Remind Me Again Why We Need Compliance Refreshers

For many organizations, the sole purpose of refresher training is to satisfy compliance requirements. Hence, the focus is on just delivering the content.  Ironically, the intent behind the 211.25 regulation is to ensure that employees receive training more than at orientation and frequently enough to remain current.  The goal is to ensure compliance with GMPs and SOPs and improve performance where there are gaps.  Improved business performance is the result and not just a checkmark for 100% attended. 

And the practice of repeating the same video year after year as the annual refresher? Efficient yes, effective, well just look at your deviations and CAPA data to answer that one.  When you shift your focus from delivering content only as the objective to a more learner-centered design, your sessions become more performance-oriented and your effectiveness reaches beyond just passing the GMP Quiz.

From passive lecture GxP refreshers to active learner centered sessions

Yet, senior leaders are not grasping that just “telling them the GMPs” is not an effective training technique, nor is it engaging.  Even if it’s backed up with a slide deck, it’s either “death by PowerPoint” or click to advance to the next slide for CBT refresher modules.   Koreen Pagano, in her June 2014 T&D article, “the missing piece”, describes it as “telling employees how to swim, then sending them out to sink, hoping they somehow can use the information we’ve provided to them to make it shore”, (p.42).  To make matters worse, employees can end up with disciplinary letters for deviations and CAPAs for failure to follow GMPs.

Look at the GXP Refresher course outline for the last 3 years at your company. What is the ratio of content to interactivity? When I dig a little deeper, I usually discover a lack of instructional design skills, and minimal creativity is a factor.  And then I hear, “Oh but we have so little time and all this content to cover, there’s no more room. If I had more time, you know, I’d add it in.”  Koreen informs us that “training is supposed to prepare employees to be better, and yet training professionals often stop after providing content” (p.43).

See What’s so special about SMEs as Course Designers?

What about using previously developed compliance materials?

I am not criticizing the use of previous course materials if they were effective.  But asking an SME to “deliver training” using a previously created PowerPoint presentation does not guarantee effective delivery. Neither does replacing clip art with new images or updating the slide deck to incorporate the new company template.   These visual “updates” are not going to change the effectiveness of the course unless the content was revised, and activities were improved. 

For many SMEs and Trainers, having a previous slide deck is both a gift and a curse.  While they are not starting with a blank storyboard, there is a tendency to use as-is and try to embellish it with speaker notes because the original producer of the slide was not in the habit of entering his/her speaking points for someone else to deliver.  Speaker notes embedded at the bottom of the notes pages within PowerPoint slides is not a leader’s guide.  While handy for scripting what to say for the above slide, it does not provide ample space for managing other aspects of the course such as visual cues, tips for “trainer only” and managing handouts, etc. 

The SME has the burden to make content decisions such as what content is critical; what content can be cut if time runs out.  Perhaps even more crucial is how to adapt content and activities to different learner groups or off-shift needs. Without a leader’s guide, the SME is unsupported and will fall back on the lecture to fill in the duration of the course. 

“SMEs put down those speaker’s notes and step away from the podium!” Vivian Bringslimark, HPIS Consulting, Inc.

Better Training Means an Investment in Instructional Design Skills

Interactive, immersive, engaging are great attributes that describe active training programs.  But it comes at a price: an investment in instructional design skills.  Trained course designers have spent time and budget to create an instructional design that aligns with business needs and has measurable performance outcomes. The course materials “package” is complete when a leader’s guide is also created that spells out the design rationale and vision for delivery, especially when someone else will be delivering the course such as SMEs in the classroom.

The Leaders Guide, invaluable for effective course delivery

A well-designed leader’s guide has the key objectives identified and the essential learning points to cover. These learning points are appropriately sequenced with developed discussion questions to be used with activities; thus, removing the need for the Trainer/SME to think on demand while facilitating the activity.  This also reduces the temptation to skip over the exercise/activity if s/he is nervous or not confident with interactive activities such as virtual break out groups, etc.

