项目干系人识别专家

Project Background

This project concerns a cloud migration and data governance program within a healthcare provider environment (e.g., hospitals, clinics, research institutes). It spans multiple critical systems and data domains such as EHR/EMR, imaging (PACS), laboratory (LIS), radiology (RIS), revenue cycle, ERP/HR, health information exchange interfaces, and IoMT/biomedical devices. The program’s objectives typically include improved scalability and resilience, enhanced security posture, cost optimization, accelerated analytics/AI capabilities, and stronger regulatory compliance.

Distinctive industry characteristics include:

• Rigorous regulatory and privacy requirements for protected health information (PHI) and personally identifiable information (PII) under applicable health data protection laws (e.g., HIPAA in the U.S., GDPR in the EU, and local health data regulations).
• 24/7 clinical operations with extremely low tolerance for downtime or degraded performance; patient safety is paramount.
• Complex interoperability standards and data flows (FHIR/HL7/DICOM), legacy on-premise dependencies, data sovereignty constraints, and hybrid-edge architecture for latency-sensitive workloads.
• Formalized data governance requirements covering consent management, access controls, data lineage, data quality, retention/disposition, master and reference data, and auditability.

Given the high complexity, effective stakeholder identification, engagement, and governance are essential to ensure safe cutover, regulatory compliance, clinician adoption, and sustained operational excellence.

Stakeholder Identification Results

Internal Stakeholders

• Project Sponsor

  • Executive Sponsor(s): CIO, CMIO/Chief Clinical Information Officer, CISO/Chief Information Security Officer, CFO (financial oversight)
  • Business Owner(s): Head of Data Governance/Chief Data Officer (CDO), VP of Clinical Operations, Head of Research (if in scope)
  • PMO/Program Director: accountable for scope, schedule, budget, benefits realization

• Project Team Members

  • Program/Project Managers; Workstream Leads (Cloud Platform, Network, Security, Data, Applications, Testing, Change)
  • Enterprise, Solution, Security, Data, and Cloud Architects
  • Migration Factory: Infrastructure/Platform engineers, DBAs, Storage/Backup, Network engineers, SRE/DevOps
  • Application Owners: EHR/EMR, PACS, LIS, RIS, ERP/HR, RCM/Billing, Integration/Interface engine, Identity/IAM
  • Data Governance Office: Data stewards, data quality analysts, MDM specialists, metadata/catalog owners, privacy officers
  • Information Security, Privacy & Compliance: IAM leads, GRC analysts, incident response, audit coordinators
  • QA/Validation & Test: test managers, clinical validation leads, performance testers
  • Change Management & Training: communications, learning, super-user network, service desk readiness
  • Site IT Leads & Biomedical/Clinical Engineering: device connectivity, edge/hybrid constraints, site readiness
  • Business Continuity/DR Team: DR planning, failover testing

• Functional Department Representatives

  • Clinical Informatics; Nursing/Physician leadership; Ancillary departments (Lab, Radiology, Pharmacy)
  • Health Information Management (HIM) and Quality/Patient Safety
  • Legal & Compliance; Risk Management
  • Finance & Procurement; Vendor Management; Contracting
  • HR/Learning & Development
  • Facilities/Physical Security (for data center decommissioning, device access)

External Stakeholders

• Customer Representatives

  • Clinical end users: physicians, nurses, allied health professionals; department chiefs and unit managers
  • Administrative/business leaders: hospital operations, scheduling/bed management, revenue cycle leaders
  • Research/IRB representatives (if research data in scope)
  • Patient and community advocacy groups (for consent, transparency, and ethics)

• Suppliers

  • Public cloud provider account team and solution architects
  • Core application ISVs and integration partners (EHR/EMR, PACS, LIS/RIS, ERP/HR, identity/SSO, integration engine)
  • Managed service providers (MSP) and managed security service providers (MSSP)
  • Network/telco carriers and connectivity partners; content delivery/edge providers
  • Tooling vendors for backup/DR, monitoring/observability, data catalog/lineage, ETL/ELT, MDM, DLP, key management
  • Hardware vendors for on-prem/hybrid components (if applicable)

• Regulators

  • Health data protection and privacy authorities
  • Healthcare accreditation and quality bodies
  • Cybersecurity oversight and incident reporting bodies where applicable
  • Payers/insurers’ audit and data submission functions
  • External auditors (financial/IT general controls)
  • Local/national data residency and sector-specific regulators

Stakeholder Analysis

Management Recommendations

• Governance and Decision Rights

  • Establish a multi-tier governance model:
    • Executive Steering Committee (Exec Sponsors, PMO, CDO, CISO): monthly decisions on scope, budget, risk appetite, major trade-offs.
    • Data Governance Council (CDO, stewards, privacy): bi-weekly policy approvals, data access models, data quality/lineage sign-offs.
    • Clinical Advisory Board (CMIO, nursing/physician leaders, HIM/Quality): bi-weekly for workflow impacts, downtime plans, validation results.
    • Security & Compliance Board (CISO, Legal/Compliance, Privacy): monthly or sprintly for IAM patterns, encryption, logging, third-party risk.
  • Define RACI for key decisions: cloud landing zone patterns, data classification and retention, identity federation model, DR targets, cutover window, rollback criteria.

