A quality management system that will not close an event without an answer

What it does

A deviation or nonconformance follows the same lifecycle every time: log it, investigate it, run a structured root-cause analysis, decide a CAPA if one is warranted, and close it. ERRA will not let it close without a completed 5-Whys chain or 6M fishbone, signed into the closure record.

An out-of-specification result runs ERRA's own two-phase investigation, modeled on FDA out-of-specification guidance: a lab-investigation phase, then a full investigation phase if the lab investigation does not clear it, feeding the material review and disposition decision that 21 CFR 111.87 requires and the rejection outcomes 111.77 sets when a specification is not met.

What's in it

• Deviation, nonconformance, CAPA, complaint, and change-control lifecycle, with CAPA effectiveness checks and supplier corrective-action requests.
• Structured root-cause analysis required to close a deviation or nonconformance, signed into the closure manifest.
• ERRA's own two-phase out-of-specification investigation, modeled on FDA OOS guidance.
• Risk register with a scored, FMEA-style workflow.
• Internal and supplier audit management, with findings that escalate directly into the QMS.
• A deterministic quality KPI glance for a readiness check, distinct from a signed management-review record.

Primary sources

• 21 CFR 111.87: material reviews and disposition decisions
• 21 CFR 111.77: what must you do if established specifications are not met

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