Quality management review

The Management Standards followed by laboratories all require that the laboratory s quality management system is reviewed periodically to ensure that it is still suitable and effective and to introduce necessary changes or improvements. The usual frequency for quality Management Review is once every twelve months. 

Are the activities performed for quality management reviewed with senior management on a periodic basis ... 

An example of items to be discussed when having a Quality Management Review (QMR) ... 

Plans for internal audits are revised regularly, for instance biaimually. Quality management reviews will include monitoring of audit outcomes and may consider whether audit frequencies are appropriate. 

Some approaches to quality management suggest that companies reduce the total number of suppliers for a service or material to just a few high quality entities. This allows the companies to symbi-otically develop relationships. Both parties can benefit greatly by using a system designed to rank preferred tollers. However, do not let the motivation to reduce the number of suppliers inhibit the critical review of potential tollers capable of performing the toll successfully. 

The management review to monitor strategic quality objectives and the performance of the system... 

It is not mandatory that you have documented procedures for forming the quality policy and the quality objectives, defining the responsibility of personnel, identifying resources, or conducting management reviews. However, section 4 of the standard is titled Quality s /stem requirements and section 4.2 requires that a quality manual be prepared covering the requirements of the standard. It follows therefore that you need to address the requirements of section 4.1 in your quality manual. You have a choice of how you address the requirements providing they are documented. 

Although termed a management review the requirement is strictly referring to a review of the quality system and not the Corporate Plan. 

The elements of the system can be construed to be the 20 elements of ISO 9001. The components of the system are different. ISO 8402 states that a quality system is the organizational structure, procedures, processes, and resources for implementing quality management. It therefore follows that in reviewing the quality system one needs to review each of these aspects. 

There is also a supplementary requirement in clause 4.1.3.2 for the management review to include the monitoring of strategic quality objectives and the regular reporting and evaluation of the cost of poor quality. 

There are two requirements addressing records of the management review which when combined require firstly that records of management review be maintained and secondly that these records provide as a minimum evidence of the achievement of objectives specified in the quality policy and the business plan and evidence of customer satisfaction with product supplied. 

Costs of poor quality were addressed under Management review and in order to provide adequate data for review, the prevention, appraisal, and failure costs need to be collected. Graphs showing the trend in quality costs for the plants, products, and processes would satisfy this requirement. 

In order to keep the system up-to-date with the needs of the business you will need to review the system when changes occur in the business. This review may be carried out at the same time as the management reviews described in Part 2 Chapter 1 however, as these reviews may be scheduled on a periodic basis, you should not allow the system to become outdated. The system should always reflect what you do and should remain ahead of actual practice rather than lag behind it. You should therefore integrate your system review with the business review so that changes in the business are implemented through the quality system rather than as an afterthought. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

To determine the procedures you need you should design the system from the top down. Some requirements will apply to many operations such as document control, corrective action, and quality records whereas other requirements may apply to only one operation, such as auditing and management review. A matrix showing this relationship is given in Appendix D. 

The requirement is also somewhat duplicated in clause 4.1.3 on management reviews. You are required to conduct management reviews to ensure quality system effectiveness and conduct internal quality audits to determine the effectiveness of the system. It would appear that the audit collects the evidence and the review ensures that it is collected. 

Informally review and consider major initiatives or campaigns (for example, PSM and Responsible Care , or other quality management initiatives) that have succeeded in your company—along with those that have failed. What made them work Incentives to participation Relevance to job or quality of life Other factors And what about the failures Lack of follow-through Weak endorsement Poor idea in the first place ... 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Resolution The development of Quality Management processes starts with a comprehensive review of existing systems and a careful review of the needs the processes must meet. Showing this process should help reassure the manager that all issues will be covered. You should also indicate what staff are likely to be involved in these processes and ask whether there are any others that should be included. 

Teams such as quality improvement teams (QIT), may be used for implementation of all Quality Management projects. These teams are usually established for specific improvement projects and consist of staff involved in the management processes under review. For this project, PSM and ESH specialists, operations, maintenance, and engineering representatives would be members of the team. 

In developing your implementation strategy, you should review experience with other projects, particularly Quality Management projects. 

Measurement of performance. Quality Management requires that measures of performance be established for every activity. These measures include end-of-pipe measurement, such as amounts of material released into the environment or injury rates, and in-process measures of how efficiently you are managing, such as time to review safety improvement proposals or total resources expended on PSM. Each team should be required to identify potential performance measures for the processes they are developing and the activities these processes manage. Many of the end-of-pipe measures will already exist these should be critically examined to ensure that they truly measure performance and are not unduly influenced by other factors. For example, the number of accidents in a fleet of road vehicles is almost directly dependent on the number of miles driven with no improvement in performance, a reduction in miles driven would reduce the number of accidents. 

Quality Management approaches encourage a comprehensive review of a system. This comprehensive approach encourages the designers to question every aspect of a system. In this way, incremental improvements are quickly identified and by implementing new approaches dramatic improvement in performance can be achieved. 

Management review - Senior management to conduct regular reviews of the quality system and its performance... 

Each laboratory in the OPMBS was required to send a copy of each workbook and the associated raw data, to study management soon after completion of the analysis. This information was provided after internal technical review but before local quality assurance review. Study management used a team of experienced residue chemists to review the results and the raw data and to ensure that the information reported was fully supportable. The laboratory remained at all times responsible for the data reported, however, and the results of the external review were formally considered to be advisory. 

To understand the difference between auditing a quality management system and conducting a quality system review. 

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