ICH Q9 kaže ovako: It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/ or internal procedures e.g., standard operating procedures). The use of informal risk management processes (using empirical tools and/ or internal procedures) can also be considered acceptable.
I dalje: Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on, for example, compilation of observations, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations and allocation of resources.
Znači, moguće je koristiti druge pristupe, a ne samo numeričke matrcie, npr. interne checklist-e ili opisnu evaluaciju rizika (no i u tom slučaju je važno jasno opisati prijetnje, razinu rizika, argumentaciju i konkretan zaključak s obzirom na ocjenu rizika, npr. je li prihvatljiv ili nije prihvatljiv).
ICH Q9 kaže ovako: It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/ or internal procedures e.g., standard operating procedures). The use of informal risk management processes (using empirical tools and/ or internal procedures) can also be considered acceptable.
I dalje: Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on, for example, compilation of observations, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations and allocation of resources.
Znači, moguće je koristiti druge pristupe, a ne samo numeričke matrcie, npr. interne checklist-e ili opisnu evaluaciju rizika (no i u tom slučaju je važno jasno opisati prijetnje, razinu rizika, argumentaciju i konkretan zaključak s obzirom na ocjenu rizika, npr. je li prihvatljiv ili nije prihvatljiv).