PLUG-IN STRATEGY: COMPLIANCE THAT FITS, CONFIDENCE THAT LAST

Fast-track inspection readinesss with clear gaps, a mock inspection, and a focused action plan. What’s included

• PV system gap analysis mapped to MAH obligations & GVP
• Inspection rehearsal (front/back room) with real‑world Q&A
• 90‑day readiness roadmap focused on high‑risk items
• Vendor oversight touchpoint for critical interfaces

Deliverables (what you receive)

1. PV System Gap and Mock Inspection Report: risk‑ranked findings with rationale and evidence references
2. Inspection Readiness Checklist: roles, evidence control, interview flow
3. CAPA Plan Starter: QMS‑ready actions with owners, timelines, and required evidence
4. Inspection Coaching Deck: do/don’t rules, model answers, drills

Timeline
2‑week assessment → 6‑week implementation → 90‑day roadmap execution

This prevents

• Last‑minute scrambling and inconsistent SME responses
• Hidden gaps surfacing on inspection day
• Unowned actions and stalled remediation

Best for
First‑time MAHs, teams preparing for a scheduled inspection/partner audit, or leaders needing rapid confidence.

Ensure PV governance and vendor oversight are structured, consistent, and inspection‑ready.

What’s included

• Governance framework with RACIs and escalation pathways
• Vendor oversight strategy: risk scoring & audit/assessment cadence
• KPI development & measurement strategy (Ops + Management views)
• Governance effectiveness review (evidence‑based)

Deliverables (what you receive)

1. Governance Playbook: governance committee structure, cadences, RACIs, escalation path
2. Vendor Oversight Strategy & Calendar: risk model, tiering, 12‑month schedule
3. Vendor Scorecard Template: KPI/quality metrics with thresholds
4. KPI Library & Dashboard Specification: definitions & visuals for internal build
5. Governance Effectiveness Review Report: findings with owners, dates, and success criteria

Timeline
4‑week design → 8‑week rollout → quarterly review checkpoint

This prevents

• Inconsistent decision‑making and poor escalation
• Vendor drift and weak evidence trails
• “Paper governance” that doesn’t operate in practice

Best for
Organisations scaling products/markets or rationalising multiple vendors and processes.

Continuous PV Quality leadership—health checks, drills, oversight, and executive advice—without adding headcount.

Deliverables each quarter

1. Quarterly Compliance Health Report: Readiness Index, Risk Heatmap, CAPA/issue status, inspection triggers, regulatory changes
2. Inspection Drill Pack:  if a drill is run based on specific scenario
3. Audit & CAPA Oversight Brief:sampling results, systemic themes, leadership attention required
4. Executive Advisory Brief: decisions needed, options, and 30‑60‑90 day priorities

Cadence
Ongoing quarterly engagement

This prevents

• Surprise risks between inspections
• Repeat findings and CAPA fatigue
• Executive uncertainty about readiness

Best for
Leaders who want visible, quarter‑on‑quarter control without a full‑time senior hire.