When Your GXP Learning Provider Becomes Your Strategic Partner

“So, they want me to ask if you would do the GMP refresher for us.”

“No.  I did the GMP Basics last year.  It’s only been 4 months and I am not going to repeat the content or water it down or “just tell them the GMPs”. 

“Well, I can’t do it by myself, not after you’ve introduced us to activities.  I don’t know how to create meaningful exercises.”

“Let me think about this some more.  What’s currently happening on site, other than last year’s 483? Do you have any updates we can use?”

“Oh, there was an audit done and you know they found stuff.  Folks are kind of hot about it, actually.”

“Okay, now we have something to work with.  I’ll do it on two conditions.  1.) That we use the audit observations and 2.) I need 90 minutes.”

“Nope, not going to happen.  No way for the 90 minutes. Oh, and they want to keep the audit observations ‘confidential’.  We’re not allowed to use them.”

“Then you’ll have to find another consultant to do it. After the training we did last year, I cannot go back to lecture only.  I built trust with your employees.  And you and I learned that we need to add time so that they can complete the quiz at the end and not feel rushed”. 

“I really want you to do it.  I will go back to the management team and tell them you said yes. But I need a proposal justifying the 90 minutes and describing what you will do with audit observations.”

The Quality of Previous Learning Provider Engagements

This organization is a leading manufacturer and distributor of regulated products.  They received Form FD-483 observations the year before.  Among the remedial actions, was a “Back to GMP Basics” training program for the entire site including indirect support and non-GMP staff.   

Not only were sessions content tailored for varying roles, but employees were also introduced to interactive exercises and collaborative activities that encouraged them to share responses with their seatmates.  For many of them, this was a totally different GMP learning experience.  Employees were no longer grumbling about the training and management was able to produce the required paperwork to the agency. 

As part of the remediation plan, the client also pledged to increase the frequency of GMP refreshers to twice a year.  Given the favorable outcome from the previous GMP Training program, it was suitable that the management team extended an offer to conduct a refresher.  What was a surprise, however, was that the management team wanted their old – “gloom and doom, thou shall follow these regulations” style of telling them the GMPs from the podium.  Why? Was this a form of punishment?  It sure felt like it.

Management Team Knew Their Priority

At the time of the above request, 4 months of the year had already transpired.  During which, a follow-up audit of their GMP systems was conducted by a separate consulting group.  The audit found numerous examples of recent noncompliance.  The site leadership team was also reminded that the 1st GMP refresher was coming due.  The head of Quality made the decision to use the GMP refresher as a corrective action for the audit.

Kudos to the Head of Quality for doing three things.  First, he recognized that the c in CGMPs was the audit findings and resulting noncompliance examples.  Two, he leveraged the resource of QA Training and demonstrated just how strategic the role should be to the organization by elevating the importance of this refresher.  He used a systems approach when he tagged the delivery of this refresher to the corrective actions for the independent audit.  This was quite novel at the time.  And third, he approved the request to provide his Training Manager some help. He connected all the dots between the independent solos!

Their Decision to Outsource

Their “GMP Trainer” was also the manager of the company-wide training database.  He was a department of one whose primary duty was data entry into a complicated and non-user-friendly training database.  Time to develop and deliver the GMP refresher was something this manager did not have.  The sooner it could be delivered, the sooner the training manager could get back to the mounting stacks of attendance records awaiting data entry.

 “Just tell them the GMPs” one more time is what the management team was originally asking for.  The learners were expected to sit and listen.  After all, they used to be scolded for poor compliance results. One employee referred to it as “shame and blame” sessions with their heads down to avoid eye contact with the presenter; especially if it was a leader from Quality Operations.

The management team wanted to bring back their learning provider and they wanted to dictate how the refresher would be conducted.  To revert to lectures only would break the trust the learners had built with the GMP Learning Provider and jeopardize any successful transfer of behavior change to the workplace.

Corrective Actions are supposed to remediate, right?

