Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

An effective risk management system is part of your quality management system.

Your risk management system will identify the probability that quality issues can arise during your product life cycle. Every risk you identify is a risk you can eliminate or mitigate. Your risk management system is a proactive tool to allows you to identify the risks in real time, analyze and assess potential root causes and devise corrective and preventive actions to eliminate or mitigate the risk.

There are four phases in an ICH Q9 risk management process.

Step 1: Risk Assessment:

  • Identify the risk, the hazards related to the risk, and recognize possible after effects.
  • Analyze the qualitative and quantitative assessment of the probability of the risk occurrence and the harmful effects of the risks.
  • Evaluate the risk.

Step 2: Risk Control: You can either eliminate or reduce the risk to a minimum level or accept the risk if it is within your acceptable limits.

Step 3: Risk Communication: You need to document and communicate the risks to your Company.

Step 4: Risk Review: You need to continually monitor and review risks throughout the product lifecycle.

Figure 1: Typical Quality Risk Management Process

*Source: ICH Q9 Guideline: Quality Risk Management; https://www.ich.org/page/quality-guidelines

There are many risk management tools you can use to assess and quantify the risks.

  • Basic risk management methods like flow charts, check sheets.
  • Failure Mode Effects Analysis (FMEA).
  • Failure Mode, Effects, and Criticality Analysis (FMECA).
  • Fault Tree Analysis (FTA).
  • Hazard Analysis and Critical Control Points (HACCP).
  • Hazard Operability Analysis (HAZOP).
  • Preliminary Hazard Analysis (PHA).

You need to integrate your chosen risk management process into your quality system. Train your personnel on your risk management process.

You can access the ICH Q9 Guideline at: https://www.ich.org/page/quality-guidelines.

PSC Biotech® offers professional services, including risk assessment, risk management, gap assessment, and a variety of audit services to help your company verify your compliance status with respect to FDA, EMA, MHRA, TGA, 厚生労働省, 国家药品监督管理局, and other regulations.

Contact us if you need support with any of these services to help you accelerate your success!


ICH Q9 Guideline: Quality Risk Management; https://www.ich.org/page/quality-guidelines

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