For medical-electronics PCBA, define which board, material lot, process step, inspection result, test result and release decision must be retrievable. Set record scope and retention against the applicable quality system, regulations, risk assessment and customer agreement. A traceability record supports review; it does not by itself establish product or supplier certification.
Set record scope and retention
Confirm which identifiers and events need to be linked for the product and market. Depending on the agreed scope, records may include material lots, process and program revisions, inspection disposition, test results, and release authorization. Set retention and access against applicable quality-system, regulatory, risk and contract requirements.
Cleanliness and contamination control
If cleaning is required, specify the assembly materials, cleaning chemistry, process conditions, verification method, acceptance criteria and handling controls. Confirm any residue limits and required evidence with the responsible product or quality owner.
Deviation and rework governance
- Define defect categories and who reviews and approves deviations or concessions.
- Specify the authorized rework instructions for the affected component and process.
- Record the agreed verification after rework and the final disposition.
Complaint containment planning
For complaints, link unit or lot identity to relevant material, process revision, inspection, test and rework records. Agree who assesses the potentially affected scope, when the initial review should begin, and which customer or regulatory notifications are required. Follow the product’s approved escalation procedure.
Where to start
Before an RFQ, identify applicable quality-system requirements, record fields, retention and access rules, change and rework approvals, and inspection or test scope. Ask the supplier to confirm which records can be provided for this build, in what format and at what point. See the quality page for the available inspection and release-record information.