The Big Why for Deviations

As part of my #intentionsfor2019, I conducted a review of the past 10 years of HPIS Consulting.  Yes, HPISC turned 10 in August of 2018, and I was knee deep in PAI activities.  So there was no time for celebrations or any kind of reflections until January 2019, when I could realistically evaluate HPISC: vision, mission, and the big strategic stuff.  My best reflection exercise had me remembering the moment I created HPIS Consulting in my mind.

Human Performance Improvement (HPI) and Quality Systems

One of the phases for HPI work is a cause analysis for performance discrepancies.  The more I learned how the HPI methodology manages this phase the more I remarked on how similar it is to the Deviation /CAPA Quality System requirements.  And I found the first touch point between the two methodologies.  My formal education background and my current quality systems work finally united.  And HPIS Consulting (HPISC) became an INC.  

In my role of Performance Consultant (PC), I leverage the best techniques and tools from both methodologies.  Not just for deviations but for implementing the corrective actions sometimes known as HPI solutions.  In this new HPISC blog series about deviations, CAPAs, and HPI, I will be sharing more thoughts about HPISC touch points within the Quality Systems. For now, lets get back to Big Why for deviations.

Why are so many deviations still occurring? Have our revisions to SOPs and processes brought us farther from a “State of Control”? I don’t believe that is the intention. As a Performance Consultant, I consider deviations and the ensuing investigations rich learning opportunities to find out what’s really going on with our Quality Systems.

The 4 cross functional quality systems

At the core of the “HPISC Quality Systems Integration Triangle” is the Change Control system.  It is the heartbeat of the Quality Management System providing direction, guidance and establishing the boundaries for our processes.  The Internal Auditing System is the health check similar to our annual physicals; the read outs indicate the health of the systems.  Deviations/CAPAs are analogous to a pulse check where we check in at the current moment and determine whether we are within acceptable ranges or reaching action levels requiring corrections to bring us back into “a state of control”.  And then there is the Training Quality System, which in my opinion is the most cross-functional system of all.  It interfaces with all employees; not just the Quality Management System.  And so, it functions like food nourishing our systems and fueling sustainability for corrections and new programs.

Whether you are following 21CFR211.192 (Production Record Review) or ICHQ7 Section 2 or  820.100 (Corrective and Preventive Action), thou shall investigate any unexplained discrepancy and a written record of the investigation shall be made that includes the conclusion and the follow up. Really good investigations tell the story of what happen and include a solid root cause analysis revealing the true root cause(s) for which the corrective actions map back to nicely.  Thus, making the effectiveness checks credible. In theory, all these components flow together smoothly.  However, with the continual rise of deviations and CAPAs, the application of the Deviation /CAPA Management system is a bit more challenging for all of us.  

Remember the PA in C-A-P-A?

Are we so focused on the corrective part and the looming due dates we’ve committed to, that we are losing sight of the preventive actions? Are we rushing through the process to meet imposed time intervals and due dates that we kind of “cross our fingers and hope” that the corrective actions fix the problem without really tracing the impact of the proposed corrective solutions on the other integrated systems? Allison Rossett, author of First Things Fast: a handbook for performance analysis, explains that performance occurs within organizational systems and the ability to achieve, improve and maintain excellent performance, depends on integrated components of other systems that involve people. 

Are we likewise convincing ourselves that those fixes should also prevent re-occurrence? Well, that is until a repeat deviation occurs and we’re sitting in another root cause analysis meeting searching for the real root cause.  Thomas Gilbert, in his groundbreaking book, Human Competence: engineering worthy performance tells us, that it’s about creating valuable results without using excessive cost.  In other words, “worthy performance” happens when the value of business outcomes exceeds the cost of doing the tasks.  The ROI of a 3-tiered approach to solving the problem the first time, happens when employees achieve their assigned outcomes that produce results greater than the cost of “the fix”. 

Performance occurs within three tiers

So, donning my Performance Consulting “glasses”, I cross back over to the HPI methodology and open up the HPI solutions toolbox.  One of those tools is called a Performance Analysis (PA). This tool points us in the direction of what’s not working for the employee, the job tasks a/or the workplace. The outcome of a performance analysis produces a 3 tiered picture of what’s encouraging or blocking performance for the worker, work tasks, and/or the work environment and what must be done about it at these same three levels.  

