Moving a Class III Manufacturing Facility

The Situation

A company wants to move its newly acquired manufacturing facility closer to headquarters. Since manufacturing also involved outsourced processes, the move required shifting outsourced process steps to new vendors. Both in-house and outsourced manufacturing processes required new validation.

The Solution

RQMIS examined the entire manufacturing process including starting materials, process, and final testing. This examination led to various corrective and preventive actions, leading to a successful Process Quality (PQ) execution. The manufacturer was able to begin manufacturing at the relocated facility.

RQMIS Helps Reestablish a Class III Implant Manufacturing Process

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

Both in-house and outsourced manufacturing processes required new validation. Prior to RQMIS involvement, multiple Process Qualification (PQ) efforts failed. Without an acceptable PQ, nothing out of the manufacturing facility could be sold.

RQMIS proposed an examination of the entire manufacturing process including starting materials, process, 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. RQMIS then recommended creating a project charter.

RQMIS examined the entire spinal-implant manufacturing process comprising 11 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:

  • 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. RQMIS identified the specific process steps that introduced the three contaminants, and recommended Containment Actions and determined a Root Causes. RQMIS then recommended Corrective Actions and Opportunities for Improvement (OFI) to mitigate future risk.

RQMIS 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.

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