The independent audit revealed several examples of non-compliant actions taken.  When categorized, these actions clustered around three main areas.  If the “corrective actions training” aka the GMP refresher was going to remediate these findings, just telling them what the regs say without any discussion or collaborative processing of what these examples were showing, would have no effect on eliminating or reducing further GMP “mistakes”.  What did the management team expect to happen because of the training?  I imagine no more examples of GMP violations?  

Aligning Business Needs with Quality Objectives Yield a Strategic Focus

Shifting the behavior towards appropriate compliance begins with shifting mindsets around compliance.  Working with the three categorized areas, the management team agreed to the following three business outcomes:

  1. Continued commitment to comply with our GMP Work Habits
  2. Follow Good Documentation Practices for our controlled documents
  3. Perform our responsibilities for operating equipment in our work areas

While these outcomes were great goals, they were also very broad and hard for learners to put into daily practice; let alone change their behavior.  Effectiveness checks for training was another commitment to the agency as part of the GMP Training program improvements.

Furthermore, measuring the effectiveness of the GMP refresher training would require more than a knowledge check if behavior change back at the workplace was their end game.  What would the CAPA effectiveness checks look like for this corrective action as well? Recall, the two quality system activities were now interlinked.

In further discussions with the Head of Quality, the business outcomes were transcribed into quality themes and key messages.  These then drove the decisions for specific content pieces and activities that targeted what compliant behavior should look like regarding the 3 quality themes. 

To further quell any negative ramifications using audit findings, the chosen examples were approved by the Head of Quality and a courtesy copy of the refresher materials was provided to the management team in advance. 

Designing, developing, and delivering the refresher course topics with even more interactive opportunities all the while ensuring that the previous GMP Basics content was refreshed, not just repeated, became the basis for the activities.  It was analogous to “a Part 2” in which employees were allowed to “interact” with both the regulations and real-time scenarios (selective audit observations). 

When a Learning Partnership Works

One of the advantages of working with a previous learning provider is the ability to create an ongoing learning path built upon previously delivered content; not just provide a “canned” presentation on the requested topic.  There is a willingness to work with internal resources and integrate existing artifacts such as audit findings into the course design so that the organization achieves its business outcomes beyond just closing the CAPAs and getting a checkmark for delivering the first of two promised refreshers. 

Value and Impact: Training Effectiveness Results

  • Assembling into pairs and groups was achieved in less time than when first introduced in the GMP Basics series.  The Learning Provider now had credibility and the employee’s earned trust. The relevance of the audit finding examples kept employees engaged with many of them asking private questions at the end of the sessions.  This was unheard of previously, thus initiating the “transfer back to my job”.  They were thinking about how these examples and the GMP content applied to them.
  • A 5-question quiz was administered as part of their effectiveness training check.  This is the classic tool for knowledge comprehension and their newly revised SOP now included Knowledge Checks (KCs) for GMP Training.  400+ employees completed the quiz.  The mean score was 91% with several achieving 100% and a few failing scores.

Why Knowledge Checks Don’t Tell the Whole Story …

Using an item analysis can reveal a lot of information about the construction of the GMP KC questions.

As always, it is possible that some memorization and sharing the correct lettered responses happen despite that there were three versions of the KC.  It is also possible that some folks do not take the time to read questions thoroughly.  And some folks don’t recognize when “all of the above” choice applies.  They are in a rush to exit the class. 

Pay attention to incorrect responses that are clearly wrong as in they don’t make sense.  It may indicate a “cheating trend” if only one version of a quiz is provided.  In this case, three versions of the quiz were used.

When responses are troubling; a follow-up discussion with an SME or a “legacy” employee is needed to determine if an old, outdated, and non-GMP practice was acceptable at one time.  Knowing this gives some insight into why it was chosen but disheartening that the behavior is still prevalent.  If the behavior is still happening, it warrants further discussions with site leadership and the Head of Quality.  It may be isolated to a few individuals and can be managed via the HR performance management system.

