[{"data":1,"prerenderedAt":393},["ShallowReactive",2],{"cms-page:complaints":3,"icon:alert-triangle":207,"icon:arrows-exchange":218,"icon:chart-bar":225,"icon:clipboard-check":238,"icon:file-text":248,"icon:flag":264,"icon:forms":271,"icon:gauge":290,"icon:message-report":303,"icon:microscope":313,"icon:notebook":335,"icon:refresh":345,"icon:route":352,"icon:school":362,"icon:signature":369,"icon:truck":373,"icon:user-shield":383},{"slug":4,"seo":5,"sections":8},"\u002Fcomplaints",{"title":6,"description":7},"Quality Complaints — QAbility Quality Management","A numbered quality complaint file with an owner, a reportability assessment, a review workflow and one-step conversion into a linked nonconformance.",[9,23,76,106,127,136,161,181,201],{"type":10,"id":11,"eyebrow":12,"title":13,"highlight":14,"blurb":15,"actions":16},"hero","top","Quality Complaints","Decide reportability on the record,","not in an inbox.","A quality complaint is a numbered file with an owner and a review workflow that starts the moment it is logged. QA records the assessment on the file itself, and every change to it lands in the audit trail. When a complaint needs an investigation, it becomes a nonconformance in one linked step.",[17,20],{"label":18,"href":19},"Book a demo","\u002Fcontact",{"label":21,"href":22},"See pricing","\u002Fpricing",{"type":24,"name":25,"id":26,"eyebrow":27,"title":28,"blurb":29,"data":30},"signature","complaintPipeline","pipeline","The complaint file","One lane, two ways out","A complaint stays Open while it is assessed and reviewed. It leaves closed on the record, or converted into a nonconformance, and conversion closes it too.",{"lane":31,"holdingStatus":32,"stages":33,"exits":59,"notDrawn":75},"Quality complaint · CMP-","open",[34,42,52],{"label":35,"actor":36,"detail":37,"facts":38},"Intake","Whoever logs it","Logged against the product, lot and customer, and classified from your own lookup lists. An imported complaint is accepted by someone, who becomes its owner.",[39,40,41],"Numbered CMP- from a per-company counter","A resolution target from your complaint SLA setting","An owner, by default whoever logged it",{"label":43,"actor":44,"detail":45,"chips":46},"QA assessment","QA, on the file","Risk level and the reportability call are recorded on the complaint itself. A database trigger writes every change to them into the audit trail, with who and when.",[47,48,49,50,51],"Regulatory reportable","Safety issue","Compliance related","Potential recall","Repeat \u002F recurring issue",{"label":53,"actor":54,"detail":55,"facts":56},"Review workflow","The owner, then an approver","Your complaint review workflow starts when the complaint is logged. Action steps go to the owner and approval steps to the owner’s department supervisor.",[57,58],"Default steps: Investigation, Review summary, Approval","The default approval step asks for an electronic signature, recorded against that step",[60,66],{"label":61,"status":62,"when":63,"gate":64,"enforcedBy":65},"Closed","closed","Approving the final workflow step closes the complaint. The owner can also close it once no step is left open.","Refused while any workflow step is still open. Only a scheduled effectiveness check may run on after the close.","server",{"label":67,"status":62,"when":68,"gate":69,"enforcedBy":65,"creates":70},"Converted to an NC","Select one complaint or several and convert. One transaction creates the nonconformance, links each complaint to it and closes each complaint.","Refused for any complaint that already has a nonconformance linked.",{"name":71,"status":72,"href":73,"link":74},"Nonconformance","draft","\u002Fnonconformance","Several complaints can