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Brian Curran


Paper vs. Electronic Approaches to Training Documentation

What’s best for complying with relevant FDA and ISO requirements?

Published: Friday, August 6, 2010 - 07:55

Food and Drug Administration (FDA) regulatory requirements (i.e., 21 CFR 211.25 and 820.25) and the quality management standards from the International Organization for Standardization (i.e., ISO 9001) mandate companies to execute and document employee training. These requirements ensure that employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of noncompliance and improve product quality. This article identifies the basis for the requirement, examines the associated challenges for meeting the requirement, and lists shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented.

Why track training?

Implementing and tracking employee training is a sound business practice that allows companies to know that employees are competent to perform specific tasks and are properly trained to do so. Without this fundamental information, organizations risk producing products with poor quality, which in turn creates higher costs due to inefficiencies, scrap, and rework. Ultimately, these companies can fail from financial losses due to systemic failures or legal repercussions.

The auditor’s mantra is, “If it isn’t documented, it didn’t happen.” Although entire chapters and books have been written to address the ISO standards certification requirements, suffice it to say that to attain ISO standards certification, auditors require documented proof of a planned and systematic training process.

Moreover, tracking and documenting training is a legal requirement for regulated companies, including those regulated by the FDA, to ensure product quality. Simply put, the stakes are too risky when dealing with ingested or injected products; therefore, the FDA legally mandates documented proof of required and completed training.

How hard can it be?

After accepting the fact that training tracking is required, most people presume that it is a relatively easy process to implement. The key information required to track training is:

1. Understanding what training is required.
2. Understanding what training has been completed.
3. Comparing those two facts to identify any gaps.
4. Using that information to close the gaps.

For the most part, the presumption is accurate. Assuming that one knows the training requirements for a specific job, tracking training for an individual is not exceedingly complex. If anything, it may be considered tedious. This is an unfair presumption because the requirement is not to just track training for an individual, but for an entire organization. Therein lies the challenge. The most significant challenges when tracking training for an organization are:

The daunting volume. The sheer number of tasks that must be handled when tracking training in a typical organization is challenging. The volume of tasks is based on corporate requirements such as company orientation, safety, environmental, quality management system, good manufacturing practices (GMP), job-specific requirements, and machine-specific requirements.

Also, there are hundreds to thousands of specific job functions or tasks. There are hundreds to thousands of employees to train, who work multiple time shifts often at multiple locations. There is a relatively high attrition in manufacturing environments. Finally, retraining requirements mean most training has to be repeated annually.

The follow-up nightmare. Whether there are a million training tasks or 10,000, there is a significant communication challenge known as the “follow-up nightmare.” The first step is identifying what training tasks must completed by whom. The next, and probably more challenging, step is communicating the training requirements to the affected trainees.

The problem is exacerbated because two-way communication is required. The training coordinator needs to communicate to the organization the tasks that must be completed and in turn needs to hear from the organization when the tasks are completed. Furthermore, the initial communication is followed with reminders and escalations to those who are delinquent in completing their training tasks.

Organizational struggles. Most organizations encounter significant challenges with ownership and accountability when tracking training. These challenges stem from the delicate balance that exists between the training coordinators who are responsible for tracking training, and the employees who are responsible for performing the tasks. By assigning the responsibility to track training to an individual, the organization implies that it is that person’s problem, not the organization as a whole, and certainly not the employee’s.

This challenge is exemplified in the common method for handling training requirements and records. Because of the sensitive nature of the documents, they are typically stored in a secure location, accessible only by requesting permission from the owner. Therefore, if an employee wishes to review completed or upcoming training, the individual must physically go to a different location and request “viewing rights” from the owner. Unintentionally, the organization has created a barrier and inhibits its employees from participating in the training tracking.

Last-minute audits and inspections. Organizations typically receive advance notice of upcoming audits or inspections, but these notices may be only days or a few weeks prior to the audit. When the notice is received, the organization must decide whether to redirect its resources to prepare for the audit. In most cases, heroic efforts are required to prioritize tasks during the day and adhere to audit preparations during the evening hours. As a result, the organization expends extra resources to produce less-than-desirable results to prepare for last-minute audits and inspections.

