A Management Review becomes necessary to “identify opportunities for continual improvement of products, processes and the system itself”. Top Management should attend. For most sites this is the Senior Management Team who report to the overall head of the site. ISO 9001, the source of Management Reviews, doesn’t state this. As described in the FDA’s Quality System Model firstly “when developing and implementing new quality systems, reviews should take place more frequently than when the system has matured”. This is very logical – more frequent reviews when underdoing changes and development of the business and system. There is also the following statement “outside of scheduled reviews, the quality system should typically be included as a standing agenda item in general management meetings”. Here the idea of a range of reviews becomes an option, perhaps discussing certain aspects of the QMS at different levels and parts of the organization at different times. What no standard states is a precise frequency, say every month, every quarter or every year. It is up to the organization, although a Management Review performed just once a year might be too long for it to really make a difference; an adequate frequency is acceptable to be between every 1 and 3 months. This generally allows time to gather useful data, take actions between reviews and even hopefully see the results of these actions at the next review.
The Management Review should cover at least the following:
●The appropriateness of the quality policy and objectives
Are these still suitable for the organization?
● The results of audits and other assessments
What audits have you had or have you done? Any areas of concern? Any shared ideas to implement?
●Customer feedback, including complaints
What do your customers think of you? Complaints, quality surveys among other information shall be evaluated.
●The analysis of data trending results
What data do you have on process performance and product conformity? Any positive or negative trends?
●The status of actions to prevent a potential problem or a recurrence
How is the status of closing down any Corrective Actions and Preventive Actions?
● Any follow-up actions from previous management reviews
Actions outstanding from previous reviews
● Any changes in business practices or environment that may affect the quality system (such as the volume or type of operations)
Do not act only reactively but be proactive! Is anything going to change soon? New shift patterns, new equipment, new customers, etc. Think upfront about the impact of these on the QMS and on the business globally
● Product characteristics meeting the customer’s needs
Evaluate Customer Service rate. Are we giving the customer what they want? Not only product of the right quality, but are we giving them what they want and when they want it?
There is no point having any Management Review meeting if no actions are to be implemented. This is where it really can work.
If you are interested in the topic of Good Manufacturing Practice, you may like to view our Good Manufacturing Practice certified training.
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