The challenge
A pre-audit assessment identified several gaps requiring correction before the supplier prequalification audit:
- Incomplete and partially implemented SOPs
- Use of generic SOPs that did not reflect GSDP requirements or operational realities
- Absence of key quality procedures
- Inconsistent documentation and calibration records
- Need for structured CAPA closure and staff retraining
The client required a fully aligned, audit-ready QMS within a defined timeline.
Approach — QMS development
A comprehensive QMS framework was designed and implemented, including:
- Revision and alignment of existing SOPs with GSDP and WHO-MQAS
- Replacement of generic SOPs with PPB-aligned, operationally accurate procedures
- Development of missing procedures
- Strengthening documentation control and calibration management
- Establishing compliance monitoring mechanisms to ensure ongoing alignment with operations
This ensured that documented procedures accurately reflected and governed daily activities — the distinction between a QMS that exists and a QMS that operates.
Audit preparation
Warehouse processes were aligned with WHO-MQAS requirements, and structured evidence packages were prepared to demonstrate compliance during the audit.
CAPA execution
Pre-audit findings were converted into structured corrective and preventive actions. SOPs were revised, documentation gaps were closed, and preventive controls were embedded to ensure sustained compliance.
Staff training
Monthly GSDP workshops were delivered to reinforce documentation discipline, operational consistency, alignment with revised procedures, and audit readiness across warehouse functions.
Results
Impact for clients
This engagement demonstrates capability in delivering true compliance systems, operational discipline, and risk control — not generic documentation. Organizations preparing for external audits can leverage this expertise to achieve higher audit scores, reduced regulatory risk, and sustainable quality systems.