API Manufacturing: SOP for Preparation of Quality Metrics Dashboard – V 2.0

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API Manufacturing: SOP for Preparation of Quality Metrics Dashboard – V 2.0

Standard Operating Procedure for Preparation of Quality Metrics Dashboard in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/197/2025
Supersedes SOP/API/197/2022
Page No. Page 1 of 16
Issue Date 14/04/2025
Effective Date 16/04/2025
Review Date 14/04/2026

1. Purpose

To define the procedure for compiling, reviewing, and publishing a Quality Metrics Dashboard that provides visual representation and trending of key quality performance indicators in API manufacturing. The dashboard facilitates management review and continuous improvement.

2. Scope

This SOP applies to the QA department responsible for collecting, compiling, analyzing, and reporting quality data from API manufacturing, QC,

warehouse, and supporting departments. The dashboard includes monthly, quarterly, and annual quality metrics and KPIs.

3. Responsibilities

  • QA Executive: Collects raw data, inputs into dashboard format, and prepares monthly reports.
  • Department Representatives: Submit timely data (deviations, CAPAs, batch rejections, etc.) using standard templates.
  • QA Manager: Reviews data trends, interprets quality KPIs, and escalates key observations to senior management.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that the Quality Metrics Dashboard is accurate, up to date, reviewed periodically, and supports strategic quality objectives.

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5. Procedure

5.1 Define Metrics and KPIs

  1. The following KPIs shall be included in the Quality Metrics Dashboard (Annexure-1):
    • Number of Deviations (Open vs Closed)
    • CAPA Timeliness (Initiated, Completed)
    • Batch Rejection Rate (%)
    • Market Complaint Trends
    • Audit Observations (Internal & External)
    • Out-of-Specification (OOS) Trends
    • Change Control Status
    • Product Release Compliance (%)
    • GMP Training Compliance (%)
  2. KPI definitions, targets, and calculation logic shall be documented in the KPI Definition Register (Annexure-2).

5.2 Data Collection and Verification

  1. Department representatives shall submit KPI data by the 5th working day of each month using the Quality Metrics Data Collection Form (Annexure-3).
  2. QA shall verify:
    • Data accuracy with source records
    • Completeness of entries
    • Consistency with previous submissions

5.3 Dashboard Preparation

  1. QA Executive shall:
    • Use the standardized dashboard template (Annexure-4) in Excel or dashboard software
    • Input monthly and YTD values
    • Use color coding (Green: On Target, Amber: Near Miss, Red: Out of Compliance)
  2. Charts shall include:
    • Monthly trend line for each KPI
    • Target vs Actual bar charts
    • Quarterly comparison tables
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5.4 Review and Approval

  1. QA Manager shall review the draft dashboard by the 10th of each month.
  2. Any anomalies shall be discussed with concerned department heads and documented in the Dashboard Review Log (Annexure-5).
  3. Approved dashboards shall be finalized and shared with:
    • Quality Council
    • Head of Manufacturing
    • Regulatory Affairs (if required)

5.5 Archiving and Retention

  1. All finalized dashboards shall be archived in the Quality Dashboard Archive Folder (electronic).
  2. Dashboards and supporting data must be retained for at least 5 years.

5.6 Trending and Management Review

  1. Quarterly trends shall be analyzed using the KPI Trend Analysis Form (Annexure-6).
  2. During Management Review Meetings, KPI performance and trends must be presented for decision-making.

6. Abbreviations

  • QA: Quality Assurance
  • KPI: Key Performance Indicator
  • OOS: Out of Specification
  • CAPA: Corrective and Preventive Action
  • YTD: Year To Date

7. Documents

  1. Quality Metrics Dashboard Template (Annexure-1)
  2. KPI Definition Register (Annexure-2)
  3. Quality Metrics Data Collection Form (Annexure-3)
  4. Standardized Dashboard Template (Annexure-4)
  5. Dashboard Review Log (Annexure-5)
  6. KPI Trend Analysis Form (Annexure-6)

8. References

  • ICH Q10 – Pharmaceutical Quality System
  • 21 CFR Part 211 – GMP for Finished Pharmaceuticals
  • EU GMP Chapter 1 – Pharmaceutical Quality System
  • WHO Guidelines on Quality Risk Management
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Quality Metrics Dashboard Template

KPI Target April May YTD Status
Deviation Closure (%) ≥ 90% 85% 92% 88.5% Amber

Annexure-2: KPI Definition Register

KPI Definition Calculation Method
Deviation Closure Rate Percentage of deviations closed within TAT (Closed/Total) × 100

Annexure-3: Quality Metrics Data Collection Form

Department KPI Value Month Submitted By
QC OOS Count 2 March 2025 Sunita Reddy

Annexure-4: Standardized Dashboard Template

A pre-formatted Excel sheet containing KPI rows, monthly columns, auto-calculated YTD, and conditional formatting.

Annexure-5: Dashboard Review Log

Date Reviewer Observation Corrective Action
11/04/2025 QA Manager Missing CAPA data Follow-up with Production

Annexure-6: KPI Trend Analysis Form

KPI Q1 Q2 Q3 Q4 Trend
OOS Events 1 3 4 – Increasing

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial Version New SOP Creation QA Head
14/04/2025 2.0 Dashboard format added; trend review included GMP Metrics Compliance QA Head
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