Mock-inspection binder checklist

Checks reset when you leave the page. Print the page if you want a paper copy.

Before the room

• Scope written in one paragraphWhich products, sites, systems, and time window are in play?
• Org chart + quality unit responsibilities currentWho answers what when the inspector asks?
• Tour path and dirty/clean flows agreedAvoid improvising the walk.
• SME list with backupsName + topic + phone. No orphans.

Core quality system docs

• Quality manual / policy (current effective)
• Change control procedure + recent examplesInclude a hard change and a soft one.
• Deviation / CAPA / OOS procedures (current)Match what people actually do.
• Document control / training procedures
• Internal audit schedule + last two reportsWith CAPAs closed or open, honestly.

The story stack (pick for your scope)

• 2–3 recent deviations with full investigationsInclude one that was painful.
• Open and closed CAPAs tied to those events
• Batch / lot records for products in scopeWith manufacturing and packaging as relevant.
• Relevant SOPs and work instructions (effective copies)Not drafts from someone’s desktop.
• Validation / qualification package indexProtocols and reports findable fast.
• Stability or annual product review slice if in scope

Data integrity & access

• List of computerized systems in scopeWho owns admin access?
• Audit trail / backup expectations known for those systemsEven if you will not open every system on day one.
• Paper/hybrid record locations mappedWhere is the original?

Hygiene pass (mechanical — before deep judgment)

• Effective dates and versions match across the stackSOP cited in the deviation is the version that was effective then.
• No obvious date-order impossibilities on the samplesApproval before the event, etc.
• Root causes on sample CAPAs are not pure circular languageSee the circular root-cause guide.
• Signature / approval blocks not blank on controlled copies in the binderPresence is not authenticity — still look.