Confirm scope and applicable documents
Before checking files, establish whether products, processes or sites have changed. Confirm applicable document versions against official sources. The audit programme should reflect the actual scope and the activities that can be observed.
Follow a complete process
Sample a purchase or batch and follow it from beginning to end. Compare order, specification, supplier approval, receipt, controls and delivery. Inconsistencies between records often reveal more than a missing form. Staff should be able to explain their roles without relying on a consultant.
Close actions using evidence
For each nonconformity, distinguish correction, cause analysis and corrective action. Closure evidence should demonstrate the promised result. An updated procedure may be necessary but insufficient when the issue concerns implementation. Check that changes reach the affected people.
Make records retrievable
Organise folders, access and versions so records are available without improvised searches. Protect personal and commercial information when sharing. Preparation should not involve retrospectively manufacturing missing records: acknowledge and manage gaps transparently.
Three questions for your team
- Who makes the decision, and using which information?
- Which record reconstructs what happened?
- How do we verify that the control works?
Practical guidance, not a replacement for applicable law or requirements. Consult the official documents linked from the scheme pages for your scope.
