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.

This blog has been merged into blog – “Why We Love and Hate Training Curricula and our LMS”.

Who is Vivian Bringslimark?

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

How committed to SOJT is your organization?

Are you looking for management support for the Qualified Trainers and the time needed to deliver SOJT?  If only we were required to have a procedure for that!  It may not be an SOP or even a policy document, but industry guidance documents provide a lot of references to management involvement.

ICH Q10 – Pharmaceutical Quality System

While not mandatory, management needs to seriously take notice of ICHQ10 guidance document released in April 2009 (1).  In particular to the following:

  • MANAGEMENT RESPONSIBILITY 2.3 Quality Planning 

“(d) Management should provide the appropriate resources and training to achieve the quality objectives”.

  • CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM

4.3 Outcomes of Management Review and Monitoring

The outcome of management review of the pharmaceutical quality system and monitoring of internal and external factors can include:

(b) Allocation or reallocation of resources and/ or personnel training.”

Under a Quality System: Managers Expectations for Training

Referencing the Sept. 2006 issue of Guidance Document for Quality Systems: IV. Management Responsibilities | B. Resources (2), we see alignment with the training CGMPs for continued training so “as to remain proficient in their operational functions and in their understanding of CGMP regulations.”  “Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).”

And my personal favorite, “When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.”  The responsibility for training under a quality system is not assigned to just one person or one function.  It is a shared responsibility across the entire organization.

Goals of the Train-the-Trainer Program (TTT) vs. OJT Program vs. Employee Qualification Program

In order to have qualified employees, they need to receive structured on the job training delivered by a qualified trainer who is content qualified and training process qualified via a Qualified Trainers’ workshop.   Each of the three “programs” has defined outcomes that are dependent upon each other.  Unfortunately, the term program has been a bit overused throughout the years and can have a variety of meanings for folks.  For purposes of this blog, TTT program means OJT Qualified Trainers workshop, OJT Program means OJT methodology/procedure and Qualified Employee program means having a robust quality training system beyond the newest Learning Management System (LMS).

As you can see from the diagram, Qualified Trainers are at the core of all three “programs”.  The OJT QT Workshop is designed to prepare the QT’s for the realities of life as a Qualified Trainer. It includes the pre-work of familiarizing themselves with the Quality Training System procedures and then in class: exploring basic learning theory and committing to what the QT signature means. The OJT Program is about delivering structuring on the job training consistently following the approved methodology. An Employee Qualification Program is the validation of training effectiveness of the OJT methodology and the clarity of the underlying procedures.

Readiness Factors for SOJT and an Employee Qualification Program

Let’s start with a written purpose statement for having qualified employees beyond it’s required.  What is the company’s philosophy on achieving qualified status?  Is there agreement among the leadership for the level of rigor required to demonstrate performance and achieve a pass rating?  Where are the SOJT program goals written?  Does a schedule exist for SOJT and qualification events other than an LMS printout with required due dates.  That is not a schedule for SOJT.  Do you have clearly defined objectives for the QT workshop captured in a document or perhaps a procedure?  Is there a single owner for all three programs or is responsibility and accountability assigned accordingly?

Ronald Jacobs and Michael Jones, in their 1995 ground breaking book, Structuring on-the-Job Training, inform us that SOJT as a system functions within a larger context, namely the organization.  SOJT is not a standalone program.  Conflicts, competing priorities and mixed messages can influence the success of your SOJT program.  What else is going on in the organization that will compete for the same set of QTs? Remember they are also your most experienced and technical subject matter experts.  How is the overall Employee Qualification program aligned with the other quality systems? 

Recognition for QTs and Qualified Status

Most QTs are not fully dedicated to delivering training for departments.   There are pros and cons for this decision.  For now, I will leave them out.  Suffice it to say, they are tasked with both their “day” job and the responsibility for delivering training when needed.  They are at times, doing two jobs.  Whether or not they are compensated additionally for delivering SOJT, acknowledging their contribution to the department and the organization is part of management support.   It takes more than “you are doing a good job, keep it up”. 

Often supervisors and managers don’t know what else they are supposed to do to show their support, other than allow them to attend the QT workshop.  The interested ones will “pop” in during lunch and chat with their direct reports.  Others will show up at the end for the poster activity (equivalent to a written test) and some will come to learn about the parking lot issues that need follow up.  The energy in the room when this happens is amazing. 

“When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.