A really good guide will also include how to segue to the next slide and manage seamless transitions to next topic sections.  Most helpful, are additional notes about what content MUST be covered, tips about expected responses for activities and clock time duration comments for keeping to the classroom schedule.  SMEs as Facilitators (Instructor Led SMEs| ILT SMEs) need to study the leader’s guide and pay attention to the icons and notes provided there. These cues indicate the differentiation from lecture, to an activity whether that be self, small group, or large group.

Given all the time and effort to produce the leader’s guide, it is wasted if the course designer and SME as Facilitator do not have a knowledge transfer session.  Emailing the guide or downloading it from a share point site will not help the SME in following the guide during delivery unless an exchange occurs in which SMEs can begin to markup their copy.  

Resource from SME as Facilitators Workshop

During the knowledge transfer session/ discussion with the course designer, ILT SMEs make notes of how the instructor transitions from one slide to the next and how s/he provided instruction for the activity. This is a good time for ILT SMEs to ask how to modify content or an activity if certain conditions should occur. Especially important for SMEs to ask is what content is critical and what content can be skipped if time runs short. It is always a good idea for the ILT SME to mark-up his/her copy of the materials. And then again after the first delivery to really make it their own leader’s guide.  For example, SMEs may want to experiment with different ways to “open a session” to get experience with a variety of techniques and observe which ones yield better results.

Why do ILT SMEs need their own Qualified Trainers workshop?

  • When GMP courses are designed with the learner’s needs in mind, including adequate duration for exercises and activities, learners begin to engage with the content through the skill of a qualified facilitator who can guide the experiential activities.
  • When learner-generated responses are immediately incorporated into the session and leveraged to enhance the debriefings, the involvement and future application back on the job is even greater.

In order to pull this off, ILT SMEs need to learn how to facilitate learning experiences such as preparing to have a facilitated discussion.  One of the biggest fears ILT SMEs have when asked to facilitate an exercise or an interactive activity is the fear of it bombing such as discussions. 

Discussions can often bomb

While popular and commonly used, discussions can also fail miserably if not designed well. Relying on the SME to facilitate the discussion without carefully preparing the path to the targeted outcome is leaving it to chance that the SME knows how to execute the activity successfully. It includes the upfront questions to ask, pertinent examples as reference, and application type activities in which clarifying comments can be addressed.

 “It takes effort to get out of your head and connect with individuals.” Ludwig, D. Training Industry, Fall, 2015, p. 23.

“… So as to remain current in the practices they perform …”

Is once a year GXP refresher enough? Before you rush to answer this question, consider the following.  Do you have:

  • a lot of human or operator error related deviations?
  • or regulatory observations that include failure to thoroughly investigate …?
  • or a large percentage of repeat deviations?

Then you might be sending the mixed message that your employees are NOT trained well enough or sufficient in their knowledge and application of the GXPs.

Twice a year has fast become the new norm.

There’s a difference between GXP training content that is delivered as a repeat of the same materials vs. new and/or updated. Yes, new content takes resources and time. But, how many times do you want to sit through the same old slides and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change. – VB

References:

  • Ludwig, D. “Lets Get Serious about Live Instructor-led Training”, training industry, Fall, 2015, p. 23.
  • Pagano, K. “The Missing Piece”, T & D, June 2014, pp. 41 – 45.
  • Rock, D. “Your Brain on Learning”, CLO, May 2015, pp. 30 – 33,48.
  • Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips.  Lexington Books, New York.

What’s so special about SMEs as Course Designers?

They have expertise and experience and are expected to share it via training their peers.  But now the venue is the classroom as well.  It’s training on course design methodology that is needed. SMEs and most trainers do not automatically have this knowledge.  Some develop it by reading A LOT, attending well-designed courses, and over time with trial and error and painful feedback.  The faster way is to provide funds to get SMEs as Course Designers at least exposed to how to effectively design for learning experiences so that they can influence the outcome of the objectives. 

