Challenges
Provide guidance and project management for the yearly Eichrecht audit, Eichrecht certification transfer and ISO9001 SV2 audit. After recent personel changes the quality organisation lacked the resources to adequatly cover audit preperation and planned certification transfer. Target for Eichrecht was no production stops or delays as a result of audit failure or certification transfer. Target for ISO9001 SV2 was continued compliance with ISO9001:2015.
Approach
First weeks consisted of team introductions and internal audits to identify opportunities for improvement and confirm process compliance. Additionally the new CAB had visisted the site prior to the assignment and provided a number of recommendation. Using the internal audit outcomes and CAB recommendations a number of processes and SOPs were updated and a new conformity test in the manufacturing process were drafted and introduced. The weeks leading up to the audit were used to ensure audit readiness both from a system and team perspective. Come audit time the function of first point of contact, and audit guide were filled.
Results
Eichrecht certification (initial) under the new CAB was continued from the expiration date of the old certificate, satisfying the goal of zero production stops or delays. ISO9001 SV2 audit was succesfully completed without a non-conformity (minor or major).