Document dependency. “If it’s not documented, it didn’t happen” signals an organization’s document dependency, but the dependency is rooted more deeply than a simple mantra. All successful manufacturing organizations view quality as a critical objective that saves money, improves customer loyalty, and improves time to market. Quality in manufacturing organizations is a function of:

• Creating the correct process design

• Documenting the processes

• Training personnel to refer to the documents and perform the processes

• Executing with perfect (or near perfect) process repetition

• Managing and documenting changes because materials, products, design, and the processes themselves are ever-changing

As a result, manufacturing organizations pursuing repeatable quality are document-centric. It follows, then, that the vast majority of training in these organizations is based on documents. Before an employee can be trained on a particular procedure, the process for that procedure is documented. In effect, the employee is trained on the document.

Industry sources confirm this tight connection between documents and training. Organizations, consultants, and auditors agree that 90 percent of training in a manufacturing organization is triggered by new or changed documents.

The paper approach

The paper approach is widely used today to track training. The following scenarios describe this approach:

• All training requirements for each position or task are documented on a piece of paper
• All training records for each person are recorded on a piece of paper
• All training certifications, resumes, and accreditations are recorded on a piece of paper
• All employees have a manila folder that organizes all the pieces of paper
• The manila folders are stored in a secure filing cabinet in a secure room

Although there are some advantages to using a paper-based system, most do not work. Tracking training on paper is feasible only for the smallest companies. When organizations exceed 100 employees, the paper-based approach begins to fail.

Advantages. The cash outlay for paper is obviously inexpensive. The true costs lie in the time and resources spent trying to maintain the system. Paper is essentially a “clean slate” from which anything could be tracked, so one could argue that this approach provides the ultimate flexibility.

Disadvantages. The primary disadvantage is the inordinate amount of time and effort that must be expended to manage and maintain a paper-based system. Even with extraordinary efforts, the paper-based system fails to meet the challenges addressed below.

Challenge No. 1: The daunting volume. Without question, there are situations when a paper-based approach works well in high-volume environments. Raw scalability is limited only by storage space required to store the documents. However, the paper-based approach can fail at tracking training whenever one of the following scenarios occurs:

• The organization determines it needs a new corporate training requirement. If there are 1,000 active employees, 1,000 training requirement documents will need to be printed. These new documents will then be added to the 1,000 folders.
• The organization updates its corporate handbook. All 1,000 employees require training. Training records for 1,000 employees must be inserted into the folders.
• The organization has 300 standard operating procedures (SOP) and work instructions. Approximately 33 percent of the SOPs are changed annually. If each employee is affected by only one of these changes (unlikely), that would still result in 100,000 updated training records that must be created.

Challenge No. 2: The follow-up nightmare. Each of the three scenarios described in the daunting volume sections requires at least two touch points. The trainee must be informed of the training requirement. Then the trainee must report that the training is completed. The number of touch points increases significantly when reminders and escalations are considered. The primary problem here is a communication issue. Simply put, the paper-based approach provides no assistance for resolving this communication issue.

Challenge No. 3: Organizational struggles. The paper-based approach prevents trainees from viewing the training problem as theirs. Rather, they view the person who owns the folders and papers as owning the problem. The paper-based approach leads to significant problems with buy-in and accountability. Perhaps more threatening, this approach can lead to organizational struggles between departments with competing objectives.

Challenge No. 4: Audits and inspections. The follow-up nightmare is intensified when scurrying to prepare for an upcoming audit or inspection because the training data aren’t current.

Challenge No. 5: Document dependency. The paper-based approach is a stand-alone island that doesn’t connect to an organization’s document control system, whether it is paper-based or electronic. Document changes magnify the problems associated with the paper-based approach by creating a higher volume of training records. Higher volumes intensify the follow-up nightmare by creating additional work for training coordinators, which leaves the organization in a poor position to host an audit or inspection.

