May I See Your Implementation Plan for this Change Control?

In Part 1, we find Cara, a performance consultant has been hired to help a former client with implementing a robust training system. After waiting 3 months for the executive leadership group to get aligned around the priority for Miguel’s RTS project, Cara finally got to debrief her assessment findings. But a new development surfaced that was unexpected.

In part 2, we observe how Cara brings her inexperienced design team up to speed on how to be a team.

In part 3, we learned how Cara facilitated the design team of SMEs through various stages of working as a team to manage internal politics and a team member’s personal agenda.

In this Final Part of the Change Readiness Gap Impact Story, the design team launches and gets a surprise visit from the agency.

“But future state is being designed on the assumption that change control will be redesigned first.  We still have a lot of preparation work to do before we are even close to submitting these for change control.  And that is why change control is out of scope for this team.  We will not delay our deliverables because we decided mid-stream to go fix change control first.   There are plans for a change control project team to begin and some of you may be tapped to participate.”

After the change control rant from their distressed team mate, whenever anyone even mentioned the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

Robust Training System SOPs: IMPLEMENTATION: The GO-LIVE STRATEGY

Through the efforts of Miguel negotiating behind the scenes, a new quality manager, Stuart, was hired right as the team began to work on the implementation strategy.  The timing was ideal because the team was ready to present their recommendations on how to go live and this was Stuart’s first priority.

Meet your new project leader

While Stuart got caught up to speed and completed his onboarding tasks, Cara transitioned out of the project manager role and back into external consultant mode.  The team had successfully designed their process flows and together decided the number of procedures that made sense for the organization as well as where to park the content.  They collaborated on the design of forms while leaving room for flexibility given the nature of work for each department.  The team had two proposals that competed with each other and Stuart, now fully up to speed weighed in with his decision.

Critical vs Important Focus

Critical vs. important: OJT documentation or curricula accuracy

The first proposal mapped a path forward based on OJT as the priority.  This was clearly identified in the gap assessment report and what appealed the most to the executives given their business objectives.  The second proposal was logical and made more sense to start from an overhaul of the curricula; ensuring that the training and qualifications were the right requirements for the right roles.  At the next meeting, Stuart took the lead and announced that he chose the curricula proposal and would defend this choice to Miguel and the executives as his first major task assignment.

Stuart was successful in his curricula proposal pitch with the executives.  He was able to make a compelling argument for both efficiency and effectiveness.  His next task was to finalize the implementation plan.  So he asked the team to meet once again to refine the “Go-Live Strategy”. 

“Please Pardon Our Appearance”

In order to move forward with the necessary tasks, the team needed the authorization to complete the work using the newly designed forms and process without approved Standard Operating Procedures (SOPs).   Releasing the new design before the sub-tasks were complete, would create an “out of compliance” situation at the onset of launch.  And yet, going forward without an approved procedure also put them in SOP violation status.

GMP Redesign SOP Dilemma

As part of the team’s drafted implementation plan, Stuart generated a change control package that documented the project, articulated the necessary steps, included the process flow diagrams as well as the forms.  Included in this packet, was the timeline for execution.  The effect of this documentation was to communicate that all these changes were not out of control but rather a controlled and planned change in the current procedures in order to make them standard once the subtasks were in place such as the updated position curricula.

Delivering the Qualified Trainers Workshop was a critical implementation task that needed to be timed with the SOP roll out.  The day before the Qualified Trainer’s workshop was to be delivered by Cara, Stuart called Cara and announced that a regulatory inspection was to begin on the same day.  While disappointed with the delay, Cara was optimistic that the training portion of the inspection would be favorable.   One month later, Stuart phoned her back.

“Can you deliver the workshop next week?” Stuart inquired.

“Yes, I’ll clear my calendar.  But how did training do?”

All in all, it went well.  We have some issues of course,” Stuart added.

“What about the training implementation plan? Was it accepted or challenged?” Cara asked.

“Well, we didn’t get cited for being ‘out of compliance’ so that was good.  But it was clearly stated that the plan MUST be executed ASAP! Hence, the reason for my call, today,” he answered.

Cara was pleased to hear that the Robust Training System (RTS) training project finally became a “Top Site Priority”.

END RESULT: Future State is now Current State

A few months later, Cara also delivered a GMP Basics course and qualified the site trainer to deliver it routinely as per the new training procedures. The RTS project was now officially closed and life as new normal began.   Their next follow up inspection was favorable.  A few minor issues and some verbal comments for training.  With this earned “regulatory approval”, the company was able to move forward with plans for launching their new product.

