Daisy keeps the paperwork that makes a shipment defensible. Certificates of analysis, lot numbers, test reports, change notifications and the traceability that connects a pallet to a production record. She is based at the Huizhou site and has worked in the quality function behind the range since 2016.
What I handle
- Certificates of analysis and lot traceability
- Test reports for particle, fibre and extractable data
- Change notifications before a specification moves
- Audit support: questionnaires, declarations and sample records
Background
Her work starts before the order. Each reference has a defined specification, a test plan and a release criterion; the certificate is a record of that, not a substitute for it. When a customer asks for a document pack, she checks what the site actually audits against — ISO 9001, ISO 13485, a customer-specific questionnaire — and builds the pack to that standard rather than sending everything and letting the reviewer sort it out.
She also handles the awkward requests: a retrospective certificate for a lot shipped eight months ago, a declaration for a material that changed supplier, a correction to a packing list. These are routine if the lot file is intact. Her job is to keep it intact.
Working with me
Send the standard you audit against and the references in scope. If you need a document pack for a qualification, say whether it is for a desktop review or a site audit — the two need different evidence.
For change notifications, tell me who should receive them and how far in advance your procedure requires. We will set the distribution list once and use it for every affected lot.