record

A record captures evidence of an activity performed or a result obtained. Examples include completed worksheets, instrument maintenance logs, authorization records, quality-control results, and documented communication of critical findings. Unlike a procedure, which tells people what to do, a record shows what actually happened. Electronic records can include metadata and audit trails as well as the visible entry.

Records should be legible, attributable, retrievable, and protected throughout their retention period. Capture information when the activity occurs, with enough context to reconstruct important decisions. Corrections should preserve the original information and identify the change according to the laboratory's rules. Retention and disposal arrangements must consider legal obligations, patient confidentiality, clinical needs, and protection against loss or unauthorized alteration, including during system replacement.

Accreditation relies on records to verify that planned controls operated in practice. A polished procedure cannot replace missing evidence of execution. Test retrieval across paper and electronic systems, check access permissions, and confirm that backups can support recovery. Record quality should allow an independent reviewer to understand the activity without relying on the memory of one employee.