Coordinating your resources is a complex task as there are several types of information that need to be considered in order to accurately schedule laboratory testing requirements.
If you are working in a regulated environment under GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices) or ISO17025, staff competencies are critical to ensure that tasks are performed correctly, standard operating procedures are followed accurately, and company policies are applied.
Compliance training under GMP regulations
Compliance training are company-mandated training courses that focus on educating participants about departmental policies, laws, and regulations.
Each company pays attention to its own training management as part of its quality management to ensure that employees meet the minimum requirements for each specific job task.
Training management requires coordination of trainers, e-learning sessions, scheduling, logistics, resource management, trainer engagement, team collaboration, cost tracking, budgeting and reporting. Training is usually recurrent sessions aimed at certifying that employees meet certain technical aspects of the job and workplace requirements. Employees are then recognised as competent to perform a range of responsible tasks. Where jobs require more specific technical skills, such as in laboratories, a training plan and strategy must be established to create a solid yet flexible matrix of competencies and tasks to be performed. In addition, technical competencies need to be renewed and reviewed within a certain time frame.
Competency-based training is a learning intervention that focuses on developing demonstrable skills through ‘learning by doing’ or ‘on-the-job’ training. The focus of this approach is on the trainee’s active participation in the learning process and their ability to demonstrate an acceptable level of performance on a given task. Learning outcomes are measured by the employee’s ability to demonstrate their skills. Trainees are usually taught first and then shadowed by senior members of their team, whom they can turn to at any time in addition to training.
To meet both performance and regulatory requirements in a GMP environment, effective and efficient training programmes should be designed to meet both compliance and competency objectives. An integrated approach should go beyond instructor-led presentations and e-learning sessions to provide on-the-job learning opportunities that develop relevant job-specific knowledge, skills, and abilities.
Proficiency Tests under ISO/IEC 17025
Some specific industries whose laboratories are certified according to ISO /IEC 17025 are required to conduct proficiency testing, an examination that tests how well someone is trained in a specific activity and field of expertise.
As such, technical personnel must pass a competency test that is part of a comprehensive assessment of technical skills and knowledge during basic training in a newly validated technology, technique, or method. Once certified, personnel can be deployed to perform these tasks.
In addition, the entirety of the laboratory processes must be certified by a proficiency test as part of an interlaboratory comparison exercise. Proficiency testing is such an important element of ISO /IEC 17025 accreditation that there is even a separate ISO standard (i.e. ISO /IEC 17043) for proficiency testing providers to assure their clients of compliance with international standards and good practice. Laboratories, clients of accredited proficiency testing providers can be confident that the programmes they rely on are carried out competently and in accordance with established technical requirements and management systems.
Integrating Training Management System with Optima
Without going into further detail about what lies behind a comprehensive training programme for laboratories looking to comply with the regulations of their industries, the result is a precise matrix of competencies vis-à-vis employees. Typically, these competencies have a cadence period in which they must be renewed before the deadline.
This is the information Optima needs to select the right person to administer a particular test. The integration of the training management software with Optima makes it easy to update the last certification date and also to update the matrix.
In addition, Optima can help plan the agenda of people for their training. Optima can be programmed to book both trainees and senior staff for learning-by-doing or on-the-job training.