“When the six elements, its sub-processes, and cross-functional quality system linkages are organized into a logical flow that is controlled by procedures, is repeatable and is in sync with an Employee Training and Development Lifecycle” – Vivian Bringslimark, HPIS Consulting, Inc.
It takes 6 elements to make a training system robust
- GxP and Training Curricula
- Planned OJT for Procedures (aka SOJT)
- Use of Qualified Trainers
- Employee Qualification and Training Effectiveness Measures
- On-Going GxP Refresher Series
- Training Documentation Process
Each of these elements plays an important role in the process of giving employees the training they need to do their jobs safely and correctly and also provide the necessary documentation to demonstrate that the training was performed properly.
1. GXPs for New Hires and Training Curricula
All new hires are expected to attend a GxP Basics training session within the first week or at least the first 30 days of employment. Many are new to the biopharmaceutical industry so, it would be ideal to complete GXP Basics on day one because immediately following New Employee Orientation, new hires have the potential to “touch” controlled documents without the knowledge of good documentation practices. GDP issues continue to challenge our industry. Why allow new hires to potentially create a deviation in their first week?
The content of a basics course is company specific but typically includes an overview of cGMP basics and why these practices are vital to the welfare of the employee, the company, and the patients who will ultimately use the company’s products. The course should include a discussion of the regulations (such as an introduction to Subparts A through K of 21 CFR 211) and the role of SOPs in maintaining quality in the life sciences environment. Although this course is especially important for those new to the industry, it should be mandatory for all new employees regardless of their previous experience. While the GMP basics remain relatively unchanged, each company includes their expectations for quality and compliance. This part of the course is why experienced new hires need to attend as well.
Another component of On Boarding for New Hires is department orientation.
The quality system regulation for training (CFR x820.25) is quite clear regarding the need for a procedure that identifies training needs. To meet the regulatory expectation, the industry has adopted the concept of curricula and has defined their process for creating and maintaining curricula. Almost all life sciences companies today who create curricula begin with defining their CORE Curriculum for ALL EMPLOYEES. And through a series of multiple discussions with SMEs and Department Heads, they continue interpreting who needs to be trained on what SOPs based on their department and their position.
Employees need to know their functional responsibilities and more specifically, what are the training requirements associated for their position. Today’s LMSes can be queried for a report/print out of these requirements, the expected type of training to be administered per item i.e. Group, SOJT, Qualification Required, etc. and the list of Qualified Trainers who are SMEs for the identified requirements.
Department orientation is NOT read and sign for all your SOPs the first week!
With the explosion of tech education tools, we’ve moved our SOPs from paper binders to eDocument systems and more recently to QMS platforms (Quality Management System). Let me be clear. Department orientation is NOT read and sign for all your SOPs the first week or even the first month. While it is convenient to park a new hire at their cubicle and assign them their training curricula, this is not training. Not even close to anything called effective training. Why not? Reading is not training. “Reading the procedure is reading what the SOP contains. Training is closing a knowledge and skill gap and then applying that information back on the job. Qualifying is performing a procedure accurately without coaching.” Vivian Bringslimark, Moving Beyond R & U SOPS, 2015, PDA TRI Newsletter.
What’s wrong with Read and Understood Training for SOPs?
Most new hires are not yet familiar enough with the company, their department or even the company’s use of jargon. There is much debate in our industry regarding the “maximum number of SOPs” that can be read in a single day. Suffice it to say, it is based on the employees’ ability to retain the information and then perform correctly according to the procedure. Some experienced new hires can manage more procedures given their previous background working in a similar environment. For them, reading their assigned procedures functions more like a refresher and a confirmation on how it’s performed “here”. A good example is the Good Documentation Practices procedure. Each company specifies its date and time format. To ask them to read numerous SOPs beyond a reasonable amount is akin to filling water into a glass and then keep pouring despite the water pooling on the table and onto the floor. You are wasting precious on boarding time and increasing the probability that a new hire will likely make an error because either they did not retain the right information for that procedure or simply could not remember what they read that day despite the signature for the “understood” portion of the R & U approach.