feed one NC. The link shows on both records, and the NC carries the investigation from here.","Not drawn: a Cancelled exit. No action cancels a quality complaint; it ends closed or converted.",{"type":77,"id":78,"eyebrow":79,"title":80,"lead":81,"media":82,"caption":83,"framed":84,"callouts":85},"annotatedShot","annotated","On the record","The assessment and the sign-off sit on the complaint","A complaint mid-review: QA has flagged it, and the approver is signing the closure step of the review workflow.","complaints.file","Complaint › CMP-006 · QA review",true,[86,91,96,101],{"label":87,"text":88,"x":89,"y":90},"The QA assessment","Regulatory reportable, safety, compliance, recall and repeat, set on the file. Here QA has ticked compliance related and repeat issue.",4.5,16,{"label":92,"text":93,"x":94,"y":95},"Number and status","CMP-006, Open. The status moves only through the server’s actions, never through the field.",80.5,13,{"label":97,"text":98,"x":99,"y":100},"A signed workflow step","The QA Closure step asks the approver for their PIN. That signature is recorded against the workflow step, not the complaint.",53,25,{"label":102,"text":103,"x":104,"y":105},"Create NC","Conversion starts from the complaint itself, and the new NC is linked back to it.",68,3.5,{"type":107,"id":108,"eyebrow":109,"title":110,"blurb":111,"columns":112,"marker":113,"items":114},"factGrid","convert","Convert to NC","What conversion writes, in one transaction","If any part of it fails, none of it is written.",4,"number",[115,118,121,124],{"label":116,"detail":117},"A draft nonconformance","With its own NC number and a customer-complaint source. Unless you write one, its description lists the complaints it came from.",{"label":119,"detail":120},"A link per complaint","A record link from each complaint to the NC, visible from both sides, so the NC shows every complaint it answers.",{"label":122,"detail":123},"Each complaint closed","Conversion is a link, not a status. Each converted complaint moves to Closed, and a second conversion is refused.",{"label":125,"detail":126},"An audit entry each","Each complaint’s trail names the NC it went into. The NC’s own entry lists the complaints it came from.",{"type":128,"id":129,"focus":130,"eyebrow":131,"title":132,"blurb":133,"emptyFrom":134,"relatedNote":135},"lineageRail","lineage-rail","complaint","Where it leads","A complaint leads to a nonconformance, and only that","There is no complaint-to-CAPA button. The nonconformance holds the evidence and the disposition, and raises the CAPA when the investigation supports it.","Complaints start here: logged by your team, or accepted from an import.","Any NC, CAPA, change request, internal complaint, quality event, inspection lot, document or custom-module record can also be linked by hand as related.",{"type":137,"id":137,"eyebrow":138,"title":139,"rules":140},"ledger","The rules","What a complaint will not let you do",[141,145,148,151,154,157],{"rule":142,"detail":143,"enforcedBy":144},"Edit the status directly","A trigger on the complaints table refuses any status change that does not come from the server’s own actions, including a direct write through the GraphQL API.","db",{"rule":146,"detail":147,"enforcedBy":65},"Close with the workflow unfinished","Closing is refused while any workflow step is still open. The only step allowed to outlive the close is a scheduled effectiveness check.",{"rule":149,"detail":150,"enforcedBy":65},"Convert the same complaint twice","A complaint that already links to a nonconformance is refused, and the refusal names it. One pattern converts once.",{"rule":152,"detail":153,"enforcedBy":144},"Change the reportability