Use a procedure that separates the immediate issue, unit correction, cause hypothesis, action proposal, implementation verification, and later effectiveness check. The original example below is a planning record with unresolved evidence, not a completed improvement or a compliance certificate.
ASQ's CAPA guide distinguishes correction of a current unit from corrective action addressing an existing cause and preventive action addressing a potential cause. It also separates cause investigation, implementation, and effectiveness evidence. This example uses those distinctions without adopting regulatory or certification claims. ASQ's CAPA guide
Keep the original problem and immediate response visible
The fictional record is CAPA01: recurring wrong-revision labels on paper kits. Unit U03 has a proposed label replacement. Record the observed issue reference, the actual affected scope to confirm, and the proposed correction beside its authorization and completion fields.
Replacing U03's label is not itself proof that a recurring cause was removed. The example has no actual authorization or completed correction evidence. Keep any containment decision and its scope as separate fields for the responsible reviewer to supply; do not declare an entire batch acceptable from one proposed change.
Treat the cause as a question to investigate
Hypothesis H01 is that mixed-revision storage bins contributed to the wrong labels. The supporting and refuting evidence fields are blank. This is a possible explanation to investigate, not a verified root cause or an accusation against an operator.
Ask what evidence connects the affected kit's label to the relevant source and revision, what would support or weaken the bin hypothesis, and whether another explanation fits the observations. Record actual evidence references, the reviewer, and the conclusion when available. A plausible narrative should not populate a verified-cause field automatically.
Describe actions without claiming they happened
Proposed corrective action A01 would separate revision bins and check the maintained approved label source. Its actual scope, authority, owner, implementation date, and evidence remain TO CONFIRM. Keep the proposal pending while the cause and relevant process decision are unresolved. Do not change controlled source records through a review copy.
Proposed preventive review P01 asks whether another comparable line has analogous exposure. Its scope and exposure need confirmation first. The existence of CAPA01 does not establish the same condition on that line or prove a preventive action is needed there.
| Record | What it represents | Current example state |
|---|---|---|
| U03 correction | Proposed fix for the affected unit | Authorization and actual completion evidence missing |
| H01 | Mixed-revision-bin cause hypothesis | Supporting/refuting evidence and cause conclusion missing |
| A01 | Proposed response to the existing issue | Actual authority, implementation, and verification missing |
| P01 | Proposed analogous-line review | Scope and comparable exposure unconfirmed |
| E01 | Later effectiveness plan | Future results not observed |
The table is a review map, not a list of completed tasks. Give each action its own owner/date/evidence fields so the status of one cannot stand in for the others.
Check implementation and later effectiveness separately
Implementation verification asks whether the authorized action was carried out as specified. It needs actual evidence of the agreed changes and the maintained approved source, with unresolved items recorded. That check still does not supply later batch results.
Effectiveness plan E01 proposes checking two future batches of ten paper kits each against the approved revision. Twenty kits is the planned scope. Actual batch IDs, dates, inspected denominators, findings, evidence references, and results all stay blank until the checks occur. Do not label the plan “20 passed.”
Confirm the effectiveness criteria and responsible reviewer before collecting evidence. If the eventual checked scope differs from the planned two-by-ten, record the actual denominator and reason instead of forcing the result into twenty. Do not treat a successful small check as proof that recurrence is impossible.
Leave closure pending until its evidence is reviewed
CAPA01 remains pending while the cause evidence, implemented-action checks, or agreed effectiveness results are missing. A status selector should never convert a proposed action into an effective action or close the record merely because someone clicked through its steps.
The closure review needs the original issue, correction/containment record, cause conclusion and evidence, authorized actions, implementation checks, actual effectiveness findings, unresolved questions, and responsible reviewer decision. Use the organization's actual procedure for that decision. This packet neither certifies ISO/FDA compliance nor modifies controlled originals.
Copy this prompt for the CAPA procedure and record
Create one complete, self-contained US-English HTML companion for “CAPA01 • evidence review packet”. Return the full HTML document, with inline CSS and any JavaScript needed for the local interactions. Use the original scenario, named records, numbers and expected cases below.