This is precisely why R & U training records are insufficient for FDA compliance. “Because the pertinent question for training is not, ‘Can you prove that your employees have read the SOPs?’ What the FDA wants to know is whether you can produce evidence that your employees understand the procedures and can perform them in accordance with the SOPs [when required to do so]. To be able to confidently answer “yes,” manufacturers must have training programs that are carefully designed, effectively delivered, regularly evaluated, and frequently updated — in addition to being well-documented.’ Bringslimark, 2004, Biopharm International.
2. SOJT for Procedures
Traditionally, on-the-job training (TOJT) consisted of having new employees watch experienced employees do their jobs, aka “follow Joe around”. The quality of these training sessions was governed by the SME on any given day and were not documented. The indication of its success was whether the trainees made mistakes. In the regulated environment of the Life Sciences Industries, such informal training is inadequate. While FDA compliance is critical for biopharmaceutical and medical device companies, it is not the only reason to have an effective GxP Training program.
Every manufacturer should be concerned about training because it is an essential component of quality. Companies cannot maintain high-quality production without high-quality training. Just as every manufacturing process must be thoroughly tested and proven to deliver consistent results to maintain product quality, effective training programs are essential to ensure that employees have the knowledge and skills they need to perform their jobs.
And this includes the next level of training for select SOPs. Equipment related SOPs, product-related processes and critical task SOPs that require hands-on training, supervised practice until proficient are typically flagged as needing Planned On the Job Training or Structured OJT to be delivered by a qualified trainer. Structured on the job training (SOJT) is an organized and planned approach for completing training requirements. This approach puts the trainee’s needs center stage: planning what makes sense for him/her to learn what and when rather than dictated by the daily demands of the schedule. What makes OJT structured? There are four distinct components:
- SOJT uses rigorous curricula tailored to the position
- SOJT sessions are carefully planned and scheduled
- SOJT sessions are delivered by a Qualified Trainer
- SOJT sessions are formally evaluated and documented
To ensure consistent SOJT steps, a robust training system also includes a description of the OJT steps in an approved Training SOP that also describes how to deliver these steps. And how to document on-the-job training; all of it or just select sessions? You’d be surprised just how many different techniques SMEs have for conducting OJT on their watch.
3. Use of Qualified Trainers
The old practice of a signed training record qualifies as a department trainer no longer meets FDA expectations. The regulations state that training “shall be conducted by qualified individuals”. Regulators want to know how trainers are selected and how they are trained to effectively teach and qualify others. Employees who have subject-matter expertise or extensive experience with a particular task may have the right knowledge but lack the skills to deliver instruction that is effectively transferred back to the job. SMEs are usually unaware of adult learning theory or ways to increase interest or enhance retention. It takes more than technical expertise or being the most senior staff member.
In their book, Structured on the Job Training, Ron Jacobs and Michael Jones list eight selection criteria for trainers to possess in order to be considered as an OJT Trainer. Notice that only two out of the eight focus on content or technical expertise.
- task knowledge and skills
- specialized training
- interpersonal skills
- literacy skills
- respect from others especially peers
- willingness to share
- concern for the organization
- (available bandwidth) job expectations that do not interfere with the ability to deliver training.
The selection criteria should be part of the training program documentation along with any supporting statements for candidate selection (for example, nominated by supervisor or responded to the call for volunteers). All nominees need to be content qualified on the subject matter they will be teaching. This means being able to produce proper documentation confirming nominee’s eligibility.
