In my work with Life Sciences companies, I’ve found that most companies today use Read & Understood training extensively.

In theory, this simplifies initiating new team members and keeping your existing staff up-to-date. No quizzes or tests to create; all QA managers have to do is publish a document and send it to those who need that information to get their job done right.

In practice, though, there are a lot more inefficiencies and waste than meets the eye. I found this out firsthand when I was asked by a large company to implement a systematic, hands-free Read & Understood system. They wanted to make it easy for QA to deploy training materials and for staff to access, review and confirm.

Initially I thought, “How hard can that be? After all, it only takes seconds to assign a page for training, right?”

It was my own underestimation that helped me uncover the gaping hole in this traditional training approach – and led me to develop Radbee’s Read & Understood Training Genius for Confluence.

The problem with traditional Read & Understood training

When it comes to Read & Understood training systems, bureaucracy is a burden that weighs on QA managers and team members alike. The larger and more complex an organization, the easier it is to get stuck in a slow-moving system that limits effective training and jams compliance.

So, for example, at the organization where I had my light bulb moment, QA managers routinely spent upwards of an hour to onboard employees – just to locate and manually assign necessary training pages. Considering that this company made tens of new hires each month and had other significant staff movement (i.e. promotions, leaves of absences, etc.), who needed to be trained at any given moment was a moving target.

Beyond staff changes, training documents also evolved over time. It quickly became clear that administering an organization-wide training program to auditors’ satisfaction was a full-time job. There was no time leftover for QA managers to ensure the quality of the actual training materials – which would in turn would support happier, more competent staff and higher quality products.

The road to a better training process

Better training, management and compliance was on my mind as I worked on my enterprise client’s Read & Understood system issues. Up close with their obstacles, I began to see significant opportunities for improvement.

First, we needed to truly automate the Read & Understood process in order to end the bureaucratic, administrative log jam and free up QA managers’ time for more important work. Staff would also enjoy a personalized view of their training obligations, with automatic nudges via email from the system to complete anything outstanding.

Added to the mix was central reporting capabilities from an easy-to-use dashboard to simplify the auditing process by making real-time, accurate compliance reports instantly accessible. All data could also be exported to Excel and used as a powerful management tool to track KPIs, including how quickly people train and which departments are more responsive than others.

This was the genesis of the Radbee Read & Understood Training Genius for Confluence. Featuring hands-free assignment, all QA managers need to do is define their training matrix rules, and the app takes it from there.

If you’re like my client, and the burden of bureaucracy is crushing your QA system efficiency and destroying company resources and QA managers’ morale, then I invite you to explore the Radbee Read & Understood app on Atlassian’s marketplace. You can also contact me for more information.

If you work for a life sciences company, you know that the impact of a well-trained team is significant. Internally, it supports greater productivity, boosts job satisfaction and improves products for a healthy bottom line. Externally, the outside world benefits from safer, more accurate software and tools for user/patient wellbeing.

Implementing a streamlined, intuitive, compliant training program can, however, be its own beast. For many companies, particularly at the enterprise level, training can be a complex, slow-moving process whose administration alone may eat up all of a QA manager’s time.

Here’s why and how you can easily leverage Confluence for easier, more effective training and compliance, regardless of how your company currently uses it:

If you’re already using Confluence for compliance

Loads of companies already use Confluence for compliance processes, particularly for controlled documents. It’s also common for those same companies to manage the training assignments on another system (often Word/Excel). Not only is this practice clunky and labor-intensive, but it’s also totally unnecessary.

Since you’re using Confluence for compliance purposes anyways, why not use it for Read & Understood training, too? RadBee created the Read & Understood Training Genius app to automate training assignments, reminders and confirmations in Confluence.

This simplifies training for staff by putting everything they need in one place, while simultaneously taking the burden of administration off QA managers. All they have to do is set the rules, and the app does the rest – including improving accuracy, pairing down infrastructure and maximising time and budget efficiencies.

If you’re using Confluence for non-compliance related processes

Plenty of companies already use Confluence for collaboration. For example, development teams may use it to manage their non-controlled materials. But many haven’t yet made the leap to also use Confluence for compliance purposes. While years ago keeping the “traditional but separate QMS IT” was understandable, today’s Confluence has dramatically increased capabilities, with innovative apps that extend it even further. This makes it a perfect solution for streamlining compliances processes, too.

For QA managers, reducing friction to increase engagement by meeting members of your organisation where they are is key. If they are already using Confluence for ongoing project management and collaboration, then that’s where your quality processes, including Read & Understood training, should also be. Once it’s integrated, you’ll find marked increases in traction and engagement among team members. It also makes it easy for auditors – the other key audience that’s accustomed to using Confluence – to review reports and confirm compliance.

In the quest for efficiency, Confluence is your knight in shining armour. It empowers your QA team to streamline processes, rescuing precious resources that can be better used to improve training quality, compliance and user experience.

