impact and probability are the two main components of Risk analysis. Looking at impact versus probability is common in order to categorize and prioritize risks as some risks may have a severe impact on product objectives but only happen on rare occasions, while others have a moderate impact but occur more frequently.

All cleanroom (sterile or OSD facility) activities involve risk. Risks are events caused by uncertainties, which can have a positive or negative effect on the product quality or manufacturing process. All activities are unique and thus the associated risk varies between activities. Therefore, Risk Management is an important part of any sterile operation as proper management increases the likelihood for a good quality product and continuous operation. Risk management involves identifying possible risks, analyzing their potential and strategy for risk mitigation. 

The risk analysis is a two-stage assessment process. Initially, qualitative methods are used to examine, categorize and determine the main risk events identified, which are relevant for a more detailed quantitative assessment. In risk analysis, risk is traditionally defined as a function of probability and impact. The probability is the likelihood of an event occurring and the consequences, to which extent the product or process is affected by an event, are the impacts of risk. By combining the probability and impact, the Level of Risk can be determined. 

There are various aspects of the product that can be affected by a risk event, such as quality, process, safety etc. There are commonly used methods for risk assessment like preparing descriptive scales or FEMA or HACCP   to rank risk in terms of probability and impact. 

GAMP Services has very high skilled  SME for risk management and impact assessment services.