LESSONS LEARNED: Breaking down silos one meeting at a time

While the project team of SMEs learned how to collaborate in order to achieve project charter deliverables, the business units were very much still entrenched in their functional silos, defending current practices.  Deviating from approved procedures, even with a regulatory recommendation to prioritize the execution of the training plan, was not well received.  Stuart and his staff faced resistance from front-line supervision with right-sizing their curricula.  Through determination and persistent “working meetings”, the curricula sub-project finished.

Given the curricula “battle”, Stuart initially backed off from communicating the big project picture in the hopes that early accomplishments would inspire the front line to continue with the tasks and not overwhelm them with too much change at once.  

Instead, the OJT checklist sub-project was also slow, tedious, and a struggle.  Incumbent subject matter experts (SMEs)were reluctant to share their expertise or participate in the generation of the OJT Checklists, let alone be required to use them and not change the content without following the change control process.  Ironically, as new SMEs were vetted, the quality of the content improved and the checklists became a non-issue.

KEY TAKEAWAYS:

  1. The decision to delay project launch until Miguel felt confident that the executive leaders would sponsor the project and approve resources for the design team was paramount for keeping the momentum going forward after the initial launch meeting.
  2. Miguel recognized early on that the identified design team SMEs needed a specially developed curriculum to prepare them for the challenges that lay ahead.  The first four meetings as introductory lessons provided context as well as content and established the project lexicon while reinforcing team ground rules.
  3. Being prepared to defend the change control packet and explain the “Go-Live” Implementation Plan with FDA investigators not only gave credence to the project but it also elevated the importance of plan execution and made completion an urgent priority. -VB

Who is Vivian Bringslimark?

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(c) HPIS Consulting, Inc.

So, we went LIVE, what happens next?

Blog # 9 is the final blog in this Redesigning Quality Systems series. Refer to blog # 7 for an overview of the 5 Steps for GO-Live Strategy.

Go-Live: Step 4 – Triage Impacted Documents

The purpose of the triage step is to manage the impact of in-process system documents the day the new design goes live.  What happens to forms that were started and not yet completed?  Employees will need to know how to move forward and still be in compliance.   The easiest path on Day 1 is to use the new form(s) to begin a new record.  But what about the documents that were already started?  The ones that were initiated.  They will reflect the previous version although in effect at the time of initiation. Anticipate these questions from affected users:

  • Do we process the old form?
  • Do we start over with the new form and add the original started document with EOD notation for missing information?
  • Do we suspend and pick up with the new form?

A good example of this situation is when paper change control requests have SOP drafts attached. The Project Manager with the guidance of the Head of Quality needs to meet prior to the launch date to carve out the decision paths based on the amount of initiated documentation stages each document contains.  These decisions and individual directions are the main tenets for daily guidance from the Project Manager and/or Quality System owner during the start and end period for the transition phase.  Revisit Step 2. 

In addition, s/he or a small team needs to answer questions that are sent via emails, phone calls, drop by’s and drop-ins for direction on how to close the loop on initiated previous versioned documents. Anticipate additional 1-1 coaching through the new paperwork until the end of the transition period. 

“What happens to forms that were started and not yet completed? ”

Vivian Bringslimark, HPIS Consulting, Inc.

When Will We Be Fully Operational with The New Design?

When this design team began putting together its go-live strategy, their impact assessment (Step 1) mirrored an “End in Mind” approach.  The project manager asked, “what needs to be in place in order for us to be fully compliant with this procedure”.  The list of items was long.  The second question – “What is the best way to accomplish this” was then asked and detailed steps were captured.  The third question focused on the estimated time to complete and so on.  In essence, the team was generating an implementation plan to guide its launch decisions.  It became clear that they needed to launch in high priority clusters

However, two cluster sets were competing for first place to launch.  One focused on the business objective while the other focused on establishing foundational principles for the quality system.  In a stunning presentation, the system owner made her compelling appeal to the site leadership team and was given the approval to begin with foundational principles despite the number of tasks and time to complete those tasks. 

In order to move forward with identified tasks from the implementation plan, the team needed the high-priority procedures to be in effect in order to gain cooperation from department managers.  This created a compliance dilemma of being out of compliance immediately upon launch.  To mitigate this gap and not create unnecessary deviations, the system owner generated a change control packet that also included the implementation plan tracker.  It gave the design team the necessary authority to invoke the changes without becoming bogged down in the compliance dilemma dialogue which derails progress. 

