To improve the effectiveness of our internal quality audit process, we created the “Audit Executioners” CI team. As a ISO 9001 and ISO 13485 certified company, we are required to complete internal quality audits. In addition, we are heavily involved in the medical equipment industry, so our customers regularly conduct their own quality audits of MPE and our quality system.
In order to exceed our ISO and customer audits, we need to truly drive advancements of our processes and sustainability. The CI team’s goals is to hold the organization to higher standards than our customers and ISO requires and incorporate best practices to ensure our quality system is best in class.
This cross-functional team dove into the challenge by brainstorming on the major root causes of why quality audits were not being effective and quickly put countermeasures in place to addresses those weaknesses.
|Area of Improvement||Counter Measure Implemented|
|No ownership and tracking of audit results.||Audit Champion established (QA Supervisor) to ensure audits and follow-ups completed timely.
Created metrics for the audit team.
|Quarterly timing of audits resulted in audits all being completed at same time.||Established monthly audit schedule with 1/3 of audits due each month.|
|Internal Audit Training, forms and auditors not robust enough to identify weaknesses.||Created internal audit training program and manual, updated forms to capture objective evidence collected and implemented rotation of cross-functional auditors.|
|Paper-based system made it difficult to collect data and access previous audits and findings.||Electronic solution using a tablet and computer company network allows auditors easy documentation, storage and accessibility to directory.|
Overall, the strong results of this project show that the Audit Executioners’ were successful in meeting and sustaining the goals set for them.
Results of Audit Findings
|Year||Internal Audit Findings||Customer & ISO Registrars Findings|
These metrics continue to be reviewed on a quarterly basis by our Audit Champion. They are then reported to our Leadership Team during our Quarterly Business Review to ensure we are sustaining our improvements.
Future improvements evolving from the Auditor Executioner’s project include: conducting risk analysis to identify critical areas within the system that should be subject to more frequent auditing than others, continued enhancement of our electronic capabilities, and utilizing the more robust audit training & system to our suppliers.