Achieving a world-class quality training program

Training initiatives have evolved over time and currently there are many technological advances that can be utilized to manage training more efficiently. Training content dissemination has evolved from rudimentary paper-based documents and instructor-led presentations to sophisticated web-based audio/video productions managed using advanced IT technology. How training is managed has evolved from manual, time-consuming, paper-based spreadsheets to automated Learning Management Systems (LMS) that have vast functionality, including pre-configured and customized recording / reporting capabilities.

The FDA’s and other international regulatory agencies’ approach to training has also evolved in stride with the technological advances. In addition, continuing observations and deficiencies related to training, place training as a high priority for these agencies. FDA’s current view regarding training is available in its Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, published September 2006, (http://www.fda.gov/cder/guidance/7260fnl.pdf) which states:

“Under a quality system, continued training is critical to ensure that the employees remain proficient in their operational functions and in their understanding of cGMP regulations. Typical quality systems training would address the policies, processes, procedures, and written instructions related to operational activities, … training is expected to focus on both the employees’ specific job functions and the related cGMP regulatory requirements.”

FDA goes on to state:
“Under a quality system, managers are expected to establish training programs that include the following:

• Evaluation of training needs
• Provision of training to satisfy these needs
• Evaluation of effectiveness of training
• Documentation of training and/or re-training

When operating in a robust quality system environment, it is important that supervisory managers ensure that skills gained from training be incorporated into day-to-day performance.”

This article highlights the components that must be considered and successfully addressed in order to attain and sustain a World Class Quality Training Program. The Goal and the related Objectives of such a program, the Challenges, and Recommendations are examined.

Training Program Goal and Objectives

In an ideal world, all companies would implement a World Class Quality Training Program for their most valuable asset – their employees. However, in the real world only a fraction of companies achieve this goal. When examined further, there are several inter-related objectives that must be met for this goal to be reached.

A World Class Quality Training Program must successfully address the following objectives:

• Provide effective training in a timely manner that:

• Is of high quality with respect to content, format and presentation, information flow, audio/video, etc.
• Is composed of current and relevant material that the employee needs to perform his/her job at an improved level,
• Utilizes interactive models of instruction to capture and maintain an employee’s attention, making the learning experience interesting and engaging, thus increases the probability that the employee will learn the material, and
• Includes an assessment yielding measurable results that demonstrates that an employee has not only learner the material presented, but can apply this newly acquired knowledge to his/her duties/activities.

• Implement cost-effective training processes through automation.
• Mitigate compliance risk by meeting FDA and international regulatory requirements and expectations.
• Increase productivity of the training staff through training process automation and the workforce receiving the training by “doing it right the first time” so there are less rejects, re-work, and re-testing.

Training Program Challenges

There are many challenges within regulated industries that must be overcome:

• Companies have employee turnover, creating a continuous need to hire and train new employees.
• Employees transition between positions with different responsibilities, duties, and GMP impact.
• The use of contractors and temporary employees is increasing.
• Manufacturing operations and priorities are continuously changing and shifting.
• Workforces are becoming increasingly multi-lingual.
• Today’s training staff and budgets are typically a fraction of what they used to be due to spending restraints.
• Training resources can be resistant to change, fearing currently available training technology.

A World Class Quality Training Program recognizes and successfully addresses these challenges. Such a program is multi-faceted and focuses on several main components, including those presented in the following sections.

Training Program Components

Unfortunately, many companies approach their Quality Training Program in a fragmented manner, that is, they may address each component “in a vacuum” without considering and addressing the relationship between the components. This approach is flawed since it can result in gaps and missed opportunities for improvement. A system approach is both the preferred and recommended approach since it is a holistic approach and includes all of the following components:

• Training Management

• Who is responsible and accountable for training?
• Is a formal, approved Quality Training Program / Plan / Strategy in place and implemented, including metrics?
• How are training activities and logistics documented and managed – manually or using a Learning Management System (LMS)?

• Training Needs / Requirements

• What are the specific needs and priorities of the workforce?
• Does the training match the expectations of the employee’s job description?
• What levels of training are needed – GMP, job-specific, SOP-specific, and others (e.g., safety)?

• Training Content

• What training is already in place and what is its quality?
• Does existing training meet current regulatory expectations with regards to content, measurable effectiveness, and documentation?

• Training Delivery

• What types of training media are most appropriate for a company?
• What types of training media are available and utilized?
• Are the Trainers qualified to present the content?

• Training Data and Documentation

• What training record / data is recorded and readily available for an inspection / audit?
• Is training data current, accurate, of high integrity and trustworthy?