Next, nominees attend a train the trainer for SOJT workshop. The Qualified Trainers Workshop is NOT SOP training on the Training SOPs. While these SOPs become the basis of the Qualified Trainer (QT) curriculum, they are read in advance as preparation for the QT Workshop and the LMS provides the tracking completion requirement. Hence, the content of the QT Workshop is not a slide deck repeat of the curriculum content. The focus is on how to deliver planned OJT for new hires and completion of department training curricula for their peers. Select process steps from the Robust Training System SOPs are referenced and discussed in more detail. However, the QT Workshop includes basic learning theory such as adult learning principles and teaching styles as well as several activities geared to the realities of teaching procedures to peers within the workplace environment.
The last step is a required performance demonstration – Trainee demonstration using the company’s steps of planned OJT in a live training session. This validates the nominees’ ability to apply the techniques from the workshop in the appropriate OJT step. Accompanying the nominees through this process is their qualified trainers’ form as described in an associated procedure.
Define the QT’s Scope of Training
If you don’t articulate the boundaries, you can end up hearing statements like “only a Qualified Trainer (QT) can deliver deviation related training sessions” and wonder how in the world did this get so out of hand?
To avoid scope creep of responsibilities for Qualified Trainers, I advise you to define what training the QT is required to deliver and is NOT required to deliver. In other words, declaring that only a Qualified Trainer can deliver OJT and observe the Qualification Event makes the scope quite clear. This will avoid broad statements such as only a Qualified Trainer can deliver SOP training or only a QT can deliver corrective actions related awareness sessions. Qualified Trainers already have a large workload, it’s imperative that the rest of the organization doesn’t add more tasks or define more responsibilities than the program’s intention.
Do you have a process? An approved SOP?
What Belongs In The Qualified Trainer SOP?
Ideally, the procedure needs to include these 4 parts:
- I. Eligibility
- II. QT Workshop / Train the Trainer Equivalent
- III. Evaluation
- IV. QT Performance Demonstration
For the full description, read more here:
4. GXP Training & Ongoing Refresher Series
This is commonly referred to as the Annual “GXP” Refresher(s). Annual GXP Refresher is NOT repeated GMP Training. It is NOT:
- A repeat of the regulations
- A repeat of the Basics Course
- Just watching a video, even if it’s a new one.
The intention is to stay current with regulatory changes and not necessarily relearn the regulations. While the aim is to refresh on the regulations, it is not necessarily meant to just repeat the training. Also included is the part – “so as to remain current” with current practice, trends and new updates. Hence, refresher training needs to include new material based on familiar content.
Today’s standard has evolved to twice a year for most organizations. The topics are varied and determined by each organization:
- Regulatory Updates and Trends
- Top Citations from Inspections
- Exploration of recent warning letter(s) as case studies
And what’s current for Your Company:
- What regulatory updates have occurred?
- What changes have been made?
- What quality improvement initiatives are happening that need to be communicated with all employees?
For additional GMP content, the remaining CFR sub-parts or intermediate GxP concepts should be included. For example, Change Control Essentials, Investigations 101, Root Cause Analysis, etc. While not necessarily a CFR regulation that these specific topics are taught, it is a strong contributing factor if your workplace is generating a high volume of deviations and CAPA investigations. A citation related to “not adequately trained in the GMP requirements of their job function” is a likely outcome. Be prepared to produce a GMP Training Policy or Training SOP that describes your GMP refresher process and have a schedule in place.
Refresher Training is not retraining either. Retraining is typically delivered as repeat SOP training. Some believe that by delivering the training again, the cause of the discrepancy will be resolved. And some folks believe that more is better, that with several repeated SOP training sessions, employees will eventually get it right. It becomes very uncomfortable having to explain to a regulator why the same SOP shows up three or more times in a training print out. They will follow up with more questions regarding possible connections to deviations and investigations. And then before you know it, you are having an additional interview about human errors.
5. Employee Qualification – Training Effectiveness Measures
“Are your employees qualified to perform their assigned functions?” This is the overarching question to address is at the heart of any effectiveness strategy. Simply producing a training record for a specific SOP may not be sufficient if departures from the procedure are observed or discovered during a records review. Being qualified is more than a supervisory review of the completion of an employee’s training matrix. 100% trained does not mean 100% effectively trained.