Guidance Document for Quality Systems, Sept 2006

To help ease the knowledge gap between a manager and their now Qualified Trainer, I started delivering the Leadership Briefing module prior to the QT workshop delivery.  The purpose is to provide an overview of the content highlights, alignment with initiatives / CAPAs/ agency commitments and more importantly to secure agreement for the following:

  • criteria for nominating a QT
  • roles and responsibilities of QT
  • scope of work QT’s can be assigned
  • expectations for QT’s post launch
  • what happens day one after workshop is done
  • what is the status of the SOJT checklists
  • scheduling and budget concerns.

If the organization says they support the qualification program, then what happens when employees achieve qualification status?  Nothing?  A non-event? Or is it announced in newsletters, plasma screens and other company announcements?  Is it a big deal to be able to perform independently and free up a much-needed QT for another learner?  I keep hearing over and over again about how there aren’t enough QT’s to deliver SOJT the right way.  One would think qualification status on SOPs, especially big complex processes deserves SOME kind of recognition.   Just how committed are the managers and supervisors?  QTs and employees draw their own conclusions about the level of real management support for the programs.  

Supporting QTs is more than participation in QT Workshop

If truth be told, after launching the QT workshop, many supervisors privately don’t support the program.  They lose their top performers during the workshop and the hours it takes to train someone. Forget about giving QTs adequate time to complete the paperwork properly! And then leadership wonders why good documentation practice (GDP) issues continue to be a problem? The non-distracted performance observations that QT’s are expected to conduct for the qualification demonstration drive supervisors and line managers crazy the most – what, they can’t do anything else but observe?  Hence, many QT’s are asked to multi-task just to get the work done: not enough resources they are told.  For supervisors, productivity and the workload will always trump SOJT and qualification events, until their bonuses include completion of training and qualification events.

What Real Support Is Supposed To Look Like

My key take away message is that attending the TTT program/ QT workshop is not the end of the OJT program or the Employee Qualification Program but rather the launching point.  Management support needs to go beyond just nominating QTs and allowing them to participate in the workshop.  The real support is in the alignment of goals, clarifying expectations continuously, allocating resources for training and budgeting time to deliver OJT using an approved OJT methodology that includes qualification events.  This commitment of time and sponsorship for qualified employees is a culture shift for many line managers and site leaders.  But actions do speak louder than words.  -VB

(1) Guidance for Industry Q10 Pharmaceutical Quality System | US Department of HHS | FDA
| CDER | CBER April2009 ICH

(2) Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S.Department of HHS | FDA | CDER | CBER | CVM | ORA| September 2006 Pharmaceutical CGMPs

Jacobs RL, Jones MJ. Structured on-the-job training: Unleashing employee expertise in the workplace.  San Francisco: Berrett-Koehler: 1995.

How can you tell if your site is ready for SOJT?

HPISC has created a 2 part checklist of questions and attributes to explore. The checklist is available gratis when you become a HPISC mailing list member. Just be sure to include that are you interested in receiving the SOJT Readiness Checklist.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Are you doing the Training 2 Step?

Has this situation ever happened to you? You are in a root cause meeting and the *CAPA Investigator is conducting an interview with the primary individual involved with the discrepancy. When questioned why did this happen, he shrugs first and then quietly mumbles I don’t know. When pushed further, he very slowly says I just kind of went brain dead for a moment.  And then silence.

While that may be the honest truth, the investigator must resist the temptation to label it as Operator Error and explore possible causes. One of my favorite root cause analysis tools for “I Don’t Know Why” response is to use the Fish Bone Diagram also known as the 4 M’s diagram. This tool provides a structured focus to explore many possibilities and not just stop at the first plausible cause; such as Operator Error. Aptly nicknamed, the 4 M’s are Man, Machine, Methods and Materials.   When the results of this exercise points to a training or operator related issue, don’t stop at “operator error –> retrain”.

Consider for a moment, what this retraining session would look like. Will re-reading the procedure be enough to “jog his memory”? Will repeating the procedure be a good use of precious time when s/he already knows what to do? More than likely it won’t prevent “going brain dead” from happening again. Instead, do the HPISC Training 2 Step:

Step 1 – confirm the results of the gap analysis

Ask: What task, what step(s) or actions are in question?

Step 2 – address why the original training did not transfer back to the job.

Using the 4 M’s diagram as the framework, explore Man, Machine, Methods and Materials questions with regards to the training this operator receives. See diagram below. The full set of questions can be found in the eBook Training Cause Analysis.

4msfortrca

Is this really worth it?

