Gap Assessments are necessary for QS redesign projects but so is the right level of support

This is the 3rd blog in the on-going Redesign Quality Systems: Achieving Successful User Adoption series. Visit Blog 1 and 2 here.

Assessments – “Truth Be Told”

Assessing the current state of the targeted quality system is analogous to collecting the “voice of the customer” input.  Discovering what is and is not working is vital to ensuring a successful redesign and ultimately user adoption. This is more than a review of the SOPs and forms; however.  Interviews are key to this phase of the project.  From the system owner to primary users, QA staff and even the LMS or the eDoc administrator are essential.  The more cross functional the input, the better the confirmation of the “data” and the “evidence”.  Which in turn, provides a truer gap assessment.

Most interviewees know the system’s weaknesses and they know how to fix it.  But they are frustrated with ignored attempts to change it.  Many simply give up trying to get it changed on their own or within their circle of responsibility.  So, when quality systems interviews are being conducted with an external consultant, some are eager to share the “dirt” on just how broken the system really is.  And some of the “fixes” are political and can only be handled when trust has been earned or when the sponsor deems it so.

We recognize Training is important but …

A small vitamin and supplements company set out to become a commercial manufacturer of pharmaceutical drug products.  Naturally, their quality systems were not robust enough to meet 21CFR 211 code of regulations. So, assessments were conducted for the major quality systems.  The Training Quality System assessment revealed several positive activities that were enabling current success and a lot of gaps that would need to be addressed to meet regulatory expectations for today’s pharmaceuticals companies. 

The sponsor explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously.

The sponsor routed the Training Gap Assessment Report to his peers and the CEO with an invitation to attend the first in-person briefing.  No one showed up except the sponsor, his direct reports and the consultant.  The meeting was rescheduled for a month later when all executives’ schedules showed availability.  One month later, the sponsor learned that key executives would be out of office during the meeting, so he postponed the briefing indefinitely.

The sponsor then arranged for a one-on-one follow-up session with the CEO and explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously. He also reiterated that in order to grow the business as intended, resources needed to be hired and the quality systems including Training needed immediate prioritization.  Or else the company would not receive approval to manufacture and could further impact its current relationship with the agency.

Three months later the meeting was scheduled.  However, the agenda took on a different focus. Particularly, the collaboration benefits of working cross-functionally with department managers and the shared ownership for the Training Quality System.  More specifically, the training project was not just a QA program, but a robust training system that impacts all employees.  This time the meeting occurred and was fully attended by all invitees.  

Change Readiness for the Design Team

With the briefing finally conducted, the sponsor explained to the consultant, that the “Design Team of SMEs” had very limited experience working cross-functionally or as a team. They knew even less about project management concepts like scope and project charters and they lacked fundamental concepts like quality systems and systems-based inspections.  And they did not know how to process map. They had been silo’d far too long.

SME Readiness Curriculum
Design Team of SMEs Readiness Curriculum

The consultant’s background included curricula building, instructional design, and quality systems redesign experience. She sketched a brief outline of the mini-curriculum for the Design Team of SMEs and the Sponsor agreed.   Over the next few weeks, they used their meeting time to work through the 4 introductory lessons.  And as a team, they used the “live” aspects of the project work to illustrate the concept and apply its principles to the progress and development of their team.   In essence, they were taught just what they needed to know in the moment the project needed it, similar to learning in the flow of work.  Four weeks later, the team was ready to begin their process mapping sessions together.

How Big is the Change Readiness Gap?

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc. All rights reserved.

Manage Your Stakeholders and Users Expectations thoughout the Entire QS Redesign Project

Engage Users from the Beginning and Throughout the Redesign Project

When Quality System redesign CAPAs are project managed using the 5 typical phases (see diagram), the progression of the project is easier to track and report status updates to stakeholders.

Involve Users throughout all phases and stages

Tapping into the different types of users for their input from the start of the project advances their engagement with the project along with the phases.

For example, during the Initiate Phase, an assessment of the current procedures, processes, and practices can include a variety of users, not necessarily the SMEs or system owners only. 

But without an organized and approved communication plan for each of these phases /stages, rumors evolve, misinformation circulates and the success of the new system being adopted is put into jeopardy.