Root cause analysis (RCA) helps us understand why the issues are occurring and provides the specific gaps that need fixing.  Hence, if PA recognizes that performance occurs within a system, then performance solutions need to be developed within those same “systems” in order to ensure sustainable performance improvement.  Otherwise, you have a fragment of the solution with high expectations for solving “the problem”.  You might achieve short-term value initially, but suffer a long-term loss when performance does not change or worsens. Confused between PA, Cause Analysis and RCA? Read the blog – analysis du jour.

Thank goodness Training is not the only tool in the HPI toolbox!   With corrective actions /HPI solutions designed with input from the 3 tiered PA approach, the focus shifts away from the need to automatically re-train the individual(s), to implementing a solution targeted for workers, the work processes and the workplace environment that will ultimately allow a successful user adoption for the changes/improvements.   What a richer learning opportunity than just re-reading the SOP! -VB

  • Allison Rossett, First Things Fast: a handbook for Performance Analysis; 2nd edition 
  • Thomas F. Gilbert, Human Competence: Engineering Worthy Performance
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When SMEs have too much “secret sauce”

Many QA/ L&D Training Managers are tasked with improving their training system and focus their efforts on the process, procedures and executable forms. An integral component of a robust quality training system is the Qualified Trainers (QT). Having a cadre of existing department Subject Matter Experts (SMEs) as Trainers can be very helpful when implementing the roll out of the new design to meet regulatory commitments and expected timelines. But, sometimes it can also lead to sustainability issues after the launch is over and the next big project becomes the new site priority.

During my on-site response to an urgent performance problem, the Head of Operations expressed deep concerns about inconsistent OJT being delivered by his trainers. A series of significant non-conformances occurred in his area. As part of the CAPA (Corrective Action Preventive Action) investigation, trainers were interviewed to uncover how they trained the identified employee(s) and what was said specifically for each step of the procedure. Their responses revealed a lack of consistent process and the use of varied content; despite having an OJT checklist, the procedure, and approved training SOPs (Standard Operating Procedures).

Once a Trainer; forever a Trainer

I was then invited into a conversation with the Training Operations Manager (My Performer), regarding her desire to upgrade the existing department SMEs as Trainers. Responsible for the effectiveness check of the CAPA corrective action and the overall quality of Operations OJT sessions, she complained that many of the trainers should no longer be considered Dept. Trainers. While she had position title influence, she was frustrated by the lack of support for her “improvement suggestion”. I became her catalyst to help her push through the fixed barrier regarding SMEs.

The site followed a cultural assumption regarding department SMEs: once a trainer; always a Trainer; regardless of feedback and informal impressions of their ability. Without any tangible criteria and lack of assessment tools, my Performer had no authority to remove under performing Dept. Trainers. Granted these SMEs were long ago chosen when the widely accepted practice of being proficient as a technician after a year earned them the designation of subject matter expert and automatically, a Dept. Trainer. Today, the Life Sciences Industry, with FDA investigators observations, has evolved their understanding to endure that it takes more than seniority and SOP training to become an OJT QT. Unfortunately, the environment where my Performer worked, the mindset about acquired expertise still held.

Significant CAPAs can be drivers for change

Undaunted, my Performer seized the CAPA as an opportunity for change. Leveraging suggested criteria and the use a form to document justification for each Dept. Trainer, she now had a process (SOP with form) that she could “educate” her colleagues on what it takes to become a Qualified Trainer. The focus of her message dramatically changed. She became strategic in her communications, using the effectiveness check portion of the CAPA as her “Why / WIIFM for Operations Managers”. In order to close out the CAPA, Managers had to complete their portion of the form.

The long-term success of my Performer depended on her owning her solution. She never lost of her original desire; she was patient and waited for her colleagues to accept today’s best practices for OJT QTs.   In the meantime, we brainstormed on a variety of feedback options that could be used to evaluate the current status of each SME at the same time the Managers completed the new form. My Performer chose a rating system and arranged for a 1-1 sessions with Operations Managers to discuss what rating they would use for each criteria if they got challenged during a CAPA investigation or a regulatory inspection.