Design the page for this task: use clearly labeled input or source records, a readable result or worked example, and an adjacent explanation of the evidence. Use a restrained visual hierarchy, left-aligned text, readable tables or stacked records, and a responsive layout at 720px and 360px. Provide meaningful labeled controls for U03 · Proposed correction; H01 · Cause hypothesis; A01 / P01 · Action proposals; E01 · Effectiveness plan; Review unresolved evidence; Select text. Use keyboard-accessible native controls and visible focus. Keep the complete content readable without an external dependency.
The following brief supplies the substantive content and constraints. Native-format requests describe the material to represent or copy manually; this HTML must not pretend to create DOCX, XLSX, PDF, PPTX, H5P or another native file, run Python/Flask/Django/Snowflake/Power BI, connect a live service, send messages, or perform an authorized real-world action. Where the task requires a native source, actual observation or separate approval, retain that requirement and leave unsupplied evidence blank.
Prepare a complete US English CAPA SOP review packet with an original filled fictional issue, separate unresolved investigation/action/effectiveness fields, role-and-evidence procedure, and closure review checklist. Not a compliance certificate or completed improvement. CAPA01 concerns recurring wrong-revision labels on paper kits. U03 label replacement is a proposed unit correction only, not proof of cause removal. Actual issue scope, containment decision, authority and completion evidence must be supplied. H01 mixed-revision storage bins is a hypothesis. Supporting/refuting evidence and verified-cause conclusion remain blank. Ask for evidence connecting issue/source/revision and alternatives; no operator blame or invented root cause. Proposed A01 separates revision bins and checks the maintained approved label source. Actual scope, approval, owner, implementation date and verification evidence TO CONFIRM. Do not change controlled originals. Proposed P01 evaluates a comparable line only if analogous exposure and scope are confirmed; no preventive-success claim. E01 plans two future batches of ten kits each against the approved revision. Twenty planned is not twenty inspected/passed. Actual batch IDs, dates, checked denominators, findings and evidence remain blank. Confirm effectiveness criteria/reviewer; if actual scope differs, retain its real denominator/reason. Separate implementation verification from later effectiveness. Closure remains pending until actual cause evidence, action checks and agreed effectiveness results are reviewed by the actual responsible role. Include original issue, correction/containment, hypothesis/evidence, corrective/preventive proposals, owner/date, implementation check and effectiveness record as distinct fields. Proposed HTML record trace preserves unresolved states; a click never approves, proves effectiveness or closes CAPA. Construction/testing pending; no automated collection, notifications or standards certification. Actual maintained procedure/records remain authoritative.
COMPLETE AUTHORED SCENARIO AND EXPECTED CASES
The following is the supplied reading/teaching/calculation record to represent in the companion. Preserve its particular content, examples, source references and unknowns. Wording about a future native implementation refers to that native task, not permission to omit this HTML companion.
# A CAPA SOP Template That Keeps Correction Separate from Effectiveness
One paper kit has the wrong-revision label. Replacing that label can correct the kit, but it does not show why the error keeps recurring or whether the next batch will avoid it. A CAPA record needs to keep those questions open until the relevant evidence exists.
Use a procedure that separates the immediate issue, unit correction, cause hypothesis, action proposal, implementation verification, and later effectiveness check. The original example below is a planning record with unresolved evidence, not a completed improvement or a compliance certificate.
ASQ's CAPA guide distinguishes correction of a current unit from corrective action addressing an existing cause and preventive action addressing a potential cause. It also separates cause investigation, implementation, and effectiveness evidence. This example uses those distinctions without adopting regulatory or certification claims. [ASQ's CAPA guide](https://careers.asq.org/career-resources/on-the-job-3/capa-corrective-and-preventive-action-for-quality-engineer-2026-112)
## Keep the original problem and immediate response visible
The fictional record is CAPA01: recurring wrong-revision labels on paper kits. Unit U03 has a proposed label replacement. Record the observed issue reference, the actual affected scope to confirm, and the proposed correction beside its authorization and completion fields.
