Compliance standards set up by authorities such as Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA) and International Organization for Standardization (ISO) aim at enabling organizations to conduct their operations with good business practices. Quality management is one of the critical components of these standards. A need for trained and competent personnel to handle quality related activities, is both a regulatory requirement and a necessity for quality assurance. However, to ensure this competency across the board, it is critical for new hires to get up to speed in the shortest possible time.
For this reason, having a comprehensive and well-structured approach to new hires induction is needed and will benefit the organization in continued quality assurance. It will also ensure employees are comfortable handling their responsibilities with the training they have received.
Both ISO 9001 And ISO 9002 state: “The supplier shall establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality.”
Typically, organizations employ a quality management system (QMS) to handle quality related activities. New employees who join an organization should be trained to use the organization’s QMS to ensure that they are aware of the processes to follow and the tools employed. Each organization employs QMS differently. Even if an employee has experience working with a QMS before, it is necessary for the employee to go through a new hire QMS training program to understand the processes, systems, and stakeholders specific to the current organization.
A good QMS training program must cover the below-given topics, in addition to organization specific business processes.
- Relevance of quality management to the organization
- Processes related to quality management activities
- Quality management system used in the organization
- Relevant compliances background (ISO, FDA etc.)
- Information structure and data flow
- Organization’s quality policy and quality objectives
- Measurement through reports and analyses in QMS
- Benefits to the employee
- Role of the employee in quality management
Training new employees involved in quality management activities serves two purposes. First, it is a required activity for ISO certifications for an organization. Second, it is an essential step to ensure continuous improvement. Specifically, with respect to new hires, some ISO specifications have clearly emphasized on the requirements for training. For example, ISO: 9004, an ISO standard that provides guidance for improved performance states that, “The need for quality should be emphasized through an awareness program which can include introduction and elementary programs for new personnel, periodic refresher programs for long-standing personnel, and provisions for personnel to initiate preventive and corrective actions.” It is thus essential to develop a new hire on-boarding program for all employees that will be associated with the quality management system.
Especially in manufacturing, new hire training helps employees protect themselves and others from safety related incidents. Formal training for new hires in this is required to comply with Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA) regulations.
Conventional new hire trainings involve orientation by HR, peer handholding and documentation handover. These techniques often prove to be inefficient as they are not goal oriented and hard to measure for effectiveness. Employees take longer to figure out how to execute their responsibilities and navigate communication workflows. Conventional unstructured approaches lead to deferred productivity of new workers.
A streamlined approach to training new hires ensures shorter ramp up time. Training for new hires can be developed and managed using a “4D” approach:
- determining the training requirements,
- developing the material for training,
- delivering the content and measuring for effectiveness,
- and finally documenting the entire activity.
Determine Training Requirements:
First step in creating a training program is to identify the requirements of an organization and specifically of the department that the new hire has joined. If the organization is adhering to standards defined by a regulatory authority such as FDA, ISO or OSHA, it is important to include specific audit and evidence related topics into the training. Broadly, this stage of training development involves listing high-level categories of topics such as quality management, regulatory compliances, employees’ standard operation procedures, safety etc. Depending on the role of the employee, it is important to differentiate the level of detail to include or exclude in the content. For senior management, a high-level overview of the quality processes may be sufficient. However, for a mid or entry-level professional, the content needs to be designed to go over each process in depth. Different employees have different levels of involvement with the systems. For people who use a Quality Management System regularly, a training covering each feature of tools and systems may be necessary.
Develop Training Material:
A list of identified topics leads to developing the content and structure of the program based on the mode of delivery. For new hires’ programs, it is important to be cognizant of the varied backgrounds of each employee. It becomes critical to identify pre-requisites required for each module, so that all trainees in the class are at the same level. Depending on the prior experience of individuals, pre-requisites must be administered as required. Another essential check is to ensure that company specific process information and organizational acronyms are introduced with sufficient detail. This will help new hires to connect the dots easily across processes and divisions within the organization.
Developing content involves creating objectives for each program, detailing out contents within each topic, selecting mode of delivery and incorporating relevant workshops. Workshops may be live hands on or simulated online sessions or take home printed worksheets. During development, content must be checked for completeness, relevance, accuracy and engaging structure.
Deliver and Measure:
A training program once defined and developed will be ready for delivery. Depending on the mode of delivery, training may be deployed for live classroom sessions or online web based modules. Instructors must be planned and deployed accordingly. Involving new hires in internal audits is an efficient approach that will familiarize them with the evidence gathering process, logging and presenting mechanisms. This will provide for a live and real time learning opportunity for the new hires to get ramped up on the processes followed in the organization. Assigning new hires, a role in QMS activities will also help them get up to speed in using QMS tools. A data collection strategy, measurement and reporting approach must be developed to enable measurement after each training. Measurement should be aimed at evaluating the trainer effectiveness, content quality and outcomes achieved.
Once a training program is defined and conducted, it must also be documented and verified whether the new employee is made aware of the processes, has gained knowledge from the material provided and has acquired competence that is needed to conduct his or her job. Documentation of these is also a key activity that is required for compliance. Training management system can be employed to conduct self-service trainings and record evidence of completion. It will also automate tracking and documenting the state of employees’ training compliance. ISO explicitly suggests that “Appropriate records of training shall be maintained.” Data gathered and documentation filed will serve as evidence for internal and regulatory audit purposes. This will also help employees and organizations for future reference and to shorten the training development time for all future training programs.
Having a well-structured on-boarding program administered through a training management system will automate several aspects of training new workers. It streamlines flow of knowledge through different types of training and reduces ramp-up time. New hire training is an important activity for an organization to ensure consistent productivity of employees. An efficient onboarding program ensures shorter ramp up time, continued quality assurance and quick adoption of compliance best practices for an organization. And a training management system will further increase the productivity.