Compliance Benchmarking
The Compliance Benchmarking feature shows your organization’s quality performance, computed from your own records, and compares it against a published industry benchmark only where one exists with a real, cited source. Where no such source exists, the page says so plainly instead of showing an invented number.
Filter benchmarking data
Section titled “Filter benchmarking data”At the top of the benchmarking page, use the three filter controls to focus the analysis.
Select a regulatory standard
Section titled “Select a regulatory standard”- Open the Standard dropdown and select one of:
- All Standards — combined view across all standards
- ISO 13485 — medical device quality management
- ISO 9001 — general quality management
- FDA CFR 820 — US FDA quality system regulation
- GMP — Good Manufacturing Practice
- ICH Q10 — pharmaceutical quality system
Select an industry
Section titled “Select an industry”- Open the Industry dropdown and select one of:
- Medical Devices
- Pharmaceuticals
- Biotechnology
- Food & Beverage
- Automotive
- Aerospace
The industry selector is kept for when a real per-industry benchmark is sourced in the future; it currently does not change which metrics show a comparison, because none do.
Select a timeframe
Section titled “Select a timeframe”- Open the Timeframe dropdown and select one of:
- Last 3 Months
- Last 6 Months
- Last 12 Months (default)
- Last 24 Months
Review benchmark metrics
Section titled “Review benchmark metrics”The Metrics tab table shows, for each metric:
- Current value — your organization’s measured performance
- Industry average / Top quartile — shown only if the metric carries a published source; otherwise the row reads “No published benchmark” across both columns
- Performance — a quartile badge (Top Quartile / Above Average / Average / Below Average) when a benchmark exists, or NO BENCHMARK when it does not
- Trend — improving, stable, or declining, computed against the published average when one exists; stable when there is nothing to compare against
- Source — the publication name and year, linked, for a sourced metric; “No published benchmark” otherwise
What was researched, and why no metric is currently sourced
Section titled “What was researched, and why no metric is currently sourced”| Metric | Definition used on this page | Research outcome |
|---|---|---|
| Deviation Closure Rate | % of deviations closed/approved/completed/resolved | No published closure-rate benchmark found. The closest real dataset (ISPE Quality Metrics Initiative, Wave 1, 2015) measures a per-lot deviation rate, not a closure percentage, and covers pharma manufacturing sites only. |
| CAPA Effectiveness | % of closed CAPAs with a recorded effectiveness-check conclusion | No named survey publishes this. The ”>=85% effectiveness target” repeated on vendor/consultancy pages has no stated sample or methodology behind it. |
| Training Completion Rate | % of assigned training completed/passed/acknowledged | No regulator or named-methodology survey publishes an aggregate completion percentage comparable across organizations. |
| Document Review Time | Mean days from creation to last update on approved documents | No public dataset reports document-control cycle time with a stated population and methodology. |
| Audit Compliance Score | % of audits completed/closed/finished | No source publishes an audit-plan completion rate matching this definition; regulator inspection statistics measure the regulator’s own findings, not a tenant’s internal audit completion. |
| Supplier Quality Index | % of supplier qualifications with an “approved” outcome | No regulator or named-methodology survey publishes a supplier-qualification approval-rate benchmark. |
This table is the human-readable form of frontend/lib/benchmarks/industryBenchmarks.ts, which the page reads to show the reason a metric has no benchmark (as a tooltip on the “No published benchmark” cell). A separate guard test (backend/tests/test_compliance_benchmarking_router.py::test_no_metric_reports_a_benchmark_without_a_source) enforces, against the live API response, that the backend never marks a metric benchmark_available without a complete source attached — a metric cannot show a number without a source, and this documentation is updated in the same PR the day a real one is sourced.
Performance levels
Section titled “Performance levels”| Level | Meaning |
|---|---|
| Top Quartile | At or above the 75th percentile of a published benchmark |
| Above Average | Between average and top quartile of a published benchmark |
| Average | Between bottom quartile and average of a published benchmark |
| Below Average | Below the 25th percentile of a published benchmark |
| No Benchmark | No published, population-matched source exists for this metric yet |
Review compliance standards
Section titled “Review compliance standards”- Scroll to the Compliance Standards section.
- For each regulatory standard, review:
- Compliance score (percentage)
- Requirements met vs. total requirements
- Last assessment and next assessment dates
- Status: Compliant, Partially Compliant, or Non-Compliant
Industry Comparison tab
Section titled “Industry Comparison tab”-
Scroll to the Industry Comparison section.
-
The radar chart and bar chart show your own organization’s values across six key metrics — there is no peer-industry overlay, because no published, population-matched dataset exists for any of the industries offered here:
Metric Description Deviation Rate Your computed deviation-closure rate CAPA Effectiveness Your computed CAPA-effectiveness completeness Training Completion Your computed training-completion rate Audit Readiness Your computed audit-plan completion rate Document Control Your computed document-approval rate Quality Score Overall composite of the above -
The “Your Metrics” card below the charts shows the same values without a ranking, since there is no published peer dataset to rank against.
The Summary tab’s Performance Trends card shows “Not yet available” until score history exists to plot (GAP-148 / KAN-749) — no trend line is fabricated in the meantime.
Visualizations reference
Section titled “Visualizations reference”| Chart Type | Purpose |
|---|---|
| Radar Chart | Your own performance across six key metrics (no fabricated industry-average overlay) |
| Bar Chart | Your performance per metric, plus an industry-average / top-quartile bar only for a metric with a published source |
| Pie Chart | Distribution of compliance statuses across standards |
The Summary tab’s Performance Trends card is a placeholder for a future line chart of your benchmark score over time — it currently states “Not yet available” because no score-history series is stored yet (GAP-148 / KAN-749).
Practical example: Preparing benchmarking data for management review
Section titled “Practical example: Preparing benchmarking data for management review”Scenario: A VP of Quality at a medical device company needs to present the organization’s quality performance at the quarterly management review.
- Navigate to the Compliance Benchmarking page.
- Set the filters: Standard = ISO 13485, Industry = Medical Devices, Timeframe = Last 12 Months.
- Review the benchmark metric table on the Metrics tab:
- CAPA Effectiveness: 88% (your org). “No published benchmark” — there is no cited industry figure to compare this against yet.
- Training Completion: 76%. “No published benchmark.”
- Deviation Closure Rate: 62%. “No published benchmark.”
- Review the Compliance Standards section. ISO 13485 shows 94% compliance (187 of 199 requirements met), with the next assessment due in 4 months. The 12 unmet requirements map to training records and supplier qualification gaps.
- Present the metrics as your organization’s own trend over time (compare this quarter’s export against last quarter’s) rather than against an industry figure, since none is currently published for these definitions.
- Note any month-over-month trend from your own records outside the system for now — the Summary tab’s Performance Trends card will plot this automatically once score history is captured (GAP-148 / KAN-749).
The management review presentation is honest about what is and is not measured against peers: your own quarter-over-quarter change is real data; there is no claimed industry position because no published benchmark exists for these metric definitions.