How to conduct management review

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1 The management must pay attention. First of all, the management review should be led by the management (the top boss) who is responsible for carrying out this review. Management review is generally conducted in the form of a meeting. So, laboratories have existed for a long time. The boss organizes a management review meeting. Secondly, the main task of management review is to evaluate the quality management system, with the aim of ensuring its suitability, adequacy, and effectiveness. Many people never quite understand the difference between management review and internal audit. Third, internal audits focus on effectiveness, to assess whether the evaluation system is functioning properly. Internal audits have issues related to compliance and effectiveness. Management review involves taking the system as the subject of discussion and evaluation, to determine whether its provisions fully meet regulatory requirements, whether they are comprehensive enough, whether they contribute to the company’s intended goals, whether there are any obstacles, and whether there are areas for continuous improvement and enhancement. The management review process falls under the “A” phase of the PDCA cycle in the system; it is a stage for continuous improvement. The focus of management review is to determine, looking to the future, whether the system is suitable for the future development environment. The management review is the highest-level quality meeting in a legal entity; it evaluates suitability, effectiveness, and adequacy. It can be combined with an administrative summary. A conclusion must be drawn from the review. Generally, the relevant department will first confirm that the three requirements are met, but also point out the shortcomings, and then put forward requests for improvement. 2 Management review plan: Generally, the quality management department is responsible for formulating the management review plan (in some laboratories, it is presented in the form of a notice or similar document), specifying the arrangements related to management reviews for the current year. After being reviewed by the management representative, it is approved by the top management. The main contents of a management review (or plan) generally include: the review time, the purpose of the review, the scope and key focus of the review, the departments (and personnel) participating in the review, the basis for the review, and the topics to be reviewed. 3 Management Review Process
The main steps in conducting a management review: Responsible personnel prepare the input materials; subsequently, during the review meeting, these inputs are evaluated, and corrective and preventive measures are proposed for any existing or potential nonconformities. After the review is completed, a management review report should be prepared, and improvements should be made to the review results as required. General laboratories should establish management review control procedures that specify the responsibilities of the department responsible for conducting management reviews, the workflow, and the relevant records that need to be generated and retained. 4 Input materials for management review: These are summary and evaluative reports on the laboratory’s quality management system, prepared by various departments based on the laboratory’s quality management manual and related procedural documents, as well as taking into account the implementation of quality management within their own departments. The most important thing is that the report should be comprehensive, providing thorough and sufficient information for the management review meeting; the format is not that important. The main contents that should be included in the input materials for management review: a) Changes in internal and external factors relevant to the laboratory ； b) Goal achievement ； c) Appropriateness of policies and procedures ； d) Status of measures taken in previous management reviews ； e) Results of recent internal audits ； f) Corrective measures ； g) Review conducted by an external agency ； h) Changes in workload and type of work, or changes in the scope of laboratory activities ； i) Feedback from customers and employees ； j) Complaints ； k) Effectiveness of the implementation of improvements ； l) Sufficiency of resources ； m) Results of risk identification ； n) Output to ensure the validity of the results ； o) Other relevant factors, such as monitoring activities and training. 5 Management Review Meeting: The management review meeting is held at the scheduled time or as notified. Persons in charge of various positions attend the meeting and submit their input materials respectively. Based on the tasks assigned to their respective departments, they summarize how the company’s quality management practices are implemented in those departments, assess whether the quality management system is appropriate and effective for the company’s current production activities, and propose suggestions for improvement. During the management review meeting, all departments and positions must speak up and provide their evaluations of the system. This is a good opportunity to improve the company’s quality management system. The top manager of the laboratory usually does not have much time to keep track of how the quality management system is functioning; this task is delegated to the management representative. Taking the time to listen to the summaries, evaluations, and suggestions regarding the company’s quality management system from the heads of various departments is a truly valuable opportunity, and it also reflects the importance that senior management attaches to quality management. Based on the input materials from various departments, along with the company’s quality policy, objectives, and current strategic direction, should the company’s quality goals be adjusted? Should the system be adapted and improved? In what aspects has there been improvement? What areas of work need improvement and further strengthening? Corrective actions must be taken for existing or potential nonconformities, or preventive actions must be implemented. 6 Management Review Report: The company shall derive outputs from the management review process and its results, and prepare a report thereon. The report output of the management review shall include the following aspects: a) The effectiveness of the management system and its processes ； b) Implementing improvements to the laboratory activities required by these guidelines ； c) Provide the required resources ； d) Required changes and improvements: In response to the improvement recommendations outlined in the management review report, the responsible department should develop a plan or strategy for implementing those improvements. Generally, the improvement requirements specified in the management review report are relatively macroscopic. Therefore, the responsible departments generally need to develop relatively detailed improvement plans or implementation strategies. If the responsible department implements the required improvements directly in its work but fails to provide relevant written documentation (including files and records), it is difficult to be convincing; this not only makes it hard to gain acceptance during external audits, but it is also challenging for the company’s quality management department, which is responsible for verifying the implementation of those improvements, to accept such a situation. Regarding the corrections identified in the management review, the quality management department should pay close attention to and monitor their progress in improvement. After the responsible department has implemented the relevant corrective actions, the quality department shall verify the implementation and effectiveness of the corrective and preventive measures. The responsible department is required to provide relevant evidence and supporting documents before the issue can be closed. 8 Increase the opportunities for review: Management reviews should be conducted in the laboratory at intervals of no more than 12 months. The annual period is used as the frequency and cycle for evaluating the company’s quality management system; however, in certain special circumstances, the frequency of management reviews should be increased to ensure the integrity of the company’s quality management system, enhance its suitability, and guarantee that the company’s production and services continue to achieve the desired results. Generally, the frequency of management reviews for the laboratory’s quality management system should be increased in the following situations: 1. When there are significant changes in the company’s organizational structure, product scope or types, or resource allocation ； 2. In the event of major quality incidents, or when customers file serious complaints regarding quality, or when such complaints occur repeatedly ； 3. When there are significant changes to laws, regulations, and other relevant requirements related to the business ； 4. When there are significant changes in market demand ； 5. When serious non-conformities in the quality management system are identified during second or third-party audits, or audits required by other laws and regulations ； 6. Other occasions when the laboratory deems it necessary to conduct a management review.