When FDA made an unannounced visit to the site weeks later, the change control packet of documentation was not only accepted as an appropriate way to cover the obvious compliance gaps in the new procedures, but the implementation dates were moved up and execution of the plan became a site priority. 

The project manager asked, “what needs to be in place in order for us to be fully compliant with this procedure”

Vivian Bringslimark, HPIS Consulting, Inc.

Go-Live Step 5: Monitor Performance and Collect Feedback.

The project ends for the consultants when the handoff is completed, and they disengage. The handoff usually includes a formal document describing the current status of the system at the point in time including deliverables, suggestions for next steps and sustainment. 

Can the team celebrate that the project is over? Or should they wait until someone determines whether it is a successful adoption? Recall Step 2 of the Go-Live Strategy defined the end date of the transition period as well.  Did this include the expected date for being fully operational? By the way, who is responsible for declaring success or needs improvement?

Phase Three – Successful User Adoption

One more component of the overall project plan is User Adoption aka Phase 3.  In my experience, this is perhaps the most overlooked phase in redesigning quality systems.  Once training is delivered and the consultants leave, “life as normal” sort of returns with pockets of progress, “learning curve” deviations and loads of suggestions for “fixing” the new design. 

In this phase, the project plan expands Go-Live Step 5 into two main activities, initial user adoption results and sustaining the redesigned quality system through controlled continuous improvement feedback loops.

User Adoption: Did we succeed?

What kind of data/evidence will you use to confirm the success of the Redesigned Quality System?  Will you be relying on the CAPA Effectiveness Check statements to determine User Adoption success?  One word of caution here. These may be too narrowly focused on particular steps as it maps back to a single observation and does not provide enough evidence to tell a complete story just yet.  

What the System Owner really needs to know is:

  • Who is following the new process?  Who is still dragging their feet? Who is confused about how to proceed? Who needs help remembering what the changes are?
  • Do we have any early examples of how or where the new process is helping to produce positive results?
  • What is the value of those results?
  • How long do I have before I am forced to release the next set of “promised” revisions?

You Need a User Adoption Study

The purpose of the study is to get data both quantitative and qualitative to address the system owner’s questions.  This means the study needs to focus on identifying the specific changes (removed, added, and modified) and then collecting the evidence to evaluate how well those changes have been transferred into this “life as normal” stage.   Whether this means reconvening the design team or initiating a new subgroup of early adopters, user input into the tools, existing KPIs, new metrics, surveys, and who to interview is another excellent opportunity for users to be involved.

It also means keeping key stakeholders and the sponsor informed and up to date.  The “project may be over” however, the adoption has only just begun.  Feedback is essential to not only determine successful adoption but to also gather detailed information for continuous improvements that feed revisions.

“In my experience, [phase 3] is perhaps the most overlooked phase in redesigning quality systems.”

Vivian Bringslimark, HPIS Consulting, Inc.

Managing “New Normal”

Life as new normal has begun. The quality system is fully operational and Affected Users are now performing their tasks.  New normal is really about managing the new workflows and the status of the current resources to sustain the new system.  Are you able to sustain the new system or are requisitions pending for more full-time employees?

A screenshot of a cell phone

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why redesigned SOPs are more than a set of revised procedures

What existing performance metrics can you leverage? Perhaps it is only a matter a slight tweaking here or there to accommodate your redesigned quality system.  In some systems that have gone digital, brand new metrics and KPIs (key performing indicators) need to be established.  Most vendors will partner with their clients and recommend industry best practices around popular metrics in use.

Anticipate periodic revisions that come from corrective actions and from the Affected User groups.  Hold focus group meetings quarterly for the first year and then semi-annually the second year to stay on top of trends and possible performance challenges to prevent unexpected deviations.

Continuously Improve the Quality System

The redesigned quality system has to feed itself.  Identify and continuously monitor the key linkages (handoffs) between one system interface and the other.  Are they working or are they becoming the source of miscommunication between users? 

How many CAPA investigations have been initiated where the handoff may have been a contributing factor?  How many small or incremental changes has the quality system undergone in the course of a year?  When will it be time to remap the process and identify all the tweaks that have occurred? Would anyone recognize the differences?  I’m betting on savvy new hires to ring the change bell and raise our awareness.  We forget just how many changes can happen to a quality system over 1 – 2 years.