call quietly","Every change to the complaint row, the five assessment flags included, is written to the audit trail by a database trigger.",{"rule":155,"detail":156,"enforcedBy":144},"Delete without the delete permission","Removing a complaint needs the complaints delete permission. The database checks it, not only the screen.",{"rule":158,"detail":159,"enforcedBy":160},"Your workflow, your approvers","The review workflow is a template you edit. Approval steps go to the owner’s department supervisor. If none is set, the step waits unassigned and the audit trail records why.","configure",{"type":162,"id":162,"records":163,"auditPackage":164,"sharing":165},"auditor","Complaints",false,{"eyebrow":166,"permission":167,"shareLink":168,"auditPackage":176,"notPackaged":180},"For your auditor","Only people with Manage Access on the module can share.",{"title":169,"points":170},"Share this record",[171,172,173,174,175],"Send it to anyone outside your company — no account needed.","They open it with a 6-digit code sent to their own inbox.","They see a read-only summary with its attachments, not your whole record.","The link expires after 30 days, and you can withdraw it at any time.","Every open is logged, so you can see who looked and when.",{"title":177,"titleAlone":178,"body":179},"Or bundle it for an audit","Bundle it for an audit","For an external audit, collect effective documents and quality records into one Audit Records Package — one link and one code for each auditor.","[records] aren’t included in the Audit Records Package — share them one at a time.",{"type":182,"id":182,"eyebrow":183,"title":184,"items":185},"faq","Complaint handling, plainly","What a complaint owner asks before switching",[186,189,192,195,198],{"q":187,"a":188},"Can a complaint be turned straight into a CAPA?","No, and that is deliberate. A complaint converts to a nonconformance: a draft NC with a record link back. The nonconformance raises the CAPA once the investigation supports it. The app has no complaint-to-CAPA conversion, so nobody opens a corrective action on a complaint that has not been investigated yet.",{"q":190,"a":191},"Is closing a complaint electronically signed?","Not the close itself, and we will not claim otherwise. The signature ledger has no complaint subject, so a close is an audited action, not a signed one. What can carry a signature is the review workflow. The default complaint review ends in an approval step that asks the approver to re-authenticate, and that signature is recorded against the workflow step. A template you build signs only where its steps ask for it.",{"q":193,"a":194},"Does QAbility file the regulatory report?","No. The complaint records whether it is regulatory reportable, next to the safety, compliance, recall and repeat flags, and the audit trail records every change to that call. Making the submission to the regulator stays with you.",{"q":196,"a":197},"What happens when the same problem comes back?","Log it as a new complaint and link it to the earlier ones as similar. A “more like this” search ranks existing complaints by their text, so you can find the matches. When the pattern needs an investigation, convert the whole set into one nonconformance.",{"q":199,"a":200},"Where is the customer support desk?","Customer tickets live in a separate module, Complaint Management, with its own records, its own permission and its own statuses. This page covers the quality complaint file. Ask us about the desk in a demo.",{"type":202,"id":203,"eyebrow":204,"title":205,"action":206},"ctaPanel","cta","Complaint to nonconformance","See a complaint assessed, reviewed and converted, with the link on both