The Quality System Management Review...The objective of the Management Review is to ensure that the Quality System is suited to business needs, efficient and effective. The review should assess performance over the previous period (since the previous Management Review), opportunities for improvement, confirm that the quality policy and objectives remain appropriate and are meeting the needs of the organisation and it’s “quality” stakeholders.
The review should be held once per year, or at most twice per year. Some organizations hold the management review quarterly, however, this runs the risk of the review becoming part of on-going operations. If held too frequently the review will fail to serve its purpose. The primary purpose of the management review, is for the senior management of an organization to stand back from day to day operations and take a high level view of the operation and effectiveness of the quality management system. The management review should be considered along the lines of a strategy meeting. Stand back, take a high level view of how the quality system is serving the organization, then set direction for the quality management system over the coming year(s).
Why do you need a management review of the quality system?It can act as a time to reflect on the past and plan for the future. It becomes a time for senior management to meet as a group to review and discuss key measures. The review ensures ongoing compliance with regulatory requirements.
Management reviews usually take into account many additional factors beyond the requirements found in the international and regulatory standards. The results of internal audits and external audits are an important source of information. Customer experience and feedback. Internal yields and trends. Quality cost analysis. Process variation changes…etc. It is important that the outcome of management review should lead to increased effectiveness and efficiency of the quality system.
International standard & regulatory expectations from the Management Review?Per ISO 9000-1 “guidelines for use” – The Management Review. “One of the important activities that executive management of the organization need to carry out, is a systematic evaluation of the status and adequacy of the quality system, in relation to expectations of stakeholders”. The Management Review addresses this requirement.
The US FDA requirements for performing a Management Review. “Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies requirements … and the manufacturers established quality policy and objectives. The dates and results of the quality review shall be documented”.
Per ISO/EN 46001, Management review. “Management with executive responsibility shall review the quality system at defined intervals … to ensure its continuing suitability and effectiveness in satisfying the requirement of this international standard versus the stated quality policy and objectives … of the organization. Records of such reviews shall be maintained”.
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The Management Review needs to result in agreed Quality Objectives.Management should document objectives and commitments pertaining to key elements of quality, such as fitness for use, performance, safety and dependability. The calculation and evaluation of costs associated with all quality elements and objectives should always be an important consideration, with the objective of minimizing quality losses. Appropriate levels of management should document specific quality objectives consistent with the quality policy as well as other objectives of the organization.
Re: key objectives and responsibilities for quality.
The organization should:
– achieve, maintain and seek to improve continuously the quality of its products in relation to requirements for quality.
– improve the quality of its own operations, so as to continually meet customers and all stakeholder, stated and implied needs.
– provide confidence to its internal management that the requirements for quality are being fulfilled and that quality improvement is taking place.
– provide confidence to the customer and other stakeholders that the requirements for quality will be achieved in the delivered product.
– provide confidence that the quality system requirements are fulfilled.
By performing a comprehensive and effective management review, an organization will:i) understand what is and what is not working within the quality system, where problems are arising, where targets and objectives are or are not being met,
ii) understand the risks to the organization in terms of product and process quality,
iii) confirm that suitable resources are available and appropriately allocated, or indeed identify where there are resource deficiencies,
iv) set clear direction for the coming period of time, set top level objectives and goals.
What should the management review include?i) Requirements of the quality management system, e.g. results of internal audits.
ii) Quality management system performance and trends.
iii) Opportunities for continual improvement.
iv) Monitoring of quality objectives.
v) Results obtained from ongoing routine quality reporting.
vi) Evaluation of the costs of quality.
The Quality System Management Review is a key component of the quality system, it is an opportunity to step back from the day to day activity and take a high level overview of how effective the quality management system is within the organization and are customer expectations being correctly anticipated, met and exceeded.
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