Summary

  • Any change we introduce into an organization must be aligned to fit the existing system or modify the system to accept the changes.
  • Quality Improvement Projects/ CAPA teams are no stranger to change and all that comes with changing old ways.  But managing change fatigue can wear us down and make us slow to outwardly embracing major change efforts. Include change management strategies that go beyond Awareness Training only.
  • This blog series outlined why some post-implementation issues can thwart our best designs for users and provided tips and suggestions to deploy during the project phases rather than waiting until post-launch to ensure User Adoption success. 

Here’s a recap of the series:

  • Blog # 1 – Redesigning Quality Systems: Achieving User Adoption
  • Blog # 2 – Manage Your Stakeholders and Users Expectations
  • Blog # 3 – Gap Assessments are Necessary for Redesign Projects but so is the right level of support
  • Blog # 4 – What to Expect When Processing Map with SMEs
  • Blog # 5 – Field Testing Your Final Draft of Redesigned SOPs and Forms: Helpful or Seen as unnecessary?
  • Blog # 6 – Change Management and It’s Little Cousin Training
  • Blog # 7 – Do I Really Need a GO-Live Strategy?
  • Blog # 8 – Is an Awareness Training Only Session Enough for Successful User Adoption?
  • Blog # 9 – So, We Went Live, What Happens Next?

Who is Vivian Bringslimark?

© HPIS Consulting, Inc.

Is an Awareness Training Session enough for successful User Adoption?

Note: This blog is part of an ongoing series. Blog # 7 – Go-Live Strategy introduces the 5 Steps.

Go-Live: Step 3 – Develop the Rollout Timeline and Training Schedules.

A redesign of the quality system SOPs more than likely resulted in significant changes in routine tasks.  What changed, what was removed, what was added that is truly new and what stayed the same? Simply reading the newest version in an e-document platform will not suffice as effective training.  Nor will reading the change history page or reviewing a marked-up version of SOP for the highlighted changes.  When your previously delivered change management sessions include this level of detail, then the content of your training session can focus more on the new process.  If successful user adoption is tied to the effectiveness check of your CAPAs, then the project team needs to discuss what the training rollout will look like.  

Identifying Critical Users

From the stakeholders’ analysis for Affected Users, consider who is directly affected and indirectly affected by the change in responsibilities. Which users are most critical to ensure success with adhering to the new steps and forms? I refer to them as the Primary Users who are directly affected. They are usually more functional in their responsibility rather by department titles or business units.  Another way to determine this is to review the responsibilities section of the new SOPs.  Who in your organization are these people? In this review, are there supporting and ancillary responsibilities with the steps and forms?  I call this group the Secondary Users that are indirectly affected.  Both sets of users need to be fully trained in their tasks and responsibilities in order to ensure that the new system will function per the SOPs. 

The Training Rollout

Training Roll Outs need to meet three different levels of Users needs.

The overarching question to address is whether or not everyone has to attend the training.  One awareness training session for both groups is extremely efficient but not nearly as effective if the training sessions were tailored based on the level of user need.  See figure at the right.  Within the indirectly affected group are the senior leadership team members. 

An executive briefing is more likely to be attended by these folks when it provides a summary of what they need to know only.  What does the general population need to know about these changes?   Keep this short and to the point. It’s the Primary Group of Users who need to not only be made aware of the changes but to also know how to execute the new forms.  Yes, this session is a bit longer in duration than Awareness Training and it should be.  These Users have more responsibilities for correct execution. 

Simply reading the newest version in an e-document platform will not suffice as effective training. Nor will reading the change history page or reviewing a marked-up version of SOP for the highlighted changes.

Vivian Bringslimark, HPIS Consulting, Inc.

Who is the Trainer?

Depending on the level of involvement of the Design Team members, the following minimal questions need to be addressed:

  • Should the Project Manager deliver any sessions?
  • Will we use Train the Trainer approach?
    • Where each design team member is assigned to deliver Awareness Training for their area of remit.
    • Do these members have platform skills to lead this session?
    • Will they be provided with a slide deck already prepared for them?
  • Solely the responsibility of the QA Training Department
    • Provided s/he was a member of the Design Team
  • What kind of Training schedule will we need?
    • Will we provide three different tiers to meet the needs of our Affected Users?

Did the Training Roll Out Meet the Learning Needs of Primary Users?