Replacing U03's label is not itself proof that a recurring cause was removed. The example has no actual authorization or completed correction evidence. Keep any containment decision and its scope as separate fields for the responsible reviewer to supply; do not declare an entire batch acceptable from one proposed change.
## Treat the cause as a question to investigate
Hypothesis H01 is that mixed-revision storage bins contributed to the wrong labels. The supporting and refuting evidence fields are blank. This is a possible explanation to investigate, not a verified root cause or an accusation against an operator.
Ask what evidence connects the affected kit's label to the relevant source and revision, what would support or weaken the bin hypothesis, and whether another explanation fits the observations. Record actual evidence references, the reviewer, and the conclusion when available. A plausible narrative should not populate a verified-cause field automatically.
## Describe actions without claiming they happened
Proposed corrective action A01 would separate revision bins and check the maintained approved label source. Its actual scope, authority, owner, implementation date, and evidence remain `TO CONFIRM`. Keep the proposal pending while the cause and relevant process decision are unresolved. Do not change controlled source records through a review copy.
Proposed preventive review P01 asks whether another comparable line has analogous exposure. Its scope and exposure need confirmation first. The existence of CAPA01 does not establish the same condition on that line or prove a preventive action is needed there.
| Record | What it represents | Current example state |
| --- | --- | --- |
| U03 correction | Proposed fix for the affected unit | Authorization and actual completion evidence missing |
| H01 | Mixed-revision-bin cause hypothesis | Supporting/refuting evidence and cause conclusion missing |
| A01 | Proposed response to the existing issue | Actual authority, implementation, and verification missing |
| P01 | Proposed analogous-line review | Scope and comparable exposure unconfirmed |
| E01 | Later effectiveness plan | Future results not observed |
The table is a review map, not a list of completed tasks. Give each action its own owner/date/evidence fields so the status of one cannot stand in for the others.
## Check implementation and later effectiveness separately
Implementation verification asks whether the authorized action was carried out as specified. It needs actual evidence of the agreed changes and the maintained approved source, with unresolved items recorded. That check still does not supply later batch results.
Effectiveness plan E01 proposes checking two future batches of ten paper kits each against the approved revision. Twenty kits is the planned scope. Actual batch IDs, dates, inspected denominators, findings, evidence references, and results all stay blank until the checks occur. Do not label the plan “20 passed.”
Confirm the effectiveness criteria and responsible reviewer before collecting evidence. If the eventual checked scope differs from the planned two-by-ten, record the actual denominator and reason instead of forcing the result into twenty. Do not treat a successful small check as proof that recurrence is impossible.
## Leave closure pending until its evidence is reviewed
CAPA01 remains pending while the cause evidence, implemented-action checks, or agreed effectiveness results are missing. A status selector should never convert a proposed action into an effective action or close the record merely because someone clicked through its steps.
The closure review needs the original issue, correction/containment record, cause conclusion and evidence, authorized actions, implementation checks, actual effectiveness findings, unresolved questions, and responsible reviewer decision. Use the organization's actual procedure for that decision. This packet neither certifies ISO/FDA compliance nor modifies controlled originals.
Implement the local companion rather than returning a text-only plan. Preserve every numerical fixture and the distinction between illustrative expectations and actual evidence. Any native-runtime or classroom tests mentioned above remain tests to perform in the proper environment; do not mark them passed. Keep edits and practice responses in this open page only, without claiming persistent storage. Provide invalid/missing-input feedback and reset behavior that agree with this specific brief. Do not claim accessibility certification, learning gains, real approvals or test results that were not observed.
Review the unresolved evidence
Use the HTML companion to inspect whether U03, H01, A01, and E01 remain distinct in the companion. Keep actual investigations, authorized changes, effectiveness records, and closure decisions in the maintained workflow.
Finish with the next evidence question visible at each unresolved stage, so correcting one label cannot silently become a verified cause, an effective action, or a closed CAPA.