Frequently Asked Questions: Risk Management
What is risk management?
Risk management is the process of identifying, analyzing, mitigating or resolving risks that could affect the quality and safety of goods and services. By implementing robust risk management processes, quality control professionals can systematically identify, assess and mitigate potential risks throughout the product lifecycle.
What is the relationship between quality and risk management?
More than ever, quality oversight calls for incorporating risk planning and mitigation into quality management systems from day one. This proactive approach enables manufacturers to anticipate and address issues before they escalate, thereby safeguarding product quality, enhancing regulatory compliance and protecting brand reputation. Integrating risk management into quality control practices enhances product quality and also fosters a culture of continuous improvement and innovation.
What are risk management standards and regulations?
There is a strong emphasis on risk management in quality standards that is accepted globally. The most common of these are ISO 9001 and ISO 13485, maintained by the International Organization for Standardization (ISO), and the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 820. These standards call for incorporating risk-based thinking at all points in a product’s lifecycle. More structured risk-management processes for medical devices are outlined in ISO 14971.
What are risk management procedures?
In general, risk management procedures involve:
- Identifying potential risks
- Conducting risk analysis
- Planning a response
- Implementing response
- Evaluating effectiveness
How can QT9 help with my risk management needs?
QT9 QMS provides an integrated platform where you can create risk assessments from other QT9 modules, including FMEA, corrective actions, nonconforming products, engineering change requests and customer feedback records.
QT9 QMS has 25-plus modules that come standard. Its cloud-based platform enables you to keep track of risk management activities and synchronize records with anyone, anywhere.
QT9 QMS is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.