While the revised SOPs were in the change control queue, the design team for this client met to discuss the difference between Awareness Training and Primary Users Training. Briefly, the differences were:

Difference between Awareness Training and Primary Users Training Content

Awareness Training is more knowledge-based.  It tends to be information sharing and very passive until the Q & A session.  A knowledge check at the end is no assurance that there will not be any deviations.  Primary Users Training is intended to focus on the behavioral changes that will be needed for adoption back in the department. The session can be a workshop with real examples that are generated from the users as part of their concerns and questions. 

The design team concluded that the differences were significant enough to warrant two different classes based on the type of user.  The risk of deviations was too great and would send a negative message to the site leadership team about the new process design.  Early adopters were not at risk because they were already trained via their participation in the design team. 

The task of developing the Awareness Training and Primary Users materials was assigned to the instructional designer on the team.   Attending the Awareness Training would not be a substitute for participating in the Primary Users class.  However, attending the Primary Users class would automatically credit the Awareness Training requirement for users if they attended.

Given that condition, the Primary Users materials also included similar content from the Awareness Training and then expanded the level of detail to include the sequence of steps for executing associated new and revised forms.  The Primary Users class was designed to provide more in-depth discussion of the changes and to provide adequate time to become familiar enough with their responsibilities to minimize disruption on the day the procedures and forms go into effect. 

The system owner then scheduled all users to attend the Awareness Training.  He concluded that there would be too much confusion between which class to attend. Since Awareness Training was being delivered first due to a very short Go-Live window, it would be better that they received the same training or so he thought.  In addition, the system owner felt that all employees were actually Primary Users and would not attend the training session if it went past 60 minutes.  As a result, Primary Users were never identified, and no learner matrix was generated.   No one asked for more training until weeks after the SOPs and forms went into effect. 

A knowledge check at the end is no assurance that there will not be any deviations.

Vivian Bringslimark, HPIS Consulting, Inc.

But rather than schedule the Primary User class, Users who had questions or concerns stopped by the department for 1-1 help instead.  For weeks, the staff was interrupted from their daily tasks and was expected to conduct impromptu help sessions.  The intent of the Primary Users class was to provide a hands-on training workshop for their impacted documents and not have to stop and go find someone for help.  The slide deck for Primary Users was eventually uploaded to a shared drive.  When the department got tired of being interrupted, the system owner put out a general email with the link and redirected late adopters to the website link.  The slide deck was not designed to be a substitute manual. 

Had the design team followed through with identifying lead champions, the Primary Users training workshop would have been delivered to a small group of users who then could have fielded questions from their colleagues.  The original design team members did not agree to be change champions nor trainers for their departments.  They complained about their workload already being heavy and had no time to address implementation questions.  That was for the training department to deliver, they concluded.  And then reported back to management that their direct reports could not attend a second session on the revised procedures.

Stay tuned.  Next blog includes Steps 4 and 5 of the Go Live Strategy and wraps up this series.  Become a subscriber so you don’t miss any more blogs. 

Who is Vivian Bringslimark?

© HPIS Consulting, Inc.

Do I really need a Go-Live Strategy for Redesigned SOPs?

Develop Your Go-Live Strategy Before Opening up a Change Control Request

Don’t underestimate what Go-Live will look like the day the new SOPs go into effect.  The overall project plan may reflect one lined task – [Go-Live] and the date, but who is responsible for making it happen?  Doc Control administration hits a button and the eDoc system sends out a notification or perhaps folks find out about the revisions and effectiveness date from their LMS notification. What else needs to be done, you ask?  Actually, a lot of things and without a detailed plan of assigned tasks or a set of instructions, the first week of Go-Live could be disastrous if not managed well.  Whether it is broken down further in the project plan or contained in the communication strategy, the plan needs to drill down into specifying how tasks and activities will be managed, by whom and by when. 

5 Basic Steps for a GO-LIve Plan
Steps to take BEFORE draft SOPs are sent to Doc / Change Control

Go-Live: Step 1 – Transition Options

Most quality system redesigns include more than one SOP.  Sometimes the project includes multiple work instructions that are designed to work in tandem.  Releasing one without the other automatically creates a departure from the new SOP.  One approach design teams take is to release the package all at once.  Other teams decide to release serially, one after the other with timed intervals to manage the learning curve. Other approaches include pairs or high priority clusters similar to a wave or a phased tactic.  All have their advantages and disadvantages. 

And all need an impact assessment that examines the details about what will change, how that change will be handled and how many users will be involved.  In other words, how many tasks could be out of compliance when the procedure(s) goes into effect?  Will the release shut down the organization on Day 1?

