Quality Risk Management

Quality Risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to quality of the drug product across the product lifecycle. The approach to managing risk is established via an evaluation of risk to quality. The evaluation is based on scientific knowledge and ultimately linked to the protection of the patient. The level of effort, formality, and documentation of the quality risk management process should commensurate with the level of risk.

Due to the massive number of tools and recommendations available, implementing QRM in a practical way can be a major challenge for pharma manufacturers. Consider the following questions regarding your current risk management process:

  • Do you use recognized risk management tools such as FMEA, FTA, PHA, or Risk Ranking?
  • Do you know how to choose the appropriate risk management tool for various situations?
  • How do you create a unified risk management strategy within an existing quality system that doesn’t have one?

Despite the challenges, QRM is worth the investment. When QRM is integrated into pharmaceutical quality systems, it encourages more informed decision making and better protection of patient safety. Plus, implementing QRM across the entire product lifecycle leads to better process understanding.

Kymanox has the knowledge and expertise to ensure your company is compliant with current QRM strategies as defined by regulatory bodies (e.g., FDA, ICH, EMA). In addition, Kymanox understands how to apply the recognized tools (e.g., FMEAs) in the appropriate way in order to scale the risk management process according to the level of risk. The consistent use of the applicable tools and methods, along with periodic review, will ensure the output of the QRM process supports your entire organization in meeting its defined goals.


QRM – Quality Risk Management

FMEA – Failure Modes and Effects Analysis

FTA – Fault Tree Analysis

PHA – Preliminary Hazard Analysis

FDA – Food and Drug Administration

ICH – International Council on Harmonization

EMA – European Medicines Agency