Sometimes verbal responses to a question in class, don’t match the chosen response in the quiz.  The quiz results could be a matter of confusion with the wording of the question especially for Assessment A in which the question had a NOT worded in it, rendering the answer to be False.  It’s akin to a double negative and it trips up a lot of people who are not test-savvy.  So be careful with questions that can be confusing or tricky.  For this client, it was worded to capture a real scenario that happens in the industry. 

This client was urged to address failing scores; results below 80%.  Their Training SOP had recently been revised to include formal assessments for GMP Training and Critical Task SOPs as part of their effectiveness checks for training.

  • The priority for the refresher was agreed to by the site management team and communicated to everyone during the sessions.  The FDA remediation plan was still a focused site objective, and this refresher was part of those activities; not something in addition to like an after-thought or add-on.
    • Three outcomes were identified as the business needs and became the driver behind content and decisions for activities. The “Big Why” for this refresher was clear and compelling.  Tangible work-behaviors were user-generated for peers to model as examples of complying with the GMP Work Habits.
    • There was continuity with previous GMP content.  The existing GMP Learning Provider connected the dots with prior content and reinforced the relevancy and importance of the GMP Work Habits.  Rapport was re-established and on-going trust for an engaging and interactive session of 90 minutes was achieved.  Minimal repeat of previous content; refresh enough to complete an activity.
  • Learning Provider negotiated with Site Management Team on behalf of the Learners Needs: to include real workplace audit observations and an additional 30 minutes of classroom time that included the GMP quiz and debrief of the correct answers. Employees left each session with the correct responses to 5 questions; their final take away from the sessions.
  • The design followed a 3-step learning model: Learn, Experience, Apply. 
    • Learn: Short lectures or vignettes was used to learn/refresh on content. 
    • Experience: Variety of ways in which the Learners engaged with the audit observations; not just a slide for each observation but small group discussion and tangible activity to complete and report back on.
    • Apply: peer feedback, debriefing.

Are you thinking about outsourcing your next compliance?  Why not form a training partnership with an industry GXP Learning Provider?  -VB

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About Vivian Bringslimark, President of HPIS Consulting, Inc.

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Batteries Not Included: Not All Trainers are Instructional Designers or Classroom Facilitators

When I left the manufacturing shop floor and moved into training, full-time trainers presented in the classroom using a host of techniques, tools and relied on their platform skills to present content.  Subject matter experts (or the most senior person) conducted technical training on the shop floor in front of a piece of equipment, at a laboratory station, or a workbench. 

For years, this distinction was clearly practiced where I worked.  Trainers were in the classroom and SMEs delivered OJT.  Occasionally a “fulltime” trainer would consult with an SME on content or request his/her presence in the room during delivery as a back-up or for the Q & A portion of a “presentation”.  It seemed that the boundaries at the time, were so well understood, that one could determine the type of training simply by where it was delivered.

Training boundaries are limitless today

Today, that’s all changed.  No longer confined to location or delivery methods, full-time trainers can be found on the shop floor fully gowned delivering GMP (Good Manufacturing Practices) content for example. And SMEs are now in the classroom more each day with some of the very tools used by full-time trainers!   What defines a full-time trainer from an SME is less important, what is necessary however is what defines effective instruction.

Your title might have the word trainer in it.  One of your responsibilities might be a qualified trainer. And you know how to use PowerPoint (PPT). Does this make you an Instructional Designer as well?  Some say yes and others cry foul as they cling to their certificates and advanced degrees. So, forgive me when I say, not every Trainer or Training Manager has the skill set or ID competency embedded in his/her toolbox.   It’s analogous to the toy box on the shelf at Toys R Us – “NOTE: Batteries Not Included”.  Except in our case, the note may be missing from the resume, but definitely embedded into the job description if you are QA L&D or HR Training and Development.

