Inspection Readiness Checker

Regulatory authority readiness check organized across 8 inspection domains. Produces a readiness score, critical gap list, and preparation action plan.

WHAT THIS CALCULATES

How ready a site is to host a regulatory inspection, scored across the eight domains an inspector actually walks — and, more usefully, which domain is weakest. A single unprepared domain is what defines an inspection, so the tool reports the gaps as prominently as the score.

THE METHOD

domainScore

evidence maturity in one domain: 0 not ready · 1 weak · 2 ready · 3 inspection-ready

domains

the eight inspection domains scored — quality system through CAPA and complaints

readiness%

the whole-number percentage of the maximum achievable score

The cap is the point of the model. An inspector chooses which thread to pull, so one weak domain can define the whole inspection regardless of a strong average — a site at 88% with one domain scored 1 is reported as partial, not strong. The 85% and 70% band thresholds are SPEQ judgement, deliberately stricter than the Annex 1 gap tool.

THE INPUTS, AND WHAT THEY MEAN

Authority focus

Which regulator you are preparing for. It changes emphasis and vocabulary — FDA works to 21 CFR 211 and the systems-based inspection model, EU and PIC/S inspectors to the GMP chapters and annexes — but the eight domains are common ground.

Domain scores (0–3)

Rate the evidence, not the intention. Score 2 only when a stranger could be handed the documentation and follow it; score 3 only when it is also trended and reviewed. "We know how to do it" is a 1.

HOW TO READ THE OUTPUT

• ›Aim for ≥85% with no domain below 2 before hosting. Those thresholds are SPEQ judgement calls for triage, not a regulator’s scoring scheme — no authority publishes a readiness percentage.
• ›Treat the priority gaps as the output. The score is a summary; the list of domains at 0–1 is the work, and it is the honest answer to "are we ready?".
• ›Scoring yourself is the weak link. A domain scored by the person who owns it reads consistently higher than the same domain scored by someone who has to find the evidence cold — have a second person verify anything scored 3.
• ›Readiness decays. A score taken six months ago describes a site that has since changed its people, processes and documents; re-run it close to the event.

WORKED EXAMPLE

A site preparing for an FDA inspection scores every domain 3 except data integrity, which is honestly rated 1 because audit trail review is not yet routine.

Authority focus

FDA

Seven domains

3 — inspection ready

Data integrity

1 — weak

A 92% score reads like a site that is ready, and the single weak domain is the reason it is not. Data integrity is exactly the thread a modern inspector pulls first, and a finding there casts doubt on every record supporting the other seven domains. The number to act on is the gap, not the percentage.

REGULATORY BASIS

21 CFR Part 211

The US cGMP regulation for finished pharmaceuticals — the basis against which an FDA investigator assesses the domains covered here.

PIC/S PE 009-16

The PIC/S GMP Guide, which harmonises inspection expectations across participating authorities including EU, MHRA, TGA and Health Canada.

FDA systems-based inspection model

The six-system framework (quality, facilities and equipment, materials, production, packaging and labelling, laboratory controls) this domain list is built on.

LIMITATIONS — READ BEFORE YOU RELY ON THIS

• ›This is an analytical aid, not a validated system, and a self-assessment rather than an audit. Reproduce the judgement with an independent reviewer — ideally someone who must locate the evidence without help — before treating a score as readiness.
• ›It scores preparedness, not compliance. A well-prepared site with a genuine GMP problem will score highly and still receive findings.
• ›The eight domains are deliberately broad. A product- or process-specific risk — a single troubled product line, a new facility, a recent recall — will not surface in a domain score.
• ›It does not model inspection history. A repeat observation from a previous inspection escalates faster than any first-time finding, and no readiness percentage captures that.

RELATED ON SPEQ