• Stakeholder Prioritization (Power–Interest)

  • Manage closely: Executive Sponsors, PMO, Data Governance Council/CDO, CISO, Clinical Informatics leaders, Core Application Owners, Cloud Provider, Core ISVs.
  • Keep satisfied: Regulators, External Auditors, CFO/Finance & Procurement, Business Continuity/DR.
  • Keep informed: Clinicians/end users, Site IT & Biomed, HIE partners, Payers, Research/IRB.
  • Monitor: Patient/community advocates, unions/works councils (elevate if project changes working conditions).

• Engagement Plan by Phase

  • Initiation/Planning: Conduct stakeholder mapping workshops; complete DPIA/PIA; finalize business case; confirm regulatory scope; sign data governance charter.
  • Design/Build: Sprint reviews with Clinical Advisory Board; security design reviews; joint architecture sessions with cloud/ISVs; data quality rules defined with stewards.
  • Validate: End-to-end rehearsals; clinical validation scenarios; DR failover test; performance testing under peak loads; interface partner testing with freeze windows.
  • Cutover: Command center with on-call matrices; executive communication cadence; well-defined rollback and contingency procedures.
  • Operate/Optimize: Hypercare with daily huddles; KPIs review; post-implementation review; continuous compliance monitoring; cost optimization with FinOps.

• Regulatory and Compliance Integration

  • Execute documented privacy impact assessments; establish lawful basis for processing and cross-border transfers per applicable law.
  • Implement and evidence controls around: IAM (least privilege, SoD), encryption at rest/in transit, centralized logging with retention, DLP, backup/restore, patching, change management, third-party risk.
  • Maintain an audit-ready evidence repository: policies, runbooks, test results, approval minutes, control mappings.

• Data Governance Operating Model

  • Formalize data domains, owners, and stewards; implement data catalog and lineage tooling; define critical data elements with quality thresholds and SLAs.
  • Enforce access governance workflows aligned to consent; implement de-identification/anonymization where appropriate; define retention/disposition schedules.
  • Establish data issue management with prioritization, root cause analysis, and remediation ownership.

• Technical and Cutover Risk Controls

  • Create migration runbooks per application and data flow; complete multiple mock cutovers; define and test rollback.
  • Set quantitative entry/exit criteria: defect leakage thresholds, performance SLAs, security gates, DR RTO/RPO demonstration.
  • Protect safety-critical workflows with read-only fallbacks and downtime procedures; coordinate with clinical operations for go-live windows.

• Third-Party and Vendor Management

  • Align on supported cloud patterns and versions; obtain vendor certification letters where required.
  • Define SLOs/SLAs and escalation paths with cloud/ISVs/MSP; conduct joint game days (incident simulations).
  • Monitor license and cost exposure; use vendor scorecards and risk assessments.

• Change Management and Adoption

  • Build a super-user network across departments; deliver role-based training; certify readiness before access is granted.
  • Provide multi-channel communications (email, intranet, townhalls) with clear “what changes/when/impact/where to get help.”
  • Staff hypercare with extended service desk coverage and rapid defect triage; publish known issues and workarounds.

• Metrics and Reporting (per stakeholder group)

  • Executive: budget vs. baseline, milestone burn-up, risk severity trend, major benefits KPIs.
  • Clinical: uptime, latency, defect impact on workflows, training completion, satisfaction scores.
  • Security/Compliance: control pass rates, privileged access reviews, incident MTTR, audit findings.
  • Data Governance: data quality scores, lineage coverage, access request cycle time, policy exceptions.
  • Operations/FinOps: cost vs. forecast, capacity/utilization, backup success, DR readiness.

• Proactive Identification of Hidden/Implicit Stakeholders

  • Engage shifts/clinics with unique workflows (e.g., ED, OR, ICU), on-call coordinators, and weekend/night supervisors.
  • Include union/works council early where work practices or training schedules are impacted.
  • Coordinate with external labs, imaging partners, and HIEs for interface cutovers; involve payer data teams for submission changes.
  • Consult research/IRB when research datasets or clinical trial systems are affected.

These recommendations, combined with systematic stakeholder mapping and clear governance, help ensure a compliant, safe, and adoptable migration with strong data governance foundations. Adjust the stakeholder list and engagement cadences to local regulatory context, organizational structure, and solution scope.

