The mere fact that our product is a “potentially life saving device” requires that we maintain only the highest standards in quality. At MBI, our quality system is the backbone of our production process. This level of control would not be possible without the total commitment of our employees. In fact, the development and continuous improvement of our quality management system has been and continues to be a group effort involving employees from every element of our production process. This kind of participation allows us to capitalize on the expertise and experience of employees with unique perspectives on our processes. This has proven to be extremely productive in proactively identifying and correcting potential risks to our quality system. Besides taking sincere pride in their work, our employees understand the importance of producing a high quality product and are committed to the total satisfaction of our customers.
The Quality Assurance (QA) Manager is responsible for all aspects of maintaining the Quality Management System. All documents and records within the Quality System are controlled at all times. The QA Manager is also responsible for directing the QC inspectors on their daily tasks. The MBI Quality Assurance department maintains Quality Manual documentation, Nonconformance Reports, Training Records, Internal and Vender Audits, Preventive Maintenance and our Approved Venders List. This process has enabled us to more closely monitor the overall performance of our Quality Management System.
Our Quality Management System is audited on a regular basis to ensure system effectiveness. Following the completion of these audits, the results are reported to the CEO and the Management Review Team(MRT). Any Non-Conformance Reports resulting from these audits are reviewed in our MRT meeting where appropriate corrective measures are discussed. The Q.A. Manager verifies the effectiveness of these corrective measures after an appropriate period of time.
Quality Assurance Department Organization
To preserve impartiality, the Quality Assurance Department functions independently of production reporting directly to the managing CEO. Product inspections are performed at every stage of the manufacturing process by a Quality Control Inspector. All inspections are carefully recorded on our “Plant Traveler” with each inspector signing his or her name along with the date that the inspection was preformed to signify acceptance. This inspection report stays with the building throughout the production process. Once the project is complete, this important record, along with many others is placed in the Project’s job file for future reference.
Our suppliers are held to standards that insure that the quality of our finished product is never compromised. Potential suppliers are carefully evaluated before being placed on our Approved Vendors List. This Approved Vendor List is maintained with the use of Quality Management software that allows us to closely track supplier performance. Our receiving inspections are quite thorough and when a problem is discovered with an order or material it is promptly dealt with in the form of a Non-Conformance Report (NCR).
Quality Management System Documentation
The Quality Management System Documentation consists of:
b) The Quality Procedures Manual – This manual entails all the policies and procedures for our QMS.
c) The Work Instructions Manual – These are our production procedures that cover every operation in our production process.
d) The Quality Forms List – This enumerates all of the forms that are used within our Quality Management System.
The MBI Quality Assurance Department conducts a series of internal audits each year covering every aspect of our quality system.
Occasionally potential clients will audit our quality system. To date, every audit of our QMS has resulted in a pass rating with exemplary marks in most cases.
We are dedicated to being the leader in providing quality products and services, which meet or exceed the expectations of our customers.