records.",{"label":18,"href":19},[208,212,215],[209,210],"path",{"d":211},"M12 9v4",[209,213],{"d":214},"M10.363 3.591l-8.106 13.534a1.914 1.914 0 0 0 1.636 2.871h16.214a1.914 1.914 0 0 0 1.636 -2.87l-8.106 -13.536a1.914 1.914 0 0 0 -3.274 0",[209,216],{"d":217},"M12 16h.01",[219,222],[209,220],{"d":221},"M7 10h14l-4 -4",[209,223],{"d":224},"M17 14h-14l4 4",[226,229,232,235],[209,227],{"d":228},"M3 13a1 1 0 0 1 1 -1h4a1 1 0 0 1 1 1v6a1 1 0 0 1 -1 1h-4a1 1 0 0 1 -1 -1l0 -6",[209,230],{"d":231},"M15 9a1 1 0 0 1 1 -1h4a1 1 0 0 1 1 1v10a1 1 0 0 1 -1 1h-4a1 1 0 0 1 -1 -1l0 -10",[209,233],{"d":234},"M9 5a1 1 0 0 1 1 -1h4a1 1 0 0 1 1 1v14a1 1 0 0 1 -1 1h-4a1 1 0 0 1 -1 -1l0 -14",[209,236],{"d":237},"M4 20h14",[239,242,245],[209,240],{"d":241},"M9 5h-2a2 2 0 0 0 -2 2v12a2 2 0 0 0 2 2h10a2 2 0 0 0 2 -2v-12a2 2 0 0 0 -2 -2h-2",[209,243],{"d":244},"M9 5a2 2 0 0 1 2 -2h2a2 2 0 0 1 2 2a2 2 0 0 1 -2 2h-2a2 2 0 0 1 -2 -2",[209,246],{"d":247},"M9 14l2 2l4 -4",[249,252,255,258,261],[209,250],{"d":251},"M14 3v4a1 1 0 0 0 1 1h4",[209,253],{"d":254},"M17 21h-10a2 2 0 0 1 -2 -2v-14a2 2 0 0 1 2 -2h7l5 5v11a2 2 0 0 1 -2 2",[209,256],{"d":257},"M9 9l1 0",[209,259],{"d":260},"M9 13l6 0",[209,262],{"d":263},"M9 17l6 0",[265,268],[209,266],{"d":267},"M5 5a5 5 0 0 1 7 0a5 5 0 0 0 7 0v9a5 5 0 0 1 -7 0a5 5 0 0 0 -7 0v-9",[209,269],{"d":270},"M5 21v-7",[272,275,278,281,284,287],[209,273],{"d":274},"M12 3a3 3 0 0 0 -3 3v12a3 3 0 0 0 3 3",[209,276],{"d":277},"M6 3a3 3 0 0 1 3 3v12a3 3 0 0 1 -3 3",[209,279],{"d":280},"M13 7h7a1 1 0 0 1 1 1v8a1 1 0 0 1 -1 1h-7",[209,282],{"d":283},"M5 7h-1a1 1 0 0 0 -1 1v8a1 1 0 0 0 1 1h1",[209,285],{"d":286},"M17 12h.01",[209,288],{"d":289},"M13 12h.01",[291,294,297,300],[209,292],{"d":293},"M3 12a9 9 0 1 0 18 0a9 9 0 1 0 -18 0",[209,295],{"d":296},"M11 12a1 1 0 1 0 2 0a1 1 0 1 0 -2 0",[209,298],{"d":299},"M13.41 10.59l2.59 -2.59",[209,301],{"d":302},"M7 12a5 5 0 0 1 5 -5",[304,307,310],[209,305],{"d":306},"M18 4a3 3 0 0 1 3 3v8a3 3 0 0 1 -3 3h-5l-5 3v-3h-2a3 3 0 0 1 -3 -3v-8a3 3 0 0 1 3 -3h12",[209,308],{"d":309},"M12 8v3",[209,311],{"d":312},"M12 14v.01",[314,317,320,323,326,329,332],[209,315],{"d":316},"M5 21h14",[209,318],{"d":319},"M6 18h2",[209,321],{"d":322},"M7 18v3",[209,324],{"d":325},"M9 11l3 3l6 -6l-3 -3l-6 6",[209,327],{"d":328},"M10.5 12.5l-1.5 1.5",[209,330],{"d":331},"M17 3l3 3",[209,333],{"d":334},"M12 21a6 6 0 0 0 3.715 -10.712",[336,339,342],[209,337],{"d":338},"M6 4h11a2 2 0 0 1 2 2v12a2 2 0 0 1 -2 2h-11a1 1 0 0 1 -1 -1v-14a1 1 0 0 1 1 -1m3 0v18",[209,340],{"d":341},"M13 8l2 0",[209,343],{"d":344},"M13 12l2 0",[346,349],[209,347],{"d":348},"M20 11a8.1 8.1 0 0 0 -15.5 -2m-.5 -4v4h4",[209,350],{"d":351},"M4 13a8.1 8.1 0 0 0 15.5 2m.5 4v-4h-4",[353,356,359],[209,354],{"d":355},"M3 19a2 2 0 1 0 4 0a2 2 0 0 0 -4 0",[209,357],{"d":358},"M19 7a2 2 0 1 0 0 -4a2 2 0 0 0 0 4",[209,360],{"d":361},"M11 19h5.5a3.5 3.5 0 0 0 0 -7h-8a3.5 3.5 0 0 1 0 -7h4.5",[363,366],[209,364],{"d":365},"M22 9l-10 -4l-10 4l10 4l10 -4v6",[209,367],{"d":368},"M6 10.6v5.4a6 3 0 0 0 12 0v-5.4",[370],[209,371],{"d":372},"M3 17c3.333 -3.333 5 -6 5 -8c0 -3 -1 -3 -2 -3s-2.032 1.085 -2 3c.034 2.048 1.658 4.877 2.5 6c1.5 2 2.5 2.5 3.5 1l2 -3c.333 2.667 1.333 4 3 4c.53 0 2.639 -2 3 -2c.517 0 1.517 .667 3 2",[374,377,380],[209,375],{"d":376},"M5 17a2 2 0 1 0 4 0a2 2 0 1 0 -4 0",[209,378],{"d":379},"M15 17a2 2 0 1 0 4 0a2 2 0 1 0 -4 0",[209,381],{"d":382},"M5 17h-2v-11a1 1 0 0 1 1 -1h9v12m-4 0h6m4 0h2v-6h-8m0 -5h5l3 5",[384,387,390],[209,385],{"d":386},"M6 21v-2a4 4 0 0 1 4 -4h2",[209,388],{"d":389},"M22 16c0 4 -2.5 6 -3.5 6s-3.5 -2 -3.5 -6c1 0 2.5 -.5 3.5 -1.5c1 1 2.5 1.5 3.5 1.5",[209,391],{"d":392},"M8 7a4 4 0 1 0 8 0a4 4 0 0 0 -8 0",241564436]