The training control approach

The “connected” approach uses a computer software application that not only addresses the training tracking needs but also provides training control. More than passively tracking training data, a training control solution actively:

• Supports a distributed model that requires trainee participation
• Continually performs gap analyses between required and completed training for all trainees
• Automatically assigns training tasks based on the gap analysis.
• Allows trainees to view their training tasks and training records as part of their day-to-day activities
• Supports trainees electronically signing when training tasks are completed.
• Synchronizes changes between documents (e.g., SOPs) and their associated courses
• Automatically triggers required training based on linked document changes
• Provides reporting of real-time data based on current status of all training tasks

Advantages. The training control solution meets all training tracking requirements, but more specifically addresses the significant challenges that cause common solutions to fail. These advantages are discussed under the challenges below.

Disadvantages. The training control approach requires a larger up-front investment than the paper approach. However, this investment is quickly recovered based on the efficiencies gained and overall reduced training costs.

Challenge No. 1: The daunting volume. The training control approach leverages the computer to automatically perform gap analysis and assign tasks. Based on the power of the computer, the specialized solution scales to handle more training tasks than people can effectively handle manually.

Challenge No. 2: The follow-up nightmare. The training control approach transforms the follow-up nightmare into nirvana (to maintain the metaphor) because it addresses communication challenges. The system automatically assigns training tasks to affected trainees when required. The system allows trainees to sign off when training is completed. Follow-up responsibilities are drastically reduced and those that remain are simplified by reporting on real-time data.

Challenge No. 3: Organizational struggles. The training control approach is designed with a distributed model that encourages and requires participation from trainees. For example, each trainee receives training tasks and views them by clicking on “My Tasks.” Each trainee views his upcoming and completed training records by clicking on “My Training Folder.” With this naming convention, the system invites each trainee to participate in the system, significantly improving both buy-in and accountability.

Challenge No. 4: Audits and inspections. The training control approach allows an organization to be audit-ready at a moment’s notice because it provides real-time training data. At any point in time, the training coordinator can view reports to represent the current status of training tasks for the entire organization.

Challenge No. 5: Document dependency. The training control approach morphs document dependency into document opportunity. Changes to documents can trigger the corresponding training tasks, either automatically or with optional human intervention. The significance of this capability cannot be underestimated. If industry sources are correct, this means that 90 percent of training in a manufacturing organization can be automated because it is triggered based on documents.


To improve and ensure product quality, regulatory and certification agencies require organizations to track employee training. The training control approach meets and exceeds the standard training tracking requirements and eliminates the challenges that cause other approaches to fail. Implementing a training control solution minimizes the risk of noncompliance and improves overall product quality.

This article originally appeared in the GxP Lifeline—Pharmaceutical, which is sponsored by MasterControl Inc.


About The Author

Brian Curran’s picture

Brian Curran

Brian Curran is senior vice president of strategic marketing and product management at MasterControl Inc. Curran joined MasterControl in 2002 to direct and expand MasterControl's product development efforts. He has more than a decade of experience leading the direction for enterprise and entrepreneurial software development companies. Curran began his career with IBM, where he spent five years leading consulting engagements with Fortune 500 companies, such as MCI, BellSouth, and many others. After this, he held several director and VP-level product management and marketing positions for entrepreneurial software development companies in the telecommunications and Web analytics sector. Curran has an MBA with an emphasis in information systems.


Electronic training disadvantage

One unmentioned disadvantage to the electronic approach - it is very tempting to overload the individual with electronic training documents. Although e-training does a better job of tracking, it cannot distinguish employee comprehension. That requires good human oversight. I suspect the average intelligent person can effectively understand and comprehend between 6 and 12 documents. When the volume of documents that are pushed to the individual exceeds 20, then the comprehension rate falls dramatically. I'm willing to bet that organizations that implement e-training programs are pushing upwards of 50 documents through the system. From the standpoint of an auditor with any degree of common sense, that is just too many.