Management Review is a requirement of both 21 CFR 820 and ISO 9001. 21 CFR 820.20 states “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 the requirements of this part and the manufacturer’s established quality policy and objectives.”
What this translates to, is that there is a requirement for the top level management to formally meet to discuss aspects of the quality system. Management Review needs to be held at a defined interval – the timeframe is not identified in either regulation so this could be yearly, every 6 months, quarterly, etc. depending on the needs of the company.
The first step in making the process of Management Review meaningful is to realize that this is not meant to be a passive activity. The potential is there for Management Review to be a dynamic, evolving set of activities with the ability to evaluate the inputs necessary to fulfill the requirements of your customers.
According to ISO 9001, clause 8.4, management review is required to monitor and analyze these items: Supplier performance, customer feedback, conformity to product requirements, and characteristics or trends of processes and products including opportunities for preventive action.
This meeting should also consider:
- Requirements of the quality management system (results of internal and external audits, for example)
- Quality metrics
- Corrective actions
- Risk management issues
- Opportunities for continual improvement
- Monitoring of quality objectives
- Evaluation of the cost of poor quality
The goal is to generate ideas for improvement in processes, the quality management system, products, and resource provisions. Meeting minutes must be documented and filed for each Management Review session.
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