Instructional Design is a recognized profession 

Instructional Design (ID) as a field of study has been offered by many prominent universities for quite some time and is now more known as Instructional Technology.  Underlying the design of a course or a learning event, is a methodology for “good” instructional design and really good instructional designers will confess that there is a bit of an art form to it as well.  Unfortunately, with shrinking budgets and downsized L&D staff, there are less resources available to develop traditional course materials of the past.  Not to mention, shrinking timelines for the deliverables.  So, it makes sense to tap SMEs for more training opportunities since many are already involved in training at their site.  But, pasting their expert content into a PPT slide deck is not instructional design. 

What is effective design? 

Basic Elements of Course Design

To me, effective design is when learners not only meet the learning objectives during training but also transfer that learning experience back on the job and achieve performance objectives / outcomes.  That’s a tall order for an SME, even for fulltime trainers who have not had course design training. 

The methodology a course designer follows be that ADDIE, Agile, SAM (Successive Approximation Model), Gagne’s 9 Conditions of Learning, etc., provides a process with steps for the design rationale and then development of content including implementation and evaluation of effectiveness.  It ensures that key elements are not unintentionally left out or forgotten about until after the fact like evaluation/ effectiveness or needs assessment.  In an attempt to expedite training, these methodology driven elements are easily skipped without fully understanding the impact of leaving them out can have on the overall training effectiveness.  There is a science to instructional design. 

PowerPoint Slides are only a visual tool

Using PowerPoint slides by themselves does not make the training successful.  It’s one of the main tools a trainer uses to meet the objectives of the learning event, albeit the main one. The “art form” occurs when a designer creates visually appealing slides / eLearning scenes as well as aligned activities and engaging exercises designed to provide exploration, practice, and proficiency for the performance task back on the job.  But there is a difference between a course that is created to help the Trainer achieve his/her agenda and one that successfully engages learners to participate, learn and then transfer their insights back home to the job where changed behavior improves the department’s metrics.

The more trainer/instructor driven the course is, the less participation is required from the learner. For example, the instructor makes all the decisions about the course objectives and content, develops the course, delivers the course, and conducts the assessment.

From passive to active to immersive

As you move along the Learner Participation Continuum, the learner is required to participate more, and the trainer does less “talking”. The learner acquires knowledge and skills through activities that s/he experiences with the assistance of a “facilitator”.  The facilitator is focused on helping the learners meet their needs and interests. It is through these firsthand experiences and facilitated dialogue with other learners that thoughtful analysis and interpretation can become the focus of the instruction. The end result is that learners take full responsibility for decisions, actions and consequences.

Moving from Presenter Controlled Training to Learner Focused Facilitation

Moving to a more Learner Focused approach shifts the effort of the design from “deliver this content” to facilitate learning transfer for performance back on the job; which is after all the end goal for a training event. The new design includes opportunities for group participation, utilization of participants’ expertise, and real-life problem solving; key principles of adult learning.

On the one end of the continuum is the lecture which is one-way communication and requires very little participation.  At the other end, we have experiential learning and now immersive learning environments with the introduction of 3D graphics, virtual simulations, and augmented reality.

Most Trainers and SMEs tend to suffer from the “curse of too much knowledge” and find it difficult to separate the need-to-know from the nice-to-know content.  As a result, it shows up in the slide deck with overburdened slides filled with a lot of “stuff”.  Training for them takes on a lecture-style format. The thought of facilitating an activity gives most SME a case of jitters and anxiety.

So, in the “SME as Facilitator” workshop, nominated SMEs as Facilitators are encouraged to step away from the podium and use their eyes, hands, and voice to engage with their audience. Easier said than done, yes. That’s why the course is designed to allow them to take small steps within the safety of a workshop environment.

But rather than trying to pull off a fully immersive session, SMEs as Facilitators are introduced to techniques that “liven up” the lecture. They are shown how to move back and forth from passive listening (sit, hear, see) to active involvement (write, construct, discuss, move, speak). This requires the ability to:

  • follow a well-organized design plan
  • capture and hold the attention of learners
  • use relevant examples and deviations if possible
  • show authentic enthusiasm
  • involve audience both directly and indirectly
  • respond to questions with patience and respect.

