Successful FDA CAPA Manufacturing Inspection

The Situation

A company wants to move its newly acquired manufacturing facility closer to its headquarters. The facility manufactures a Class III spinal implant device, among other things. Since manufacturing also involves outsourced processes, the move requires shifting outsourced process steps to new vendors.

Both in-house and outsourced manufacturing processes require new validation. Prior to RQMIS involvement, multiple Process Qualification (PQ) efforts have failed. Without an acceptable PQ, nothing out of the manufacturing facility can be sold - which is obviously a big problem.

The Solution

RQMIS proposed an examination of the entire manufacturing process - including starting materials, internal processes, and final testing. An RQMIS Quality System Engineer with extensive manufacturing and R&D experience lead a Corrective Action Preventive Action (CAPA) Investigation. CAPA is but one part of a Quality Management System (QMS).

The complexity of the manufacturing process as well as the need to involve resources from several departments across the company required RQMIS to obtain Executive Management buy-in. Once they had that, RQMIS recommended creating a Project Charter.

RQMIS examined the entire spinal implant manufacturing process, comprising eleven main process modules and hundreds of individual process steps, supplier processes, and the Process Failure Mode and Effect Analysis (pFMEA).

RQMIS investigation drove the conduct of various surface analysis tests on key components and an examination of a newly instituted cleaning step which included:

• Scanning electron microscopy (SEM)
• Energy Dispersive X-Ray Spectroscopy (EDS); a chemical microanalysis technique
• Fourier-transform infrared spectroscopy (FTIR) in both reflection and Attenuated Total Reflection (ATR) mode

RQMIS, working with an analytical chemist at a Surface Analysis company, detected three surface contaminants. We identified the specific process steps that introduced the three contaminants, recommended Containment Actions, and determined a Root Cause. We then recommended Corrective Actions and Opportunities for Improvement (OFI) to mitigate future risk. Our team also reviewed test results to verify that the material and surface properties of the components did not statistically change. The results indicated that no new risks arose due to the introduction of the cleaning process step.

RQMIS work resulted in the successful completion of the PQ and made it possible to relaunch the spinal implant.