Now vs. Later – Timing is Everything!

A few years ago, a client received a pretty involved FD-483.  One of the corrective actions was to enhance the Training Quality System.  So, a project team was deployed, process maps verbally approved, and the revised SOPs were in various stages of being ready for a field test.  The design team was concerned that SOP decisions for in-process drafts could impact the final drafted SOPs significantly. The team needed to be able to update a final draft SOP immediately without getting bogged down in their change control process.  Not to mention managing a new round of awareness training that could change a week later!

So, as part of the Go-Live strategy, a decision was made to schedule the release of the procedures all at once when the final set of SOPs were ready to go to Change Control.  It was determined (assessed), that too many little changes for the Training System would result in confusion, retention issues, and a paperwork nightmare controlling which version of the form was correct.  This is a popular option for design teams because the coordination of new changes happens on the same day and is much easier to track. Albeit the learning curve can be high as the site works on closing the size of their change gap.

During the development of the last set of SOPs, FDA conducted a follow-up visit for the FD-483.  One of the training CAPAs was not yet completed. It was waiting for the redesigned set of procedures to go into effect.  The new version would encompass this observation and essentially close it out.   Unfortunately, this incomplete CAPA created a hold for product to be released.  As a result, the priority to complete a retrospective qualification of 700(+) “trainers” derailed the Training Quality System project for close to 4 months.  Additional immediate fix CAPAs were also generated.  Ironically, these CAPAs could have been avoided if the design team chose the serial release option. 

Go-Live: Step 2 – Who Will Do What, When?

Establish roles, responsibilities, and priorities for the transition period.  This means identifying the beginning and end date for the transition from what we used to do to what we will do by what date. When do we anticipate being fully operational with the new procedures?  Is the end date automatically the day the procedures go into effect? Or is there a sequence of tasks that need to be executed before the Go-Live date? Have those tasks been assigned to individuals with clear expectations and due dates?

We’re Still Open During Our Construction Phase!

One client began their Go-Live Strategy with Step 2 to help assess the impact of the changes to her organization which dictated the decision to release each SOP serially; one at a time.  Using a worksheet, each targeted SOP was listed vertically while impact criteria were listed horizontally.  The team need to “see” associated form numbers, cross-referenced SOPs, the actual impact, mitigation steps, how to transition, other impacted documents, disposition status and dates of those other documents and of course next steps. 

With careful examination of what tasks, forms, and steps were actually changing, the Project Lead was able to realistically determine how much time it would take to mitigate the impact.  Subtasks such as final form revisions and revisions to other documents were being monitored and project tracked as well. 

This information shaped a pragmatic and timed sequence of events. Resulting in the conclusion that releasing one SOP at a time was the most effective way to transition into the future state with minimal disruption despite that the overall policy document would have to be revised multiple times during the transition period.  The project lead volunteered to be the taskmaster on those subsequent policy changes and updates for the stakeholder briefings.

What else needs to be done, you ask? Actually, a lot of things and without a detailed plan of assigned tasks or a set of instructions, the first week of Go-Live could be disastrous if not managed well.

Vivian Bringslimark, HPIS Consulting, Inc.

Included in this impact assessment were numerous immediate response CAPA corrective actions.  It was vital to ensure that future state procedures did not eliminate commitments that were made to the agency.  These CAPAs resulted in subprojects that also needed to be managed within the overall quality system redesign project.  Given the scope of these projects, completion dates were projected to be 6 – 9 months out.  Yet, the future state quality system procedures were expected to be operational way before these subprojects came to fruition. 

In essence, the day the SOPs went into effect, the site would automatically be out of compliance and numerous deviations would have to be initiated.  To manage the SOP change gap, an overarching CAPA was approved to allow the organization to meet agency milestones and move forward with the new process while working on the subprojects.   With each planned release of a future state SOP, the impact assessment worksheet was updated with feedback including future release notes.

Be sure to be notified for the next blog – Step 3 – Training Rollout. Subscribe to Theory vs. Practice in the left sidebar menu.

Catch up on the previous redesigned Quality Systems blogs here.

Who is Vivian Bringslimark?

© HPIS Consulting, Inc.  All rights reserved.

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

Retraining and Refresher Training: Aren’t they one in the same?

I say no, not at all. Ask an Operations Manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.