While lecture has its merits, today’s learners want engaging content; that is timely, relevant and meaningful.  And while virtual reality and simulations are engaging and very immersive, courses and learning events using these techniques rely on well-funded budgets.  Most Training Departments are not that fortunate.   In the middle of the range are “lively lectures” and alternate methods such as:

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

Take the 1st shift right.

It’s really about starting with the learners’ expectations and the current organizational culture and then moving one step to the right. If they are used to lectures from SMEs, then work on delivering effective lectures before experimenting with alternate training methods. The overnight shift may be too big of a change for the attendees to adjust to despite their desire for no more boring lectures. Small incremental steps are the key.

Shift to the right when ready for the upgrade

Moving from Lecture to Delivering an EFFECTIVE Lecture

Thoroughness in the preparation reflects care and thoughtfulness. Learners appreciate the personal desire to deliver a livelier lecture. Stepping away from the podium forces the Trainer/SME to take action and allow the learners to “get up close” with the SME as Facilitator. This in turn is reflected in the learner’s desire to respond to questions and dialogue during a facilitated discussion. The rule of thumb for lecturing is approximately 8-10 minutes max. For virtual sessions, the rule of thumb is approximately 5 minutes. 

Take the 2nd Shift: Cut Content to Add Interactivity

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

“STOP TALKING and get learners engaged in some form of activity, practice or reflection exercise”, Vivian Bringslimark, HPIS Consulting, Inc. 

One of the benefits of shifting to this learner focused design is the opportunity for learners to process the content, to make it meaningful for themselves and then associate memory links to it for later recall when the moment of need is upon them.  This can’t happen while the trainer is lecturing.  It happens during activities and reflection exercises designed to generate their own ideas during small group interactions and link it back to the course content/objectives.  Learners are prompted to openly discuss issues and problems within a “learning lab” style environment. Trainers become empathetic listeners as they create a climate of trust and safety. They become a Facilitator.

Of course, this shift also requires that site leadership and local management not only support the facilitated learning lab concept but follow through on issues and concerns that surface. Failure to do so undermines not only the facilitator’s credibility but the entire training program.

Wow, won’t this take longer to design, you ask?  Yes, in the sense that the design is now from the learner’s point of view. This means that the designer will need to research examples, collect data, and might have to develop a story from an incident, a deviation or significant CAPA, etc. The reward is that the Trainer/ Classroom SME stops talking and gives employees more engaging learning sessions. So learners become more accountable for participating and guess what – the SME’s session is no longer a boring podium speech

References:

Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips.  Lexington Books, New York.

Who is the Author, Vivian Bringslimark?

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SME Impact Story: The Real Meaning of TTT

White Paper: Step Away From the Podium

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Compliance Training: No More Passive Learning

Special Thanks to LTEN for Publishing this article!

Looking for inspiration to liven up a lecture? I have 10 ideas for you.

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No More Boring GMP Lectures |Impact Story about how to introduce more interactivity into GMP Refresher sessions.

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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 the 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.

Retraining Quote

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).

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 but 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, a 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

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Facilitating the Shift from Passive Listening to Active Learning

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

This blog has been merged with “Batteries Not Included: Not all Trainers are Instructional Designers and Classroom Facilitators”.

Tired of repeat errors – ask a Performance Consultant to help you design a better corrective action

Given the constant pressure to shrink budgets and improve the bottom line, managers don’t usually allow themselves the luxury of being proactive especially when it comes to training.  So they tend to fall back on quick-fix solutions that give them a check mark and “clear their desk” momentarily.  For the few times this strategy works, there are twice as many times when those fixes backfire and the unintended consequences are worse.

This blog has now been merged with Reframing a Training Request.

