Conduct Management Review

Once you have completed your trial run and made final revisions to both your checklist and procedure, the design team should present the observation process to management. This step should be one of the milestones on your initial schedule. Use this meeting as an opportunity for 

All design team members who want to participate should be involved in this presentation. The recognition from management should reinforce their participation in the safety process. 

Purpose Obtain management approval to implement observation system. 

Background on how the design team came into being 

Observation procedure Management s role Next steps 

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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. 

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. 

Conducting management reviews and ensuring that quality objectives are established... 

During the initial audit evidence of progress on audit and review actions, and progress toward Cl targets has to be demonstrated. Hence it is not sufficient for the supplier to have defined Cl targets, and not sufficient for internal audits and management reviews to have been conducted - there has to be evidence of achievement. 

Reporting product realization measurements to management (clause 4.2.4.2) Conducting project reviews (clause 4.2.4.3)... 

Although there is no requirement for you to have a documented procedure for management review, you need to ensure that certain information is brought before the review and the review produces certain results. As you are going to conduct these reviews frequently you may want to ensure they follow a repeatable process and an obvious way to achieve this is through a documented procedure. 

Conduct project review with upper management. 0 18. Declare the project complete. 

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

Internal audit Audits conducted by the organization itself for management review purposes - also called first-party audits. 

A typical period for conducting a management review is once a year. It is absolutely necessary to have feed back from this review of the laboratory s work in order to profit from it. 

A typical period for conducting a management review is once every 12 months. 

Management reviews are conducted based on the review inputs and any decisions and actions taken as a result of the management review are the review output . The information taken as input to the management reviews could be the results from audits and self-assessment of the laboratory, feedback from customers and results from benchmarking activities, the laboratory activity performance, the status of corrective and preventive action... 

The management reviews are conducted with a planned agenda to provide direction for the company s quality operations. Input from outside and inside sources are welcome to ensure continuous improvement. The audit findings and areas of quality concern are discussed. It is ensured that corrective and preventive measures are taken on time. The review input includes statistical evaluation of process performance and product conformity. 

Company name) has identified and assigned a management representative to ensure quality policies are established with due consideration to customer focus. Management reviews are conducted to ensure that the defined objectives are met. 

Conduct a review of chemical agent disposal facility operations and records management for the ambient air monitoring for agent, and for exhaust stack and other waste stream emissions of agent and other substances of potential concern (SOPCs) that are characteristic of these facilities. Use Occupational Safety and Health Administration, and Environmental Protection Agency criteria for initial identification and evaluation of SOPCs. 

Management should acknowledge the risk results of the process hazard analysis reports. If the risks of the process hazards analysis are not acknowledged by management, review team members will feel their effort has be in vain and that recommendations do not have to be dealt with. Where management does not acknowledge their results, their importance will suffer and therefor the quality will degrade. Eventually this could produce a situation that existed before the reviews were conducted, i.e. hazards and risks are not really known or fully understood. 

A management review will usually be conducted periodically, with one or more validation reports used as feedback on the overall validation program. Although shown as the last phase of management cycle, reviews can and should take place throughout validation. The review endeavors to draw out lessons from the validation conducted to date, to consider the impact of any regulation developments, and to report any recommendations. The overall aim is the continuous improvement of the company s validation capability. 

The Project Manager and the Contract Engineer will conduct independent reviews of the technical and commercial parts, respectively. 

Adopting a defined management strategy at the onset of implementation ensures that all subsequent plans follow a consistent approach in developing strategies and plans and conducting proper management reviews. 

Identify weaknesses and performance deficiencies Hold responsible parties accountable Conduct periodic management review of the system Cultivate a positive safety culture Commit to managing the safety culture Communicate to reinforce objectives... 

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