Q385 · What is “Quality Risk Management” (QRM)? How…

Q385 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing quality risks that may arise throughout a medicine’s lifecycle. It goes beyond simply “following rules”: it proactively and prospectively identifies where things could go wrong and how serious the consequences could be, and allocates resources accordingly, giving priority to high-risk areas. In day-to-day operations, QRM can be applied when conducting risk assessments of different suppliers; assessing risks that may arise from a change during change control; using risk tools to analyse root causes when investigating deviations; and determining the frequency and depth of self-inspections or supplier audits on a risk basis. The key is to make your quality management activities more targeted and direct limited resources where they are most needed.

📘 Regulatory basis

The International Council for Harmonisation (ICH) Q9 guideline, Quality Risk Management, is a globally recognised industry standard. The principles of QRM have been fully incorporated into PIC/S GMP and GDP guidelines, requiring licence holders to establish and operate their quality systems on a risk-based basis.

📗 Drew Tang's recommendations

We recommend that clients start with simple risk management tools, such as FMEA (Failure Mode and Effects Analysis). For example, you could organise a cross-functional team to conduct an FMEA of your goods receipt process, identify all possible “failure modes” (such as receiving the wrong goods or a faulty thermometer), assess their likelihood, severity and detectability, and then develop improvements for high-risk points. Incorporating QRM thinking into day-to-day decisions can make your quality system “smarter” and more efficient.

📕 Risk notice

In the modern pharmaceutical regulatory environment, a Quality Management System (QMS) without risk management is considered outdated and ineffective. If you cannot explain to inspectors why you classify a particular area or process as high risk and have introduced additional controls, or why you consider a deviation low risk and have dealt with it in a simplified way, this may indicate that your decisions are arbitrary and lack a scientific basis. This will reduce the regulatory authorities’ confidence in your overall quality system.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

What is “Quality Risk Management” (QRM)? How is it applied in our day-to-day operations?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang