For companies who are required to have standard operating procedures (SOPs), managing changes and ensuring affected employees are up to date is a constant challenge. Especially for companies whose weekly revision churn rate is from 10 to 150+ revisions. The standard approach is to “get ‘em done” in the fastest amount of time. The end goal for most people is the proverbial (√) and lots of records claiming “read and understood” the procedure.
Don’t get me wrong. I am a huge fan of both these methods especially for training related errors. However, there are a lot of other quality tools in the problem solving toolbox that aren’t as popularly used. In this blog, I will continue part two of the previous blog, RCA Meetings vs. Problem Solving Discussions in which I presented an alternative problem-solving model that helps investigators take a deeper dive into understanding the problem first (#1), then asking a series of questions to generate possible causes (#2) that move from the event trigger to patterns to systems glitches.
So many tools, so little time!
Before Google became a verb, the best way to learn about a problem-solving tool was to ask someone, ask to borrow his or her “The Memory Jogger” pocket guide, or wait patiently to take your course. Getting information at your fingertips instantly is no longer a barrier. But the consequence of too many available tools can lead to confusion and indecision resulting in sticking to what is familiar instead. One way to mitigate the bewilderment is to choose these tools by which stage the investigation is in and whether the team needs to analyze the process or the collected data.
Where are you in the investigation?
Are you exploring and just learning more about the triggering event? Are you generating possible causes and need an organized decision making technique? Or are you verifying and eliminating causes? Refreshing on the purpose of the tool helps the Lead Investigator make the right tool choice. Consider the Job Aid: Which Tool to Use When?
WHAT IS THE ASSIGNABLE CAUSE?
Just because the team has generated more than one possible cause does not mean that one of them has to be the root cause by default. Has the team asked the “second right answer”? Charles “Chic” Thompson, in his book, What a Great Idea, explains that we’ve been trained to look for the right answer, to seek the one and only answer, ever since we started school. Instead, he suggests that we ease “into a new frame of mind” by asking a host of questions in search of potential solutions. Included in this perspective, is asking, “dumb” but penetrating questions that lead to finding “the true source of bottlenecks buried deep in habitual routines of the firm”.
When the team
has really explored all possible causes, then it’s time to switch tools and use
data analysis tools such as histograms, run/control charts, and/or scatter
“A fishbone represents opinions. Opinions must be verified with facts before action to change is taken.”
Waste Chasers: A Pocket Companion to Quality and Productivity, p.43.
Pareto charts can be very helpful when you need to display the relative
importance of all of the conditions in order to identify the basic cause of the
problem. It helps the team to focus on
those causes that will have the greatest impact if solved. The team has to agree on the most probable cause
aka the root cause. One of the best
decision making tools I’ve experienced is Nominal Group Technique. NGT provides a way to give everyone in the
group/team an equal voice in the selection.
Team members rank the items without being pressured by others. Therefore, it builds commitment to the team’s
choice through equal participation in the process.
What is the solution?
One of the
most versatile tools in the arsenal is brainstorming. It’s quick; it’s easy to administer and
almost everyone has experienced a session or two. We like it because it is an efficient way to
generate a lot of ideas that are free of criticism and judgment when
At this point in the investigation, some members on the team finally get to share their ideas on how to solve the problem. For teams pressed for time, having already made ideas sounds like a gift ready to be opened. And yet, there can be a tendency to allow the eager problem solvers to dominate the discussion and solution path forward.
A nice warm up exercise prior to the solution brainstorm, is to assign an individual idea map first. By mapping individuals’ own thoughts first, they are not lost to the group’s brainstorming results when the time comes to participate in the session. The original ideas, thoughts, and even impulses can be easily shared since they have already been captured in their own idea map.
For teams stuck in the “same old way” mindset or wrestling with a frustrating repeat problem, try switching up the brainstorm trigger word. For example, the trigger word “when solved” can help us work backwards. Or use the opposite trigger word and brainstorm on ideas to make it true. Try a random trigger word or a metaphorical trigger phrase such as (the problem …) is like … the day after a vacation when … . I’ve seen amazing idea maps resulting from stepping up the brainstorming trigger words. If the team is still stuck, compare all of the maps to look for commonalities or common themes. And sometimes you just have to change your shoes or take a walk outside to shift your thoughts.
