Please Pardon Our Appearance: We Are Remodeling Our Quality Training System!

An urgent request to fix a broken training system is typically the point of entry for my Robust Training System (RTS) makeovers.  When I join the conversations, I discover that a lot of “work” has already begun.  So, I take a deep dive into the documentation to “hit the ground running and get caught up to speed” as quickly as I can. By this time, the agency response letter has already been sent with commitments to correct observations and promises to fix system issues.  And immediately, CAPAs are opened to track these activities. Sigh.  [CAPA = Corrective Action Preventive Action]

So often, immediate fix CAPAs are generated so quickly and only focused on the fast fix of the observation, that the short-term benefit becomes a major barrier for the long-term prevention of a systems upgrade.  The advice that is given to a CAPA owner is “don’t fixate on the big picture right now, we can always revise it later…”. “We’ve only got 15 days to respond to the agency”.  While revisions are part of our SOP management system, revising the CAPA fix to something else in the next revision can appear to look like it was only for the FD-483 observation or the Warning Letter response. 

And a lot of the time, those CAPA fast-fixes conflict with a proposed future state.  It can become a huge obstacle to redesigning an effective and efficient quality training system.  There is a belief that it takes too long to map out the proposed future state and pinpoint exactly where the observation or citation gets corrected.  Given how some redesign projects are managed, there is a lot of truth to that belief.  So, the rule of thumb is to correct first, then come back and “improve” later when site employees have a moment to catch their breath.  But closing out those fast-fix CAPAs in record time prevents redesign projects from moving forward because available SMEs are busy executing the corrective actions.  What’s really frustrating is realizing that the fast fix is incompatible with the proposed future state. Sigh again.

Little CAPAs and Big CAPAs

By little CAPAs I am referring to the immediate fix corrective actions and in no way am I minimizing their importance.  Their scopes tend to be single focused and short term.  By comparison, big CAPAs are created when many of the little CAPAs are rolled into one big CAPA.  The scope is expanded to include the related little CAPAs because the corrective actions relate to each other, impact each other, and may produce repetitive paperwork.  So, all the CAPAs get bundled together in an overall CAPA aka, the big CAPA.

Little CAPAs and Big CAPAs

When this occurs, be careful that little CAPA commitments to the agency via response letters don’t get lost in translation.  By that I mean, the fast fixes need to remain visible or traceable in the deliverables of the project.  If by chance those steps were removed or changed, be prepared with heavily documented justification with appropriate approved signatures like Department Heads.  Take note, merging little CAPAs into one big overarching CAPA usually changes the completion timeline given that the scope of the big CAPA is bigger.  For most projects, this is a welcomed relief.  It can also change the timelines of the little CAPAs.  Be mindful of the commitments made to the agency. 

But We’ll Be Out Of Compliance The Second The SOPs Go Into Effect!

One way to keep multiple CAPAs visible is to create subprojects that are also managed within the overall future state project.  Sometimes these projects have completion dates projected to be 6 – 9 months out.  Yet, the future state quality system procedures need to be operational before these subprojects can come to fruition.  In essence, the day the SOPs go 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 (the Big CAPA) can be generated to allow the organization to meet agency milestones and move forward with the new process while working on the subprojects.  The key to this approach is ensuring that the implementation plan is written, approved, up to date, and indicating progress forward.

During the development of the last set of redesigned SOPs for a client, FDA conducted a follow-up visit for the original FD-483 inspection.  One of the little 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.  

As part of their Go-Live strategy, a decision was made to schedule the release of the revised procedures all at once when the final set of SOPs was ready to go to Change Control.  It was determined 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.

Unfortunately, this incomplete CAPA created a hold for product to be released.  As a result, the priority to complete a retrospective qualification of 700(+) SMEs as Trainers derailed the Training Quality System project for close to 4 months.  Painfully, additional immediate fix CAPAs were also generated.  Ironically, these CAPAs could have been avoided if the design team chose to release each SOP as it was ready instead of waiting for all of the SOPs to go into effect all at once.