Relying solely on this metric as a measure of training effectiveness, creates a false sense of security for everyone. It only confirms that 100% of the training requirements were documented. More than likely this was achieved by R&U and eSign for the curricula requirement. But, can the employees perform their assignments according to written procedures? The very procedures they signed for?
“Effective training is really a degree of the transfer of learning back to the job.” Bringslimark, March 2015, GxP Lifeline.
Measuring effectiveness of SOP Training requires a “performance” assessment. Examples of employees’ performance show up in batch records and executed forms every day. In addition, deviations and CAPAs are areas where employees’ ability to perform procedures can be evaluated. During a regulatory inspection, investigators will conduct this “paper” performance audit and observe live real-time performance during the “walking” tour of the facilities. Will the regulators conclude 100% effectively trained?
I believe that “100% trained reports and SOP quizzes” are not enough to satisfy the performance challenge for training effectiveness. Companies are now expected to document how they qualify their employees. Being “SOP” qualified is the demonstrated ability of an employee to accurately perform a task or Standard Operating Procedure independent of his OJT Qualified Trainer with consistency to meet acceptable quality standards.
Employee Qualification does two things. First, it validates that the training was effective and that it has transferred back to the job. And qualification provides a documented final performance check that the employee can perform and comply with the approved procedure confidently. Whether it’s called certification, qualification, performance assessment, proficiency or some other name, it is a separate event from on the job training and coaching/practice sessions.
A Qualification Event requires an observation of the task (or SOP) being performed or a critical review of the output produced by a Qualified Trainer who is also qualified on said SOP/ task. I call this being “Content Qualified”. This means that grandfathering QTs is not acceptable practice. Here’s why. Without a formal assessment of their skills, there is very little evidence to document their qualifications. I continue to be amazed at what the qualifying evidence looks like upon an audit. It needs to be the documented ability to perform the procedure accurately and complete performance outcomes at the expected level of quality.
When seniority is the only factor for nominating an SME, their paperwork is often the weakest. In some cases, they are not even up to date with the most current version of the procedure! This is why the “grandfathering” of SMEs, especially senior SMEs, is frowned upon by external regulators. All technicians need to be qualified, including QTs. Remember an effective training program documents the qualifications and performance of both the trainers and the employees being trained.
GMP Training Program Effectiveness Measures
What about the GxP training events that are delivered? What form of effectiveness measures are you using? While there are no definitive standards, industry practices have been observed forming expectations about conducting training evaluations. Examples include some form of knowledge check for GxP Training, especially the refresher series but not necessarily a written assessment or test. External regulators want to know:
- Do employees comprehend what they are training on?
- Is GMP content transferring to back to the job?
- Do they know their GMPs?
A Quiz/ test/ knowledge check (KC) can measure knowledge retention and possibly comprehension if it includes challenge questions about real workplace situations. Making them a popular evaluation tool. However, be mindful though of the danger of “teaching to the test” or using the search function within the edoc system to find the answer in the SOP. Most of the knowledge retained is immediately flushed within hours of “passing the test” or satisfying the LMS generated quiz. So, having a quiz is not a guarantee that the knowledge transforms itself back on the job.
6. Training Documentation Process
LMSes are very helpful for recording history and tracking overdue requirements. Having an electronic system makes the training history reconciliation more efficient and at any given time, a training requirements completion report or an overdue list can now be generated. But if completion of training requirements is not being supervised, or folks don’t know who is qualified to train them, you do not have a robust training system regardless of the level of sophistication of your LMS. Having an LMS not matter how connected it is to your QMS platform, is not a substitute for your Quality Training System. It’s the effectiveness of the training that is delivered and the quality of the documentation that matters. All of the 6 elements of a robust training system must integrate seamlessly. The LMS is just a repository of this data.
