{
  "schemaVersion": "1.0",
  "title": "Quality Management System (QMS)",
  "lang": "en",
  "prd": {
    "oneLiner": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
    "goal": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
    "whyNow": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
    "category": "Internal operations system",
    "platforms": [
      "Web"
    ],
    "problem": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
    "solution": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
    "alternatives": "Email, chat, spreadsheets, and manual ledgers",
    "differentiator": "Manage intake, processing, and operations data as one connected source of truth.",
    "targets": [
      {
        "name": "Quality practitioner and shop-floor worker managing quality standards and inspection results",
        "role": "Requester and operational user",
        "needs": "Quickly register needed work and know its status.",
        "pain": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove."
      },
      {
        "name": "QMS and quality-assurance operations coordinator",
        "role": "Operations administrator",
        "needs": "Manage priority and history and review operations metrics.",
        "pain": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove."
      },
      {
        "name": "System and policy administrator",
        "role": "Operations and security administrator",
        "needs": "Manage access, policy, and audit history.",
        "pain": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove."
      }
    ],
    "scenarios": [
      {
        "text": "An operational user registers required work and checks its status.",
        "start": "P1"
      },
      {
        "text": "An operator processes queued work and handles exceptions.",
        "start": "P5"
      },
      {
        "text": "System and policy administrator reviews policy and access.",
        "start": "P9"
      },
      {
        "text": "System and policy administrator reviews audit records and operating metrics.",
        "start": "P10"
      }
    ],
    "northStar": "Share of operations requests completed on time",
    "kpis": [
      {
        "name": "On-time processing rate",
        "target": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
        "baseline": "Not measured",
        "method": "Monthly aggregation of state changes against target dates",
        "refs": [
          "F6"
        ]
      },
      {
        "name": "Operations visibility",
        "target": "100% of key work tracked",
        "baseline": "Not measured",
        "method": "Share of records connected to reporting",
        "refs": [
          "F11"
        ]
      },
      {
        "name": "Auditable operations rate",
        "target": "100% of key changes retained",
        "baseline": "Not measured",
        "method": "Monthly audit-log and change-history review",
        "refs": [
          "F12"
        ]
      }
    ],
    "inScope": [
      "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration",
      "Inspection, defect, nonconformance, corrective action, audit, and document-history lookup",
      "Inspection execution, nonconformance classification, root-cause analysis, CAPA approval, effectiveness validation, and closure handling",
      "Defect rate, nonconformance, CAPA due date, audit, and cost-of-quality reporting",
      "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration validation and duplicate prevention",
      "Search, filter, and history management",
      "Owner, priority, and SLA management",
      "Approval and policy review",
      "Exception, rejection, and reprocessing",
      "Notifications and subscriptions",
      "External integration and data synchronization",
      "Role, permission, and audit management"
    ],
    "nonGoals": [
      "External customer portal",
      "Replacing adjacent systems such as accounting or payroll"
    ],
    "assumptions": [
      "User and organization data are available through company SSO.",
      "Operators manage policy and classification criteria."
    ],
    "risks": [
      "Weak initial classification can cause incorrect processing.",
      "Stale source data can reduce operational trust."
    ],
    "openQuestions": [
      "What defines urgent processing and approval?",
      "What are the post-completion verification and reopen rules?"
    ],
    "constraints": [
      "State, owner, and priority changes require audit logs.",
      "Access is limited by role.",
      "Permission, policy, and state changes require audit logs."
    ]
  },
  "requirements": [
    {
      "id": "R1",
      "title": "Intake and data quality",
      "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
      "status": "todo",
      "priority": "high",
      "acceptance": [
        {
          "text": "Required context, changes, ownership, and status are retained in an auditable record.",
          "done": false
        }
      ],
      "features": [
        {
          "id": "F1",
          "title": "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration",
          "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration core processing rule",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration exception and audit handling",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        },
        {
          "id": "F2",
          "title": "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration validation and duplicate prevention",
          "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration validation and duplicate prevention core processing rule",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Quality standard, inspection plan, inspection result, nonconformance, and CAPA registration validation and duplicate prevention exception and audit handling",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "id": "R2",
      "title": "Records and search",
      "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
      "status": "todo",
      "priority": "high",
      "acceptance": [
        {
          "text": "Required context, changes, ownership, and status are retained in an auditable record.",
          "done": false
        }
      ],
      "features": [
        {
          "id": "F3",
          "title": "Inspection, defect, nonconformance, corrective action, audit, and document-history lookup",
          "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Inspection, defect, nonconformance, corrective action, audit, and document-history lookup core processing rule",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Inspection, defect, nonconformance, corrective action, audit, and document-history lookup exception and audit handling",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        },
        {
          "id": "F4",
          "title": "Search, filter, and history management",
          "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Search, filter, and history management core processing rule",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Search, filter, and history management exception and audit handling",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "id": "R3",
      "title": "Processing and ownership",
      "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
      "status": "todo",
      "priority": "high",
      "acceptance": [
        {
          "text": "Required context, changes, ownership, and status are retained in an auditable record.",
          "done": false
        }
      ],
      "features": [
        {
          "id": "F5",
          "title": "Inspection execution, nonconformance classification, root-cause analysis, CAPA approval, effectiveness validation, and closure handling",
          "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Inspection execution, nonconformance classification, root-cause analysis, CAPA approval, effectiveness validation, and closure handling core processing rule",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Inspection execution, nonconformance classification, root-cause analysis, CAPA approval, effectiveness validation, and closure handling exception and audit handling",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        },
