Training is the cog that drives quality in organizations. It’s only through training that businesses can transform their theories on quality into practical systems and processes.
Compliance with quality standards, such as those set by the Federal Drug Administration (FDA) and the International Organization for Standardization (ISO), also requires suitable employee training.
Under those standards, companies are required to:
- train employees in quality management
- establish procedures detailing how staff members are trained
- maintain Quality System Regulation (QSR) and/or ISO compliance training records
- demonstrate competency, if required to do so.
FDA and ISO quality standards requiring training
Globally accepted standards relating to across-the-board quality management systems, and Good Manufacturing Practice (GMP), QMS and risk management in the pharmaceutical and medical device manufacturing industries, require comprehensive employee training.
Examples of the relevant standards are:
- ISO 9001
- FDA QSR
- ISO 13485
- ISO 14971.
Common employee training challenges
A number of challenges commonly limit the effectiveness of employee training programs.
Scale and complexity
Because each part of an organization is unique, diverse training material is required to cover all aspects of quality management. Developing an extensive library of course content and training techniques, suitable for a cross-cultural and cross-generational workforce, is time-consuming and expensive.
Standardizing training methods and material in a large, constantly changing work environment is a major challenge.
Organizations are often ill-prepared for an audit or FDA inspection, as paper-based training compliance records are difficult to organize, store and retrieve.
Ineffective competency testing
Many businesses fail to develop and implement testing that adequately evaluates the trainees’ grasp of the training material, and whether they can fulfil quality tasks properly.
As training co-coordinators develop, prepare and implement a training program, they typically spend an inordinate amount of time on administrative tasks. This adds to costs, delays, and frustration.
Why isoTracker’s training management software is a game changer
isoTracker training management software is a lean, single-source solution designed to tackle employee training challenges head-on.
It automates and streamlines all facets of training, from facilitating course set-up to generating training records and reports.
Consider the following five advantages of isoTracker’s training management software:
- Easy set-up – the software is quick and simple to set up and to use. It makes it easy to create course material in various formats, develop comprehensive testing to evaluate competency, and design training task roles.
- Fast and efficient training – because the training process is simplified through automated processes, it’s possible to train more people, more quickly. Productivity is enhanced, risks are identified and resolved timeously, and quality is improved across the organization.
- Identification of areas for improvement – the system makes it easy to obtain and record feedback from employees, stakeholders, and customers, and includes built-in corrective and preventive action (CAPA) features.
- Administrative capabilities – training reports and records are organized, stored, and automatically updated to enable quick and easy retrieval and reviews.
- Simplified compliance – training is compliant with ISO and other regulatory bodies.
isoTracker offers modular, subscription-based quality management software that’s secure, cloud-based and affordable. It includes a document control module, as well as complaints management, audit management, and training management modules, with built-in CAPA capabilities.