Retraining is typically delivered as repeat training. Corrective Actions from *CAPAs usually trigger these types of required training events. In the context of the specific CAPA, we uncover the error, mistake, non-conformance or what I like to call performance discrepancy from expected outcome. It is believed that by delivering the training again, the cause of the discrepancy will be resolved. That is if the root cause was determined to be a lack of knowledge, skill or not enough practice.

Some folks believe that more is better and that with several repeated training sessions, employees will eventually get it right. It always amazes me that we find time to do repeat training over and over again but complain very loudly for refresher training, significant **SOP revision training or even new content training.   (*Corrective Actions Preventive Actions, **Standard Operating Procedures).Retraining Quote

Refresher Training implies that training was already provided at least once. The intention here is to review on that content.   A lot of regulatory training requirements are generated to satisfy this need. Common examples are Annual GMP Refreshers and several OSHA standards such as Blood Borne Pathogens training. While the aim is to refresh on the content, it is not necessarily meant to just repeat the training. Also included is the part – “so as to remain current” with current practice, trends and new updates. Hence, refresher training needs to include new material based on familiar content.

Upon Biennial SOP Review

There are some folks who would like to use this required SOP activity to coincide with the need to “refresh” on SOPs already read and/or trained. The rationale being that if the SOP hasn’t revved in 2 or 3 years time, more than likely the training hasn’t been repeated either. So, it sounds like a good idea to require that SOPs be “refreshed” upon using the same SOP cycle. One could argue for the prevention of errors; thus, in theory, this sounds very proactive.

But donning my Instructional Designer Hat, I ask you, what is the definition of training – to close a knowledge gap or skill gap. What value is there for forcing a mandatory “refresher reading” on SOPs just because the procedure is due for technical review? In practice, this becomes one huge check mark exercise leading to a paper work /LMS backlog and might actually increase errors due to “information overload”! Again, what gap are you trying to solve? In the above refresher scenario, we are avoiding a compliance gap by satisfying regulatory requirements.

Refresher Retraining

Defending Your Training Process

For those of you who have fielded questions from regulators, you can appreciate how the very training record produced generates follow up questions.   How you describe the conditions under which the training occurred or is “labeled” can impact the message you are sending as well. Calling it retraining instead of refresher training implies that training had to be repeated as a result of a performance problem not meeting expectations or standards. Whereas refresher training occurs at a defined cycle to ensure that the forgetting curve or lack of practice is not a factor of poor performance. It is a routine activity for satisfying regulatory expectations.

For end users, clarifying the difference between refresher training and “repeat” training in your Policy/SOP not only defines the purpose of the training session, it also provides the proper sequence of steps to follow to ensure maximum effectiveness of the training. There’s a difference between training content that is new /updated vs. delivered as a repeat of the same materials.   Yes, new and/or updated design takes resources and time.   How many times do you want to sit through the same old same old and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change.   You just might want to review your Training SOP right about now. – VB

 

 

With a little help from my Validation Colleagues – The Training Protocol

In the blog, “Learning on the Fly“, I blogged about an urgent learning need requiring instructor-led classroom delivery that needed to be facilitated among a group of talented SMEs.  During the needs assessment portion, I hit a huge barrier.

“I teach GMP Basics and conduct Annual GMP Refreshers several times a year and preach to audiences that you must follow the procedure otherwise it’s a deviation.  And in less than two weeks, I am expected to teach a process that is changing daily!   Yet on the other hand, how could I teach a work instruction that is known to be broken; is being re-designed and not yet finalized?”

My dilemma challenged the essence of my “learned” compliance belief system about following the 1st basic GMP principle – “thou shall follow written procedures”!  The instructional designer side of me screamed – how can you teach flawed content?  That’s wasted training that results in scrap learning. How is that training going to be effective beyond a check in the box?

And then it hit me – validation engineers use protocols to capture their “change in process” work.  Whether it’s experimental batches, 3 batches for process validation or *IQ-OQ-PQ protocols for equipment qualifications.  They are validating the procedure or the new process before it can become the standard operating procedure by developing the plan, developing acceptance criteria, managing the unexpected deviations and capturing the results.  So why couldn’t I borrow the concept and adapt it to my situation?

While it was the intention of the business unit leader to deviate from the approved set of work instructions, a planned deviation would not be appropriate in this case.  The purpose of the training sessions was to test the new sequence of steps and confirm the robustness of the criteria to make correct decisions where needed.  The learners would still be in compliance with the quality policy document and would still meet the intention of the quality system regulation.  They were essentially testing the future “how-to steps” for the proposed new work instructions.

