Case Processing at Scale-Quality Without Overtime

Case volumes spike unpredictably. Without a plan, teams lurch between overtime

and backlog, and quality slips just when regulators pay attention.

This playbook keeps case processing efficient and reliable. You will implement a

triage matrix, balance workloads across internal and external teams, apply

risk-based QC sampling, and monitor performance so every case is processed on

schedule with the right rigor.

Why scaling case processing matters

• Regulatory compliance: Delayed or inaccurate case submissions trigger

findings, warning letters, and CAPAs.

• Patient safety: Timely evaluation surfaces signals earlier.

• Cost control: Overtime and expedited vendor fees erode budgets when volume

spikes catch you unprepared.

• Talent retention: Predictable workloads reduce burnout and turnover in

safety operations.

Step 1: Engineer a triage matrix that adapts

• Categorize cases by seriousness, expectedness, product priority, reporter type,

and geographic origin.

• Define target turnaround times (TAT) per category (e.g., 24-hour triage for

SUSARs, 7-day processing for non-serious spontaneous cases).

• Specify reviewers for each tier: nurses, physicians, senior safety scientists.

• Update the matrix when new products launch or when market reporting rules

change.

• Publish the matrix, train teams, and embed it into workflow tools.

Step 2: Balance workload with real-time dashboards

• Build dashboards showing incoming volume, case status, aging, and capacity per

team or vendor.

• Allocate work daily using load-balancing rules—consider language skills, time

zones, and complexity.

• Establish SLAs with outsourced partners that mirror internal targets. Monitor

compliance and quality metrics by partner.

• Maintain decision logs explaining why cases were routed or escalated to support

inspections.

Step 3: Apply risk-based quality control

• Design QC sampling by case tier: 100 percent for high-risk categories during

onboarding, tapering to 20 percent as performance stabilizes.

• Focus QC on data accuracy, medical assessment quality, timelines, and narrative

clarity.

• Track finding types (major, minor) and feed results into coaching plans.

• Increase sampling or deploy targeted retraining when error trends emerge.

Step 4: Standardize playbooks and automation

• Provide structured templates for narrative writing, medical assessment, and

MedDRA coding.

• Automate routine steps—duplicate detection, follow-up scheduling, reporting

deadlines—using safety databases and RPA where feasible.

• Create quick-reference guides for new hires and vendor staff to ensure

consistency.

Step 5: Monitor and iterate with metrics

Track indicators that show control:

• Percentage of cases processed within TAT.

• Backlog size by tier and site.

• QC findings per 100 cases and corrective action closure rates.

• Vendor performance (cycle time, quality, SLA adherence).

• Resources used (FTE hours, overtime) versus plan.

Share metrics weekly with safety leadership and monthly with executive sponsors.

Use dashboards to forecast staffing needs for seasonal promotions or product

launches.

45-day roadmap

1. Days 1-10: Analyze three months of case volume. Identify peak periods and

current bottlenecks.

2. Days 11-20: Draft the triage matrix with safety physicians and operations

leads. Pilot on one therapeutic area.

3. Days 21-30: Deploy workload dashboards, train teams, and align vendors on

updated SLAs.

4. Days 31-45: Implement risk-based QC sampling, track findings, and report

cycle time improvements.

Frequently asked questions

• Should we outsource? Hybrid models work best: retain high-risk or complex

cases internally, outsource routine volume with clear quality expectations.

• How do we handle sudden surges? Maintain a flexible staffing pool, cross-

train employees, and establish surge agreements with vendors.

• What about automation? Use auto-narrative generation and duplicate

detection, but keep medical judgement with trained professionals.

• How often should we revisit the matrix? Quarterly at minimum, and after

significant portfolio changes or regulatory updates.

Sustain the win

Review throughput and quality metrics weekly, refresh capacity plans monthly, and

rotate QC reviewers to keep skills sharp. Celebrate teams that maintain

turnaround times while reducing rework. With a structured approach, case

processing stays calm—even during spikes.