Quality Risk Management: What’s new in ICH Q9(R1)?

Read a summary of the most important changes here:

Chapter 4 ‘General Quality Risk Management Process’

The QRM process flow chart has been amended. The QRM term definitions are unchanged but are now applied more consistently. To this end, the process step ‘Risk Identification’ has been renamed ‘Hazard Identification’. In section 4.3 ‘Risk Assessment’, ‘Hazard Identification’ is described instead of ‘Risk Identification’.

What is the background to this change? The term ‘risk’ has always been defined by the hazard, the harm to health that could result from the hazard and the combination of the severity of this harm and its probability of occurrence. In practice, however, the term ‘risk’ has often been used as a blanket term for everything. The adjustments in the new version of the guideline are intended to clarify the distinction between ‘hazard’ and ‘risk’ so that the terms are used consistently in practice in accordance with their definitions.

Chapter 5 ‘Risk Management Methodology’

Three new sections have been added:

• 5.1 ‘Formality in Quality Risk Management’
• 5.2 ‘Risk-Based Decision-Making’
• 5.3 ‘Managing and Minimizing Subjectivity’

A QRM principle formulated back in 2005 states that the effort, formality and extent of documentation should be commensurate with the level of risk. Over the years, it has been recognised that there was uncertainty and confusion in the industry and among the supervisory authorities regarding the interpretation of this formulation. Section 5.1 describes which factors help to determine the necessary effort, the required formality and the required scope of the documentation.

The original version of ICH Q9 already referred to the application of QRM principles in decision-making, but there was a lack of clarity about what good risk-based decision-making actually means, how risk-based decisions can be made and how decision-making can be improved through QRM. Section 5.2 describes guidelines and approaches to risk-based decision-making and their basis, namely process and product knowledge.

Industry and authorities have recognised that hazards and their effects, i.e. patient harm, the probability of patient harm and its possible extent, are perceived differently. This leads to subjectivity in the results of the risk assessment and thus reduces the effectiveness of the QRM processes. Contrary to the actual objective of QRM, this can even lead to a higher probability of occurrence and an increased extent of possible patient harm - e.g. if the extent or probability of occurrence is underestimated. Bias and behavioural factors must be recognised and controlled in order to exclude subjectivity as far as possible. According to section 5.3, this requires a high level of product and process knowledge and expertise in the application of QRM methods and tools.

Chapter 6 ‘Integrating of QRM into Industry and Regulatory Operations’

Section 6.1 ‘The Role of QRM in Addressing Product Availability Risks Arising from Quality/Manufacturing Issues’ has been added. The section describes quality and manufacturing factors that can affect supply reliability and hence product availability. They include, but are not limited to, the following:

• Manufacturing Process Variability and State of Control
• Manufacturing Facilities and Equipment
• Oversight of Outsourced Activities and Suppliers

Summary: The revised ICH Q9(R1) takes into account the previous experience of industry and authorities in dealing with quality risk management. This relates in particular to the correct use of terms, the right degree of formality and effort, as well as the avoidance of subjectivity in the application of QRM.