## Case Study:
Electronic Record Retrieval During FDA Audit

The FDA had just completed an audit of a leading medical OEM. The medical OEM informed their contract manufacturer that the FDA would be arriving the following week for an audit of several high volume class 2 medical devices. In addition to a general audit, the FDA in particular wanted to review DHR’s for products built at a certain time and with components from particular lot codes.

## The Challenge

During an FDA audit, the ability to produce correct, clear and verifiable quality records in a timely manner is essential. Implemented properly, the right MES/MOM solution can provide the structure for, and ensures compliance with key elements of the FDA QSR (Quality Systems Regulation). A leading OEM of class 2 medical devices had outsourced production of its products to Sanmina, a leading contract manufacturer of medical products. Eight of Sanmina’s medical manufacturing facilities use the 42Q cloud solution. The FDA would be at Sanmina in a few days, and Sanmina knew the FDA was expecting to see:

- DHR’s for production of high volume medical devices, built within a certain date range.
- DHR’s for products built using integrated circuits from specific lot codes.
- Test and parametric data for specific products.
- Training records related to a work instruction ECO (Engineering Change Order).

Example of 42Q electronic DHR, with hyperlinks to traceability information for key components.

## The FDA Audit

The FDA auditor asked to see DHR’s from a specific date range. These DHR’s were delivered to the auditor in a matter of minutes, since they were all online in an easily searched database. Training records were produced, and the auditor was impressed to discover that training records were also electronic with linkages to PLM (Product Lifecycle Management) software, and ensured that the operator was trained to the latest revision of the procedure. Next, validation data for the quality system and 42Q were reviewed by the auditor. The auditor commented that the overall implementation of electronic DHR’s, component traceability and operator training was one of the best he had seen.

## Why 42Q

Sanmina has been using 42Q as its MES/MOMS core for many years in multiple medical manufacturing facilities producing both high volume medical devices, along with highly complex diagnostic imaging equipment. The implementation has become very mature:

- All electronic DHR’s. DHR’s are “evergreen”, with any product rework or subsequent upgrades or repairs automatically appended to the original electronic DHR.
- The electronic DHR’s have automatic linkages to component lot data for complete electronic traceability.
- Integration with training record databases and software. Operators badge scan into their workstations, and if they are not trained to the current work instruction revision, they are locked out.
- Automatic upload of test and parametric data, associated with a specific device serial number.
- Full integration with production equipment via API’s (e.g. barcode scanners, label printers, test equipment).
- Multi-plant integration and visibility in the top level DHR: Genealogy, traceability and linkage of sub-assembly DHR’s (e.g. PCBA’s built in other Sanmina plants) to the top system level DHR.

## Results

The speed of producing the requested information, along with the quality and consistency of the records resulted in a successful audit. Comments made by the FDA auditor during the closing meeting were highly complementary regarding the implementation and validation of the quality system. Positive comments were also made about the complete “end to end” integration and electronic records made possible with 42Q, from incoming inspection through production, all the way to the shipping dock.