Managing Stakeholders Expectations

A popular activity from the project management toolbox is to conduct a stakeholder analysis whereby a list of affected folks is captured.  And their role with the project team is clarified.  A handy acronym called PARIS can be followed: Participant, Accountable/Owner, Reviewer, Input Required, Sign-off required before proceeding. Also popular is a RACI matrix chart where;

  • R = Responsible
  • A = Accountable
  • C = Consulted
  • I = Informed.

So who are the stakeholders for the quality systems? In a quality system redesign, the following types of stakeholders are usually present,

  • Sponsor
  • System Owner
  • Managers
  • QA, HR, IT if it includes technology platform or upgrades
  • All affected Users.

Additionally, team members can identify their stakeholders’ relationship to the project which can be very helpful when the project hits barriers and is sent derailing off timelines.

Executive Sponsorship is a Key Success Factor

Quality systems by their nature are interdependent and frequently cross into boundaries of other departments’ workflow. Sponsorship is needed especially if the changes are significant, there are multiple quality system projects happening at the same time and other site initiatives all vying for the same resources.  Every quality system redesign project needs an executive sponsor:

  • To approve resource requests
  • To become aware of the impact of the changes being proposed
  • To be informed with the most current status

Thus, naming the sponsor holds this person accountable for the expected results. Thereby endorsing the project and becoming an advocate for the team’s work.

The Communication Strategy

Once the stakeholders have been identified and categorized, the next activity is to determine what level of involvement is necessary.  Ask them directly.  Ask them how often and in what format do they prefer. If you think one size fits all stakeholders, think again.  Many a project has derailed, missed its goal or became defunct as a result of miscommunication and misunderstandings.  Often stakeholders do not interact directly with the team.  It’s the Project Manager’s responsibility to be the interface.  One way to achieve this is to conduct briefings.

Briefings as a Communication Medium

The purpose of briefings is to provide updates on the project regarding timelines, milestones, deliverables and unresolved issues.  The expected results for a redesigned quality system are not always clearly understood because of confusing priorities and diluted focus.

Not all briefings have to be conducted in person via meeting time and conference room space.  Storyboard updates can be routed electronically.  Weekly updates, interim reports, and even significant project meeting minutes can be useful for briefing the stakeholders.  Make sure you match the type with the frequency as per your stakeholder analysis and communications strategy.  As the project progresses through its phases, stakeholders’ roles can change.  Use these briefings to continuously check-in for feedback and adjustment with frequency and format.

Routine Stakeholder Briefings: An example in practice

One client of mine decided to leverage the cadence of their standing update meetings and used the proposed system changes as the focus of the agenda.  As each procedure progressed to working-draft status, the Project Manager invited the key stakeholders and guest users to the meeting.

She diligently took notes in the drafts, captured their concerns on the parking lot flipchart and brought up issues from the design team for further exploration and discussion among the system owners. Then she invited them back to the next briefing to review the newest SOP drafts and secured a verbal approval for the draft so that the draft did not get hung up in disagreements among the approvers during formal change control. 

They used the briefings to work through their issues and concerns.  She would point to where the previous discussion was now resolved and often, she would provide an explanation as to why a concern or an issue did not get acknowledged in the procedures as discussed.  Participation in these meetings was generally good; a few key leaders were absent from time to time.  So, occasionally one-on-one meetings were scheduled for critical approvers.

In the next blog, I will walk through assessments in more detail. – VB

Feeling a bit lost with the sequence of this blog? It is second in the Redesigned Quality Systems series. Check out the kick-off blog here.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc. All rights reserved.

Redesigning Quality Systems: Achieving Successful User Adoption

What really happens to “change initiatives” after the CAPA due dates are met? Is the project done because the consultants leave? Or is it when the new priority has been re-directed to another pressing issue? What kind of post-implementation support is there for the leader charged with the ultimate responsibility for the improved performance of the redesigned quality system(s)?

But how did we get here?

The Compliance Situation

Whether it was a Warning Letter, a series of problematic 483 Inspections, or an OAI letter from FDA, you are now facing a compliance situation that has become your #1 priority.  If you are like most companies in this situation, Quality Improvement (QIP) Teams or CAPA groups are formed and are typically managed with an outside Compliance Consulting firm that is leading the overall compliance strategy using a popular 5 phased project plan.  See the visual example below.

Commonly used project phases for quality systems stages

Congratulations on taking action to quickly rectify your status with the agency.  In most cases, the redesign of one of more quality systems is part of the commitments made to the FDA, sometimes with very aggressive due dates.