Be Mindful Of The Quest For The Perfect SOP

The most typical corrective actions involve revising procedures to include a changed step, a form revision, or in some cases, a completely overhauled process that includes multiple work instructions or SOPs.  Standard Operating Procedures mean a description of the approved steps for the task at hand to be followed repeatedly without exception or deviation.  But SOPs are not static, they change frequently which is a good thing for folks who seek improvement and a source of exasperation for the end users assigned to keep current with their procedure revisions.  

Change fatigue is real and can often be the root cause of SOP deviations.  CAPA owners need to be made aware of the learning curve for major revisions. Hence, awareness training and primary end-user workshops are integral for implementation strategies.  However, the antidote for SOP change fatigue is not waiting for the perfect SOP that will never change again!  But knowing in advance that a procedure is going to revise multiple times is also frustrating.  Just when end users get used to the change(s), the SOP changes again and quite possibly re-introduces a host of deviations almost suggesting that the changes are a waste of time and energy. 

There Is No Such Thing As The Perfect SOP; Don’t Delay CAPAs Unnecessarily

What then is the remedy? Conducting impact assessments of the change(s) and then managing the go-live strategy for awareness training, triage support, and FAQ type communications depending on how big the change gap is.  And this is exactly the approach that one Quality System L & D Manager implemented as part of the go-live strategy for a major overhaul of her training system. 

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

Agile Approach Enables SOP Change Resilience

The timed sequencing of these revised SOPs addressed potential version confusion and change fatigue.  By managing smaller rollouts, there was less impact on the organization.  The Training Manager was able to introduce the employees to SOP change resilience by combining awareness training, project briefings and end user feedback for the “next SOP revision”.  Rather than dread the next release, end users discovered that their feedback was taken into consideration.  And in most SOPs, the next release didn’t really change anything but rather added another component or element of the future state that they were now ready to implement. 

The iterative design and roll out expedited a continuous improvement cycle that kept the project moving forward to meet FDA commitments, milestones, and stakeholder expectations.  -VB

There is no such thing as the perfect SOP!
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Who is the Author, Vivian Bringslimark?

(c) HPIS Consulting, Inc.

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.

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.
BandAidsPicture1
Why the Band Aids Keep Falling Off
OpErrorPicture1
Operator Error: Is That Really the Root Cause?

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Remember, we are not allowed to talk about 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 see how Cara facilitates the design team of SMEs through various stages of being of team.

“Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

“But, who are you?  I mean you just can’t walk in here and change our procedures!” she retorted.

“Ah, yes, I have been vetted by Miguel, you know, the VP of Quality and have already met several of his peers during the assessment debriefing meeting.  They have all read the assessment report and agreed for these SMEs to be the design team.  You can look me up in Linked-In later if you want to.  But for now, would you like to take a seat or will you stand for the rest of the lesson?” she asked.

The timing and sequencing for the last lesson, “Foundations of Teamwork” was not accidental.  Cara set up the curriculum to build knowledge first with an immediate need to apply in order to close their knowledge and experience gap and prepare them for the much-needed discussions without getting bogged down in terminology.  This last lesson introduced them to stages of team development and what to expect as the honeymoon phase of the project faded and the real work began.  A key piece of this lesson was to emphasize how to offer a different perspective while maintaining respect to team members (their peers) rather than remaining silent when not in agreement.

(Re)-DESIGNING A SYSTEM: FUTURE STATE VISION

With these 4 lessons delivered, Cara returned to the previous assignment of marked up process flows.  Cara anticipated that most of the team might have difficulty envisioning a future state that would be different from their current state.

Design Team Readiness Curriculum

“Thank you for your time and participation in the last four meetings and special thanks for those of you who have already been trained on these concepts.  The temptation to skip it and finish other pressing work was very real and your enthusiasm to show up and attend speaks volumes to your commitment to the team and for the project,” said Cara.

But that’s not how we do it here!

“Before we delve back into these marked-up process flows, I ask that you remain open to ideas and suggestions not only from me but from your colleagues who have come from other similar companies.  It may be difficult to envision a future state that looks different from today, but please don’t let that become a barrier for you.  If you find yourself thinking or saying ‘that’s not how we do it’, then you need to ‘fess up and ask for patience’ while you recognize what state you’re in.  Can you all do this?” Cara asked.

