GxP Lifeline

5 Essentials to Effectively Manage a Quality System


Before anyone can manage a great quality system, they need to make sure it is developed the correct way. Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s life cycle, from startup through maturity, the quality needs are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act that everyone in industry encounters. The most successful companies do critical assessments of their needs and gaps in the present and in the future, and then deploy a risk-based approach to their quality system to achieve their goals. Below is a breakdown of the 5 most essential things to do to effectively managing a quality system.

#1 Identify Your Needs

It’s critical to identify the quality standards, regulations and/or requirements surrounding the company’s products, service and business needs. Think about these major points when developing and/or assessing a quality system and how they apply within the company.

  • Geography – In which countries does the company manufacture, distribute or conduct business?
  • Industry – The type of product or service sector such as medical device, pharmaceutical, combination product, cosmetic, nutraceutical, service, or other?
  • Use Setting – Is the product used at home and/or institutional settings?
  • Regulatory Agencies – Is registration with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), etc.?
  • Standards – Certify to an international standard (i.e., ISO 9001, ISO 13485 or other) Is there a competitive advantage/or requirement to be registered
  • Manufacture – Are you manufacturing in-house or outsource to another manufacturer?

#2 Create Milestones to Analyze and Implement Upgrades

Creating milestones is one of the most important parts of having a great quality system, and it is the focal point of any phased approach to managing quality systems. The phased approach ensures that

companies are meeting basic requirements in a timely manner with the expectation that there will be continuous improvement through periodic assessments and modifications with the existing quality system.

Main Elements of a Quality System

Management responsibility and commitment to the quality management system (QMS), ensuring ongoing communication with and support from the organization to follow the quality system.

  • Resource management – Ensuring the right people are doing the right things.
  • Employee competence against their job requirements.
  • Product realization – How is the product or service developed, transferred to manufacturing, and delivered to the customer while providing safety and efficacy.
  • Evaluation – What metrics from the quality system are used to assure compliant product and customer satisfaction, and drive continuous improvement.

#3 Use an Electronic QMS That Is Right for Your Company

When deciding how the quality system will be controlled it is important to understand different electronic QMS options based on the company’s needs. With electronic systems, there are ones that are controlled manually, electronically, or with the hybrid combination of the two. All these approaches can drive compliance, but their effectiveness depends on the scale, complexity, and needs of the quality system that’s in place. Typically, startup or early stage organizations can benefit from basic manual systems or hybrid systems that automate some of the more labor-intensive quality functions such as document control. While midmarket organizations can benefit from increased automation through hybrid or enterprise QMS systems that address multiple quality needs such as document control, deviation control, nonconformances, equipment calibration, equipment maintenance orders, audits, corrective and preventive action (CAPA), change control, training, and functions that control product outputs. And large organizations can benefit from integrating enterprise QMS systems with their enterprise resource planning (ERP) and related systems for even greater interoperability.


 Manual, Paper-based

  • Low cost.
  • Easily changeable.
  • Time consuming.
  • Cumbersome as data grows.

Stand-alone systems   typically one or a few   functions such as CAPA   or document control.

  • Relatively low cost.
  • Effective for key single systems.
  • Generally requires minimal.
  • configuration, works right out of the box.
  • Minimal adaptability.
  • No integration with other quality functions.

 Enterprise QMS

  • Automates the entire quality function.
  • Modules are integrated.
  • Some systems integrate with the company’s ERP system.
  • Costly.
  • More resources/expertise to implement and maintain.

#4 Ensure Staff Is Properly Trained in Quality and Don’t Be Afraid to Seek Help

With any position at any company it is imperative that staff is properly trained, and part of that training must include how to utilize the quality system properly. No one wants to get flagged in an audit for something that could have been avoided by proper training. Companies require a competent and knowledgeable individual to be the quality system leader. They will oversee implementation, keeping the system compliant and pushing forward improvements. It is also a part of the quality system leader’s job to ensure that either current staff is or can be trained on maintaining the quality system and if not, that the gaps are filled temporarily with contractors until the training is complete or the positions are filled. Quality system leaders can perform a skills assessment to analyze the skills of in-house quality personnel against the company needs.

Temporary gaps are common and can be closed by hiring consultants that can provide specialized knowledge without paying for a full-time employee. These include aren’t limited to:

  • Internal and external audits.
  • Training on key topics or necessary regulations.
  • Medical liaison for complaints, clinical, etc.
  • Other complaint handling.

#5 Use a Risk-Based Approach When Evaluating and Implementing Improvements Across the Quality System

When it is time to evaluate and start implementing changes in a quality system, the focus during the evaluation should be on risk and how to mitigate as much of it as possible. First, evaluate the areas of risk throughout the product’s life cycle and identify what the greatest risks are. Once the major risks have been identified, find the areas in the quality system that are related to these risks and develop improvements to the prosses that mitigate the risk while still staying compliant. This approach ties in with No. 2 on the list, create milestones to analyze and implement upgrades. The milestones and upgrades created should be a part of this risked-based approach.


Choosing the appropriate quality system and making sure it is managed the right way is crucial in any business’s success. When the quality system is not functioning in line with the companies needs it will have a ripple effect throughout the quality and compliance of the product and it is the Quality Manager’s job to make sure that the system operates smoothly. By using the 5 Essentials to Effectively Manage a Quality System above, leaders will know what to look for when evaluating their current system for improvements or will have a guide to creating a new, successful, system that is right for the company.


Brian Matye is CFO at Regulatory Compliance Associates Inc. His career includes more than 25 years in senior engineering leadership roles at Baxter Healthcare Corporation, GE Healthcare and Medtronic, with experience in all phases of high-reliability systems, medical product development and systems deployment.

He came to Regulatory Compliance Associates Inc. in 2010 as general manager of RCA’s southeast regional office in Tampa, Florida, leading the firm’s business development functions as well as providing consulting services in the areas of quality, engineering, and regulatory compliance for medical device clients.

As chief financial officer, Mayte possesses executive-level experience in all phases of life science product development and product release. A highly skilled problem solver with excellent interpersonal skills, his areas of expertise encompass business development, profit and loss statement (P&L) creation and management, inter-departmental coordination, process definition, and quality assurance.

His depth of knowledge includes medical device, quality systems and pharmaceutical development regulations. Mayte’s innate ability to turn customer concerns into actionable engagements as well as maintain good client interactions is key to RCA’s success. He graduated from the University of Wisconsin–Superior with a bachelor’s degree in mathematics and earned his MBA in operations from the University of Minnesota.

Regulatory Compliance Associates is an enterprise partner with MasterControl.

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