This is a ready-to-use worksheet for reconciling an analytical injection sequence during second-person review. Its single job is to prove that every injection the instrument performed maps to a documented purpose, so an injection that appears on the instrument but nowhere in the reported record, the fingerprint of testing into compliance, cannot slip past. The reviewer counts and accounts. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
Purpose
Confirm that the total number of injections in the instrument sequence log equals the sum of injections with a documented purpose (samples, standards, blanks, brackets, system suitability, and documented aborts with a reason), leaving zero unexplained. An unexplained injection must be resolved before the result set is accepted.
Field definitions
The reconciliation
Count table
Resolution of any gap
Acceptance criteria
The sequence reconciles when the instrument total equals the accounted-for total and the unexplained gap is zero. Any nonzero gap must be resolved, and if resolution shows a real sample run that never reached the report, the result set is not accepted and the event is escalated as a possible testing-into-compliance concern.
Filled specimen
The following completes the worked reconciliation from the second-person review article. Numbers are illustrative.
Count table
Resolution of any gap
Here the two-injection gap resolved to legitimate, unlogged equilibration injections that produced no result, confirmed in the audit trail. The reviewer documented the resolution and accepted the set. Had either injection been a real sample run whose result was never reported, the set would be rejected and escalated: that is the outcome the worksheet exists to force into the open.
Common findings this worksheet prevents
- An orphaned injection, a run the instrument performed that appears nowhere in the reported record, never detected because the sequence was never reconciled.
- Testing into compliance, where unfavorable results were generated then discarded so only the passing run was reported.
- A reconciliation asserted (“sequence checked”) with no count, so it cannot be verified.
- Aborted or invalidated injections with no contemporaneous reason, counted as documented when they are not.
How to adapt this worksheet
- Add rows for technique-specific injection purposes (for example, sensitivity or resolution solutions).
- For dissolution and multi-vessel methods, adapt the count to vessels and the profile rather than injections.
- Pair this worksheet with the audit trail review work instruction and the analytical data review record.
- Keep the reviewer who reconciles distinct from the analyst who generated the sequence.
