Quality Risk Register Template
A risk register records what could go wrong, how likely and how serious it is, and who is acting on it. This template scores each risk as likelihood times impact so a quality or operations team can rank them, track mitigation and show evidence of risk-based thinking.
| ID | Risk description | Area | Likelihood (1-5) | Impact (1-5) | Score | Mitigation / action | Owner | Next review | Status | |
|---|---|---|---|---|---|---|---|---|---|---|
15 | ||||||||||
8 | ||||||||||
12 | ||||||||||
9 | ||||||||||
8 |
Use a 5 by 5 matrix: scores of 15 and above are commonly treated as high, 8 to 14 as medium and below 8 as low. Agree these bands with your management team and record them in your procedure.
Feed your risk register from ERP signals
Optional: discuss surfacing supplier and quality trends from your ERP into risk reviews.
Optional. The tool and every export work without this. No spam.
How to use the register
Add one row per risk. Write the description as an event plus consequence, such as supplier misses delivery causing line stoppage. Rate likelihood and impact from 1 to 5 using definitions your team agrees on, then record the mitigation, an owner and a review date. Update the status as work progresses and re-score after actions are in place. Review the register in management review and after any significant incident, audit finding or change.
- Describe cause, event and consequence, not a vague topic
- Give every risk one named owner
- Set a next review date, not only a closed date
- Re-score after mitigation to show the residual risk
The scoring method
The score is likelihood times impact, giving 1 to 25. A common banding treats 15 or more as high, 8 to 14 as medium and under 8 as low, though you should define your own and keep it consistent. The matrix is simple and easy to explain, but it hides large impact with low likelihood, so flag any impact of 5 for review regardless of score. For safety critical products use FMEA severity scales rather than a generic matrix.
Reading the result
Sort by score and take the top five to your management review. Compare the highest and average score: a high average suggests widespread weakness, while one outlier suggests a single target. Count accepted risks and check they have a recorded reason and approver. Over time, the aim is to see scores fall as mitigations take effect and new risks appear from changes rather than neglect.
Common mistakes and ISO 9001 links
ISO 9001:2015 clause 6.1 asks organisations to determine risks and opportunities and plan actions, but does not require a formal risk method or register. A register is a convenient way to show it. Common mistakes are creating a long list once a year, scoring without evidence, and leaving mitigation vague. Link risks to FMEA lines, supplier scorecards and audit findings so the register stays alive instead of being a document written for auditors.
Frequently Asked Questions
Is a risk register required by ISO 9001?
ISO 9001:2015 requires risk-based thinking and planned actions to address risks and opportunities, but it does not mandate a specific format. A risk register is a common, practical way to document it.
How is this different from an FMEA?
An FMEA analyses failure modes of a specific design or process in detail. A risk register is broader, covering supplier, people, regulatory and business risks at a higher level. Many companies use both and link them.
What matrix size should I use?
Five by five is common and gives enough resolution. A three by three matrix is quicker but coarse. Whatever you choose, define each level in words so ratings are repeatable.
How often should the register be reviewed?
At least in each management review, and monthly for high risks. Also review after incidents, audits, process changes or new customer requirements.
If your risks relate to ERP data such as supplier delivery or quality history, Netray can discuss pulling signals automatically. The register is free and complete as is.
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