Drafting a quality framework agreement (QFA) for ongoing supply
A QFA is a standalone quality document between buyer and supplier. It sets the quality management system, inspection protocol, audit rights, deviation handling, and product recall procedures that support the commercial supply agreement.
This is an 8-step workflow for drafting a quality framework agreement that sits alongside a supply or manufacturing agreement and governs product quality, audit, and non-conformance.
Before you start
- Executed or draft supply/manufacturing agreement
- Identified regulatory regime governing the product
- Supplier's current quality accreditation (ISO 9001, ISO 13485, etc.)
- Buyer's quality management procedures and batch release regime
The workflow
Align with the supply agreement
Map the QFA against the supply agreement so warranty, defect, and indemnity clauses align. Resolve any conflicts by precedence clause in the QFA.
Define the quality management system
Specify the QMS standard required (ISO 9001, ISO 13485, GMP) and certification evidence the supplier must maintain throughout the term.
Draft inspection and acceptance procedures
Set incoming goods inspection protocol, acceptance criteria, sample sizes, and the deemed acceptance period for buyer inspection.
Draft audit rights
Include routine annual audit rights, for-cause audits, and regulator audits. Specify notice period, scope limits, and cost allocation.
Address deviation and change control
Require supplier notification of any process, material, or facility change. Distinguish major changes (requiring buyer consent) from minor changes (requiring notification only).
Draft non-conformance and recall obligations
Include root cause analysis obligations, CAPA (corrective and preventive action) timelines, recall cooperation, and cost allocation on recall.
Address record retention and traceability
Set record retention periods aligned to the regulatory regime (often 7 years, or product life plus 2 years for medical devices). Require batch-level traceability.
Execute and establish governance
Execute the QFA and set quarterly quality review meetings. Appoint quality contacts on both sides with escalation paths.
What you will have at the end
An executed QFA supporting a resilient supply chain with clear quality obligations, audit rights, and recall procedures.
Common issues
- QFA and supply agreement conflicts with no precedence clause
- Audit rights drafted so narrowly they cannot support a for-cause investigation
- Change control carve-outs that let the supplier change key inputs without notice
- Recall cost allocation that leaves the buyer bearing costs for supplier-caused recalls
- Record retention periods below the regulator's requirement
Run this workflow on a real matter
Quillio drafts QFAs mapped to ISO 13485 and TGA GMP requirements and cross-references them against your supply agreement for conflict resolution. See /practice-areas/commercial-lawyers.
This workflow is a general guide. Quality regimes are regulator-specific — adapt the framework to the applicable regulator (TGA, FSANZ, CASA, APVMA).
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