Why ICH Q9 was revised
ICH adopted Q9(R1) at Step 4 on January 18, 2023 (PMDA copy of ICH Q9(R1)). FDA published it as final guidance in May 2023, describing it as “a targeted revision of the 2006 guidance” (FDA). The Federal Register notice listed four problems it addresses (Federal Register):
- “high levels of subjectivity in risk assessments and QRM outputs”
- “lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work”
- “lack of clarity on risk-based decision-making”
- “product availability risks due to manufacturing quality issues”
What Q9(R1) says
| Topic | Key text from FDA’s Q9(R1) guidance (FDA) | What it means for your template |
|---|---|---|
| Principles | Risk evaluation “should be based on scientific knowledge and ultimately link to the protection of the patient”; effort and documentation “should be commensurate with the level of risk” | Scale the template to the decision |
| Subjectivity | ”While subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled” | Define scales, use data, record assumptions and dissent |
| Formality | ”Formality in quality risk management is not a binary concept (i.e., formal/informal)“ | Choose a formality level and justify it |
| Decision-making | ”Risk-based decision-making is inherent in all quality risk management activities” | Record the decision, not just the score |
| Product availability | Quality and manufacturing issues, including GMP non-compliance, are “a significant cause” of shortages | Include supply impact in assessments |
| Hazard identification | ”The systematic use of information to identify potential sources of harm” | Start from data, not brainstorming alone |
The guidance lists tools including FMEA, FMECA, FTA, HACCP, HAZOP, PHA, and risk ranking and filtering. RAPS noted the new section on managing subjectivity in section 5.4 (RAPS).
Quality risk management template (Q9(R1)-aligned)
Part A: Scope and formality
| Field | Entry |
|---|---|
| Risk question | One specific question, e.g. “What is the risk to sterility from moving filling to Line 3?” |
| Decision this informs | e.g. approve change, define validation scope |
| Formality level | Low / medium / high, with justification based on uncertainty, importance and complexity |
| Team | Names and functions; include people with direct process knowledge |
| Data sources | Deviations, complaints, OOS, stability, supplier data, prior assessments |
Part B: Assessment (example rows, FMEA-style)
| Hazard / failure mode | Potential harm | Cause | Severity | Occurrence | Detection | Risk | Existing controls | Evidence for ratings |
|---|---|---|---|---|---|---|---|---|
| Filter integrity failure | Non-sterile product | Damaged filter | High | Low | Medium | Medium | Pre/post-use integrity test | 3-year integrity test data |
Part C: Control and decision
| Field | Entry |
|---|---|
| Risk reduction actions | Actions, owners, dates |
| Residual risk and acceptance | Accepted? By whom, on what basis |
| Product availability impact | Could this affect supply? Mitigations |
| Decision | The risk-based decision made |
| Review trigger | When to revisit (new data, change, periodic) |
Q9(R1) checklist
- Risk question and decision stated before scoring
- Formality level chosen and justified
- Rating scales defined in advance, with examples per level
- Ratings backed by data; assumptions and uncertainties recorded
- Diverse team with process knowledge; dissenting views documented
- Hazards identified systematically from data, not only brainstorming
- Product availability and shortage risk considered
- Decision recorded and linked to the assessment
- Review planned as knowledge grows
Check your QRM procedures against Q9(R1)
Many QRM procedures were written for the 2006 guideline and say nothing about formality, subjectivity or product availability. AI document assessment can read your QRM SOP and recent risk assessments against Q9(R1), flag missing elements and cite the passage behind every finding.
Run a sample regulatory document assessment on your QRM procedure. AskDona shows the evidence; your QA team decides.
FAQ
When did ICH Q9(R1) take effect? ICH adopted it on January 18, 2023; FDA issued it as final guidance in May 2023 (FDA).
What are the main changes from Q9? Clarifications on subjectivity, formality, risk-based decision-making and product availability risks (Federal Register).
Is FMEA required? No. Q9(R1) lists FMEA among several tools; choose the tool and formality that fit the risk question.
How do we reduce subjectivity? Define scales in advance, use data, involve a diverse team and record assumptions. Q9(R1) says subjectivity “may be controlled” (FDA).
References
All pages opened and checked by October 9, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: Q9(R1) guidance page | Regulator guidance | May 2023 | Final status |
| FDA: Q9(R1) guidance PDF | Regulator guidance | May 2023 | Key text and tools |
| Federal Register: Q9(R1) availability | Regulator | May 4, 2023 | Four issues addressed |
| PMDA: ICH Q9(R1) text | Regulator copy | Jan 18, 2023 | Step 4 date |
| RAPS: ICH adopts Q9(R1) | Trade press | Jan 25, 2023 | Subjectivity section |