Kvalitetsriskhantering

Kvalitetsriskhantering, often translated as quality risk management, is a systematic process for the identification, analysis, evaluation, control, and review of risks associated with the quality of a product or service. Its primary objective is to ensure that the quality attributes of a product or service are consistently maintained and that potential threats to these attributes are proactively addressed. This approach is particularly crucial in highly regulated industries such as pharmaceuticals, medical devices, and food production, where product quality directly impacts patient safety and public health.

The process typically begins with risk identification, where potential hazards or undesirable events that could affect quality are brainstormed and documented. Following identification, risk analysis involves understanding the nature of the identified risks and determining the probability of their occurrence and the severity of their potential impact. Risk evaluation then compares the analyzed risk against pre-defined risk criteria to decide whether a risk is acceptable or requires mitigation. If mitigation is necessary, risk control measures are implemented to reduce the identified risks to an acceptable level. Finally, risk review is an ongoing process to monitor identified risks, assess the effectiveness of control measures, and identify any new risks that may emerge over time.

Effective quality risk management is not a one-time activity but an integral part of the entire product lifecycle, from development and manufacturing to distribution and post-market surveillance. It relies on scientific knowledge, expert judgment, and a thorough understanding of the product and its manufacturing process. By systematically managing risks, organizations can enhance product consistency, improve patient safety, and meet regulatory requirements, ultimately leading to higher overall quality and greater stakeholder confidence.