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.
5. Procedure
5.1 Define Metrics and KPIs
- 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 (%)
- KPI definitions, targets, and calculation logic shall be documented in the KPI Definition Register (Annexure-2).
5.2 Data Collection and Verification
- Department representatives shall submit KPI data by the 5th working day of each month using the Quality Metrics Data Collection Form (Annexure-3).
- QA shall verify:
- Data accuracy with source records
- Completeness of entries
- Consistency with previous submissions
5.3 Dashboard Preparation
- 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)
- Charts shall include:
- Monthly trend line for each KPI
- Target vs Actual bar charts
- Quarterly comparison tables
5.4 Review and Approval
- QA Manager shall review the draft dashboard by the 10th of each month.
- Any anomalies shall be discussed with concerned department heads and documented in the Dashboard Review Log (Annexure-5).
- Approved dashboards shall be finalized and shared with:
- Quality Council
- Head of Manufacturing
- Regulatory Affairs (if required)
5.5 Archiving and Retention
- All finalized dashboards shall be archived in the Quality Dashboard Archive Folder (electronic).
- Dashboards and supporting data must be retained for at least 5 years.
5.6 Trending and Management Review
- Quarterly trends shall be analyzed using the KPI Trend Analysis Form (Annexure-6).
- 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
- Quality Metrics Dashboard Template (Annexure-1)
- KPI Definition Register (Annexure-2)
- Quality Metrics Data Collection Form (Annexure-3)
- Standardized Dashboard Template (Annexure-4)
- Dashboard Review Log (Annexure-5)
- 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
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 |