Now before you fire off a rant of emails to me, I did not copy and paste the validation protocol template.  I did however, include a “please pardon our appearance while we are under construction” paragraph in the training plan to document the departure from the current set of work instructions.  This protocol like section also included our intentions for the outcomes of the sessions and stipulated required SOP training of all affected users once the finalized set of work instructions were approved and went into effect.

Sometimes the very solution can be found around the next cubicle.  –VB

*Installation Qualification, Operational Qualification, Performance Qualification

(c) HPIS Consulting, Inc.

“Learning on the fly” or is this what they meant by the Agile Learning Model?

When Rapid Design for E Learning found its way into my vocabulary, I loved it and all the derivatives like rapid prototyping.  And soon, I starting seeing Agile this and Agile that.  It seemed that Agile was everywhere I looked.  When Michael Allen published his book, LEAVING ADDIE for SAM, I was intrigued and participated in an ATD (formerly known as ASTD) sponsored webinar.  It made a lot of sense to me and “I bought into the concept”.  Or so I thought …

 

A few weeks back, I joined a project that was already in-progress and had to “hit the ground running to get caught up to speed”.  The element of urgency was the anticipation of a post FDA visit following a consent decree.   If you’ve experienced this “scene” before, you can relate to the notion of expedited time.   As part of remediation efforts, training events needed to be conducted.  I learned during a meeting sometime my first week, I was to be the trainer.  Okay, given my background and experience, that made sense.  Sure, in a few weeks when we have the new procedure in place, I’d be happy to put the training materials together, is what I was thinking.  Wait – in two weeks?  Are you kidding me?  I’m not the SME and I don’t even have the software loaded on my laptop yet.  Well, some cleaned up version of those words was my response.

 

But what about all that buzz for rapid design and prototyping I’ve been reading about?  In theory, I totally bought it.  But, this is different I argued with myself.  This is compliance with a quality system for a company who is undergoing transformative change as a result of a consent decree!  I teach GMP Basics and conduct Annual GMP Refreshers several times a year and preach to audiences that you must follow the procedure otherwise it’s a deviation.  And in less than two weeks, I am expected to teach a process that is changing daily!   Yet on the other hand, how could I teach a work instruction that is known to be broken; is being re-designed and not yet finalized?  Stay tuned for a future blog about how I overcame this dilemma.

 

My bigger issue was to get out of my own design way.  I’m classically schooled in *ADDIE and with 25+ years as an instructional designer, very comfortable with how to design, develop and deliver training.  All I needed was more time and it hit me!  I was so focused on what I needed, that I was missing the urgency of the learners’ needs.  It was time to put theory into practice and take the agile plunge into the domain of the unknown.

 

By shifting the prioritization away from perfectly designed classes with pristine training materials, I was able to diagnose that the need was to get the learners into a live classroom.   They needed to see the database software in action and “play in the sandbox”; the training materials could follow afterwards.  I shifted my role to facilitator and found the true SMEs to navigate the software screens and explain how to complete field transactions.  To my surprise and delight, trainer-wannabes volunteered to paste screen shots into participant worksheets so they could take notes.  I became a scribe and worked on sequencing these pages for the next round of attendees.  Together, we all collaborated to meet the urgent need of the learners.   And we documented it!  Once they had the tour and sand-box time, the learners were paired up with a buddy for guided instruction of real entry into the live system.  The following week, the department was able to go live with a project plan that focused on a series of interim roles, changed roles and transitioning responsibilities within established roles.  The project launched on time to meet commitments promised to the agency.

 

It was energizing and empowering for the learners. A truly collaborative experience for the SMEs and the biggest surprise of all was that they thanked me.  Me?  I did not deliver the training; I was not the SME nor did I provide perfect training materials.   If I had pursued my classically trained ADDIE technique, we’d still be waiting to deliver those sessions.  However, I’m not ready to throw ADDIE over board yet.  She has served me well and continues to be an appropriate technique in most of my training needed situations.

 

My lesson learned was this: when the need is for speed and the design is not the key focus, I need to give up control to the SMEs and Learners and focus on facilitating the best learning experience given the daily change challenges and system constraints.   Is this “learning on the fly” or agile learning in practice?  You decide.

 

*NOTE: ADDIE = Analyze, Design, Develop, Implement, Deliver – classic phases of Instructional Systems Design (ISD) Technique.