Our electropolishing and passivation processes have been validated in accordance with Quality Management Systems-Process Validation Guidance authored by SG3 and endorsed by The Global Harmonization Task Force.
While our medical device customers will require their electropolishing vendors to perform process validation, our diligence in addressing this benefits our customers in all industries, as the steps taken have helped to ensure that while operating within our specified parameters, we have demonstrated that our process will consistently yield product that will meet the requirements of our customers.
Able has completed its validation protocol and performed the validation for its electropolishing and passivation processes including:
Able Electropolishing began the process by first outlining our process in a detailed flow chart, which helped define a FEMA. The potential failure modes outlined in the FEMA provided a basis to design a validation protocol that would encompass the three aspects of the process validation.
All process equipment was tested in accordance with operation manuals, and our preventative maintenance scheduled was integrated into our ISO-quality system to ensure that critical process equipment remains calibrated.
Able then identified the process variables that determine electropolishing and passivation outcomes, and defined operating ranges, and verified that all coupons processed within these ranges were indeed within appropriate criteria (dimensionally, aesthetically and for passivity).
Upon verification of this data, Able re-ran these tests, obtaining SPC data that showed statistically the consistency of our process over an extended period of time.
Able Electropolishing continues to improve its quality management systems, and considers our recent efforts to perform process validation in a manner consistent with ISO:13485 to be an advantage to our customers who are looking to provide world-class metal components to their customers.
Contact us to learn more about electropolishing and passivation
Carbon steel is widely favored in manufacturing for its affordability, hardness and ability to undergo heat-treatment to increase durability. Used in gears, springs, and other critical metal parts, it’s known for versatility and reliability.
Precision and reliability are non-negotiable standards in the aerospace industry, where every component must meet strict requirements for performance, durability, and safety.
With the addition of a fourth-generation tabletop Scanning Electron Microscope (SEM), Able’s state-of-the-art suite of analytic tools continues to grow to meet the requirements of high quality finishing for increasingly sophisticated metal parts.
Stainless steel alloys are prized by manufacturers across industries for their durability and corrosion resistance. Unfortunately, when free iron isn’t removed from the surface of stainless steel parts after machining or stamping, the inherent benefits of stainless alloys diminish: contaminated…