CAPA Teams Produce Good Work

The individuals assigned to these teams collaborate on the necessary decisions to redesign current procedures and produce streamlined processes that link the inputs and outputs of key critical quality systems.  Team members trace and re-trace the process several times to challenge their thinking and include steps for non-routine situations that are known to happen occasionally.  They examine how the current forms will be used to ensure that the right information is captured and forwarded on to the next system when required.  For some system redesigns, new forms need to be created or undergo significant modifications that result in better compliance to form requirements. 

When Due Dates Are Met

Is there a collective sigh of relief?  Is the project now completed?  It might appear that way since the consultants have left and the new SOPs are in effect.  The mindset at this point may be akin to: “So long as we met the due dates and everyone has been trained, the new system redesign should run smoothly, right?”  Ideally yes, but the reality is no.  I often hear comments like these: “even though we trained everyone and sent out GO-LIVE emails, there is still a lot of confusion.” Another classic one is “the learning curve for new system changes is expected to be high initially considering how many changes we made.”

So what happened?  Was there a rush to complete the awareness training and collect knowledge checks as evidence of effective training?  It is no surprise that training on the new procedures follows the redesign.  But what is a surprise is when the Training Group is notified to make it all happen just days before the due date. 

When is the Training Group invited to the project meetings?

Often the Training Group is late to the planning conversations and sometimes very late to the rollout discussions. There’s never enough time to deliver a proper training session, so in 60 minutes or less, folks are supposed to have all their concerns addressed and get “trained” on all the changes. 

Suggestions and new ideas are captured for the “next revision” because it’s “kind of too late” to revise the procedures at this point.  And when the deviations start racking up, we sigh, shrug our shoulders and check the box for human error/learning curve.  There is a better way to manage the rollout.

This new blog series will examine why “training only roll-outs” are not enough to gain 100% participation and compliance with changes associated with Quality Improvement Plans (QIP) / Continuous Improvement Plans  / Strategic Action Plans. 

I often hear comments like these: “even though we trained everyone and sent out GO-LIVE emails, there is still a lot of confusion.”

I will include descriptions of additional project tasks/actions that need to be designed, planned for and incorporated into the overall QIP that are often left out or neglected. One such area is Affected Users

In this blog series, I will also identify several opportunities for the inclusion of Affected Users and how best to include them throughout the project phases. The series will wrap up with additional blogs on suggestions for maintaining the new changes for sustained performance improvement. 

Sign up now at the left sidebar to ensure you don’t miss an issue!  -VB

BONUS Material available

You might be interested in reading this BioPharma article about Quality Systems.

Looking for Remediation support? Check out these items in the HPISC library.

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc. All rights reserved.

Will You Please Just Sign the Training Form!

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.

What’s a Trainer now Performance Consultant to do? With all this focus on training effectiveness and return on stakeholder expectations, how does a Training / Performance Consultant demonstrate his/her worth when the real outcome is a rushed end-user who has less than 20 minutes to train on the changes?

According to Rummler and Morrill*, it comes down to how serious do the changes need to be? Performance consulting is about closing gaps in results, training is about closing gaps in knowledge and skill. So, consider analyzing what precipitated the SOP change. Was is it a significant CAPA issue or FDA commitment that requires a solution more than “Read and Understood”/ e-sign for the revised SOP?

In other words, isolate the underlying issue that prompted the change. How significant is the change in the procedure? Is it vital enough to improve performance results?  Then take a performance consulting approach for these changes. Don’t fret about the others requiring only knowledge. Those SOP revisions can be managed using routine training techniques whose goal is numbers trained.

What Do They Really Need to Know About the Revised SOP?

The HPI/HPT approach ties the results back to the business outcomes. If the end goal is truly a √ for SOP revision training, you have met the expectations. But as Trainer/ Performance Consultants, we know this is not an acceptable measure for any type of formal review. (Human Performance Improvement / Human Performance Technology).

What we can do is use a modified root-cause approach to address why the procedure changed and then incorporate the what, the where and the when into the training session. Take advantage of the revision history page if available. The SOP Author has listed what changed. Call him/her and ask why the change was made. Perhaps it is related to a deviation or audit observation that other employees need to know about. Find out when the changes will go into effect and how will folks be notified.

