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9.4 The Quarterly Business Review (QBR) & Quality Strategy

Management Review is frequently misunderstood as a bureaucratic "death by PowerPoint" ritual. In a high-performance EMS environment, this is the single most critical strategic alignment event of the year. It is the mechanism where Top Management is legally and operationally forced to confront the reality of the Quality Management System (QMS). If the QMS is the engine of the factory, Management Review is the diagnostic check engine light. The objective is not to report "status"; it is to secure resources, authorize changes, and pivot strategy based on empirical data.

The Input Architecture (Data Integrity)

A Management Review without validated data is merely a collection of opinions. The inputs must be standardized to ensure year-over-year comparability.

Standard Agenda Inputs (ISO 9001 / 13485 Mandate):

  1. Audit Results: Internal, Customer, and Regulatory findings.
  2. Customer Feedback: Satisfaction scores, RMA rates, and specific complaints.
  3. Process Performance: Yield (FPY/RTY), OTD (On-Time Delivery), and Supplier Quality metrics.
  4. CAPA Status: Aging of open actions. (Are we closing issues or letting them fester?)
  5. Changes: Pending NPIs, facility moves, or regulatory shifts.

Pro-Tip: Do not present raw data spreadsheets. Present trends. A yield of 98% looks good, but a downward trend from 99.5% over three months is a crisis.

The Output: Decisions, Not Minutes

The measure of a successful review is the "Action List," not the meeting minutes. Every session must result in tangible decisions regarding resource allocation.

Decision Logic for Outputs:

  • IF a Key Performance Indicator (KPI) has missed the target for 2 consecutive quarters:
    • THEN a formal Corrective Action (CAPA) is mandatory. Hope is not a strategy.
  • IF a KPI has exceeded the target for 4 consecutive quarters:
    • THEN the target is too low. Raise the Standard or reduce inspection frequency to save cost (Risk-Based Thinking).
  • IF Resource constraints (staff/equipment) are identified as the root cause of a bottleneck:
    • THEN Top Management must formally approve budget/hiring or accept the risk in writing.

Continual Improvement (The Kaizen Loop)

Improvement is distinct from "Correction." Correction fixes a broken process; Improvement upgrades a working process.

The CI Hierarchy:

  1. Stabilize: Eliminate chaos. (Goal: Predictable Process).
  2. Standardize: Document the "One Best Way." (Goal: Reduced Variation).
  3. Optimize: Reduce cycle time or waste. (Goal: Efficiency).

Kaizen Event Triggers:

  • Chronic Scrap: "We always lose 2% at Wave Solder." -> Trigger a focused improvement event.
  • Walking Waste: Operators walking > 5 steps to get parts. -> Trigger a 5S/Layout event.

Final Checklist

Review Element

Requirement

Success Indicator

Frequency

Defined interval (e.g., Quarterly)

Scheduled in Calendar

Attendance

Top Management (CEO/Ops Dir)

Quorum Met

Inputs

Data Trends (not snapshots)

Visual Graphs / Pareto

Risk Review

Updates to Risk Register

New Risks Added/Retired

Outputs

Resource Decisions

Budget/Action Assigned

Minutes

Audit Trail

Signed & Dated

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