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Practice resource

Documenting quality responsibilities across a supply chain

Use this record to show who provides, checks, approves and updates manufacturing information when more than one organisation contributes to a product.

IAHPM · 12 October 2026 · Version 1.0

Manufacturing personnel checking packaged goods in a warehouse

Define the interface

Name the item or service, the supplying organisation, the receiving organisation and the finished-product context. Separate contractual ownership, operational responsibility and the legal duties that each party holds under the applicable framework.

Responsibility matrix

Information or decision Supplier provides Manufacturer reviews Approval owner Change notice Record retained by
Specification
Test method and result
Manufacturing or service change
Nonconformity or complaint information
Release information

Worked change example

A sensor supplier proposes a process change and reports no change to the component specification. The record still identifies who receives the notice, which supporting information is supplied, who assesses effects on the finished device, whether incoming or finished-product testing changes, how existing stock is treated and who approves use.

The example does not assume that “no specification change” means “no product impact”. It makes the assessment and decision owner visible.

Information handover

For every required record, state the format, timing, recipient and acceptance check. Define what happens when information is incomplete or late. If a test is performed by a service provider, record the method version, sample identification and route for investigating an unexpected result.

Follow a problem

Walk one example backwards and forwards through the chain: how the issue is identified, which batches or configurations are affected, who investigates, who communicates with customers or authorities where required, and how a correction reaches every relevant record.

Maintain the record

Review the matrix after a supplier, site, specification, test method, contract or product configuration changes. This worksheet supports a discussion; it does not replace a quality agreement, contract or legal allocation of responsibility.

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