CAPA01 • evidence review packet — Separate immediate unit correction from a verified cause and corrective/preventive action; define and record later effectiveness evidence…

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<span class="eyebrow">Quality procedure / fictional paper-kit issue</span><h1>One corrected label is not an effective CAPA.</h1><p class="lead">Trace CAPA01 from the unit correction to the evidence still needed for closure.</p><section class="panel"><div class="row"><span class="pill">CAPA01 · Pending review</span><span class="muted">Recurring wrong-revision labels on paper kits</span></div><div class="trace"><button type="button" id="stage-u03" class="secondary">U03 · Proposed correction</button><button type="button" id="stage-h01" class="secondary">H01 · Cause hypothesis</button><button type="button" id="stage-a01" class="secondary">A01 / P01 · Action proposals</button><button type="button" id="stage-e01" class="secondary">E01 · Effectiveness plan</button></div><h2 id="stage-title"></h2><p id="stage-description" class="draft"></p><p id="next-evidence" class="notice" aria-live="polite"></p><div class="metric-grid"><div class="metric">Correction<strong class="big">Proposed</strong><span>U03 label replacement</span></div><div class="metric">Cause<strong class="big">Unverified</strong><span>H01 mixed-revision storage bins</span></div><div class="metric">Effectiveness<strong class="big">Not observed</strong><span>2 × 10 kits planned; no actual results</span></div></div></section>
<section class="panel"><h2>Investigation and action record</h2><p>Enter actual evidence references only when available. Notes do not alter the fictional issue or controlled source records.</p><div class="grid"><label for="issue-ref">Observed issue reference</label><input id="issue-ref" type="text" value=""><label for="affected-scope">Actual affected scope</label><input id="affected-scope" type="text" value=""><label for="containment">Containment decision and scope</label><input id="containment" type="text" value=""><label for="correction-authority">U03 actual authorization</label><input id="correction-authority" type="text" value=""><label for="correction-completion">U03 actual completion evidence</label><input id="correction-completion" type="text" value=""><label for="supporting">H01 supporting evidence</label><input id="supporting" type="text" value=""><label for="refuting">H01 refuting evidence / alternatives</label><input id="refuting" type="text" value=""><label for="cause-reviewer">Actual cause reviewer</label><input id="cause-reviewer" type="text" value=""><label for="cause-conclusion">Actual cause conclusion and evidence</label><input id="cause-conclusion" type="text" value=""><label for="action-scope">A01 actual scope</label><input id="action-scope" type="text" value=""><label for="action-owner">A01 actual owner</label><input id="action-owner" type="text" value=""><label for="action-authority">A01 actual authorization</label><input id="action-authority" type="text" value=""><label for="action-date">A01 actual implementation date</label><input id="action-date" type="text" value=""><label for="implementation">A01 implementation verification evidence</label><input id="implementation" type="text" value=""><label for="preventive-scope">P01 comparable-line scope / exposure evidence</label><input id="preventive-scope" type="text" value=""><label for="preventive-owner">P01 actual reviewer / date</label><input id="preventive-owner" type="text" value=""><label for="criteria">E01 agreed effectiveness criteria</label><input id="criteria" type="text" value=""><label for="effectiveness-reviewer">E01 actual responsible reviewer</label><input id="effectiveness-reviewer" type="text" value=""></div><p>Proposed A01 separates revision bins and checks the maintained approved label source. P01 asks whether a comparable line has analogous exposure; that exposure is not established.</p></section>
<section class="panel"><h2>Separate action accountability</h2><div class="grid"><label for="correction-owner">U03 actual responsible owner</label><input id="correction-owner" type="text" value=""><label for="correction-date">U03 actual correction date</label><input id="correction-date" type="text" value=""><label for="preventive-authority">P01 actual review authorization</label><input id="preventive-authority" type="text" value=""><label for="preventive-review-evidence">P01 actual review findings / evidence</label><input id="preventive-review-evidence" type="text" value=""></div><h2>E01 / two future batches of ten</h2><p><strong>20 kits planned</strong> is not 20 inspected or 20 passed. Record actual scope, findings and evidence without forcing the denominator.</p><div class="grid"><label for="batch1-id">Actual first batch ID / date</label><input id="batch1-id" type="text" value=""><label for="batch1-count">Actual first inspected denominator</label><input id="batch1-count" type="number" value=""><label for="batch1-findings">Actual first findings / evidence / result</label><input id="batch1-findings" type="text" value=""><label for="batch2-id">Actual second batch ID / date</label><input id="batch2-id" type="text" value=""><label for="batch2-count">Actual second inspected denominator</label><input id="batch2-count" type="number" value=""><label for="batch2-findings">Actual second findings / evidence / result</label><input id="batch2-findings" type="text" value=""></div><label for="scope-reason">Reason for any actual scope difference</label><textarea id="scope-reason"></textarea><label for="closure-reviewer">Actual closure reviewer / decision evidence</label><input id="closure-reviewer" type="text" value=""><label for="unresolved">Unresolved questions</label><textarea id="unresolved"></textarea><button type="button" id="review-gaps">Review unresolved evidence</button><p id="review-result" class="notice" aria-live="polite"></p><label for="packet-text">CAPA procedure and evidence packet</label><textarea id="packet-text" readonly></textarea><button type="button" id="select-packet-text" class="secondary">Select text</button><p id="packet-text-status" class="muted">Select the text, then use your device’s copy command. Nothing is saved.</p></section>
<details><summary>Procedure and closure boundary</summary><ol><li>Record the original issue/scope; assign containment and correction authority.</li><li>Investigate H01 using supporting/refuting evidence, source/revision links and alternatives.</li><li>Confirm the cause/process decision and authorized actions.</li><li>Verify implementation separately from later effectiveness.</li><li>Confirm E01 criteria and reviewer; retain actual batch results and denominators.</li><li>Use the maintained procedure for responsible closure review, including unresolved questions.</li></ol><p>Implementation is not later effectiveness. A small successful check would not prove recurrence impossible. This HTML packet is not a maintained native procedure, controlled-record editor or compliance certificate; nothing is approved, closed or saved here.</p></details></main><script>const $=id=>document.getElementById(id);const on=(id,fn)=>$(id).addEventListener('click',fn);const text=(id,value)=>$(id).textContent=value;const bind=(id,fn,event='input')=>$(id).addEventListener(event,fn);const selectText=id=>{if(!$(id).value){text(id+'-status','Complete the required fields before selecting text.');return;}$(id).focus();$(id).select();text(id+'-status','Text selected. Use your device’s copy command; nothing has been sent or saved.');};
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This is a proposed correction of the unit, not evidence that a recurring cause was removed.','Confirm issue scope, containment decision, authority and actual completion evidence.'],h01:['H01 / cause question','Mixed-revision storage bins may have contributed. Supporting and refuting evidence are missing; H01 is a hypothesis, not a verified cause or operator-blame finding.','Link the affected label to source/revision evidence; investigate support, alternatives and refutation before a conclusion.'],a01:['A01 and P01 / proposed actions','A01 proposes separate revision bins and an approved-source check. P01 proposes reviewing another line only after scope and analogous exposure are confirmed.','Confirm actual scope, owner, authority, implementation date and verification. No implementation or preventive success is established.'],e01:['E01 / later effectiveness','Plan two future batches of ten kits against the approved revision. 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