Documenting quality responsibilities across a supply chain
A responsibility matrix, change example and handover checklist for manufacturers, suppliers, laboratories and service providers.
Read the resourcesectors
Ingredients, components and contract manufacturing
Make specifications, changes and responsibilities visible across every organisation that contributes to a finished health product.
Define each role
Supplying an ingredient, manufacturing to a specification, performing a test and placing a finished product on a market are different roles. Record the product and process information each party controls and the decisions it is authorised to make.
Four handovers to document
Specification: what is supplied or performed and how conformity is shown.
Change: what must be notified, by whom and before which use.
Release information: which records accompany a batch, component or service result.
Problem handling: how a nonconformity, complaint or correction moves across the chain.
A change example
If a component manufacturer changes a process parameter, the record should show whether the component specification changes, which evidence is supplied, who assesses the finished-product effect and whether existing stock can be used. “No specification change” is information, not a substitute for the agreed assessment.
Use the responsibility record
Reporting a manufacturing environmental case study
A blank case-study record and worked calculation for baseline, boundary, production context, result and limitations.
Read the resourceMembership and participation
Manufacturers, specialist suppliers and service organisations use different membership categories. Eligibility follows the legal organisation's actual activities; membership is not supplier, site or product certification.