Qualitätsrisikomanagement

Qualitätsrisiko, or quality risk, is the potential that a product, process, or system will fail to meet defined quality requirements, possibly leading to nonconformities, recalls, or customer dissatisfaction. Quality risk is typically described by the likelihood of a failure and the severity of its consequences, sometimes including the ability to detect the failure before it reaches the customer.

Quality risk management uses structured methods to identify, assess, mitigate, and monitor risks throughout the product life cycle. Typical steps include risk identification, risk assessment (likelihood and impact), risk control (mitigation actions), and risk communication to stakeholders.

Common frameworks and tools include Failure Modes and Effects Analysis (FMEA), hazard analysis, fault tree analysis, and risk registers; ISO 9001's risk-based thinking; and sector-specific standards such as ICH Q9 Quality Risk Management for pharmaceuticals or HACCP in food safety. Quantitative approaches may use probabilistic models, but many contexts rely on qualitative judgments when data are limited.

Quality risk management is often integrated into design, development, production, supplier management, and post-market surveillance. Its aim is to reduce the probability and impact of quality failures to an acceptable level, support informed decision making about releases and changes, and improve overall process capability.

Limitations include subjectivity in scoring, data gaps, and the challenge of balancing risk reduction with cost and time. When applied well, Qualitätsrisikomanagement supports regulatory compliance, product safety, and a proactive quality culture.