QMS Compliance Remediation Project: The situation
PharmOut has performed a number of “rescue” missions over the years, and frequently undertakes QMS Compliance Remediation Projects. In this instance a large multi-national medical device company based in Sydney received a long list of deficiencies for their Australian facility after repeated compliance audits by the Australian Therapeutic Goods Administration (TGA).
Unfortunately, due to the pressures of daily operations, and the loss of key staff (retirement), the resources to address the deficiencies were simply not available.
With the deadline looming for their response to the audit findings, and the possibility that the TGA could demand that shipments cease, the company asked PharmOut to help respond to the notices of deficiencies and achieve sustainable compliance and perform a whole QMS rewrite, addressing massive compliance issues.
QMS Compliance Remediation Project: The solution
With only six months until the return of the TGA auditors, PharmOut quickly installed a Project Manager and several experienced medical device compliance consultants.
They applied a 4-step process to resolve the deficiencies:
- Consulting with stakeholders to achieve engagement in both the cultural change required and the project’s goals.
- Restructuring the site’s Quality Management System (QMS) that had evolved rather organically over the years. A logical and consistent approach was applied to document type and hierachy. This meant making sure that documents that were called policies actually were policies – not work instructions.
- Reviewing the underlining business processes the QMS was supporting, applying Lean principles to make the processes more efficient as well as compliant.
- Training operational staff through ISO 13485 training courses, as well as ISO14971 training courses both online and classroom, as well as procedure-specific training for appropriate staff. PharmOut developed site specific eLearning modules to provide on-demand training on key procedures in the company’s QMS.
When the TGA returned, six months after their last visit, the company successfully passed the audit. The people and processes that PharmOut installed within the company will ensure ongoing compliance, reducing the business risk to the company.
Need to buy the ISO 13485 standard, the link can be found here.