While the results were not formally documented, my Performer was effective with the assessment rating exercise.   The Managers reconsidered who they wanted to nominate based on the new formal criteria and the informal ratings discussions. They did not automatically submit the form for all existing Dept. Trainers. A constructive dialogue then ensued regarding skills remediation support for those SMEs deemed as potentials. At last, my Performer achieved her desired outcome. “As catalysts, we build a bridge, light the path, and give [ ] our hand to help [ ] demolish or jump over obstacles”, (Haneberg, 2010, p.96). I was privileged to be part of a dramatic shift in their training culture.

An alternate alignment exercise

For many, adding ratings suggests a formal performance assessment and this can raise HR issues if not fully supported by the organization. In addition, many Operations Managers do not have the luxury of “weeding out undesirables”. They simply do not have enough SMEs to complete the training curricula generated requirements. Yet, there needs to be mutual consent between manager and identified SME in order to effectively deliver the OJT Methodology and to ensure a successful learner experience.

For those situations where automatically re-nominating existing SMEs is raising a red flag, I created the Trainer Mojo Assessment.  Nominated SMEs and existing SMEs as Trainers rate themselves on 10 attributes that align with the characteristics of an effective OJT Trainer.   Low scoring SMEs/QTs are encouraged to have a discussion with their management regarding continuation in the program and possible action steps. For SMEs/QT’s that score in the On-Target range, this is both validation of the nomination and confirmation that manager and QT are in sync. For high scoring QTs, this is also confirmation and an early indicator for potential QT Rock Stars!

Haneberg, L. Coaching up and down the generations. Alexandria, Virgina:ASTD, 2010.

You might be interested in the Impact Story – From Dept. SME to QT.

From Dept. SME to QT

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

What’s the difference between Trainers and Performance Consultants: Aren’t they one and the same?

After 10 years of HPI consulting, I’m still being asked this question a lot.  In the blog, “Isn’t this still training”, I shared why it still looks like training.  Alas, this blog brings us to the beginning of another series within the Human Performance Improvement (HPI) arena.  I’m calling it “HPI: Making it Work for Compliance Trainers”. So, in this blog, I will expand upon 6 elements of comparison to illustrate the difference between the two and the depth of impact one has over the other. 

FOCUS

Training addresses the learning needs of employees.  Various definitions include closing the knowledge and skill gap of what they know now and what they know afterwards.  It’s built on the assumption that the cause of the gap is a lack of knowledge and skill.  Performance Consulting addresses business goals and performance needs of the affected employees.  Training is just one of the possible solutions that can be used; not the only one.

OUTPUTS

A training solution delivers a structured learning event.  Whether it is a classroom or virtual or self -led, the event itself is the end goal.  Performance Consulting or HPI projects are implemented to improve performance.  The end goal is not about the solution such as the specific HPI Project, but rather a positive change in performance that leads to the achievement of the business goal.  The endpoint is “further down the road”.  So it takes longer to produce the results.

ACCOUNTABILITY

With training, the Trainer is held accountable for the event.  In a lot of organizations, there is an implied but not spoken accountability for the results back on the job.  But without the proper systems and support mechanisms in place, many Trainers get “blamed” for training transfer failure.  Here’s the big difference for me.  Performance Consultants (PCs) partner with their internal customers, system owners and business leaders in support of the business goals.  The accountability for improved performance becomes shared across the relationships.

ASSESSMENTS

Trainers typically conduct a needs analysis to design the best learning “program” or course possible.  PCs conduct performance analyses gaps assessments to identify causes that can go beyond knowledge and skills.  See the blog, “Analyses du jour”.

MEASURES
Trainers
very often use course evaluation sheets as a form of measurement.  In the Compliance Training arena, knowledge checks and quizzes have also become the norm.  PCs measure the effect on performance improvement and achievement of business objectives.

ORGANIZATIONAL GOALS

This is another key differentiator.  Training is viewed as a cost typically.  Compliance Trainers are all too familiar with the phrase, “GMP Training is a necessary evil”.  PCs become business partners in solving performance gaps and accomplishing organizational goals.

For a visual graphic and expanded description of these 6 elements, you can request HPISC white paper, Why They Still Want Training?

I also recommend that you request the HPISC white paper, Performance Analysis: lean approach for performance problems.