Training Management

Training Management is listed first since it is the most important element of a World Class Quality Training Program. Without proper management, support and funding, a World Class Quality Training Program will not be attainable. Responsibility and accountability for training is the cornerstone of a sound training program. Management needs to be directly and actively involved as it would in any other business operation. Like in other operations, a well thought-out and approved program / plan / strategy must be followed to identify, prioritize, monitor, and measure progress. The vast majority of company operations are implemented utilizing automated systems; therefore, shouldn’t training take advantage of an automated system such as an LMS? Training should not be viewed as simply a lower-level operation, but as a critical high level, core operation, including the same level of priority, attention, and management commitment as other enterprise operations receive. After all, training affects all employees, all company operations, all products / services provided by a company, and all end-users of a company’s products / services.

Training Needs / Requirements

Training requires discipline and the ability to identify and prioritize the specific training needed for each employee and/or job position based upon the impact of an employee’s activities, responsibilities, and duties. A formal Needs Assessment is an effective tool to evaluate these needs and to formulate a training curriculum. Typically, basic training on GMP, safety, and human resource-related topics are provided to employees. As an employee’s activities become increasingly specific, intermediate and advanced job-specific training should also be provided. This training usually focuses on the specific SOPs that the employee is responsible for executing. For smaller companies, there may be a single employee responsible for particular operations, thus a Learning Plan identifying the training needs for this specific employee can be developed. Since larger companies may utilize multiple employees for the same operations, a Curriculum for these employees as a group can be developed. Whether a Learning Plan, Curriculum, or both are utilized, the training included must focus on and address the specific activities of the employee.

Training Content and Delivery

Once the training needs have been identified, assessed, and prioritized, the appropriate training content and media must be identified, evaluated for suitability, and developed or purchased. Typically, third party courseware, whether it be instructor-led or web-based, is designed and produced to be universal in nature since the courseware will be purchased by multiple companies with different needs, workforces, operations, processes, and products / services. As training becomes more specific to an employee’s job function, it usually involves the specific SOP that the employee follows; therefore, this level of training is usually developed in-house.

How does one evaluate the plethora of training options with regard to quality and price? No two companies have the exact same training needs. Factors such as management’s commitment to training, availability of qualified trainers and training administrators, access to computers and the Internet, available funding, etc. impact the training required by and provided by each company. Today’s successful training programs utilize a “blended” approach, that is, a combination of the available training formats and delivery options.

There is an increasing trend for companies to no longer utilize mass instructor-led training where a consultant addresses a large audience in the non-interactive form of a monologue. This format of training has been shown to be ineffective, and since it typically does not included any type of formal assessment to evaluate and demonstrate to what extent an employee has learned and can apply his/her new knowledge, it does not meet current FDA expectations. Instead, forward thinking companies are increasing their use of web-based, e-learning courseware for such training since it is now available in a variety of subjects, is cost-effective, is available 24/7 to learners, includes recordable assessment options and maintains detailed training records thereby meeting FDA’s newly specified expectations.

As an added note of caution, there are multiple vendors who provide web-based training; however, not all courseware vendors approach the development and delivery of their courseware in the same manner, resulting in a wide variety of quality. It is highly recommended that companies thoroughly evaluate third party training courseware to confirm the quality of the courseware and the integrity and subject matter expertise of the courseware vendor. Other factors to be considered include a vendor’s courseware maintenance/change control/content update practices, adherence to technology standards (SCORM/AICC compliance), navigability, ease of use, multi-lingual availability, and ability to re-access courseware for periodic reference purposes following the completion of the course. Where possible, it is further recommended that a qualified company representative “test drive” the courseware prior to its purchase to confirm that it meets the company’s training needs, standards and expectations.

Training Data and Documentation

The FDA expects that a company not only provide effective and measurable training to its workforce, but that this training is accurately documented, the related data is of high integrity and that this data in maintained in a secure manner where it can be easily retrieved for inspection / auditing purposes. Manual, paper-based systems are not an effective means for meeting these expectations. As stated earlier, a Quality Training Program, just like other core business operations, warrants automation and all of the associated benefits. An automated, validated, and GXP/Part 11-compliant LMS can provide this necessary level of compliance while optimizing a training program’s processes and increasing the productivity of a training staff. A high quality LMS can prove instrumental in effectively managing the entire Training Lifecycle from planning, through delivery, to recording/reporting, taking advantage of available functionality and tools, provided this system has been properly configured and validated.

Summary

The FDA has recently set the expectations for treating training as a quality system. The need for companies to raise the bar in terms of meeting these expectations will continue to grow as more and more inspections cite training as a problem. Achieving a World Class Quality Training Program is not a simple process, but a process that requires solid managerial discipline, employee input, and a great deal of planning and homework. Time spent up-front planning for a World Class Quality Training Program and assessing both the challenges / limitations and opportunities / benefits that are currently in place will prove instrumental when moving forward. A clear vision and plan supported by management and implemented by qualified personnel will ultimately yield the desired results. Lastly, partnering with a proven vendor of high quality, web-based training products / services that meets or exceeds the expectations discussed above and can provide a turn-key training solution including a state-of-the-art LMS will also greatly contribute to the success of your World Class Quality Training Program.