General Masters, Inc.®

Quality Assurance Services

Quality Assurance (QA) program is now mission-imperative as organizations face an ever-changing threat landscape and business drivers such as the risk related to compliance programs. Indeed, some organizations cannot be in business without an effective Quality Assurance program. General Masters provides comprehensive and professional QA program implementation services deemed suitable for respective organizations.

The Food and Drug Administration, Department of Energy, other Federal Agencies and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production QA processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-production QA for Healthcare manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001.

As part of our service offerings, we provide a detailed step-by-step documented QA program to ensure that effective pre-production QA is established and effectively in place and explore the key concepts of design, product, and process.

QA is a system of required procedures, checks, audits, preventive, detective and corrective actions to ensure that all design, environmental monitoring, performance, research, sampling, and technical reporting activities are of the highest achievable quality. QA also determines whether regulatory mandates, compliance requirements regarding facilities, products or services meet or exceed expectations. General Masters will establish a long-term partnership with your organization to implement an effective QA program for your company.

Many people make the mistake of confusing quality control with quality assurance. This is an easy mistake to make as the two are quite similar on the surface. While QA and QC are similar, a closer look will reveal several basic differences. Quality control focuses on the product, while quality assurance focuses on the process. Quality control includes evaluating an activity, a product, process, or service while quality assurance aims to ensure processes are sufficient to meet clearly defined objectives. In a nutshell, quality assurance ensures a product or service is created, implemented, or produced correctly, whereas quality control determines if the “end result” is satisfactory or not.  GMI is your leader in affordable QA consulting, consisting of the following steps or phases:

·        Planning: During the planning phase, interrelated problems are assessed, objectives are established, and problematic processes are cited. Processes that may be required to deliver the necessary results are established or developed.

·        Implementation: During the implementation phase, developed processes are set in motion.

·        Monitoring: The monitoring phase is an ongoing process, usually handled by a manager or consultant, which involves evaluating and testing the implemented process to make sure they meet the objectives. This also involves monitoring for potential problems and future improvements.

·        Action: During the action phase, if necessary, actions are applied if the results require any changes.

·        Training: As part of our service offering, at the completion of the QA program implementation, all assigned staff of your organization are fully trained.

Auditing and Review of QA programs

ISO 9000 is an international standard that many companies use to ensure that their QA system is in place and effective. Conformance to ISO 9000 is said to guarantee that a company delivers quality products and services. To follow ISO 9000, a company's management team decides QA policies and objectives. Next, the company or an external consultant formally writes down the company's policies and requirements and how the staff can implement the system. Once this guideline is in place and the QA procedures are implemented, an outside assessor, such as General Masters, examines the company's implemented QA system to make sure it complies with ISO 9000. We will perform our review to ensure your program complies with ISO 9000. As subject matter experts in QA program implementation matters, General Masters is better positioned to conduct an effective review of the QA programs that were not implemented by us. Our review is comprised of these key steps:

·        Risk assessment of your QA program.

·        The key controls of the program.

·        Testing of the key controls of the program to ensure they are functioning as intended.

·        Management Report.

Also, General Masters offers effective review of the QA programs that were not implemented by us.

Our service offerings:

In developing products and services, quality assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements. A quality assurance system is said to be in compliance with regulatory mandates, increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. We have developed a consulting practice for delivering comprehensive (software, documentation, compliance tools, ongoing monitoring environment, and hardware) to address your QA needs.  Our QA consulting services cover these areas:

·        Government regulatory compliance programs.

·        Research & Development program.

·        Manufacturing facilities program.

·        Packaging facility program.

·        Pharmaceutical manufacturing program.

·        Hospitals and clinical programs.

·        Education programs.

·        Financial Industry programs.

·        Physical Plants' program.

·        Services organizations' program.

·        Transportation programs.

·        Software and hardware programs.