To quiet fears that this was all a big waste of time or that “management will never buy into any of this” Cara initiated a project issues log.  She assured them that this list would be on the agenda for each weekly check-in with Miguel.  And the updates would be reflected in the weekly project status updates.  Teams often stall or lose momentum when issues and concerns go unresolved, so Cara told the team that this was also part of her role as interim project manager.

“Remember, we are not allowed to talk about change control!”

Each week the team met to redesign one process flow at a time from the training policy to curricula management to qualified trainers, training delivery, and effectiveness measures.  Cara monitored how the team shared their differing points of view and how receptive they were to work on a joint process that could be implemented across the functions not just for Operations or for the QC lab. 

Without fail, the energy and momentum would derail when the discussion found its way to the current state of their change control quality system.  Once again, the role of Cara as interim project manager was to get them back on track, future-focused, and not get mired in current barriers.  For the most outspoken member of the team, this nearly shut her down.  It was a real barrier and nearly threatened to compromise the team’s future success.

“Yes, there is no denying that change control needs to be fixed.  That what we are proposing will not fly with how it is defined today,” said Cara. 

“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.”

And then Cara directed the next question to the member in distress.

“Can you proceed with us knowing that change control is out of scope for us?” she asked.

“No.  This is the wrong priority and all this work will have to be redone because it will be rejected by the Change Control Manager when it’s all said and done!” she retorted. 

“What if you were to be the Change Control Manager, would this change your viewpoint?” asked Cara.

“No, I don’t want to be the Change Control Manager.  I just want change control fixed now,” she snapped and then shared a litany of items that were being delayed because of the backlog in change control.

“Can you proceed with us or shall we find a replacement for you?” Cara asked again.

“Let’s continue and I’ll make a decision before our next meeting,” she mumbled.

The rest of the team sat still and watched the volley back and forth.  Apparently, this was not the first time the team experienced their peer’s change control rant.  This time, however, the team was mesmerized by how Cara maintained respect while letting their peer air her frustration; truly modeling team rules and getting to the heart of the matter.  Cara practiced what she taught in the earlier lessons.  After this episode, whenever anyone even said the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

Want to finish the story? May I See Your Implementation Plan for this Change Control?

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Interested in Robust Training System resources?

You might find the Redesigning Quality Systems blog series insightful. Read the series here.

Congratulations, you have been selected to be on the Design Team

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.

Miguel then went on to explain, “they don’t know how to be a team. They know even less about project management concepts like scope and project charters and they lack fundamental concepts like quality systems and systems based inspections. And they certainly don’t know about process mapping. It’s not their fault, many of them never worked anywhere else but here. They have been siloed far too long.”

In part 2, we pick up with Cara meeting the design team for the first time.

“Do you know why you are here?” asked Cara.  As expected, most of the SMEs shrugged sheepishly.  To that end, Cara provided a brief explanation of the request and then presented a high-level view of the assessment gaps to the SMEs as the basis for the project scope.

For some of you, being on a team and working with process maps is quite familiar.  Yet, there are others here today, where this will be their first project as a team of SMEs.  I’ve been asked to provide a few short introductory ‘lessons’ to help orient us around a set of ground team rules and establish a common lexicon for this project.

SME Design Team Readiness Curricula

Cara continued.  “Over the next few weeks, we will begin our time together with one of these lessons.  As a team, we will use ‘live’ aspects of our project work to illustrate the concept and apply its principles to our progress and development of a team. Let’s begin with ‘Six Elements of Robust Training System’ .”

After the lesson was presented, Cara asked the SME design team to locate the assessment report and match the gaps to the six elements.  This exercise helped the team achieve one of the learning objectives and at the same time rendered the report more meaningful for their project kick-off. 

Miguel then went on to explain, “your ‘Design Team of SMEs’ has very limited experience working cross-functionally or as a team.”

The next lesson “Launching a Project Team” introduced the team to project management 101 terms and the concept of a project charter.  The application exercise became the completion of their project charter and familiarize themselves with the project management terms being used for the RTS project. In preparation for the third lesson, the team was asked to review a set of generic training process maps and mark up their copies with comments and questions.

