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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.


At the top of the benchmarking page, use the three filter controls to focus the analysis.

  1. 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
  1. 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.

  1. Open the Timeframe dropdown and select one of:
    • Last 3 Months
    • Last 6 Months
    • Last 12 Months (default)
    • Last 24 Months

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”
MetricDefinition used on this pageResearch outcome
Deviation Closure Rate% of deviations closed/approved/completed/resolvedNo 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 conclusionNo 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/acknowledgedNo regulator or named-methodology survey publishes an aggregate completion percentage comparable across organizations.
Document Review TimeMean days from creation to last update on approved documentsNo public dataset reports document-control cycle time with a stated population and methodology.
Audit Compliance Score% of audits completed/closed/finishedNo 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” outcomeNo 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.

LevelMeaning
Top QuartileAt or above the 75th percentile of a published benchmark
Above AverageBetween average and top quartile of a published benchmark
AverageBetween bottom quartile and average of a published benchmark
Below AverageBelow the 25th percentile of a published benchmark
No BenchmarkNo published, population-matched source exists for this metric yet

  1. Scroll to the Compliance Standards section.
  2. 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

  1. Scroll to the Industry Comparison section.

  2. 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:

    MetricDescription
    Deviation RateYour computed deviation-closure rate
    CAPA EffectivenessYour computed CAPA-effectiveness completeness
    Training CompletionYour computed training-completion rate
    Audit ReadinessYour computed audit-plan completion rate
    Document ControlYour computed document-approval rate
    Quality ScoreOverall composite of the above
  3. 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.


Chart TypePurpose
Radar ChartYour own performance across six key metrics (no fabricated industry-average overlay)
Bar ChartYour performance per metric, plus an industry-average / top-quartile bar only for a metric with a published source
Pie ChartDistribution 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.

  1. Navigate to the Compliance Benchmarking page.
  2. Set the filters: Standard = ISO 13485, Industry = Medical Devices, Timeframe = Last 12 Months.
  3. 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.”
  4. 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.
  5. 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.
  6. 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.