A lab quality manager checks off an item on a checklist while inspecting the lab

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Introducing the Lab Quality Management Certificate

Online training and development program for lab quality managers

Written byScott D. Hanton, PhD andDan Zuccarello
| 4 min read
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Lab quality is essential to ensuring the satisfaction of key lab stakeholders. There are many different approaches to delivering high-quality outcomes. Quality systems are just as diverse as the types of labs that exist, however, there are elements of lab quality that are consistently part of these different programs. 

The lab quality manager role

One thing all labs have in common is an individual who is responsible for the implementation, performance, and improvement of the quality program. This role might be part of the lab manager’s position or be filled by a full- or part-time lab quality manager or an experienced scientist. Since most lab quality leaders are trained scientists with little formal training in lab quality, the Lab Manager Academy has developed a new certificate program in lab quality management to help existing quality leaders further develop their skills and to prepare potential lab quality leaders to take on these responsibilities. 

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The best labs understand that lab quality is part of everyone's responsibility . . .

Lab quality management can be a challenging role. Quality managers are often viewed as the police of the lab—enforcing quality procedures and acting against staff who fail to comply. However, the best labs understand that lab quality is part of everyone’s responsibility and the lab quality manager is helping everyone ensure the delivery of high-quality results and outcomes that will best serve the needs of the lab’s key stakeholders. 

Successful lab managers build a culture of quality that aligns the whole staff with the drive to deliver on their stakeholders’ needs. They build this culture by empowering people, implementing the components of a compliant quality program, and influencing staff to deliver their work in compliance with the expectations of the quality program. To be successful, quality managers need a variety of leadership, management, and lab quality skills and knowledge. This certificate is designed to provide managers with these basic tools. 

A solution to lab quality management challenges

The new Lab Manager Academy Lab Quality Management Certificate contains a series of 10 interactive, online courses that provide existing and potential quality managers with practical knowledge of building and maintaining a quality program within their organizations. As the subject matter expert for this program, Dan Zuccarello, founder of RBF Consulting LLC, emphasizes that building an effective culture of quality reduces the friction between the quality unit and the rest of the lab and drives a high degree of excellence for the organization.

The Lab Quality Management Certificate has been designed and developed based on our real hands-on experience in managing laboratories. The courses are presented using examples, stories, and current industry standards to clearly show how quality can be implemented, delivered, and managed. The program provides learners with a series of tools to help them deliver their responsibilities more easily, faster, and with better outcomes.

Lab Quality Management Certificate overview

The certificate program is delivered in two five-course streams. The first stream focuses on the skills and knowledge required to develop and lead a lab quality program: 

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  1. Culture of quality – deliver the customs, habits, beliefs, and stories that will align all lab staff with the quality strategy of the lab.
  2. Quality management – improve the leadership skills required to manage the lab’s quality program.
  3. Quality management system (QMS) – evaluate and implement a digital QMS.
  4. Analysis and improvement – improve change management, risk management, and continual improvement.
  5. Customer or stakeholder satisfaction – obtain feedback, learn, and drive changes to support the key stakeholders.

The first stream provides the background, definitions, and overall components of an effective lab quality program. These courses will help quality managers understand and build programs that communicate commitment to quality to staff, internal stakeholders, and external stakeholders. 

Successful lab managers build a culture of quality that aligns the whole staff with the drive to deliver on their stakeholders' needs.

The second stream of the lab quality management certificate is designed to provide quality managers with approaches, knowledge, and skills to implement very specific components of common quality programs: 

  1. Documentation – deliver all aspects of a fully compliant ALCOA++ program
  2. Instrument qualification – deliver effective design, installation, operational, and performance qualifications (DQ, IQ, OQ, and PQ).
  3. Training – deliver effective proficiency training programs that go beyond the routine and keep both learners and trainers engaged.
  4. Data integrity and auditing – ensure stakeholders can trust the data and reports delivered by the lab and learn the details of lab audits.
  5. Data review – implement robust and effective peer and quality review processes.

Each course in this certificate program is designed to deliver modern adult learning experiences in a full e-learning environment. Each course is expected to take about one hour and contains valuable audio, written content, interactive elements, thought-provoking activities, and a quiz to demonstrate competence with the material.

Lab quality—the key to a successful lab

The lab quality management certificate is a vehicle for quality managers to better understand the concept of quality as it relates to their lab. Quality is not just a job for someone else, but the joint responsibility of every member of the team and organization. It’s everyone’s responsibility to assess the level of control and the level of compliance with processes and procedures and then take action to improve the culture and quality of your lab.

The expectation is that in completing these 10 courses, the lab quality management certificate provides the methods and tools—based on years of experience, trials, successes and failures—for you as a quality manager to successfully build a quality program for your organization. Simply put, the keys to success lie in building or influencing a culture of quality and the answer can be found through empowering your staff, building a sound program, leaving a legacy that stands over time, and influencing those around you to work in a compliant manner. The outcome is a lab that delivers more successfully for their key stakeholders, is more confident in its reported results, is driven to undergo continual change for improvement, and is more successful in delivering its mission and purpose. 

Learn more about the Lab Quality Management Certificate at the Lab Manager Academy. 

About the Authors

  • Scott D. Hanton headshot

    Scott Hanton is the editorial director of Lab Manager. He spent 30 years as a research chemist, lab manager, and business leader at Air Products and Intertek. He earned a BS in chemistry from Michigan State University and a PhD in physical chemistry from the University of Wisconsin-Madison. Scott is an active member of ACS, ASMS, and ALMA. Scott married his high school sweetheart, and they have one son. Scott is motivated by excellence, happiness, and kindness. He most enjoys helping people and solving problems. Away from work Scott enjoys working outside in the yard, playing strategy games, and coaching youth sports. He can be reached at shanton@labmanager.com.

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  • Dan Zuccarello currently serves as principal consultant for RBF Consulting Group, LLC located in Hightstown New Jersey. During his 40+ year career in industry, Dan has established and managed pharmaceutical, food, and petrochemical laboratories. Currently he provides consultation services for subject matters such as: computer system validation, elemental impurities, extractables and leachables (EL), ICH stability, expiry dating, product development (R&D), quality management systems, safety, and waste management. He has published and presented several papers on extractables and leachables and elemental impurities. He holds a BA degree from the University of Delaware and an MBA from Rutgers Graduate School of Business–Camden New Jersey.View Full Profile

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