“Excuse Me, Who are You?”

At the beginning of the next lesson, a nominated SME stepped into the room just as Cara finished the opening of their third lesson “Process Mapping Quality System Documents”.

“Hello, are you joining us today or only staying for the presentation?” asked Cara.

“Well that depends on how you answer my question,” she replied. 

“Please sit down and I’ll do my best to answer it,” Cara responded.

But she stood in the doorway anyway and continued. 

“Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

“As I explained during the kickoff and then again during the first two lessons that you were absent from, I am not here to train you on your procedures.  These folks here are the experts on that.  I am here to work with them on your training process.  Training is a quality system and your process needs to be robust enough to handle all of the training elements within that system.  The assessment I conducted revealed many areas that are not up to today’s standards nor FDA expectations,” Cara replied.

“But, who are you?  I mean you just can’t walk in here and change our procedures!” she retorted.

“Ah, yes, I have been vetted by Miguel, you know, the VP of Quality and have already met several of his peers during the assessment debriefing meeting.  They have all read the assessment report and agreed for these SMEs to be the design team.  You can look me up on Linked-In later if you want to.  But for now, would you like to take a seat or will you stand for the rest of the lesson?” she asked.

Reluctantly, she stepped into the room and found a seat.  This third lesson oriented the team on process mapping diagram shapes and commonly used terms, as well as a balanced discussion on vertical process flows vs. horizontal “swim” lanes.  Using their marked-up copies, Cara facilitated a question and answer exercise on project management terms, concepts and flow only. 

The team was asked to continue reviewing the process flow diagrams as their homework task but this time to focus only on content within the shapes and was told that after the next lesson, the collaboration of ideas and suggestions would begin.

Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

The timing and sequencing for the last lesson, “Foundations of Teamwork” was not accidental.  Cara set up the curriculum to build knowledge first with an immediate need to apply in order to close their knowledge and experience gap and prepare them for the much-needed discussions without getting bogged down in terminology. 

This last lesson introduced them to stages of team development and what to expect as the honeymoon phase of the project faded and the real work began.  A key piece of this lesson was to emphasize how to offer a different perspective while maintaining respect to team members (their peers) rather than remaining silent when not in agreement.

Stay tuned for Part 3, where Cara works with the Design Team to envision the future state for their robust training system.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Learn more about Robust Training Systems here.

How Big is the Change Readiness Gap – Part 1

This blog is Part 1 of an impact story about recognizing what a robust training system (RTS) meant for the future of a small vitamin and supplements company.  But first, they needed to build their change foundation in order to sustain their desired state.

First comes awareness: discovering where the gaps are

Miguel finished his preliminary assessment of the company’s quality systems as part of his first 90 days task list.  The Training Quality System was the last one on his list.  He sighed.  This is not going to be easy, he said to himself.  With so many systems needing to be updated, I cannot do this alone, he concluded.  So, he clicked on his laptop and located a recent congratulations email from a LinkedIn contact who happened to be a performance consultant (PC).  In the subject line, he typed, “I need your help, got time to chat?“.

Miguel explained to Cara the PC, that he was recently hired as VP of Quality.  His first major initiative was to get the organization ready for a comprehensive systems-based inspection.  They had been successfully producing products with sales above forecasted targets for several years now.  Previous regulatory inspections were favorable and did not indicate GMP compliance issues that couldn’t be mitigated with a few minor procedure updates.  “So, the Board of Directors decided it was time to launch a new product line and become a commercial manufacturer”.  He took a breath and continued.

“What I am finding is that they have very basic rudimentary systems for making OTC supplements, but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.

To which, Cara asked, “What about training?  What’s in place?”

Nothing, really.  I mean they have a procedure and all, but it’s not like what you did for me last time.  It’s nowhere close to today’s standards or FDA’s expectations.

Current State of Affairs

Miguel then went on to describe the small QA Training staff, their reporting structure and then asked when Cara could be on site.  She refreshed Miguel on her approach and reiterated that an assessment of the current state was in order.  He gave her the contact information for his Quality System Manager and ended the call relieved that his PC was available and interested in helping him succeed with his initiative. 