What is the best way to implement the solution?
Now, the team is responsible for bringing their ideas into reality aka the corrective actions / CAPA Plan. One of my favorite tools is the Force Field Analysis when the team is working on corrective actions. The tool helps team members to identify forces and factors that will support or work against the solution of an issue so that the positives can be reinforced and /or the negatives eliminated or reduced. It forces the team to think through all the aspects of making the desired change a permanent one.
“After falling in love with your idea, you must also be prepared to fall out of love.”
Charles Thompson, What A Great Idea, p.161.
Now Just Do It
corrective action(s) may be the longest duration depending upon the scope of
the project and therefore needs to be managed using project management
techniques. And that could be the basis
of another blog series.
Close the Investigation
Before the investigation can be closed, the effectiveness check needs to be performed and evaluated as described in the CAPA plan. Over the course of the incident and its CAPA, the story evolves. This is normal and expected especially as we learn more. To an outsider reviewing the investigation report, the story and all the supporting evidence has to be understandable, even to someone internal to the organization but not involved in the investigation, the CAPA or the project.
Investigator must review the entire file one more time to finalize the problem
statement and confirm the cause statement given what is known at this final
point of the investigation. The
following is a list of questions to ask:
the report easy to follow? Is there a logical flow?
the report free of unnecessary documentation? Is it uncluttered?
there sufficient information to back up the investigation, results and the
the report support decisions about product disposition?
Part One of this blog suggested the use of a more creative problem-solving approach to help us see our problems using systems thinking perspective. Systems Thinkers understand complex relationships and their interdependencies. They step up and take responsibility to fix the problem.
In part two,
I suggested different problem solving tools to use depending on the investigation
stage and the team’s task. As a
Performance Consultant, the problem solving approach and the plethora of
“quality” tools has me excited about identifying the true root cause and
implementing systematic solutions as the corrective actions because we have to
get better at solving our problems. System
puts a problem into a context of the larger whole with the objective of finding the most effective place to make an appropriate change and
it can help us identify and respond to a series of changes before those changes lead to more unwanted deviations and CAPAs.
Isn’t that the purpose of the PA in CAPA, the preventive actions? -VB
I began this Deviation and CAPA series with the intent to share what I call the human performance improvement (HPI) touch points; where HPI and the CAPA quality system have cross -over connections. See The Big Why of Deviations and Why Do CAPAs Fail Their ECs. In this two-part blog, I will reveal another noteworthy HPI crossover connection.
If you perform a Google search on CAPA process and the ensuing steps,
the results are varied but in general, industry follows a routine process that
looks like the following:
“CAPA” Program includes procedures for:
If you are satisfied with the results you are getting, great, more
success to you! One of the misconceptions
about today’s CAPA process is that it suggests the steps start and end cleanly
and the process moves in a linear fashion. I have one of those theory vs.
practice moments where what is supposed to happen “if you correctly follow this process” does not happen in reality. That somehow it’s the fault of the lead
investigator if it’s not progressing as described.
Deviations and CAPA investigations are not theoretical. As the investigation unfolds and the true story is discovered, we learn quickly that the process is really iterative. Often we find ourselves back at the beginning, rewriting the event details and fine tuning the problem statement or re-examining the root cause because a repeat deviation occurred. Frustrated that the clock is ticking and the pressure to get ‘em closed is always in the forefront of the investigation, there is no time allowed to think outside this process; no room for creatively solving the problems. The mere mention of creativity makes some compliance professionals break out in hives.
I get it. The intention of the process is to provide a structured approach to conduct the investigation and manage the related CAPA when assigned. Otherwise, it’s too overwhelming and unwieldy. We could go down a rabbit hole and never close an investigation or come up with totally out of the question corrections. However, it seems to me that we’ve ingrained these steps into routine habit, that our root cause investigation meetings have also become check the boxes to get the CAPA closed on time! Hence, our industry is still getting “inadequate investigation” observations. Could there be a causal relationship?