  • Will it be upon an effective date?
  • Or a trigger condition that now has a different decision path?
  • Or is it a completely overhauled FORM to be used?

Include these notes as part of your preparation for end-users to recognize when to make the changes in their tasks. PLEASE NOTE: Revision training is not to be used as a substitute for planned OJT or new hire SOP Training.

SOP Revisions Needing Real OJT: Will Management Agree with Your Recommendation?

But what if the SOP revision requires more than a “tell and forget” discussion?

  • Are the changes significant enough to require a demonstration? 
  • Will a one-time demo by the Qualified Trainer (QT) be enough to call it OJT?  
  • Does the revision require some practice to unlearn the old way and learn the new steps? 
  • How confident are your Qualified Trainers in redirecting this discussion with management regarding the most effective method to use, despite that it will take longer to complete the training notification flags?
Some SOP Revisions require more than a R & U checkmark.

First and foremost, the QT signature means that learners were assessed as having learned the content of what was delivered.  Can the QT confidently say their colleagues are trained in the revision and can perform the revision without errors?  Again, it comes down to how critical-to-quality is the new change?  Can the department / site / organization incur waste as in mistakes, scrap work, delayed release of product, and/or re-work as a result of “lack of proper training for the revision”? After the fact, many managers have “a case of amnesia” about their original directive regarding the SOP revisions. “Just tell them what the changes are, better yet, have them R & U and sign the darn form already!”  With more deviations being opened, these same managers now question why they have QTs in the first place.  Funny how there’s time to do the training properly a second time?

I realize this is easier said than done especially for new QT graduates.  A directive is a directive, I understand.  In these cases, documentation matters and needs to be explicit that demonstration requirements were waived by “Management Decision”.  When the investigation points back to a QT, the documentation will provide what content was covered and to what level of demonstration and practice was included; if any.  If none are required, then the risk for mistakes is minimal.  These questions, as painful as they are can be excellent references for future events where OJT is really needed for a significant SOP revision.  -VB

(c) HPIS Consulting, Inc. All rights reserved.

Who is Vivian Bringslimark?

*Rummler, G. and Morrill, K. “The Results Chain”. T & D, Feb 05; 26—37.

ASTD HPI— www. Astd.org/content/education/ certificateprogram/HPI

Robinson, DG and Robinson, JC. Performance Consulting: Moving Beyond Training; 1995.

HPIS C. has articles, impact stories and white papers.

Please Tell Me There Are More Quality Tools Than Fish Bone and the 5 Whys!

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 diagrams.

“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 facilitated properly. 

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

Implementing the 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. 

The Lead 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:

  • Is the report easy to follow? Is there a logical flow?
  • Is the report free of unnecessary documentation? Is it uncluttered?
  • Is there sufficient information to back up the investigation, results and the outcome?
  • Does the report support decisions about product disposition?

Conclusion

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 Thinking,

  • 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

Root Cause Analysis and Qualifying Investigators Coaching Briefs
  • Charles “Chic” Thompson, What A Great Idea: Key Steps Creative People Take, HarperPerennial, 1992.
  • The Memory Jogger: A Pocket Guide of Tools For Continuous Improvement, GOAL/QPC, 2nd 1988.
  • Waste Chasers: A Pocket Companion to Quality and Productivity, Conway Quality, Inc.

Conducting Root Cause Investigation Meetings vs. Facilitating Problem Solving Discussions

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:

  • Compliant “CAPA” Program includes procedures for:
    • Discovery and Notification
    • Containment
    • Impact Assessment
    • Product Investigation
    • RC Investigation
    • Corrective Actions (CA)
    • Prevention Actions (PA)
    • Effectiveness Checks (EC)
    • Close

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 CAUSES?

“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.

(c) HPIS Consulting, Inc.

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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(c) HPIS Consulting, Inc.

Investigations 101: Welcome Newbies

So the event description is clarified and updated. The assigned investigator is up to speed on the details of “the story”.  What happens next? What is supposed to happen?  In most organizations, there is rush to find the root cause and get on with the investigation.  A novice investigator will be anxious to conduct the root cause analysis (RCA).  S/he can easily make early root cause mistakes like grabbing the first contributing factor as the root cause without being disciplined to explore all possible causes first.