After two days of back-to-back interviews and a review of the requested documents, Cara wrote the report with recommendations and arranged for a conference call with Miguel and his site trainer.  With observations confirmed, the remainder of the discussion focused on a review of the project phases in which the recommendations would be implemented.  Cara requested an on-site meeting with the primary stakeholders to debrief the findings and provide an overview of the Robust Training System (RTS) project.  Together they were going to be asking for a team of cross-functional resources.  Miguel agreed it was a good idea and they set a date and time. 

“… but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.

Is training really a priority?

The day before the meeting, Miguel learned that his boss would not be on-site and therefore unable to attend the meeting.  He called his PC and together they picked a new date; one month out.  Once again the meeting was canceled due to the unavailability of Miguel’s boss and his peers to attend a 60-minute briefing on what they all deemed was a critical and important project for the company’s future state.  This time, Miguel did not automatically re-schedule.  Instead, he postponed the meeting indefinitely.

Three months later, he contacted Cara.  “I apologize for the delay.  I believe we are now ready to have you come back on-site,” he said.

“Okay, this is great news.  What happened?”

“After I canceled your meeting for the second time, I had a heart-to-heart ‘chat’ with my boss.  Believe me, it was not an easy conversation to have with him.  I told him that without his support and I meant physically show up and attend this debriefing meeting, no one else will show up nor take this project seriously.”

“Wow!  That was a bold move for you just being hired and all,” Cara exclaimed.

“Oh, I already told them in my interview that I was going to shake things up and that if this isn’t what they wanted, don’t hire me.  But if you are serious about growing your business, I’m the quality guy to make that happen for you,” he replied.

“So how did you leave it with him?  Is he going to attend the meeting?” Cara asked.

“No.  A lot has changed since you were here.  All good and in the right direction.  I mean with the leadership and with funding.  We are finally getting job requisitions approved and attracting experienced candidates for interviews,” he explained.

“This is good news; we are going to need those people to help implement many of the quality system improvements,” Cara responded.

(Re)-DESIGNING A SYSTEM: PROJECT LAUNCH

They switched gears and focused on the agenda for the debriefing meeting.  Miguel asked Cara to emphasize certain slides in her presentation; namely, the collaboration benefits and the shared ownership of the quality training system.  More specifically, he wanted to hone in on the message that this 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.  

After the executive briefing meeting, Miguel asked Cara to join him in his office. 

“Okay, that went better than expected, don’t you think?” asked Cara.

“Yes, there was a lot of discussions last week about the importance of this (your) RTS project,” he replied.

“Oh good.  I’m glad we waited three months.  The project would have floundered and then died on the vine,” Cara replied.

Seriously, yes, but now we have another problem.  Let’s call it a challenge; a training and development challenge that I believe is right up your alley,” he said.

Miguel then went on to explain, “your ‘Design Team of SMEs’ has very limited experience working cross-functionally or as a team.”

He explained further. “They don’t know how to be a team.  They know even less about project management concepts like scope and project charters and they lack fundamental concepts like quality systems and systems based inspections.  And they certainly don’t know about process mapping. It’s not their fault, many of them never worked anywhere else but here.  They have been siloed far too long.”

“Oh, okay.  This does change things a bit”, Cara replied.

“I was thinking about your curricula building background and quality systems work.  You could work with them and provide the necessary training that they need” he suggested.

“Yes, it means more time on-site and I need to push out the due dates for the deliverables.  But I’m concerned about content overload.  Why don’t I teach them what they need to know in the moment the project needs it, you know like just in time training?”  she said aloud.

Miguel nodded his approval and Cara left his office with a sketched outline of a mini-curriculum for the Design Team of SMEs.  Two weeks later the team met for the Project Kickoff meeting.

Part Two: Cara has to teach and coach her design team of SMEs on how to be a team, introduce them to quality systems, project management concepts and how to process map a quality system.

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Who is Vivian Bringslimark?

(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.

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Catch up on the previous redesigned Quality Systems blogs here.

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