So, if you seek something else, I am proposing a problem-solving model below that mirrors very closely with CAPA. The following problem-solving steps give us the freedom to consider new ideas and new possibilities for solving the same repeated problems without violating our Deviation and CAPA procedures.
DEFINING THE PROBLEM
It sounds simple enough to do.
Collect the event details. Answer
the universal questions. And lo behold,
the problem should be evident. SMEs
unwittingly suffer from the curse of too much knowledge and as they learn more
about the event, they tend to form early hypothesis about the problem especially
if they’ve seen a similar event. They
tend to collect evidence about problems they are familiar with and
understand. Unfortunately for most, they
seldom go beyond their current knowledge base.
In the Qualifying SMEs as Investigators Program, nominees are asked to discuss and prepare their response to the following question: Is the problem different from the cause? Initially, everyone nods his or her head yes with a baffled look as to why further discussion is needed. In their break out groups, I ask them to prepare their group rationale. And then it happens, a few will inadvertently slip in the cause with the problem explanation and to their amazement they are stunned at hearing these words. Alas, that’s the point. Before you can assign the root cause, you need to know what the problem really is.
WHAT DO I ASK TO FIND THE
“To find the answer, ask a lot of questions first”. The discovery of a non-conformance, deviation or discrepancy is usually triggered by an event and thus the investigation begins here. In the event stage, not only are investigators collecting details they also interview the individual performers who are involved. However, there are three levels of interaction that can influence performance:
The individual performer level
The process level
The systems level.
To identify the possible causes not just the obvious one, the
investigation team needs to move beyond just the event triggers.
Moving from Events to
Patterns and Systems Influences
If we keep the scope limited to the event and performers involved “as an isolated incident”, we often find that the easy way out (aka the fastest way to close the investigation) will often lead back in with more repeat deviations. So, we need to expand the investigation to include other individuals and /or other similar incidents to look for a pattern or a reoccurring theme.
As investigators, we need to keep asking questions that enable information sharing to drive a deeper understanding of what the individuals were/are experiencing when performing their part of the tasks within the process.
Mapping the task/process helps SMEs to re-trace the steps or sub-tasks rather then rely on their memory (their expertise reservoir). Many SMEs think they know the procedure and will often state a step from an older version of the SOP or will be surprised to see new changes in the most current version of the procedure. In this group review, SMEs can look for weaknesses and offer their insights about the point of discovery.
Within this process analysis/review, ask are there other procedures that have been implicated in other deviations? What about the hand offs; the linkages between the procedures and other quality systems? Are these clearly defined and understood or are these the basis of “miscommunication” causes between other groups? The big question to ask is what would happen if we left it alone? What other systems would be impacted? When investigation teams are given the time to explore (investigate) enough, they often find these system glitches just waiting to contribute to another deviation.
Problem Solving ala Systems Thinking
Peter Senge in his 1990 ground breaking book, The Fifth Discipline: The Art and Practice of the Learning Organization,
describes a system as being perceived whole whose elements “hang together”
because they continually affect each other over time and operate toward a
common purpose. There’s a pattern of
interrelationships among the key components of the system, including the ways
decisions are made. Often invisible
until someone points them out.
Systems thinking allows problem solvers to see the event in the context of the whole system not just individual performers or procedure. They see patterns of recurring problems that deepen their understanding of the situation and leads them to reframe the problem, thus providing a new framework from which to generate an additional set of possible causes.
The next blog will continue describing the problem-solving model and explore other quality tools investigation teams can use. – VB
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When we start talking about deviations and CAPAs, we can’t help having a sidebar discussion about root causes and more specifically the rant about finding the true root cause. I intentionally skipped that content in the previous blog. It was my intention to kick off the new Deviation and CAPAs blog series by first looking at deviations by themselves. And the learning opportunities deviations can provide us about the state of control for our quality systems. From those deviations and ensuing CAPA investigations, I ask you this: are we improving anything for the long term (aka prevention). Are we making any progress towards sustaining those improvements?
