NEWS
r4subrisk 0.3.1
- Metadata and documentation polish for CRAN submission; no user-facing changes.
r4subrisk 0.3.0
- Add
risk_monte_carlo(), which puts uncertainty on the FMEA scores. An RPN is
built from three integer judgements, so a single number hides how confident
the assessment is. The simulation samples each probability, impact, and
detectability around its assessed value and reports the distribution of RPN,
per risk and for the register as a whole, including a 90% interval and the
probability that each risk is actually critical. The random state is set and
restored per call when a seed is given, so results are reproducible without
disturbing the caller's RNG.
r4subrisk 0.2.0
- Add
risk_reduction_summary(), which quantifies the risk removed between two
registers: total and mean RPN reduction, percentage reduction, and counts of
risks reduced, downgraded, added, and resolved.
- Add
plot_risk_heatmap() and risk_heatmap_data() for the standard FMEA
probability by impact heatmap, with an optional interactive plotly version.
- Add a pluggable risk-model interface:
risk_model() plus the pre-built
risk_model_fmea(), risk_model_probability_impact(), and
risk_model_ich_q9(). apply_risk_model() scores any set of risks to a
normalized 0-100 value so alternative models feed the same Risk pillar.
- Add vignette: "Case study: FMEA risk on a pilot submission", a worked
before-and-after mitigation walkthrough using the example risk register from
r4subdata.
- Clarified the package DESCRIPTION: "R4SUB" expands to "Ready for Submission"
(previously "R for Regulatory Submission", inconsistent with the rest of the
ecosystem).
r4subrisk 0.1.1
- Add vignette: "Risk Management with r4subrisk" covering
create_risk_register(),
compute_risk_scores(), apply_mitigations(), compare_risk_registers(),
and evidence_to_risks() integration.
r4subrisk 0.1.0 (2026-03-03)