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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Moving from Lecture to Delivering an EFFECTIVE Lecture

While lecture has its merits, today’s learners want engaging content that is timely, relevant and meaningful. Yet, most SMEs tend to suffer from the “curse of too much knowledge” and find it difficult to separate the need-to- know from the nice-to-know content.

Presenting for them takes on a lecture style format. The thought of facilitating an activity gives most SME a case of jitters and anxiety.  So, in the HPISC. “SME as Facilitator” workshop, attendees are encouraged to step away from the podium and use their eyes, hands and voice to engage with their audience. Easier said than done, yes. That’s why the course is designed to allow them to take small steps within the safety of a workshop environment.

But rather than trying to pull off a fully immersive session, SMEs as Facilitators are introduced to techniques that “liven up” the lecture. They are shown how to move back and forth from passive (sit, hear, see) to active involvement (write, construct, discuss, move, speak). This requires the ability to:

  • follow a well organized design plan
  • capture and hold attention of learners
  • use relevant examples and deviations if possible
  • show authentic enthusiasm
  • involve audience both directly and indirectly
  • respond to questions with patience and respect.

Great presentations are like great movies. They open with an attention-seeking scene, have drama and conflict in the middle so you stick around long enough to see the hero survive and they close on a memorable note. Using the movie analogy, a SME as Facilitator can open the session with something more than his/her bio. They can pick a notable career achievement that most folks aren’t aware of.  Keeping the interest alive, the SME can then draw the connection of content to the audience and address the WIIFM question on everyone’s mind. (WIIFM = What’s in it for me?)

While we don’t need to add to anyone’s stress load, overcoming conflict makes for great story telling. Case studies, major CAPAs, deviations and audit observations make it real life. Use of visuals especially diagrams is visually appealing to learners and keeps them engaged. (CAPA= Corrective Actions Preventive Action Investigations)

Thoroughness in the preparation reflects care and thoughtfulness. Learners appreciate the personal desire to deliver a more lively lecture. Therefore, I like to use the concept of a lecturette; 10 minute blocks of time to chunk up complex topics. Interspersing a 10—15 minute lecture segment with an activity whether self, small group or stand up at the flipchart, gives learners the opportunity to engage with new and/or more complex content in smaller doses.

Stepping away from the podium forces the SME to take action and allow the learners to “get up close” with the SME as Facilitator. This in turn is reflected in the learners desire to respond to questions and dialogue during a facilitated discussion. The rule of thumb for lecturing is approximately 20 minutes max. But with today’s technology buzzing away at your fingertips or on the tabletop, I’d say more like 10 or 15 minutes max if you are an engaging facilitator.

difference between a novice and wise teacher

Remember, the goal of a session is to maximize retention of the audience, not just tell them the content. Attendees learn more if the SME as Facilitator can focus their attention on the topic and deliver content that is relevant to their work situation. Involving the learners in a variety of ways is the key to effective lectures and great presentations. – VB

You might also want to get up to speed with current trend for SMEs – check out the blog post – Are your SMEs becoming duo purposed? Comments welcomed.

Are all your SMEs Qualified Trainers?

I got a phone call from my Lead SME’s boss one morning. “How many more sessions do you need”, I asked him. I had already delivered 4 back-to-back workshops with class sizes of 25-30 SMEs; which was beyond optimal. So I asked him why. I needed to find out what was driving the surge in identified Qualified Trainers (QTs). I learned that a retrospective qualification needed to take place in order to close out an inspection observation. The total number of SMEs needing “proper paperwork” was well over 700. Since the redesigned training system was now in effect, these undocumented SMEs as Trainers would have to follow the new procedure. Or would they? Our discussion shifted to what type of training these SMEs will be delivering.

I then shared a related story with him. Several years prior, I got entangled with a “CAPA crisis” that involved QTs. No sooner did we launched the QT program and put the new procedure into effect, the CAPA quality system temporarily shut down shipping over a weekend. Upon return to the site, I was summoned to an emergency meeting from the security gate. Amazingly, a new practice/rule that only a Qualified Trainer can conduct training evolved from “only OJT QT’s can deliver OJT and perform Qualification Events” as per the SOP! This was clearly a case of misunderstood scope.

Does every SME need to be qualified as a Trainer?

In the Life Sciences arena, there are 5 recurring situations that require training: Self, Corrective Actions, Classroom (ILT), Structured OJT, and Qualification Events (Performance Demos).

Self can be achieved by the individual reading the procedure and the signing the training record. This is also known as Read & Understand (R & U) for SOPs.

Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally a SME or the SOP Author is needed to ensure credibility of the content.

Classroom (Instructor Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skill set needed is facilitation / managing the classroom and delivering content as designed by the instructor. A new trend is emerging for SMEs to deliver this training. And, they need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation. This is NOT the same course as the OJT-QT Workshop.

Structured OJT is On the Job Training delivered by a Qualified OJT SME using the approved OJT Methodology. OJT QT’s attend the Qualified Trainers Workshop.

Qualification Events (Performance Demonstrations) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME.

Can having too many QTs be a problem?

It can be when there is no one else to train; to deliver OJT steps. While many of you may be wishing for this situation, it can eventually happen if staffing levels are adequate, shifts are normalized and SOPs revisions are managed via R & U only with the LMS.   How do you keep your QTs engaged and fresh if there are no opportunities for OJT sessions? I have some ideas for you to explore.

When this situation occurs, it’s an appropriate time to administer the Trainer Mojo Assessment. Based on the QTs scores, it might be time to say thank you for a job well done for the low scoring QTs. You may be pleasantly surprised by who is ready to walk away from the training role? Or you may have a cadre of QTs who legitimately need more training and hence, the need for some new modules is now justified.

Another activity to pursue is re-examining the practice of online R & U only for SOP revisions. I bet some of those revisions were worthy of a face to face discussion and there is probably at least one in the past year that required a demonstration of task for optimum transfer of learning back on the job. *Just because all employees are now qualified, doesn’t mean the program sits in hiatus waiting for new hires to join the company.

What else can you offer bored and under utilized QTs? What about a 30 minute refresher series or developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators? Just an idea or is it a viable solution? – VB