Combination Products Risk Management - Dr. R. Wedge - ISO 14971:2019 vs. ICH Q9 (R1)

Sep 22, 2026

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Combination Products Risk Management presentation compares ISO 14971:2019 and ICH Q9 (R1) for managing risks across the product lifecycle. It outlines differences in planning requirements, risk assessment inputs such as hazards, hazardous situations, and probability decomposition, and approaches to risk control including design safety, protective measures, information for safety, and verification of effectiveness. The content also covers overall residual risk determination, risk communication, review before commercial launch, and planned and unplanned production and post-production activities.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages19

Reading Time7 min

AccessFree to download

ISO 14971:2019 vs. ICH Q9 (R1)

Overview

Planning

Risk Assessment

Risk Control

Overall Residual Risk & Risk Communication

Risk Management Review

Production & Post-Production Activities

Merging The Two Approaches

Combination Product Risk Assessments

Combination Products Risk Management Integration of ICH Q9(R1) & ISO 14971:2019 Dr. R . Wedge Associate Research Fellow, Pfizer Inspiring Collaboration. Leading Innovation. Making a difference. Inspiring Collaboration. Leading Innovation. Making a difference. ISO 14971:2019 vs. ICH Q9 (R1) Similarities, Nuances & Differences Overview ISO 14971:2019 ICH Q9 (R1) Inspiring Collaboration. Leading Innovation. Making a difference. Planning • Requires a risk management plan . • Scope of planned activities • Assignment of responsibilities & authorities • Method of evaluating and criteria for acceptability of overall residual risk • Verification activities • Activities related to collection and review of production & postproduction information • Retained in Risk Management File . • Does not require plan as process step. • Process starts with defined problem or question . • Assessment of formality required. • No requirement for Risk Management File . • Scope of risk management activities documented. • Definition of risk criteria and specification of acceptable levels . Inspiring Collaboration. Leading Innovation. Making a difference. Risk Assessment • Document intended use, characteristics affecting safety & reasonably foreseeable misuse . • Identification of hazards in normal & fault modes . • Hazardous situation defined as a term . • Probability of occurrence can bedecomposed into P1 and P2 . • Requires well-defined problem description or risk question . What might go wrong? • No use of the term hazardous situation . • Identification of hazards . • Evaluation of risks associated with exposure to hazards . • Severity and occurrence used as factors to determine the level of risk • Level of risk evaluated against documented criteria . Inspiring Collaboration. Leading Innovation. Making a difference. Risk Control • Risk control option analysis . • Inherent safety by design • Protective measures • Information for safety • Verification of implementation of risk control measures . • Verification of effectiveness of risk control measures . • Specification of individual residual risks . • Benefit risk analysis . • Focus on decision making to reduce and accept risks . • Effort to reduce risk proportional to the level of risk. • Acceptance of risk can be formal or passive . • Reduction of severity and occurrence . • Assessment of whether risk control measures lead to further risks or significance of existing risks . • Reduction of risk to an acceptable level. Inspiring Collaboration. Leading Innovation. Making a difference. Overall Residual Risk & Risk Communication • Determination of benefit/risk ratio . • Benefits of intended use • Contribution of residual risks • Risk control hierarchy • Clarity of IFU • Results of Design Validation, Clinical Evaluation etc. • Literature • Generally acknowledged start of the art • Generation of Risk Management Summary Report. • Output of risk management process appropriately documented. • Disclosure of residual risks to regulators and the patient/user. • Effort to reduce risk proportional to the level of risk. • Acceptance of risk can be formal or passive . • Focus on balance between benefits, risksand resources . • Communication of information to decision makers . Inspiring Collaboration. Leading Innovation. Making a difference. Risk Management Review • Review of the execution of the Risk Management Plan prior to commercial launch. • Agree on acceptance of overall residual risk. • Agreement of methods to collect and review production and postproduction information . • Outputs of QRM process communicatedin individual reports . • Frequency of review determined based on level of risk. • May involve reconsideration of original acceptance decision . • Outputs of risk management reviewed and monitored as new knowledge about and experience with risks are gaine

FAQs

What are the key planning differences between ISO 14971:2019 and ICH Q9 (R1)?

ISO 14971 emphasizes a risk management plan including scope, responsibilities, evaluation criteria for overall residual risk, verification activities, and retention in a Risk Management File. ICH Q9 starts from a defined problem or question and requires documented scope and risk criteria without a dedicated Risk Management File as a process step.

How does the risk assessment step differ between the two approaches?

ISO 14971 uses terms such as hazardous situation and includes identification of hazards in normal and fault modes, with probability decomposition (e.g., P1 and P2). ICH Q9 uses a well-defined problem description or risk question and does not use the term hazardous situation, while still requiring identification of hazards and evaluation of risk levels against documented criteria using severity and occurrence.

How are overall residual risk and risk communication handled?

Both approaches focus on benefit/risk balance and documenting outputs of the risk management process. ISO 14971 highlights contributions of residual risks, risk control hierarchy, clarity of IFU, and generating a Risk Management Summary Report for appropriate disclosure to regulators and patients/users, alongside communication to decision makers.

Sep 22, 2026

Upload by Franzy