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Inspection readiness 90-day plan

A phased 90-day plan for the run-up to an FDA or MHRA inspection — 33 dated tasks across three phases, each phase ending in a gate you either pass or do not.

Most teams do not fail an inspection on the facts; they fail on retrieval. This plan turns "we should get ready" into a dated schedule: inventory the evidence and measure how long retrieval really takes (days 1–30), close the gaps while rehearsing unannounced record requests (days 31–60), then hold steady and re-measure (days 61–90). Every task carries an owner, a due date, and a definition of what "done" looks like.

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Inspection readiness 90-day plan — the Excel workbook you download, showing its three phases, owners and gate columns
Inspection readiness 90-day plan — the Excel workbook you download, showing its three phases, owners and gate columns

What the plan covers

The workbook has three tabs. An Instructions tab explains how to work the plan and why retrieval time is the column that matters. The 90-Day Plan tab carries 33 tasks grouped under three phase banners, each with an owner, a due date, a status dropdown, a retrieval-time column, and a plain statement of what “done” looks like. The Phase Gates tab holds the 12 gates — four per phase — that decide whether a phase is actually finished.

The structure follows the companion 90-day inspection readiness guide, which explains the reasoning behind each phase.

  • Days 1–30 — inventory every record type an investigator asks for, name an owner, and measure retrieval time honestly
  • Days 31–60 — close gaps in risk order while running unannounced retrieval rehearsals in parallel
  • Days 61–90 — hold the line: change freeze, visible metrics, briefed roles, and a re-measure against the baseline
  • A pass/fail gate at the end of each phase — a phase is not done because its tasks are ticked
  • Owner, due date, status and evidence-reference columns on every task

Why retrieval time is the column that matters

Inspections are rarely lost on whether a record exists. They are lost on how long it takes to produce it, complete and current, while somebody waits. That is why every retrieval task in this plan has a time column, and why the instruction is to measure rather than estimate — a rounded-down number hides the exact problem the plan exists to fix.

Rehearsal is the other half. Phase two asks you to have a non-owner request records at random, including one whose owner has left, because that is the dependency an inspection will eventually expose for you.

How this differs from the readiness checklist

Our inspection readiness checklist is a snapshot: twenty record types, rated Ready / Gap / N-A, telling you where you stand today. This 90-day plan is the schedule that closes those gaps — dated tasks, owners, and gates over a quarter.

Most teams use both: run the checklist first to find the gaps, then work this plan to close them, and re-run the checklist at day 90 to confirm the numbers actually moved.

Frequently asked questions

How long before an inspection should we start preparing?

Ninety days is a practical window rather than a regulatory one — no agency prescribes how long you should spend preparing. A quarter is long enough to find your retrieval problems, fix the ones that matter and prove the fix held, and short enough that whoever committed to something in week two still remembers it in week eleven.

What actually gets tested in an inspection?

Retrieval, more than existence. An investigator asks for the CAPA behind a finding, the training record for an operator, the audit trail for a result — and the speed and completeness of the answer signals whether you control your quality system or merely store it. That is why every retrieval task in this plan carries a measured time.

What is a phase gate and why does it matter?

A short list of conditions that must be true before the phase counts as finished — for example, that retrieval no longer depends on any single named person. Tasks can all be ticked while the underlying problem survives; the gate is what catches that.

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