This is management support for SMEs as Trainers.   SMEs who attend an ID basics course learn how to use design checklists for previously developed materials.   These checklists allow them to confidently assess the quality of the materials and justify what needs to be removed, revised or added; thus, truly upgrading previously developed materials.

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Compliance Training: No More Passive Learning

Special Thanks to LTEN for Publishing this article!

Looking for inspiration to liven up a lecture? I have 10 ideas for you.

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No More Boring GMP Lectures |Impact Story about how to introduce more interactivity into GMP Refresher sessions.

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Retraining and Refresher Training: Aren’t they one in the same?

I say no, not at all. Ask an Operations Manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.

Retraining is typically delivered as repeat training. Corrective Actions from *CAPAs usually trigger these types of required training events. In the context of the specific CAPA, we uncover the error, mistake, non-conformance, or what I like to call performance discrepancy from the expected outcome. It is believed that by delivering the training again, the cause of the discrepancy will be resolved. That is if the root cause was determined to be a lack of knowledge, skill, or not enough practice.

Retraining Quote

Some folks believe that more is better and that with several repeated training sessions, employees will eventually get it right. It always amazes me that we find time to do repeat training over and over again but complain very loudly for refresher training, significant **SOP revision training or even new content training.   (*Corrective Actions Preventive Actions, **Standard Operating Procedures).

Refresher Training implies that training was already provided at least once. The intention here is to review on that content.   A lot of regulatory training requirements are generated to satisfy this need. Common examples are Annual GMP Refreshers and several OSHA standards such as Blood Borne Pathogens training. While the aim is to refresh on the content, 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.

Upon Biennial SOP Review

There are some folks who would like to use this required SOP activity to coincide with the need to “refresh” on SOPs already read and/or trained. The rationale being that if the SOP hasn’t revved in 2 or 3 years time, more than likely the training hasn’t been repeated either. So, it sounds like a good idea to require that SOPs be “refreshed” upon using the same SOP cycle. One could argue for the prevention of errors; thus, in theory, this sounds very proactive.

But donning my Instructional Designer Hat, I ask you, what is the definition of training – to close a knowledge gap or skill gap. What value is there for forcing a mandatory “refresher reading” on SOPs just because the procedure is due for technical review? In practice, this becomes one huge check mark exercise leading to a paper work /LMS backlog and might actually increase errors due to “information overload”! Again, what gap are you trying to solve? In the above refresher scenario, we are avoiding a compliance gap by satisfying regulatory requirements.

Refresher Retraining

Defending Your Training Process

For those of you who have fielded questions from regulators, you can appreciate how the very training record produced generates follow up questions.   How you describe the conditions under which the training occurred or is “labeled” can impact the message you are sending as well. Calling it retraining instead of refresher training implies that training had to be repeated as a result of a performance problem not meeting expectations or standards. Whereas refresher training occurs at a defined cycle to ensure that the forgetting curve or lack of practice is not a factor of poor performance. It is a routine activity for satisfying regulatory expectations.

For end-users, clarifying the difference between refresher training and “repeat” training in your Policy/SOP not only defines the purpose of the training session but also provides the proper sequence of steps to follow to ensure maximum effectiveness of the training. There’s a difference between training content that is new /updated vs. delivered as a repeat of the same materials.   Yes, a new and/or updated design takes resources and time.   How many times do you want to sit through the same old same old and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change.   You just might want to review your Training SOP right about now. – VB

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Facilitating the Shift from Passive Listening to Active Learning

On the one end of “The Learner Participation Continuum” is a lecture which is a one-way communication and requires very little participation.  At the other end, we have experiential learning and now immersive learning environments with the introduction of 3D graphics, virtual simulations, and augmented reality.