For details on how Radbee’s Read & Understood Training Genius for Confluence app can help you streamline your training process, check it out on the Atlassian marketplace. You can also contact me for more information.

Ensuring that your team is well trained and your company will pass compliance audits with flying colors is much easier with our new Read & Understood Training Genius App for Confluence. It empowers QA managers with greater control and time-saving automation — all that needs to be done is to set the training matrix rules and the app takes it from there.

What is a training matrix?

The training matrix is comprised of three components:

• Users who need to be trained. This could be individuals, a department, or everyone in the company.
• Pages that these users need to train on, such as a quality manual or Standard Operating Procedures (SOPs).
• Conditions, which trigger that training — for example, every time the document is updated or it’s a refresher period.

Defining your training matrix

To start using the app, all you have to do is to establish the rules that articulate your training matrix. Because rules can be adjusted over time, it’s best to start small with a single, simple rule, and expand from there as your needs evolve.

An example of a simple rule is: “Each time our SOP is updated, everybody in our organization must read them.”

To make that rule work in Confluence, you will need to configure three elements:

1. Users: Define a Confluence user group and make everyone on your team a member of that group. You can use the default group, confluence-users, or alternatively, a specifically created group: for example, training group. Double check to be sure that only those who need to train are in this group.
2. Pages: Set a distinct Confluence label for all pages that users need to be trained on. For example: training page.
3. Define your first training wizard rule that connects users with their training pages. Do it via the rule type  “NOT_TRAINED_PAGE_VERSION.” This rule is the default, “out of the box” rule for the app, just to help you get started.

And that’s it! All you have to do is give it a few minutes to take effect for all required users to receive their training assignment. FYI, the default grace period before changes take effect is just 15 minutes, and you can configure that differently if you’d like.

Exceptions and extensions

It’s easy to extend that basic configuration to suit your company’s needs.

For example, it’s often not necessary for people to train when there’s a small update — only when it’s an “official” one. In that case, you can use the Comala Publishing app to segregate intermediate from official approvals, and then create a rule which applies only to the official version of pages.

While your users may not need to train on every version, if they do need a refresher once a year, you can easily make that adjustment. All you have to do is change the rule type from “NOT_TRAINED_PAGE_VERSION” to “REFRESHER” and indicate the refresher period.

Keep in mind that more rules can be added on top of your initial rule to extend the training applied on your system. Don’t worry if some rules overlap — a user will never be assigned duplicate training tasks. In other words, if a user has to be trained on a page because of two different rules, they will only be assigned once.

Smart, automatic, and easy to work with — that’s the point of the Read & Understood Training Genius app for Confluence. If you have any questions, please don’t hesitate to contact us.

If you are using Comala Workflows App to manage your controlled documents, then your “read and understood” rules should be aware of the workflow status of the page.

For example, if you would like people to train on pages that have a new official version, which is about to or has recently gone into effect, you’ll want users to be notified. On the other hand, if your updates are still in the process of being authored, reviewed and/or approved, you want to be sure the system stays mum until it’s official.

The easiest way to achieve this depends on whether you are also using Comala Publishing or not.

Case 1: Without Comala Publishing

If you’re not using Comala Publishing, both your unofficial and official versions will be on the same physical Confluence page. It’s likely, then, that you’ll want to achieve something that looks like this:

1. All users belonging to the Confluence group “training_group” must confirm that they’ve read and understood the new training pages.
2. The only pages that users from “training_group” must confirm are those related to the official new version, in “Comala Approved” status.

To achieve this, we will use Confluence labels and will put the label “training_page” on any page that is in the applicable Comala status. The Comala macro language allows you to add this label to the page when it transitions into this status, and then to remove it when it exits the status.

Here’s how the code might look:

{workflow:name=Simple approval workflow|key=spaceworkflow-2069888558|label=simple1}
   {description}
       The Simple Approval Workflow has 2 states.
       In Progress: Staff edit pages, not visible to non-team members. Approved: Staff approve, visible to public.
   {description}
   {state:In Progress|approved=Approved|taskable=true}
       {approval:Review|assignable=true}
   {state}
   {state:Approved|final=true|updated=In Progress|hideselection=true}
   {state}
   {trigger:statechanged|state=Approved}
       {set-label:training_page}
   {trigger}
   {trigger:statechanged|state=In Progress}
       {remove-label:training_page}
   {trigger}
{workflow}

In that example, the page is labeled as a ‘training_page” when it is approved, and the label is removed when it goes back into draft state.

Combine this with the following Training Genius rule:

{
   "rules": [
       {
           "name": "Default rule",
           "pageFilter": {
               "type": "PAGE_LABEL",
               "value": "training_page"
           },
           "userFilter": {
               "type": "USER_GROUP",
               "value": "training_group"
           },
           "ruleTypes": [
               {
                   "ruleType": "NOT_TRAINED_PAGE_VERSION"
               }
           ]
       }
   ]
}

This rule triggers a read and understood assignment to each new page version only when the label “training_label” exists on the page.