Let’s step back a moment and quickly review typical steps for CAPAs:
The purpose of an Effectiveness Check (EC) is for verifying or validating that actions taken were effective and do not adversely affect product, device or process. It goes beyond the statement in the investigation form to include a follow-up activity that closes the loop on the specific CAPA. If an effectiveness check fails meaning the CA/PA was not effective or another deviation /nonconforming incident has occurred, we go back to the beginning and either start again or in most cases, we re-open the investigation. The pressing question is why did the EC fail? Almost instinctively, we believe that we did not find the true root cause. Perhaps. Was there a rush to close the investigation? Probably. Did the investigation team grab the first probable cause as the root cause because the “problem” felt familiar? Maybe. Or is it a case of a fix that backfired into unintended consequences? Possibly. I will also suggest that the CA/PA may not have been aligned properly.
Ask these 3 questions about CA/PAs
Is the CA/PA Appropriate? The focus of this question is about the affected people. What is the size of this audience? Is it mainly one person or groups of people?
Can the CA/PA be executed efficiently? Is it for one site or multiple sites?
Is the CA/PA Economical? What budget is available?
Is it a “cheap” fix or a 3 – 6 month project? Or an expensive solution of more than 6 months and will need capital expenditure funding?
Is the CA/PA Feasible? The real question is about the timeline.
Need it fast – within 3 months or
Have time – don’t need until more than 3 months from now.
And then there is the unspoken 4th question – is the CA/PA “political”? I experienced first hand what happens to CAPAs that are politically oriented. Most of them failed their ECs. Request “Can You Stay a Little While Longer”. The best CAPAs are the ones that map back to the root cause.
Introducing the HPISC CAPA
On the left hand side, you will recognize the 3 traditional tasks to
complete. After the EC is written, trace
upwards to ensure that the EC maps back to the CA/PA and that the CA/PA maps
back to the root cause; hence, the bottom up arrow. On the right hand side are performance
improvement activities that I use as a Performance Consultant (PC) to bring
another dimension to the CAPA investigation, namely, Human Performance
Before I can write the root cause statement, I examine the “problem” also known as a Performance Discrepancy or an incident and I conduct a Cause Analysis that forces me to take a three tiered approach (the worker, the work tasks, the workplace) for the possible causes and not get bogged down in observable symptoms only. The Performance Solution is more appropriately matched to the identified gap. In theory, this is what the corrective action(s) is supposed to do as well. During the performance solution planning, determination of success and what forms of evidence will be used happens with key stakeholders. So that collecting the data happens as planned, not as an after thought, and the effectiveness is evaluated as discussed.
What can we really
In RCA/CAPA meetings, I often hear about what management should do to
fix the working conditions or how most of the operator errors are really
managements’ fault for not taking the culture factor seriously enough. While there may be some evidence to back that
up, can we really control, reduce or eliminate the human factor? Perhaps a future blog on understanding human
errors will be released.
Design work situations that are compatible with
human needs, capabilities and limitations
Carefully match employees with job requirements
Reward positive behaviors
Create conditions that optimize performance
Create opportunities to learn and grow
Clues for Failed
One of the first activities to perform for a failed EC is to evaluate the effectiveness check statement. I have read some pretty bizarre statements that challenge whether the EC was realistic to achieve at all. The conditions under which we expect people to perform must be the same as the conditions we evaluate them during an EC review. So why would we set ourselves up to fail by writing ECs that don’t match normal workplace routines? What, because it looked good in the investigation report and it got the CAPA approved quicker?
Next, trace back each of the CAPA tasks to identify where to begin the re-investigation. I also suggest that a different root cause analysis tool be used. And this is exactly what we did while I was coaching a cohort of Deviations Investigators. Future blogs will discuss RCA tools in more detail. -VB
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.
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.
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 andhope” 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
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 workenvironment 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
Rossett, First Things Fast: a handbook for Performance Analysis; 2nd
Gilbert, Human Competence: Engineering Worthy Performance
Oh but if it did, life for a supervisor would be easier, right? Let’s face it, “people” problems are a big deal for management. Working with humans does present its challenges, such as miscommunications between staff, data entry errors, or rushing verification checks. Sometimes, the task at hand is so repetitive that the result is assumed to be okay and gets “a pass”. Add constant interruptions to the list and it becomes even harder not to get distracted and lose focus or attention to the detail.