This blog has been merged with “Batteries Not Included: Not all Trainers are Instructional Designers and Classroom Facilitators”.

Using Neuroscience to Maximize Learning: Why we should start paying attention to the Research

In October 2015, I had the privilege to have a discussion with Anne-Maree Hawkesworth, Technical Training Manager of AstraZeneca, Australia before the 2015 GMPTEA Biennial Conference kicked off. Anne-Maree was in Orlando, Florida to present her concurrent session entitled Insights from ‘Inside Out’ – Employing lessons in neuroscience to facilitate successful learning” during the conference. As an avid fan and follower of the neuroscience literature being published, I was hungry to learn more and she generously gave up a few hours of her time to meet me with over a latte and a nibble of delicious chocolate from Australia.   What follows is a snippet of the exchanged dialogue.

Q: Why has neuroscience become so popular all of a sudden?

Actually it’s been around for a while. It’s not new, even though it sometimes seems that way. For example, look at Ebbinghaus Forgetting Curve that is so frequently referenced. It was first introduced 1885. And there are other classic research studies available if you conduct a good search.

Q: Why do trainers need to pay attention to neuroscience and the recent literature?

Quite frankly, they need to start learning how to design their training using these principles. They have to stop lecturing from the slides and speaker notes.

Q: Okay, then what do they need to know?

Concepts like chunking, memory techniques, and the effects of multitasking. Multitasking is very bad for learning. You end up learning nothing. It becomes a waste and yet we are multi tasking now more than ever. For example, management is expecting us to do more. For example, take an e learning course and answer their emails while taking the course!

V- this means the design has to change.  AMH- exactly!

Q: We need help. What should trainers tell Management about neuroscience?

That less is actually more. Stop requiring us to dump more content in slides. We end up remembering less. If you won’t believe us, there’s scientific evidence to back up what we are saying! And don’t dictate how we use the classroom. For example, I have my learners standing for most of the sessions involving activities that I facilitate. In one of my sessions, I had removed the chairs from the room and used ZERO slides.   Imagine that! Oh and I love flip charts!

Bonus Tip: AMH shared a little secret with me. She revealed that Production folks like to do flip chart work. They just don’t want to be the spokesperson. So if you can get them past that, they’ll love being busy writing on the chart.

Q: I noticed that you didn’t include motivation in your slide deck. Was that intentional? How are they related?

I only had 60 minutes, but yes motivation is so very important. We have to keep them motivated to learn. We have to continually grab their attention.   It should be one of the 12 principles.

Q: Earlier you mentioned Chunking. What trends are you seeing in micro learning? Are you implementing any of it?

I am looking at small chunks of learning at the time you require the learning as opposed to “Just in Case” learning that tends to occur months in advance.  Micro-learning is great for follow-up to formal class room or eLearning to boost memory. I like micro-learning in the form of case studies and in particular branching scenarios. Cathy Moore has some great material on her blog and webinars on branching scenarios.

I also like to chunk information within my training and use lots of white space to help separate pieces of information, this helps in facilitating learning.

Q: I work with a lot of Qualified SME Trainers from Production.   How do you get past the brain lingo when you explain neuroscience?

You explain that there are parts of the brain that do different things at different times. There is no need to turn the session into brain science 101. I show them a slide or two and them move on.

Q: Earlier you mentioned “principles”. Can you elaborate on that?

I’d love to but we are near the end of our time together. I can recommend trainers look up John Medina’s 12 Brain Rules.  Briefly they are,

  1. Survival
  2. Stress
  3. Attention
  4. Sensory Integration
  5. Vision
  6. Exploration
  7. Exercise
  8. Sleep
  9. Wiring
  10. Memory
  11. Music
  12. Gender

Alas, I could have dialogued with her for the entire conference albeit, she was jet jagged and the latte was wearing off.   Thank you Anne-Maree for sharing your thoughts and effective classroom delivery techniques with us.   Together, we will shift the classroom design mindset.   -VB

Calling ALL User Generated Tools Home

What do I mean?  You know, job aids, tools users have created, and SME cheat sheets.  I’ve even seen task instruction sheets, quick reference guides for completing forms, and process flow diagrams.  But I’m not talking about posters on the wall describing how to turn on the projector in the conference room.  In this 3rd issue of Making It Work for Compliance Trainers series, I blog about why creating and openly sharing user-generated tools may not be a good thing in a regulated environment.

