A quality system (QS) consists of processes that are implemented and documented to ensure that product quality is reproduceable, consistent, and meets specification requirements. The concepts that make up a general overview of quality systems can be applied across multiple industries – from pharmaceuticals to electronic devices to food.  

The primary practices of a QS include tracking, investigating, and resolving product defects; applying metrics to determine if the production processes are on a positive or negative track; and managing, controlling, and documenting changes. These practices ensure that product quality consistently meets customers’ needs and expectations, provides a mechanism to evaluate and eliminate waste in the production process, and provides management with fact-based data to support strategic decisions.  

Quality Systems Team Skillset Overview for Implementing Changes

The following skill sets are recommended skillset in a team responsible for deploying a new quality systems or making changes to an existing system. There may be one or more skillsets per person depending upon the scope and size of the project. These may be categorized or assigned as follows: 

• Project Manager (PM): Responsible for managing communication, and ensuring clear, concise, and current information – including project scope changes – is provided to the client Project Sponsors. This person is also responsible for tracking overall budget, progress, and timeline of the project. 
• Business Analyst (BA): Plays a critical role in quickly understanding and identifying the user requirements needed to support the project, pulling from knowledge gained on previous projects and/or industry experience. The BA needs to build relationships with the client as they “come up to speed” and grasp the project needs while simultaneously performing an evaluation of existing requirements against industry best and lean practices.  
• Quality: Key to evaluating and adhering to the clients Standard Operating Procedures (SOPs) and assessing areas to enhance or streamline compliance. This person ensures that the project methodology meets the clients existing procedures, current industry best practices, and applicable regulatory and compliance standards. This person also serves as a liaison to the clients quality representatives to support the internal quality program, including writing change controls, performing deviation investigations, creating CAPAs, etc. 
• Information Technology (IT):  Recommends strategies for data migration from legacy systems and provide guidance for options on maintaining new systems, including options such as Service as a Software (SaaS) with a vendor/outsourced-provided administration, or a locally hosted system with in-house system administrators. This person also provides a thorough evaluation and recommendation for system requirements to ensure minimal lag time between transaction as well as the ability to support the scoped and future user base while evaluating data integrity, backup, and failover strategies and the disaster recovery process. 
• Change Management and Training: Provides both internal and external teams with a mitigation strategy to focus engagement on a successful path for timely change communication, and well-thought-out training deliveries. By leveraging the expertise of external project members and client representatives, the appropriate internal people can be identified to provide feedback on past project hurdles and successes. It’s imperative to ensure users are open to a change strategy to move from existing processes to a new process, resulting in increased user engagement and adoption of the new system. Otherwise, the system will not be fully utilized, and the expected benefits and returns may not be realized or be as impactful as expected by the client Project Sponsors.   

Moving Forward with a Quality Systems Team

Having a well-rounded quality systems team to support your project will provide the best opportunity for compliance, user adoption, engagement, and overall success. Clarkston can help provide you with all these skills needed for an effective quality systems team to complete the project. 

Contributions from Melton Coskrey