, independent and documented process to objectively evaluate the conformity and effectiveness of the organization's quality management system according to the quality management system standards and audit criteria, which plays an important role in the continuous improvement of the quality management system. The following is the knowledge I brought to you about the composition of the internal quality audit system of large enterprises. Welcome to reading.
Background knowledge:
The quality management system audit is a systematic, independent and documented process to objectively evaluate the conformity and effectiveness of the organization's quality management system according to the quality management system standards and audit criteria, which plays an important role in the continuous improvement of the quality management system. According to different customers, audit can be divided into internal audit and external audit. Internal quality management system audit, also often called internal quality audit, is an enterprise (or organization) audit of its own quality management system. Its purpose is to determine the degree to which the quality management system meets the requirements of the organization itself, and whether the quality management system is effectively implemented and maintained.
For a large enterprise, the quality system contains almost all the process elements in the quality standard. If the internal audit of an enterprise is conducted by a single-level audit department, the breadth and depth of the audit are bound to be limited by the number of auditors, and the lack of internal audit materials will lead to the analysis results of the audit report not truly reflecting the operation of the quality management system, thus restricting the improvement of the quality management level of the enterprise. Therefore, the author believes that after the quality audit business within the enterprise reaches a certain level of proficiency, it is completely possible to build a multi-level and three-dimensional quality audit system, and gain more improvement value through the application of big data. The implementation of this work includes the following aspects:
1 construction of multi-level three-dimensional quality audit system
The internal quality audit system of an enterprise is divided into three levels, namely, I-level audit, II-level audit and. The first-level audit is the highest-level audit, and the full-time auditor of the quality audit department in the enterprise organization audits all processes and departments involved in the quality management system on behalf of the company; The second-level audit is a system-level audit, and the part-time auditor in charge of the business function system of each process in the enterprise organization organizes the quality audit of each professional system; Three-level audit is the self-audit of part-time auditors in grass-roots units.
What is the Iso 9000: 2005 standard applicable to? Process? Definition: A set of interrelated or interacting activities that transform input into output. Usually the output of one process will directly become the input of the next process. In order to make the organization run effectively, the organization must systematically identify and manage the application process.
The Training Department is responsible for organizing and implementing the system-level quality audit of personnel training; Archives is responsible for organizing the implementation of document control system-level quality audit; The Technology Department is responsible for organizing and implementing the system-level quality audit of technical management; The metrological department is responsible for organizing and implementing the system-level quality audit of metrological management; Mechanical equipment management department is responsible for organizing the implementation of system-level quality audit of equipment and facilities management; The Quality Control Department is responsible for organizing and implementing the system-level quality audit of technical inspection management; The production preparation department is responsible for organizing and implementing the system-level quality audit of tooling management; Physical and chemical testing center is responsible for organizing the implementation of physical and chemical testing management system-level quality audit; The purchasing department of parts is responsible for organizing and implementing the quality audit of outsourcing management system level; The Quality Assurance Department is responsible for organizing the implementation of quality improvement system-level quality audit.
2. Selection of auditors
Not all people can become auditors, he refers to people with specific ability requirements, in ISO19011:2002 standard? Ability? Defined as: the personal quality of proof and the ability to apply knowledge and skills of proof. Therefore, only those who have good personal qualities and make good use of relevant knowledge and skills can be competent for the audit work and become a qualified auditor. GB/T19011-2003 standard puts forward nine requirements for auditors' personal qualities, such as moral quality, cheerful thinking, good communication, good observation, perception, adaptability, perseverance, judgment and self-reliance. Only with the above requirements can we express fairly, listen carefully and understand correctly in the audit process. The application ability of knowledge and skills mainly refers to the ability to understand, master and handle affairs through study and practice in specific fields. These knowledge and skills must be acquired through education, work experience, auditor training and audit experience.
Therefore, enterprises should choose employees with strong analytical judgment, strong writing and language expression skills, decent style, seeking truth from facts, mastering and being familiar with the quality management system documents within the audit scope, and having the basic technical and business knowledge of auditors, so that they can receive training from national qualification training institutions, obtain the qualification certificate of internal auditors, and receive regular internal audit related knowledge and business training.
3, the preparation of audit procedures
Enterprises should establish an internal quality audit procedure with PDCA as the audit idea, and guide full-time auditors at the company level and part-time auditors at the system level and grass-roots units to implement the audit according to unified audit standards. Is PDCA cycle planned? Conduct (do) inspection? Dispose of (behavior) 4
Working method of cyclic continuous improvement composed of elements. The plan is made for implementation, and the effect of implementation can only be confirmed through inspection; Examination is the premise of treatment, and treatment is the purpose of examination. Only through treatment can we lay the foundation for making plans for the next cycle.
The first stage of applying PDCA cycle to internal audit is the audit plan stage, that is, how to make the audit plan should be stipulated in the procedure. The audit plan is used to guide the implementation of the audit, and should clearly stipulate the audit purpose, audit scope, audit criteria, audit type, audit time and audit frequency. The record of audit content should take the checklist as the carrier, and the quality management system audit checklist should be compiled by the quality management system process or department as the unit based on the quality management system process program documents; The main production line audit checklist is based on the corresponding tripartite, customer specifications and quality system procedures, and is compiled by production line as a unit. The annual audit should include personnel, equipment, materials, operating procedures, environment, process control and other factors; Based on engineering data and customer specifications, the product quality audit checklist is compiled according to the typical structure and processing characteristics of the project products.
The second stage of applying PDCA cycle to internal audit is the audit implementation stage, that is, how to implement internal audit should be stipulated in the procedure. Usually, the audit method is on-site audit; The auditee shall arrange jurors; The auditor shall confirm the compliance according to the terms of the audit checklist and record the evidence of compliance; After the audit, the auditor will communicate the audit results with the auditee and form an audit conclusion, which will be signed by the auditee for confirmation. The procedure should also stipulate how the auditor writes and sends out the non-conformance report when the nonconformity is found, how the responsible unit responds after receiving the non-conformance report, and how the auditor tracks and verifies the nonconformity.
The third and fourth stages of applying PDCA cycle to internal audit are the review and improvement stages of audit plan, that is, the plan should stipulate that the audit plan should be reviewed at appropriate intervals to evaluate whether it has achieved its purpose and identify opportunities for improvement. The procedure should provide for the establishment of an audit data analysis and tracking system; Usually, after the audit is completed as planned, the auditor should prepare an annual quality audit report. The annual quality audit report should classify the problems and causes in the data analysis and tracking system, analyze them by department, process, production line and annual trend, and give audit conclusions on the compliance, effectiveness, adequacy and applicability of the annual operation of the system. The conclusion of audit report should be used as the input of management review, and the review result may lead to the improvement of corrective and preventive measures and audit plan.
conclusion
In the process of establishing and maintaining the quality management system, the internal quality management system audit has been playing an active role. It can be said that the quality audit has promoted the continuous maintenance and improvement of the quality management system to a certain extent, and provided a direction for the improvement of the quality management system. The effective implementation of quality audit is one of the goals pursued by quality management system. According to the internal characteristics of enterprises, by constructing a multi-level and three-dimensional internal quality audit system, the collection and analysis of quality audit data are increased, which is conducive to managers' representatives to judge the operation of enterprise quality management system more accurately and provide improvement direction for the development of enterprise quality management system.
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