Quick answer
A pilot lot should answer a stated question. The plan must define the inputs, method, quantity, checks, records and review decision before assembly starts.
Scope of this guide: This guide explains practical pilot planning. Completing a pilot does not by itself qualify a supplier, process or product. The responsible device manufacturer defines that decision.
What decision should the pilot support?
State the question in one sentence. The pilot may test the assembly method, fixture, training, inspection plan, record set or a defined combination.
Keep development work separate from formal qualification work. If the method is still changing, identify the lot as development work and list the open points.
Which inputs must be fixed before the lot?
List the drawing, material, instruction and inspection revisions. Identify the fixture, operators, material lots, sample quantity and numbering system.
Agree how any departure from the plan will be recorded. The customer should define the evidence needed for its review.
What belongs in the review package?
Include identified samples, material links, assembly records, inspection results and records of any rework or nonconforming result. Review the samples and records together.
ISO 13485 and the FDA QMSR give quality-system context. Neither source creates one pilot format for every medical component.
Sources: ISO — ISO 13485: quality management for medical devices · FDA — Quality Management System Regulation (QMSR)
Agree these points before assembly starts
A short written protocol helps both teams work from the same plan.
- Pilot purpose and the decision it should support.
- Controlled drawing, material, method and fixture revisions.
- Sample quantity and identification method.
- Inspection criteria and records in the review package.
- Rules for departures, rework and failed results.
- Named reviewers and the written decision after review.
Source notes
Sources and further reading
- ISO — ISO 13485: quality management for medical devices
ISO explains the purpose and scope of ISO 13485. The practical checklists in this guide are AJSM suggestions, not text from the standard.
- FDA — Quality Management System Regulation (QMSR)
FDA explains the current US medical-device quality-system regulation and its use of ISO 13485:2016 by reference.