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
You might want to also read:

What will it take to gain access to HPI/HPT Projects?

It’s more than a name change.
Adding Performance Consulting to your department name or position title sounds like a good idea at first. You know, help get the word out and ease into Performance Consulting projects, right? Well not exactly. Adding it on is exactly what happens; possible projects get added on to your workload and the “regular” training requests keep coming. It becomes a non-event. Dana Gaines Robinson and James C. Robinson, authors of Performance Consulting, strongly recommend that you create a strategic plan for your transition. And that’s exactly what I did in 1997.

Technical Training is now known as Performance Enhancement Dept.
But not without first discussing my plan with my boss and then pitching it to his staff at his weekly meeting. My plan included the need for the change and a comparison of the traditional training model and the performance model. In this comparison, I listed the percentages of training to consulting ratios and where the shift would occur. Training was never going away, but that we would do less and pick up more performance consulting work instead. I used the now familiar line – training is not always the answer. (Back then it was a very edgy statement.)

And I included in my pitch, the recommended pieces from the Robinsons’ seminal book: mission, vision, guiding principles, services, responsibilities and even who are customers were by percentages. Key to this plan and acceptance, was that we never said no to a training request, but re-framed it into why and how will we measure success. If we couldn’t design a measurement strategy from the beginning, we were obligated to turn the project down. And the General Manager agreed with that guiding principle.

NOW OPEN FOR BUSINESS!
While we waited for feedback and project requests, I invited myself to a quality meeting about a GMP concern from a Line Trainer. When no one volunteered to complete a suggested task, I raised my hand and took the assignment. Cheers, we had our first project and we were now open for business. The task was then assigned to a direct report who thought I was crazy or evil, but I described how this assignment could catapult us into the limelight and showcase exactly the kind of performance work we were capable of doing. Intrigued but still doubtful, he took on the research task and I took on the rest of the project since I had the vision and could connect the dots. We got 3 more requests after we went public with our first project.

One of my best requests that first year was a request for Peer Mentoring. Oh did I want this project. I met with the requester and listened to his case. I researched the topic (remember this was 1997) and got some ideas about a possible solution. When I pressed on about measuring the success, he was vague and said, you know, as part of organizational awareness. I was in love with the topic and what it could mean for the operators and for the new PE department, but I could not find enough support to measure the success nor justify the time and resources to make it happen. We had to scrap the project request. This was the Evaluator Role coming out loud and clear. And this news got around fast. The PE department was not a dumping ground for someone else’s yearly objectives.

Okay, that’s great, but who does GMP Training?
During our success, we still managed the Compliance Training requirements as part of our agreement. Folks got so used to us and how we managed both the compliance side and performance enhancement requests, that we no longer had to explain what PE was and who we were. So upon biennial inspection from FDA, the inspector asked, “Well then, who does GMP Training”? So, I was asked to put Training back into our department name and become known as TPE: Training and Performance Enhancement which felt like we were back to square one. But the requests kept coming and the projects got much better.

My favorite project was the “Checking Policy”. It had everything going for it. Unfortunately for the company, a very expensive error was made by an operator and site leadership wanted him terminated. The GM who was our unofficial sponsor knew there was a better way to manage this and he needed to find the true root cause of the performance discrepancy, so he reached out to me. The rest of the story is long, so I’ll spare you the details, but three additional projects resulted from this request and all three included operators as my SME Team. This was unheard of at the time and really highlighted what an asset they were to the company despite the costly mistake. Turns out it wasn’t his fault, what a surprise!

Alas, the time came for me to leave that company and take on external consulting full time. When given the opportunity to reinvent myself once again years later, I reflected on the times when I was most engaged and excited about going to work. It was those Performance Enhancement projects that gave me such powerful examples of successfully aligning improvement projects with the business needs. But rather than do it again for one single company, I created HPIS Consulting instead so I could share the approach with more than one company.

So as this “Gaining Management Support” series concludes, I summarize all the related blogs with this final question and provide an overview as the answer.

What will it take?
Developing trust with business partners for starters. Ongoing skill development as an Analyst, a Change Manager, an Evaluator and of course, a Performance Solutions Specialist to build credibility. A good transition plan with vision for 1-3 years and tentative plans for year 4 and 5. And the courage to take projects no one else wants if you want to become a Performance Consultant bad enough. We did it and I’ve never been happier! -V

Gaining Management Series includes the following blog posts:

If the only tool in your toolbox is a hammer …
Are you worthy of your line partner’s trust?
Wanted: Seeking a business partner who has performance needs
First, make “friends” with line management