        {
          "id": "F6",
          "title": "Owner, priority, and SLA management",
          "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Owner, priority, and SLA management core processing rule",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Owner, priority, and SLA management exception and audit handling",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "id": "R4",
      "title": "Approval and exceptions",
      "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
      "status": "todo",
      "priority": "high",
      "acceptance": [
        {
          "text": "Required context, changes, ownership, and status are retained in an auditable record.",
          "done": false
        }
      ],
      "features": [
        {
          "id": "F7",
          "title": "Approval and policy review",
          "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
          "status": "todo",
          "priority": "mid",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Approval and policy review core processing rule",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Approval and policy review exception and audit handling",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        },
        {
          "id": "F8",
          "title": "Exception, rejection, and reprocessing",
          "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
          "status": "todo",
          "priority": "mid",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Exception, rejection, and reprocessing core processing rule",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Exception, rejection, and reprocessing exception and audit handling",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "id": "R5",
      "title": "Notifications and integrations",
      "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
      "status": "todo",
      "priority": "mid",
      "acceptance": [
        {
          "text": "Required context, changes, ownership, and status are retained in an auditable record.",
          "done": false
        }
      ],
      "features": [
        {
          "id": "F9",
          "title": "Notifications and subscriptions",
          "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Notifications and subscriptions core processing rule",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Notifications and subscriptions exception and audit handling",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        },
        {
          "id": "F10",
          "title": "External integration and data synchronization",
          "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "External integration and data synchronization core processing rule",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "External integration and data synchronization exception and audit handling",
              "desc": "Connect quality standards, inspections, nonconformances, root-cause analysis, CAPA, validation, audits, and quality reporting in a QMS flow. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "id": "R6",
      "title": "Insights and controls",
      "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
      "status": "todo",
      "priority": "mid",
      "acceptance": [
        {
          "text": "Required context, changes, ownership, and status are retained in an auditable record.",
          "done": false
        }
      ],
      "features": [
        {
          "id": "F11",
          "title": "Defect rate, nonconformance, CAPA due date, audit, and cost-of-quality reporting",
          "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
          "status": "todo",
          "priority": "high",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Defect rate, nonconformance, CAPA due date, audit, and cost-of-quality reporting core processing rule",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Defect rate, nonconformance, CAPA due date, audit, and cost-of-quality reporting exception and audit handling",
              "desc": "Quality standards, inspection results, nonconformances, corrective actions, and audit material are fragmented, making the cause and effectiveness of repeated-defect remediation hard to prove. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        },
        {
          "id": "F12",
          "title": "Role, permission, and audit management",
          "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
          "status": "todo",
          "priority": "mid",
          "acceptance": [
            {
              "text": "Required context, changes, ownership, and status are retained in an auditable record.",
              "done": false
            }
          ],
          "specs": [
            {
              "title": "Role, permission, and audit management core processing rule",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            },
            {
              "title": "Role, permission, and audit management exception and audit handling",
              "desc": "Increase corrective-action completion for recurring nonconformances and establish traceability for inspection and audit evidence. Retain change, failure, and reprocessing conditions with history.",
              "acceptance": [
                {
                  "text": "Required context, changes, ownership, and status are retained in an auditable record.",
                  "done": false
                }
              ]
            }
          ]
        }
      ]
    }
  ],
  "ia": {
    "sections": [
      {
        "id": "S1",
        "title": "Intake and data quality",
        "pages": [
          {
            "id": "P1",
            "title": "Operations dashboard",
            "type": "top",
            "refs": [
              "F1",
              "F1:0",
              "F3",
              "F4:0",
              "F7:1",
              "F11"
            ],
            "children": []
          },
          {
            "id": "P2",
            "title": "Work list",
            "type": "page",
            "refs": [
              "F3",
              "F3:0",
              "F4",
              "F1:0",
              "F4:1",
              "F8",
              "F11:0"
            ],
            "children": []
          },
          {
            "id": "P3",
            "title": "Create record",
            "type": "page",
            "refs": [
              "F1",
              "F1:1",
              "F2",
              "F5",
              "F8:0",
              "F11:1"
            ],
            "children": []
          }
        ]
      },
      {
        "id": "S2",
        "title": "Records and search",
        "pages": [
          {
            "id": "P4",
            "title": "Record detail",
            "type": "page",
            "refs": [
              "F3:1",
              "F4:1",
              "F11",
              "F2",
              "F5:0",
              "F8:1",
              "F12"
            ],
            "children": []
          },
          {
            "id": "P5",
            "title": "Processing workspace",
            "type": "page",
            "refs": [
              "F5",
              "F5:0",
              "F6",
              "F2:0",
              "F5:1",
              "F9",
              "F12:0"
            ],
            "children": []
          }
        ]
      },
      {
        "id": "S3",
        "title": "Processing and ownership",
        "pages": [
          {
            "id": "P6",
            "title": "Approval and exception queue",
            "type": "page",
            "refs": [
              "F7",
              "F7:0",
              "F8",
              "F2:1",
              "F6",
              "F9:0",
              "F12:1"
            ],
            "children": []
          },
          {
            "id": "P7",
            "title": "Notifications and integrations",
            "type": "page",
            "refs": [
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        "id": "S4",
        "title": "Insights and controls",
        "pages": [
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}