I think it is. Conducting these 2 steps will accomplish two objectives.   It will provide further evidence that some kind of training is needed. And it will highlight what areas are in need of revising either for the performer, the training program or course materials. Yet, there are some who will resist this added work because it’s easier to find blame than to uncover the cause. Fixing the true root cause could trigger a re-validation of the process or an FDA filing if it’s a major process change.   Why create more work? Isn’t it easier to just retrain ‘em? No, not really. Finding the true root cause is the only effective way of eliminating many of the costly, recurring problems that can plague manufacturers.

But what if

screen-shot-2016-10-19-at-4-33-39-pm

Some folks will push back with the excuse – “this never caused a problem until now”, so it must be the operator’s fault! This may be the first time it was discovered but that does not mean the procedure is 100% accurate. Often, experienced operators know how to work around an incorrect step and don’t always report a misstep in the procedure while a less savvy operator follows the procedure and causes the non-conformance to occur. See Sidebar SOP Logic Rules. Is the procedure difficult, lengthy or requires weeks to become proficient let alone qualified? Was the qualification routine or performed as a simulation? Was the procedure written with support from a lead operator or qualified trainer? Did the draft version undergo some kind of field test or dry run prior to release? And the classic situation, are proposed changes hung up in change control awaiting effective release?

Understanding Why Human Errors Occur

Industry practice is evolving to explore why people make the decisions they do by looking at the Organization’s systems. It’s usually a poor decision made somewhere in the error chain. We must believe that the person who made the poor decision did not intend for the error to occur. As part of CAPA investigations, we need to explore their physical environment as well; the conditions under which they make those decisions. The Training Program Improvement Checklist can be requested using this link to capture your findings.

If you are going to spend time and money on training, at least identify what the gap is; fix that and then “train” or provide awareness on what was corrected to prevent the issue from re-occurring again.   That is after all, the intention of *Corrective Action Preventive Action investigations. -VB

HPISC has articles, impact stories and white papers.
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Why the Band Aids Keep Falling Off
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Operator Error: Is That Really the Root Cause?

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

When SMEs have too much “secret sauce”

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

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

Once a Trainer; Forever a Trainer

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

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

Significant CAPAs can be Drivers for Change

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

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

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

An alternate alignment exercise

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

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

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

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

From Dept. SME to QT

The Client Request –”Can you help us upgrade our Trainer Qualification process?”

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

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 at 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.

Why Do CAPAs Fail Their Effectiveness Checks?

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?

Corrective Actions Preventive Actions (CAPA) Steps

Let’s step back a moment and quickly review typical steps for CAPAs:

CAPA Components

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 Performance Chain

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 Improvement (HPI). 

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 control?

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.

Management Can:

  • 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 professionally.

Clues for Failed Effectiveness Checks

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

Facilitating the Shift from Passive Listening to Active Learning

On the one end of “The Learner Participation Continuum” is lecture which is a one way communication and requires very little participation.  At the other end, we have experiential learning and now immersive learning environments with the introduction of 3D graphics, virtual simulations and augmented reality.

In the middle of the range are effective “lectures” and alternate methods such as:

  • Demonstrations
  • Case Study
  • Guided Teaching
  • Group Inquiry
  • Read and Discuss
  • Information Search.

Shift one step to right to begin the move to active learningNow before you insist that the SME as Facilitator move to the far right and conduct only immersive sessions, a word of caution is in order. It’s really about starting with the learners’ expectations and the current organizational culture and then moving one step to the right. If they are used to lectures from SMEs, then work on delivering effective lectures before experimenting with alternate training methods. The overnight shift may be too big of a change for the attendees to adjust to despite their desire for no more boring lectures. Small incremental steps is the key.

How is this done? Upfront in the design of the course materials. The course designers have spent time and budget to prepare a leaders guide that captures their vision for delivering the course.  SMEs as Facilitators (Classroom SMEs) need to study the leader’s guide and pay attention to the icons and notes provided there. These cues indicate the differentiation from lecture, to an activity whether that be self, small group, or large group. While it may be tempting to skip exercises to make up for lost time, it is better for learner participation to skip lecture and modify an activity if possible.

During the knowledge transfer session/ discussion with the course designer and/or instructor, Classroom SMEs make notes of how the instructor transitions from one slide to the next and how s/he provided instruction for the activity. This is a good time for Classroom SMEs to ask how to modify content or an activity if certain conditions should occur. Especially important for SMEs to ask is what content is critical and what content can be skipped if time runs short. It is always a good idea for the Classroom SME to mark-up his/her copy of the materials. And then again after the first delivery to really make it their own leader’s guide. -VB

Speaking of personalizing their leaders’ guide, SMEs may want to experiment with different ways to “open a session” to get experience with a variety of techniques and observe which ones yield better results.