Actual behavior vs. performing as expected
In their book, Performance Consulting: Moving Beyond Training, Dana Gaines Robinson and James C. Robinson describe performance as what the performer should be able to do. A performance problem occurs when the actual behavior does not meet expectation (as in should have been able to do). Why don’t employees perform as expected? Root cause analysis helps problem solvers and investigators uncover a myriad of possible reasons. For Life Sciences companies, correcting mistakes and preventing them from occurring again is at the heart of CAPA systems (Corrective Actions Preventive Actions).
A closer look at performance gaps
Dana and James Robinson conducted research regarding performer actions and sorted their results into three categories of obstacles:
Hopefully, employees are trained using an approved OJT (On the Job Training) Methodology in which they are shown how to execute the task and then given opportunities to practice multiple times to become proficient. During these sessions, they are coached by Qualified Trainers and given feedback on what’s right (as expected) and given specific instructions to correct what’s not right with suggestions for tweaking their performance so that their final performance demonstration is on par with their peer group. At the conclusion of the qualification event, employees must accept that they now own their deviations (mistakes) from this point forward. So what gets in the way of performing “as they should” or in compliance speak – according to the procedure?
Is it a lack of knowledge, skill or is it something else?
The Robinson’s explain that performance is more than the training event. It’s combination of the overall learning experience and the workplace environment that yields performance results. Breaking that down into a formula per se, they suggest the following: learning experience x workplace environment = performance results.
The root cause investigation will include a review of training and the qualification event as well as a discussion with the performer.
Is it a lack of frequency; not a task often performed?
Is it a lack of feedback or delayed feedback in which the deviation occurred without their awareness?
Is it task interference?
The work environment includes organizational systems and business unit processes that together enable the performer to produce the outcomes as “expected”. These workplace factors don’t always work in perfect harmony resulting in obstacles that get in the way of “expected” performance:
Lack of authority – unclear roles, confusing responsibilities?
Lack of time – schedule conflicts; multi-tasking faux pas?
Lack of tools – reduced budgets?
Lack of poorly stored equipment/tools – lost time searching?
Isn’t it just human nature?
Once the root cause investigation takes on a human element attention, it’s easy to focus on the performer and stop there. If it’s the first time for the performer or first instance related to the task, it’s tempting to label the event as an isolated incident. But when it comes back around again, it becomes apparent there was a “failure to conduct an in-depth investigation” to correct and prevent. Not surprisingly, a push back of “Operator Error as Root Cause” has forced organizations to look deeper into the root causes involving Humans.
Who’s human nature?
Recall that one of the categories of the researched obstacles was “conditions of the immediate managers”. This makes managers uncomfortable. With so much on their plates, managing a people performance problem is not what they want to see. A silver bullet like a re-training event is a nice activity that gets a big red check mark on their to-do list. However, Robert Mager and Peter Pipe, in their book, Analyzing Performance Problems, provide insights to managing direct reports that may lead to unintended consequences. A brief list can be found here – scroll to Tool: Performance Causes. (It’s not always the performer’s fault.)
It takes all three to correct a performance problem
The third category of researched obstacles clustered around “conditions of the organization”. I’ve already discussed task interference above. To suggest that organizations are setting up their employees to fail is pushing it just a bit too far. So I won’t go there, but it is painful for some leaders to come to terms with the implication. In order to prevent issues from reoccurring, an examination of the incidents and quite possibly a restructuring of systems have to occur, because automatic re-training is not the only solution to a “people performance problem”. –VB
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:
A hammer is the right tool to drive a nail into wood or dry wall, etc. supporting the adage “right tool for the right job”. Until the closet you installed comes off the wall and you realize that perhaps you needed screws instead or an additional widget to support the anticipated load. It isn’t until “in-use” performance feedback is collected that the realization of a different tool and additional support mediums are needed. Providing training (as in formal instruction) as the solution to a performance issue is analogous to using a hammer for every job.
Site leaders want business partners who can help them succeed with organizational goals, yearly objectives and solve those pesky performance issues. The more valuable the “trainer-now-known-as-performance-consultant is in that desire, the more access to strategic initiatives. So, the more you want to be recognized as a business partner to the site leaders, you need to continue to build your “solutions toolbox” that includes more than delivering a training event or LMS completion report.
