As a manufacturer of orthopaedic medical devices under the QS Regulation and ISO 13485, your company is responsible for the implementation and maintenance of a formal Quality Management System (QMS).
When a nonconformity is identified, your company will determine the significance, associated risk and potential for recurrence. You may then decide that the nonconformity has little associated risk or is unlikely to recur. In such cases, your Review Board may decide only to carry out a correction (rather than a full blown, costly and time-consuming corrective action).
Your Quality Review Board (QRB) may encounter issues or trends from quality data that have not actually caused a nonconformity, but may do so in the future. Such situations may call for preventive action.
Correction: An action to eliminate a detected nonconformity. A correction can be made in conjunction with corrective action. Corrections can be, for example, re-work or retraining.
Corrective action (CA): An action to eliminate the cause of a detected, systemic nonconformity or other undesirable situation. There can be more than one cause for nonconformity. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. The CAPA system is always described as an integral part of the QMS and is driven by Planning, Measurement and Analysis, Improvement and Management Support.
Preventive action (PA): Action to eliminate the cause of a potential nonconformity or other undesirable situation. Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.
Nonconformity: Non-fulfillment of a requirement.
Quality Review Board (QRB): A cross-functional group of process owners and ad hoc representatives deemed by a company to be responsible for deciding the disposition of all defective products and out-of-compliance processes (nonconformances).
It’s critical to establish the involvement of management during, for example, Management Review or during QRB sessions in actions taken in response to nonconformities or potential nonconformities. Management is responsible for improvement, compliance and enablement of the QMS at all levels of your company.
In the process of planning measurement and analysis, your QRB needs to take into account data sources, the measurement of the data elements within each data source, the frequency of monitoring and the analysis to be performed within a data source, or across data sources. Managing risk is a primary driver for making these determinations and giving disposition to nonconformities in a compliant manner. The measurement of data elements should be done in a way that ensures that your company processes are effective in managing the operations and maintaining an operative, process-based QMS. Each of the data elements on your company’s dashboard should be established, with specific requirements for measurements that are monitored routinely.
The Quality Review Board: A Risk-based, Cross-functional Team of Process Owners
The QRB consists of at least these representatives from the following processes within your QMS:
- Functional process owners responsible for the viability of second level procedures.
- Suppliers, contractors and consultants who could advise the QRB, e.g. requiring an expert, brought to the QRB on an ad hoc basis.
- Any member of the company who could advise the QRB on similar subjects.