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 should benefit 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 our customers’ criteria.
Documented and Validated
Able has completed its validation protocol and performed the validation for its electropolishing and passivation processes including:
- Installation Qualification
- Operational Qualification
- Performance Qualification
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.