Thus it makes sense to get the Investigators trained in root cause analysis. Unfortunately for many, this is the ONLY training they receive and it is not nearly enough. RCA is a subset of the investigation process and the training agenda is heavy on the tools, which is perfectly appropriate.  But when do they receive training on the rest of the investigation stages like determining CAPA significance and writing the report?  Given the amount of FD-483 observations and warning letter citations for inadequate investigations that continue to be captured, I’d say we need more training beyond RCA tools.  As a result, we are starting to see FDA “recommendations” for trained and QUALIFIED Investigators.  This means not only in how to conduct a root cause analysis, but also the Deviation and CAPA Process. 

This goes beyond e-sign the Read and Understand procedures in your LMS

E-Doc systems are a great repository for storing controlled documents.   Searching for SOPs has become very efficient.  In terms of documenting “I’ve read the procedure”, very proficient and there’s no lost paperwork anymore!  But learning isn’t complete if we’ve merely read through the steps.  We also need to remember it.  At best, we remember that we read it and we know where to find it when we need to look something up.  Does that translate to understood?  Maybe for some. 

To help us remember the actual steps, we need to do something with the knowledge gained.  This is where the responsibilities section of the procedure tells us who is to do what and when.  But the LMS doesn’t include structured and guided practice as part of the assigned curricula.  Unless your equipment and complex procedures are also flagged for Structured OJT and possible Qualification Events as in most Operations groups, practice happens incidentally as part of on the job experience.  Feedback is typically provided when there’s a discrepancy or a deviation.  This is reactionary learning and not deliberate practice. 

If we want Deviation Investigators to understand and remember their tasks (procedures) so they can conduct investigations and write reports that get approved quickly, then we need to design learning experiences that build those skills and ensures accurate execution of assigned roles and responsibilities for Deviations and CAPAs. They need an interactive facilitated learner centered qualification program.

More than just studying a set of procedures and filling out related forms

It’s about putting the learners; the assigned SMEs as Investigators and QA Reviewers, at the center of the whole learning experience.  It’s about empowering them to take charge of their own learning by enabling them to experience real work deviations / CAPA investigations and to deliberately practice new skills in a safe environment with the assistance of adult learning facilitator(s) and coaches.  Thereby bridging the “R & U Only Knowledge Gap”.

The look and feel of the program follows a Learn By Doing approach with customized learning content, using interactive techniques and offering more hands-on opportunities for them to engage with real work application that ensures learners are immediately using the knowledge and tools in class and for their homework assignments thus increasing the connections for knowledge transfer.

This requires a shift from the traditional mindset of a classroom course where the emphasis is on the expertise of the instructor and the content. The learners and their learning experience becomes the priority.  The instructor’s task isn’t to deliver the content, it’s to help their learners acquire knowledge and skill.

Shifting the priority to a more engaging Learning Experience

Qualifying SMEs as Deviation Investigators Program

This unique curriculum uses a variety of teaching methods fostering more balanced and meaningful instruction over the duration of the program.  It is not a single course or 2-day training event.  It is delivered in modules, with weekly “homework” assignments consisting of active deviations and open investigations.

“Spaced learning works, in part, because the brain needs resting time to process information, create pathways to related information, and finally place the new information into long-term memory – the main objective of learning.” (Singleton, Feb 2018, p.71). 

Each module revisits the Investigation Stages and builds on the prior lessons by reviewing and debriefing the homework.  Then, expanding on that content and including new lessons with increasing intensity of the activities and assignments.

By design, the program provides time and space to interact with the content as opposed to delivering content dumps and overwhelming the newbies; short-term memory gets maxed out and learning shuts down. The collaborative participation and contributions from the Investigators and Program Facilitator(s) result in better overall engagement. Everyone is focused on accomplishing the goal of the program; not just checking the box for root cause analysis tools.

The goal of the program is to prepare subject matter experts to conduct, write and defend investigations for deviations and CAPAs.  The program also includes QA reviewers who will review, provide consistent critique and approve deviations, investigations, CAPAs. Attending together establishes relationships with peers and mutual agreement of the content.  The learning objectives describe what the learners need from the Deviation and CAPA quality system procedures while the exercises and assignments verify comprehension and appropriate application.

“Learning happens when learners fire their neurons, not when the trainer gives a presentation or shows a set of Power-Point slides.” (Halls, Feb 2019, p.71).

Qualified, really? Isn’t the training enough?

