The announcement, and the hunt that follows
An inspection date arrives. The quality manager starts a folder and a list. Where is the latest version of the witnessing SOP? Did we complete the audit on storage checks last quarter, and where are the results? Which staff are overdue their training updates? Were actions from the last incident review closed?
Everything exists somewhere: a shared drive with several versions of each document, binders in the lab, a training spreadsheet, meeting minutes in email. Finding it and proving it is current is the work.
Why evidence is scattered
- Documents are saved in shared drives with inconsistent names and versions.
- Audit schedules and results are tracked separately from the SOPs they relate to.
- Training records live in a spreadsheet kept by one person.
- Actions from incidents and audits are recorded in minutes, not tracked to closure.
- Nobody can see, at a glance, which evidence is out of date.
Staff turnover makes it worse. The person who knew where the storage audit results were kept may have moved on, and their folder structure made sense only to them. Evidence that was properly produced can still be impossible to find, which, in an inspection, looks much the same as evidence that was never produced.
What the scramble costs
Senior staff time is pulled away from patients and the lab for weeks. Gaps discovered during preparation are fixed in a hurry. Out-of-date documents and unclosed actions are easier for inspectors to find than they are for the clinic, because inspectors look systematically.
| Evidence | Where it usually is | In an evidence library |
|---|---|---|
| SOPs | Shared drive, several versions | One current version, with history and review date |
| Audit results | Spreadsheets and emails | Stored against the audit schedule |
| Training records | One person's spreadsheet | Per person, with due dates |
| Incident actions | Meeting minutes | Tracked to closure with owners |
| Equipment records | Lab binders | Linked to the relevant SOPs and audits |
How we build an evidence library
- We set up a structured library in a tool that suits you, often Microsoft 365 or SharePoint with a custom front end, organised around the areas your quality manager uses for inspection.
- Each document has an owner, a current version, a review date and a link to the areas it supports.
- Audit schedules sit alongside results, and missed or overdue audits show clearly.
- Training records are held per person, drawn from your existing records, with due dates and reminders.
- Actions from incidents, audits and meetings are tracked with owners and due dates until closed.
- A dashboard shows what is overdue or due soon, so gaps are fixed through the year.
- An export assembles a pack of current evidence for any area, ready to review before an inspection.
The library holds and organises evidence your team produces. We do not write SOPs or interpret licence conditions. Those remain with your person responsible and quality lead.
What changes for the quality team
Preparation becomes a review of what is already in place rather than a search. Overdue items are visible all year, so they are fixed before an inspection is announced. Owners get reminders about their own documents and actions.
Document owners benefit as well. A lab manager who owns a dozen SOPs sees their own review dates and open actions, rather than hearing about them in a flurry of emails before an inspection. Quality becomes a steady, year-round routine, which is how most quality managers want it to work anyway.
Is inspection preparation painful for you?
- Preparation takes weeks of senior staff time.
- Several versions of the same SOP exist on the shared drive.
- Training records live in one person's spreadsheet.
- Actions from incidents and audits are hard to prove closed.
- Gaps are found during preparation rather than beforehand.