The Dilemma

As a Performance Consultant (PC) or HPT specialist, works with SMEs, Key Performers, or STAR employees, s/he invariably uncovers or discovers that their SMEs have “other” tools they’ve developed that help them be so good at what they do.  While these are helpful to the key performers, it presents a dilemma for the PC who is also a Compliance Trainer or a QA Manager.  “If I expose the source of their secret sauce, will I break trust and create a barrier to the relationship?  On the other hand, if I don’t speak up about this tool, what assurance do I have that the content is approved by the Quality Control Unit (per GMP) and is version controlled?

Why create them in the first place?

To get grounded, the PC/Compliance Trainer needs to perform a quick cause analysis upon the discovery of the tool.  Why was it created in the first place?  Is there information or steps missing from the standard operating procedure (SOP)?  Was this tool created to “chunk up” the steps or create bite-sized training materials that evolved into a job aid?  Or is it a maneuver to bypass the change control system?  The answers to the questions could provide the basis for a more user-friendly revision or at least be officially approved as a supporting tool to the SOP upon the next version release.

What’s the big deal?

Rejection of product, deviation from approved written instruction that could result in adulterated product, additional follow up testing, and rework are all forms of waste to the organization.  Not to mention that consistency is the key to compliance and assuring public confidence in approved marketed products.  If folks are not using the approved procedure, then there’s an issue somewhere.

To what level of control is needed?

That is the most sought after question regarding job aids and user tools.  The answer lies in each company’s level of risk and its document hierarchy.  I’ve seen extreme cases where “NO Paper” on the floor means not even an SOP is allowed to be in hand.  I do believe that some level of control is needed to ensure that the content is valid, is in sync with the current procedure and users have the most current version of the tool.  Can your organization defend the level of control?  Are you sure about that?  Or do you use a “don’t tell and we won’t ask policy”?  Are folks making errors because they followed an uncontrolled worksheet vs. the approved procedure?

Tips for Establishing Level of Control

  • If the tool /job aid is tied to a procedure, it needs to become a required tool and included in the SOP.
  • Job aids should not be a standalone orphan.  It needs to have a procedure that it supports.  The use of the job aid is included in the hands-on training so folks know how to use it properly and where to access it if it is not “attached” to the SOP.

o   For example, some companies have a separate numbering system for these exhibits and the storage location may not be in the same folder directory as the parent SOP.

  • If more than one tool / job aid / worksheet exists per procedure, then an appendix or reference section needs to highlight the existence of these “tools in use”.
  • Establish an amnesty initiative to raise awareness for the quality and compliance consequences of using uncontrolled tools.

Calling all User Generated Tools Home

The purpose of the initiative is to allow users to admit that they have these tools and that no performance consequences will follow when they surrender them.  The second focus of the program is to find a proper home for these tools once they are deemed valuable.  They need proper care and nourishment.  In other words, content is valid, accurate, up to date and approved for use.  The PC/Compliance Trainer is the ideal conduit to make this happen.

One company that I visited did just that and more.  Once it was discovered that a series of mistakes were coming from an old tool that had been downloaded and copied to their desktop, a team of auditors was dispatched to observe the removal of all tools from employee’s desktops.  The 2nd phase of their program was the identification of an owner for the share-point site who now manages access and content revisions.  The 3rd phase includes a content/tool submission process that is vetted by a designated users group of SMEs.

Is it time for a Job Aid/Users Tool Amnesty Project where you work? – VB