As we begin to wrap up this series on gaining management support, we’ve been exploring how to forge relationships with line managers and earn their trust by being trustworthy. In the blog (Are you worthy of your line partner’s trust?), I asked if you were also trust worthy as a Performance Consultant (PC).
Do you have the necessary competencies to tackle the additional performance solutions? A logical next step is to review the plethora of literature that has been published on the multiple roles for a Performance Consultant. These include Analyst, Change Manager, Solutions Specialist, and Evaluator. There are more, but let’s start with an overview of these four.
A trainer with strong instructional design skill could argue that s/he has loads of experience with 3 of the 4 roles sans solution specialist. To that end, ADDIE has been the methodology and the foundation for successful training events for years. A sound training design analyzes need first and incorporates change management elements and includes evaluation activities for level 1(reaction) and level 2 (learning) of the Kirkpatrick Evaluation Model. So how hard could it be to master the role of Performance Consultant? Doesn’t every solution have a training component to it anyway?
Maybe and maybe not. As the traditional role of technical trainer evolves into Performance Consultant, the skills needed are evolving as well to keep up with management expectations for alignment with business needs.
The PC wears the hat of Analyst when working the business analysis and performance analysis portion of the HPI methodology honing in with the skill of asking the right questions and being able to analyze all of the contributing factors for performance causes. This is more than a needs analysis for designing a course.
The Solution Specialist role relies heavily upon systems thinking skills and is already way outside the power point training solution. As a problem solver working the probable causes from the Performance Cause Analysis, s/he opens the toolbox and can look past the “training design tray” into other alternative performance solutions. There is much more than a hammer in their toolbox. NOTE: For more details on those types of solutions, navigate to paragraph “HPI Approach” within the blog link). Implementation experience grows with each executed solution and a great PC also develops good project management skills.
During implementation, the PC may also have to wear a dual hat of Change Manager. Process changes, culture change and more require strong facilitation skills and process consultation techniques to manage the different phases of change depending on the nature of the solution and the size of the change impact.
And the Evaluator role surfaces at or near end of project implementation as the solution launches and goes live. Feedback collection, standards setting and re-assessing the performance gap to determine success or additional gap analysis.
The role of Performance Consultant requires more variety of skills and depth of project experiences. While training solutions are part of the PC toolkit, a training manager’s toolbox typically does not offer other performance solutions. It’s usually a hammer when a swiss army knife is what’s needed. –VB
References: William J. Rothwell Editor, ASTD Models for Human Performance Improvement: Roles, Competencies, and Outputs. 2nd Ed, 1999.
In this current series of gaining management support we’ve been exploring how credibility, trust and access impact or influence relationships with our business partners. In Stephen Covey’s, The 8th Habit: From effectiveness to greatness, he informs us that you cannot have trust without being trustworthy. As Performance Consultants (PCs) continue to demonstrate their character and competence, their line leaders begin to trust them more and more.
From those initial getting-to-you-know-you chats (see previous blog) to requests for help discussions, the give trust and return trust has been reciprocated and continues to strengthen the relationship. With each request / opportunity, PCs are demonstrating their character traits and further developing their Human Performance Improvement (HPI) technical competence and experience.
Following the HPI/HPT model gives the PC the ability to articulate the big picture of how this request, this performance gap, this project, relates to organizational goals thus illustrating a strategic mindset. And by following the related methodology, PCs demonstrate strong project management skills while implementing changes systematically; not just a quick course to fix a perceived knowledge gap or motivation problem.
So PCs become worthy of receiving their partners’ trust. Line partners in exchange merit their trust by giving it. Are you trustworthy as a Performance Consultant? Do you have the necessary competencies to tackle the additional performance solutions? Stay tuned for more blogs on what those competencies are and why they are so helpful for PCs. In the meantime, check out the sidebar “Ten Steps for Building Trust” from Alan Weiss in Organizational Consulting. -VB
Covey,SR. The 8th Habit: From effectiveness to greatness, USA, Free Press, 2004.
Weiss, A. Organizational Consulting: How to be an effective internal change agent, USA, Wiley, 2003.