Quality Audits and Gap Assessments
MBCA provides complete quality audits and gap assessments. Both include full reports including detailed recommendations for system improvement, methods to reduce regulatory risk, and ways to increase business efficiency based on industry standard practices.
Gap assessments are typically done at the beginning of a compliance project and are a critical part of the planning process. The results enable MBCA to determine the scope of the project needed to fully implement your customized quality management system solution and will give your organization a wholistic view of the potential regulatory compliance risks within the Quality Management System.
Quality Audits are typically done to achieve a specific goal or goals for the client. Internal Audits, mock FDA inspections, and external quality audits can be conducted as full quality system audits or focused audits in one or more areas. One or more auditors will be assigned to the audit project based on the size of the organization and the complexity of the products, processes, and services to be audited.
Supplier Audits are conducted according to your Supplier Audit schedule. MBCA does all the work while your team can focus on running the business. First, MBCA will contact the supplier and work out scheduling details. Then, MBCA plans and prepares for the audit. The audit is completed at the supplier site and the audit report is written and delivered to you, the client. At your request, MBCA will do the follow up to make sure the supplier is responding appropriately to any findings. MBCA keeps your team fully aprised throughout the process and the audit report always goes to you and not the supplier. MBCA understands that qualifying and maintaining your suppliers is time consuming and takes valuable personnel away from their day to day responsibilities. Let MBCA do the work for you! For more details on the full array of Supply Chain services, see our Supply Chain Managment page.
A sample listing – Quality Audits and Gap Assessments:
- Supplier Audits (complete quality system)
- Supplier Audits (focused follow-up audits to verify effectiveness of corrective actions)
- Full Qaulity System Audit following a merger or acquisition
- Focused Internal Audits
- QSIT style Audits
- ISO 13485 style Audits
- Process Audits
- Mock FDA Inspections
- Part 11 focused audits
- Preparation Audits (prior to FDA, ISO, or other external auditing body)
- Clinical Study Audits
- Focused Audit – Contract Design House
- Quality System Audit – Contract Manufacturer