Many organizations have formal Quality Management Reviews, which take place periodically and where data is reviewed by senior management. The object most Quality Management Reviews is to provide an overview of the results from the Quality Control and Quality Assurance functions. The review forms part of an organization’s Quality Management Systems (such as is detailed in ISO 9001). The issues covered will vary between different workplaces. However, issues often included issues are results of audits; discussions of follow up items; a review of progress relating to non-compliances and discussions relating to the effectiveness of corrective and preventative action; test and sampling efficiency times; customer complaints; rejects; out of specification results from test data; microbiological contamination issues and trends in relation to processing of product and to the manufacturing environment. Issues of major concern are often considered using risk management techniques
Data is presented by participants from different departments. The data is normally measured against a target (to allow for effectiveness, efficiency, and capability to be measured). This can be relatively straightforward, such as the number of internal audits completed against a target level (such as 95% of audits to be completed to schedule) or more complex when relating to statistical process control charts for laboratory test data.
Participants should include representatives of laboratories, production, process, pharmacy, and ward management. Meetings are held either monthly, quarterly, or annually. Where problems or upward trends are identified the aim of the meeting is to identify the risk, assign a priority, to agree actions and to track progress. For issues that cannot be satisfactorily dealt with these are referred to senior management. Quality Management Review meetings may sometimes elect to form subgroups to examine specific areas, such as sampling, new processes technologies and so on.
It is important that the outcomes of the Quality Management Review are communicated to all members of staff.