Recall the Definition of RTS One More Time
“When the six elements, its sub-processes and cross-functional quality system linkages are organized into a logical flow that is controlled by procedures, is repeatable and is in sync with an Employee Training and Development Lifecycle.” We’ve examined what the 6 elements are and why “how-to” work instructions are needed to execute them. Next, we’ll explore how the quality systems interface with each other through training system linkages.
Cross Function Quality Systems
Training interacts with every other system, so it is imperative that the hand-offs to three critical quality systems are defined and well understood by system owners: Change Control, Deviation Management/CAPA, and Internal Auditing.
Document / Change Control
SOPs make up approximately 75 – 80% of training curricula and staying current with revisions is a key requirement of Change Control. So, the outputs of Change Control or Document Control (SOP revisions) must be incorporated as a training input and managed appropriately as updated training requirements. This triggers your Curricula Maintenance Procedure or process section in your Training SOP.
Deviation CAPA Management
Corrective actions resulting from deviations and CAPA investigations generally trigger some form of training documentation. And the investigation follow up will inevitably require a search for the paperwork within the Training group. So, the Quality Training System needs to identify these as additional inputs to be handled through the same process. Most LMSes are sophisticated today to produce these records IF the proper CAPA notification is coded properly.
Internal Auditing is also integral to ensuring that the quality training system remains robust. The Quality Training System must undergo an independent review to ensure compliance with the training procedures as well and not just a review of training records. These additional needs (inputs) feed the continuous improvement loop back into the Quality Training System thus creating a self-sustaining system.
The holistic view of a Quality Training System contains 4 interconnected quality systems: Training plus the three described above. This implies that a series of actions can be repeated each time training is needed or required regardless of the content. i.e. SOJT or GMP Basics for New Hire. Some folks refer to it as a process. But here’s where it gets confusing. We mix in the word system and then interchange system, process, procedure and even program when we describe training. So, does a program mean a system or a course or a particular subject matter curriculum? See what I mean.
To complicate the concept some more, there could be more than one procedure to accomplish “training”. For example, designing content is separate from uploading attendance into a database or how to qualify SMEs as a Trainer. In these organizations, “the training program” consists of mini processes that are often fragmented and decentralized thus managed by multiple owners that regularly lead to conflicting work practices for training. The result is a broken training system that creates frustration for its end users and becomes a barrier for partnering with line management. We tend to see only our part and don’t fully appreciate the impact our decisions have on the other processes. So, for some folks, it’s hard to think of training as a system, let alone a quality system.
The Quality Training System (which includes the 6 elements) has 3 Big Blocks of Training Actions: Preparation, Delivery, Measuring Effectiveness.
I find it helpful for training system owners to have a high-level policy type document to describe the overall process flow and orient end users on where the “6 element” processes are used in order to ensure the sequence is kept in order. The more procedures there are, the more critical these linkages become. But rather than having one all-purpose document that can total to more pages than desirable, SME teams collaborate on what makes sense for the organization.
So, In Conclusion
When all the pieces and parts are contained within high-level systems view, responsibilities for each process (or procedure) are still assigned regardless of the departmental reporting structure. The systems view promotes a shared ownership of the entire system, not just the individual training processes. Thus, ensuring a more consistent training experience from trainer to trainer as well as ensuring classroom GMP sessions are designed and effectively delivered. I’ll leave you with this lingering comment:
At the 2015, Biennial GMP TEA conference, FDA Investigator, Ileana Barreto-Petit spoke on training observations, said that she always cites training as an observation because she recognizes that training does not get enough management support. Are you prepared? – VB
*Jacobs, RL and Jones, MJ. Structured on-the-job training: Unleashing employee expertise in the workplace. San Francisco: Berrett-Koehler; 1995.
Lessons learned about implementing a Robust Training System:
Who is Vivian Bringslimark, the Author?
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