Medical device traceability and the adoption of best practices for such high-reliability manufacturing is more than simply compliance with 21 CFR Part 11 of the FDA guidelines. Aegis systems take a holistic approach to supporting high-reliability and traceability manufacturing, rather than addressing point issues of compliance. This holistic approach is discussed below:

AEGIS' HOLISTIC APPROACH TO HIGH-RELIABILITY AND MAXIMUM TRACEABILITY MANUFACTURING

• Support Labor Force Excellence: Quality and control start with data preparation and delivery of information to the factory floor. Begin the process of building in quality by providing each assembly, setup, inspection, diagnostic, and rework operator with the correct visual documentation they need to do their job perfectly. Furthermore, electronically assure the appropriate revision documents display at each station for any given unit scanned at each station automatically.

• Assure Proper Equipment and Station Setups: There is little business benefit in providing traceability to a poorly setup process resulting in incorrect product manufacture. Aegis solutions electronically ensure proper tooling, materials, component, and consumables setups at every machine and manual assembly station in the entire process to preclude materials errors..

• Total Traceability: Aegis traceability includes not only the movement and experience of the product through the route, but all materials used either on the product or in its processing, as well as the process variables that emerge from all machines involved in its manufacture or test. Greater depth of medical device component traceability and greater scope across then entire factory flow than any alternative solution.

THE OUTPUTS OF TOTAL TRACEABILITY TO EXCEED
21 CFR PART 11 TRACEABILITY REQUIREMENTS

Reverse Traceability Report:

• All units containing a particular lot and part number component, or units processed with a particular lot consumable or tool.

Product and Process Traceability Report:

• BOM and Process revision records.

• Electronic approval records of BOM and Process reviews with feedback notes and reviewer authentication.

• Process deviations released during the production of that unit.

• WIP history complete with logged operator at each station.

• Panel to image ID map records.

• Pallet to panel or image ID map records.

• Component part number and lot records of reference designator to image to lot.

• 'From-To' Lot records for components removed and replaced in-process.

• Part number and lot records for all tools, chemicals, and consumables used in the processing of the unit.

• Pre-production operator checklist confirmation per station.

• False positive inspections records and station.

• Rework and repair to connection level records.

• Unresolved defects at time of report generation.

• Measurement data records for all measurements derived from any process or test equipment in the route.

• Symptom/Defect records from ICT and functional test results and diagnostics.

• Parametric operator data collection (such as trim settings, adjustments, specially serialized components, etc.) from each station applicable in the route.

• Process alarms emerging from any machine in the route while the unit was within it's transfer zones.

• Process events emerging from any machine in the route while the unit was within it's transfer zones.

• Assembly children unit numbers and serial numbers.

• SPC metrics of any measurement data in-process such as reflow oven or thermal profiling data sets such as maximum zone temperature, soak duration, oxygen levels, etc.