This is a ready-to-use evaluation. It is completed at the curriculum-item level, for a cohort of trainees or a whole role, to answer a different question than an individual training record does: did this training actually work, not just did people complete it. Replace every <<FILL: ...>> placeholder, route it through your training or quality function, and file it with the curriculum item it evaluates. A field-definition table and a filled specimen follow. This content is educational reference to adapt and verify, not legal or regulatory advice.
Form control
| Field | Entry |
|---|---|
| Form title | Training Effectiveness Evaluation |
| Form number | <<FILL: FRM-ID, e.g. FRM-QA-020-03>> |
| Parent SOP | <<FILL: SOP-ID for training program management>> |
| Version | <<FILL: version>> |
Trigger for this evaluation
| Field | Entry |
|---|---|
| Curriculum item evaluated | <<FILL: item name, governing document number and version>> |
| Reason this evaluation was triggered | <<FILL: scheduled periodic check / repeat training-related deviations on this procedure / a failed prior evaluation / new or revised curriculum item>> |
| Population covered | <<FILL: role(s), number of people trained on this item>> |
| Evaluation period | <<FILL: from date>> to <<FILL: to date>> |
Part A: Comprehension check (if used for this item)
| Field | Entry |
|---|---|
| Assessment used | <<FILL: quiz name / version>> |
| Pass threshold | <<FILL: e.g. 80 percent>> |
| Number assessed | <<FILL>> |
| Number passed on first attempt | <<FILL>> |
| Common wrong answers / weak concepts | <<FILL>> |
Part B: Field observation
| Field | Entry |
|---|---|
| Number of personnel observed performing the task | <<FILL>> |
| Observation method | <<FILL: direct observation on the bench / floor / video review of a recorded run>> |
| Number observed performing the task correctly per procedure | <<FILL>> |
| Deviations from procedure noted during observation | <<FILL: describe, with identifiers>> |
Part C: Error-rate trend
| Field | Entry |
|---|---|
| Metric used | <<FILL: e.g. deviations per 100 batches, OOS rate, audit-trail exceptions per review cycle, re-integration frequency>> |
| Baseline period and rate | <<FILL: dates and rate before the training intervention>> |
| Post-training period and rate | <<FILL: dates and rate after the training intervention>> |
| Sample size adequate for the comparison? | <<FILL: Yes/No, with basis>> |
| Direction and magnitude of change | <<FILL: e.g. reduced from 3.1 to 0.9 per 100 batches>> |
Part D: Overall determination
| Field | Entry |
|---|---|
| Pass/fail criteria applied | <<FILL: e.g. comprehension pass rate at or above threshold AND observed correct-performance rate at or above threshold AND error-rate metric improved or held at an acceptable level>> |
| Outcome | Effective / Not effective / Partially effective (specify which part failed) |
| If not effective, root cause suspected | <<FILL: training method / procedure itself / equipment or system / unrelated to training>> |
| Action triggered | <<FILL: none, curriculum content revision, method change (e.g. R&U to OJT), procedure revision, or referral to CAPA>> |
| Action owner and due date | <<FILL>> |
| Evaluator (name, signature, date) | <<FILL>> |
| QA review (name, signature, date) | <<FILL>> |
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Curriculum item | Text, with document number/version | Yes | Training/QA | At evaluation start |
| Trigger | One of the listed categories | Yes | Training/QA | At evaluation start |
| Comprehension check results | Counts and percent | If item uses a quiz | Training | During evaluation |
| Field observation results | Counts and narrative | If hands-on task | Supervisor/SME | During evaluation |
| Error-rate trend | Metric, two periods, direction | If a measurable proxy exists | QA | During evaluation |
| Outcome | One of three fixed values | Yes | Evaluator | At close |
| Action triggered | Text, tied to root cause | If outcome is not fully effective | Evaluator/QA | At close |
Retention: keep with the curriculum item’s file for not less than <<FILL: retention period>>.
Instructions
- Do not treat this as an individual competency check; that belongs in the person’s own training and competency record. This form asks whether the training approach itself works across the people who received it.
- Complete whichever parts apply to the curriculum item’s method: a read-and-understand item may only have Part C available, a hands-on task should have Parts B and C, and a CBT or ILT item with a quiz should have Part A.
- An error-rate trend needs enough volume on both sides of the comparison to mean something; state explicitly if the sample is too small to draw a conclusion, rather than reporting a change that is not really evidence.
- If the outcome is not effective, the default action is not to retrain the same people again on the same content; identify whether the method, the procedure itself, or something outside training is the real driver, and route accordingly.
- Route to QA for review before closing, particularly when the outcome is not effective or the action includes a procedure change.
Filled specimen
The following shows the form completed for an OOS recognition and escalation curriculum item, triggered by repeat training-related deviations. Numbers and names are illustrative.
| Field | Entry |
|---|---|
| Curriculum item | OOS recognition and escalation, SOP-QC-030 rev 04 |
| Reason triggered | Repeat training-related deviations: 4 of 9 training-linked deviations this year cited this procedure |
| Population | QC Analyst I and II, 18 people trained |
| Evaluation period | 01 Jan 2026 to 30 Sep 2026 |
Part A: comprehension check. Assessment QUIZ-030-v3, pass threshold 80 percent, 18 assessed, 17 passed on first attempt. Weak concept: distinguishing a suspect result from a confirmed OOS before escalation.
Part B: field observation. 6 analysts observed handling a suspect result on the bench. 4 of 6 followed the procedure correctly; 2 of 6 informally reprocessed before escalating, which the procedure does not permit.
Part C: error-rate trend. Metric: OOS-related training deviations per quarter. Baseline (Q1 2026): 2. Post-training period (Q3 2026, after a retrain in June): 2. Sample size adequate: marginal, only 2 quarters of comparable volume. Direction: no measurable improvement.
Part D: overall determination. Outcome: Not effective. Root cause suspected: the procedure itself, not the training; the field observation shows people understand the rule in the abstract (quiz pass rate 94 percent) but do not apply it consistently at the bench, which points at an ambiguous decision point in SOP-QC-030 rather than a knowledge gap. Action triggered: procedure revision to clarify the suspect-result decision point, plus a job aid at the bench, referred to CAPA-2026-0198 rather than a third round of individual retraining. Evaluator: A. Patel, 04 Oct 2026. QA review: R. Gomez, 08 Oct 2026.
This is the intended use of the form: the comprehension check alone would have looked fine at 94 percent, and only the field observation plus the flat error-rate trend exposed that the training was not the actual problem.
Common inspection findings this form prevents
- Effectiveness reported as a completion percentage or a quiz pass rate with no observation or trend evidence behind it.
- The same curriculum item retrained repeatedly with no measurable change in the deviation rate it was meant to fix.
- A comprehension check that looks strong while field observation, never performed, would have shown a different picture.
- No documented root-cause reasoning connecting an ineffective outcome to a specific fix (method, procedure, or something else).
How to adapt this form
- Set your form number and parent SOP in the control block.
- Define your own pass/fail criteria for Part D in the parent SOP, and apply the same criteria consistently across every evaluation.
- Choose error-rate metrics that are actually available and meaningful for the task; do not force a trend metric onto a procedure with too little volume to support one.
- Link the action field to your CAPA and change control systems so a procedure-level fix is tracked as such, not folded back into training records alone.