Each audit was conducted in identical fashion, with a final report and CAP being provided outlining Non-conformances, Observations, and Strengths, along with associated severity levels (Critical, Major, or Minor) for each Nonconformance and Observation. The primary goal of the audit was not to enhance the manufacturing procedures, but rather to evaluate the processes of the centre and ensure adherence to industry best practices. In the 2017 audit, the Manufacturing Centre was determined to operate to a high standard, although several areas for improvement were identified. However, in the 2018 audit, the majority of the corrective actions provided the previous year had been addressed and implemented. This resulted in a reduction in Non-conformances (over 50%), and an increase in observed strengths (over 100%). As a result of the ESP Manufacturer’s adherence to industry best practices and enhanced focus on manufacturing excellence, the Manufacturer was provided with an ALS Certificate of Compliance. While this certificate is not an industryrecognized certification, it identifies the Manufacturer as one that applies effective and repeatable quality management in the manufacturing of ESP’s, and meets or exceeds industry established best practices.