Achieving “Qualified status is the ultimate measure of the training program effectiveness.  For newly assigned Investigators, it means the company is providing support with a program that builds their skills and confidence and possible optional career paths.   Being QUALIFIED means that Investigators have undergone the rigor of an intensely focused investigations curriculum that aligns with the task and site challenges.  That after completing additional qualification activities, Investigators have experienced a range of investigations and are now deemed competent to conduct proper investigations.

For the organization, this means two things.  Yes, someone gets to check the FDA commitment box.  And it also means strategically solving the issues.  Better investigations lead to CAPAs that don’t fail their effectiveness checks.  Now that’s significant performance improvement worthy of qualifying Investigators!  -VB

References:

  • Campos,J. The Learner Centered Classroom. TD@Work, August, 2014, Issue 1408.
  • Chopra,P. “give them what they WANT”, TD, May, 2016, p.36 – 40.
  • Halls,J. “Move Beyond Words to Experience”, TD, February, 2019, p. 69 – 72 DL.
  • Parker, A. “Built to Last: Interview with Mary Slaughter”, TD, May, 2016, p. 57.
  • Singleton, K. “Incorporating a Spiral Curriculum Into L&D”, TD, February, 2018, 70 – 71.

HPISC Coaching Brief available here.

The Investigation Hand-off: Is it a handshake or missed step?

Upon discovery and containment of a deviation or non-conformity, the investigation begins.  Whose responsibility is it, the one who discovers it or the one who gets assigned to investigate it?  In most organizations, it is not the one who discovers the performance discrepancy.  It usually gets assigned to an SME or a dedicated investigator if QA has the resources. 

The hand-off between the discoverer and the assigned investigator is not always clearly defined and is often vaguely described in the CAPA procedures. And here is where the first misstep has potential to delay the start of the investigation clock. In this third blog of the Deviation and CAPA series, I intend to argue for the importance of the “hand-off” especially if investigations are assigned to SMEs and staff who were not present during initial discovery, containment and notification activities.

Making the Hand-off Formal

The purpose of the hand-off is to acknowledge responsibility for the investigation and review all actions taken up to the current point in time.  Given the nature of the event, the significance and urgency to move forward, there can be a lot of confusion, misinformation and misunderstanding of roles, responsibilities and authority.

One misconception that can occur with novice investigators is the lack of awareness that the investigation details can change and should be revised as the investigation unfolds especially the event description.

Please Tell Me the Story (again)

There are 3 main elements in every “story”.  Usually a cause and effect flow to the story unfolds and becomes the basis of the narrative that is told or captured in the investigation form.   Next are the key variables that reveal the impact.  The trick is to recognize and capture them and not get bogged down or distracted in the extra details.  And then, there are the two sides of every story.  The investigators job is to find the similarities among the interviews especially if there has been a long chain of events occurring before the hand-off.

A second misconception with new investigators is to park all the information in the investigation form as possible drafts and then revise and revise and revise again until they are finished.  Alternatively, they could use a tool that is designed to capture and review the details for the event.

The Investigators Hand-Off Tool – Tell Me the Story

The tool is essentially a worksheet to capture, review and collate the answers to the “Universal Problem Solving Questions”. 

  • What Happened?
  • Where did it happen?
  • Who was involved?
  • When did it happen?
  • How did it happen?
  • How big is the scope of the problem?

Notice that “why did it happen” is not included. How it happened can easily morph into why it happened if not carefully checked.  At this stage of the investigation, root cause analysis is way too early and can misguide the investigation.  Investigators in a rush to get their assignments done, need to stay true to the CAPA process and confirm the event details and then finalize the problem as they know it; more about problem statements in a future blog. 

“How it happened” is more about how it was found and how it was discovered?  “Where it happened” is seeking clues about a breakdown in the process, the procedures, paperwork and/or batch records.  Something happened somewhere and the investigation has to first identify what and where before the why.  Having these questions answered accurately allows for a richer probable cause identification step and eventual determination of the true root cause(s). 

Until the next blog is released, I have a homework assignment for you.  Reread your Deviation and CAPA SOPs specifically looking for the roles and responsibilities for the Initiator and the Investigator.  Are they clearly written? Ask your assigned Investigators (if this applies at your site) if they follow a hand-off guide or use any kind of fact-finding/event description worksheet.  If you are interested in the HPISC Tell Me the Story worksheet, you can find it here.  May all your CAPAs map back to the true root causes.  -VB