Operational Guide — Approved Supplier List (ASL) Maintenance

AA-PROC-ASL-LOG — Approved Supplier List Maintenance
This artifact provides continuous evidence that the Approved Supplier List (ASL) is accurately maintained, controlled, and traceable.

Minimum evidentiary expectations include:

Auditor focus: confirmation that only qualified suppliers are authorized and that ASL changes are controlled and justified.

WIN-PROC-ASL-MAINTAIN
Enforces controlled creation, maintenance, and modification of the Approved Supplier List (ASL).

Add, update, or remove suppliers based on approved qualification outcomes.
Maintain approved materials, services, and risk levels.
Document ASL changes with effective dates and authorization.

Control outcome: The ASL remains accurate, current, and authoritative for all GMP procurement decisions.

Authority resides in the applicable Family Pack. The AA and WIN above are reproduced verbatim for reference only and are maintained under formal change control in the Family Pack.

This Operational Guide is non-authoritative and provides execution guidance only. It does not modify, reinterpret, or replace governing documentation.

Process: Approved Supplier List (ASL) Maintenance
Business Process Owner: Supplier Quality / Procurement
Primary Systems: Supplier Management System, QMS, ERP
Applies When: Supplier qualification outcomes or performance drivers require ASL update

Operational Step Sequence

This sequence supports controlled maintenance of the Approved Supplier List and aligns execution to the requirements defined in the Family Pack.

  1. Identify the ASL change driver (e.g., approved qualification outcome, status change, or removal).
  2. Confirm that supporting qualification or performance documentation is available and approved.
  3. Add, update, or remove the supplier entry in the ASL as applicable.
  4. Maintain associated approved materials or services and the assigned supplier risk level.
  5. Record the effective date of the ASL change.
  6. Route the ASL update for required authorization.
  7. Document approval of the ASL change and retain traceable records.
  8. Ensure the updated ASL is accessible for downstream procurement decisions.
Operational Ownership & Change Flexibility:
The operational steps described above are owned by the Business Process Owner (BPO). These steps may be updated without formal change control, provided execution remains aligned with the intent and outcomes defined in the governing Family Pack.
Escalation:
Any ASL update lacking supporting approval or traceability is escalated prior to use for procurement decisions.

Completion Criteria

Execution is complete when ASL changes are documented with effective dates, authorized, traceable to qualification or performance drivers, and the ASL accurately reflects suppliers approved for use.