The direct link to Tired of Repeat Deviations.

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Calling ALL User Generated Tools Home

What do I mean?  You know, job aids, tools users have created, and SME cheat sheets.  I’ve even seen task instruction sheets, quick reference guides for completing forms, and process flow diagrams.  But I’m not talking about posters on the wall describing how to turn on the projector in the conference room.  In this 3rd issue of Making It Work for Compliance Trainers series, I blog about why creating and openly sharing user-generated tools may not be a good thing in a regulated environment.

The Dilemma

As a Performance Consultant (PC) or HPT specialist, works with SMEs, Key Performers, or STAR employees, s/he invariably uncovers or discovers that their SMEs have “other” tools they’ve developed that help them be so good at what they do.  While these are helpful to the key performers, it presents a dilemma for the PC who is also a Compliance Trainer or a QA Manager.  “If I expose the source of their secret sauce, will I break trust and create a barrier to the relationship?  On the other hand, if I don’t speak up about this tool, what assurance do I have that the content is approved by the Quality Control Unit (per GMP) and is version controlled?

Why create them in the first place?

To get grounded, the PC/Compliance Trainer needs to perform a quick cause analysis upon the discovery of the tool.  Why was it created in the first place?  Is there information or steps missing from the standard operating procedure (SOP)?  Was this tool created to “chunk up” the steps or create bite-sized training materials that evolved into a job aid?  Or is it a maneuver to bypass the change control system?  The answers to the questions could provide the basis for a more user-friendly revision or at least be officially approved as a supporting tool to the SOP upon the next version release.

What’s the big deal?

Rejection of product, deviation from approved written instruction that could result in adulterated product, additional follow up testing, and rework are all forms of waste to the organization.  Not to mention that consistency is the key to compliance and assuring public confidence in approved marketed products.  If folks are not using the approved procedure, then there’s an issue somewhere.

To what level of control is needed?

That is the most sought after question regarding job aids and user tools.  The answer lies in each company’s level of risk and its document hierarchy.  I’ve seen extreme cases where “NO Paper” on the floor means not even an SOP is allowed to be in hand.  I do believe that some level of control is needed to ensure that the content is valid, is in sync with the current procedure and users have the most current version of the tool.  Can your organization defend the level of control?  Are you sure about that?  Or do you use a “don’t tell and we won’t ask policy”?  Are folks making errors because they followed an uncontrolled worksheet vs. the approved procedure?

Tips for Establishing Level of Control

  • If the tool /job aid is tied to a procedure, it needs to become a required tool and included in the SOP.
  • Job aids should not be a standalone orphan.  It needs to have a procedure that it supports.  The use of the job aid is included in the hands-on training so folks know how to use it properly and where to access it if it is not “attached” to the SOP.

o   For example, some companies have a separate numbering system for these exhibits and the storage location may not be in the same folder directory as the parent SOP.

  • If more than one tool / job aid / worksheet exists per procedure, then an appendix or reference section needs to highlight the existence of these “tools in use”.
  • Establish an amnesty initiative to raise awareness for the quality and compliance consequences of using uncontrolled tools.

Calling all User Generated Tools Home

The purpose of the initiative is to allow users to admit that they have these tools and that no performance consequences will follow when they surrender them.  The second focus of the program is to find a proper home for these tools once they are deemed valuable.  They need proper care and nourishment.  In other words, content is valid, accurate, up to date and approved for use.  The PC/Compliance Trainer is the ideal conduit to make this happen.

One company that I visited did just that and more.  Once it was discovered that a series of mistakes were coming from an old tool that had been downloaded and copied to their desktop, a team of auditors was dispatched to observe the removal of all tools from employee’s desktops.  The 2nd phase of their program was the identification of an owner for the share-point site who now manages access and content revisions.  The 3rd phase includes a content/tool submission process that is vetted by a designated users group of SMEs.

Is it time for a Job Aid/Users Tool Amnesty Project where you work? – VB