プロジェクト背景

• 業種：離散製造（多品種・中量生産を想定）
• 対象：MES導入および設備・機器（PLC/NC/センサ）との接続、ERP/PLM/WMS/品質システムとの連携
• 目的：現場可視化、トレーサビリティ強化、OEE/稼働率向上、不良削減、標準作業徹底、段取り時間短縮
• スコープ：要件定義→設計→機器接続/データ収集→MES構築→統合テスト→段階的本番化→運用定着
• 制約/リスクの例：生産停止回避、リアルタイム性、データ品質、OT/ITセキュリティ、既存設備のレガシーIF、現場受容性

干系人識別結果

内部干系人

• プロジェクト発起人
  • 経営層（製造本部長/工場長/IT部門長）
  • ステアリングコミッティ（投資・優先度決定）
• プロジェクトチームメンバー
  • プロジェクトマネージャ/PMO
  • MESアーキテクト/アプリリード
  • OTリード（設備制御/SCADA/PLC）
  • インフラ/ネットワーク/サーバ（OT/IT）
  • データエンジニア/インテグレーション（OPC UA/REST/Message Bus）
  • 情報セキュリティ（OT/IT統合セキュリティ）
  • QA/テスト、移行/カットオーバー、教育/トレーニング
  • 変更管理/コミュニケーション
• 職能部門代表
  • 製造/現場監督（ライン長、班長、オペレータ代表）
  • 品質保証/品質管理（検査、異常管理、トレーサビリティ）
  • 保全/設備管理（予防保全、MTBF/MTTR、停機計画）
  • 生産管理/計画（スケジューリング、指図）
  • 生産技術/IE（工順/工程設計、治具）
  • 物流/倉庫（在庫、搬送、ラベル/バーコード/RFID）
  • 購買/調達（部材マスタ、サプライヤ連携）
  • 財務/原価（工数/原価配賦、実績計上）
  • 法務/コンプライアンス、労働組合/従業員代表、人事/教育

外部干系人

• 顧客代表
  • 工場オーナー側業務オーナー/ユーザー委員会（多拠点なら拠点代表）
  • 監査/内部統制部門（外部監査対応）
• 供給者（ベンダー/パートナー）
  • MESパッケージベンダー、アドオン開発ベンダー
  • システムインテグレータ（SI）
  • 設備メーカー/PLCベンダー/ロボットメーカー、センササプライヤ
  • 通信/ネットワーク機器、OTセキュリティソリューション
  • クラウド/IaaS/PaaS、DB製品ベンダー、バックアップ製品
• 監督機関・標準/認証
  • 産業安全・労働安全衛生関連
  • 情報セキュリティ/データ保護のガイドライン
  • 品質マネジメント/業界規格（例：ISO 9001 等）
  • 産業データ通信規格/参照モデル（例：ISA-95、OPC UA 等）

干系人分析

管理建议

• 経営スポンサー/ステコミ（影響度：高）
  • 方針/成功基準を明文化（KPI：OEE、直行率、リードタイム等）
  • 月次ガバナンス（進捗・リスク・変更承認）、優先度と資源の迅速調整
• 製造現場代表・業務オーナー（高）
  • 共同要件定義（Gembaワークショップ、ペーパープロトタイプ）
  • 段階導入（パイロット→段階展開）、現場でのUAT基準の合意
  • 変更影響の可視化（作業手順/タクト影響、教育計画）
• OT/設備・保全（中-高）
  • 設備接続計画（停機ウィンドウ、ロールバック、IF試験/フェイルセーフ）
  • インタフェース管理（ICD、タグ/信号管理、時刻同期、サンプリング設計）
• MES/ITアーキテクト・データ（中-高）
  • 参照モデル（ISA-95）準拠の階層/マスタ設計、標準API/OPC UA採用
  • データ品質SLA（完全性/正確性/遅延）、メタデータ/系譜管理
• セキュリティ（中-高）
  • OT/IT分離とゼロトラスト原則（認証/認可、資産/脆弱性管理、監視）
  • 変更管理/パッチ運用の合意（停止計画と連動）
• SI/ベンダー（高）
  • 契約で品質/納期/SLA/保証/保守を明確化、変更要求の評価基準と見積プロセス
  • 共同テスト計画（FAT/SAT、性能/耐障害、切替手順書）
• 品質保証/監査（中-高）
  • 逸脱/是正プロセスのデジタル化、監査証跡と権限設計
  • トレーサビリティ要件（ロット/シリアル/原材料）をUAT項目に組込み
• 物流/生産計画/財務（中）
  • ERP/倉庫/原価とのカットオーバー整合（締め/棚卸日程、インタフェース切替）
• 変更管理・教育（横断）
  • 役割別トレーニング、スーパーユーザー育成、現場サポート体制
  • コミュニケーション計画（目的/効果/影響/問い合わせ窓口）
• リスク管理（横断）
  • クリティカルパス監視、段階ゲート、リハーサル（DR/バックアウト手順）
  • 生産停止リスクへの緩和策（冗長/バイパス運用、手作業手順の確保）