Please note that this is the default rule that is installed with the app, so no need to tweak it if you are happy with its structure.

Case 2: With Comala Publishing

If you are using Comala Publishing to publish the approved pages into a separate official space, facilitating read and understood is also simple.

Let’s assume that:

1. Each required training page is labeled “training_page”  and is published to the space called, “Published Documents” whenever there is a newly approved version.
2. You need to verify that each new training document release will be read and understood by appropriate users (i.e. those in the “TRAINING_USER” group).
   

In this instance, the only thing you need to modify is the Training Genius rule, which will simply indicate that read and understood is restricted to the PUBLISHED space.

The code will look like this:

{
   "rules": [
       {
           "name": "Default rule",
           "pageFilter": {
       "and": [
         {
           "type": "PAGE_SPACE_NAME",
           "value": "Published Documents"
         },
         {
           "type": "PAGE_LABEL",
           "value": "training_page"
         } ]
     }
,
           "userFilter": {
               "type": "USER_GROUP",
               "value": "training_group"
           },
           "ruleTypes": [
               {
                   "ruleType": "NOT_TRAINED_PAGE_VERSION"
               }
           ]
       }
   ]
}

Whether you’re working with Comala Publishing or not, RadBee’s Read & Understood Training Genius for Confluence makes it simple for QA managers. All you need to do is define your training matrix rules, and the app takes it from there.

I invite you to explore my RadBee Read & Understood app on Atlassian’s marketplace. You can also contact me for more information.

Standard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance.

But oftentimes, the reality is different. Regulations and standards tend to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get the job done is strong.

Thus “best practices” can actually become a euphemism for cutting corners and taking an apparently easier way out.

True best practices are bespoke — they have to be written to suit your organisation, period. While this may take some time up front, in the long-run, it’s a smarter strategy. Anything else can pave the way to wasted effort, non-compliance, and unsuccessful products.

“Best practices” are infectious

The idea of best practices has been spreading for years, riding on some common business contexts:

• Expensive Quality Systems consultants: What you might be paying for is the application of the consultant’s standard template — regardless of whether or not the SOPs are actually best for your company.
• Lightening-fast SOPs from a new QA hire: When QA professionals move from one job to the next, they often bring along “tried and tested” SOPs. This bag of tricks can be a useful shortcut to quickly ramp up and deliver results.
• Overuse abuse: The term, “best practices” is so overused that it’s essentially meaningless. Who and how can a “best practice” declaration be challenged? Even if you’re able to pass a compliance audit, it doesn’t ensure that your process is efficient in terms of time, resources, or money. Be wary of anyone who tosses around the term “best practices” — there’s a good chance that they may not have a true grip on what your organisation actually needs.

Without your organisation’s real best interests in mind, “best practices” is just a Band-Aid that won’t hold up when your SOPs are put to the test of time.

Common SOPs pitfalls

Before getting into how to be sure you are employing true best practices, let’s do a small reality check:

• Don’t let the name fool you — SOPs are not standard: It’s rare to have a practice that is “one-size-fits-all.” Best practices depend on the size of the organisation, the regulatory context, the products and the maturity of the quality system.
• The status quo is wasteful: Using best practices can lead to overly complex procedures. To omit something from a SOP requires more understanding then to add something in. Also, changing the status quo requires courage. This means that “best practices” often obscure options for simplification.
• Compliance isn’t assured: It would be nice to think that using best practices as a rule of thumb for your SOPs ensures compliance, but the ever-evolving world of regulations combined with the way people tend to cling to outdated practices poke holes in that theory.

How to ensure your SOPs embody best practices

Unfortunately, there is no magic bullet when it comes to Quality Assurance. In a world where resources are scarce, it’s critical to eliminate waste by making your SOPs as simple as possible. The true “best” way to put a quality system in place is to start with the regulatory requirements. From there, implement the most straightforward process possible… and then look for ways to streamline it even further.

Getting your processes right takes an iterative approach of regularly reviewing your system and eliminating steps when possible — which may take years. Still, consistent compliance with a basic process is far better than a complex approach that exists only on paper.

When it comes to quality systems, the best practice you can take is to commit to ever-evolving actions towards compliant, efficient bottom-line results.

Getting your team to confirm they’ve read and understood documents is only half the battle.

Granted, it’s an important battle to win. It’s why we love getting feedback like this on our Read & Understood Training Genius app for Confluence:

“It’s great — one of our developers was behind with 69 read & understood trainings. After I nagged her, she was able, using the Training Genius, to sign-off these 69 read & understood docs in one evening.”

So while the developer was able to get through her mandatory trainings, it’s hard to imagine that she actually read and understood 69 procedures, work instructions, and guidances in one night.

This points to a harsh reality: Read & understood trainings tend to be a tick box exercise for trainees because compliance usually trumps comprehension. Writing to suit the auditor’s standards often stands in direct conflict with what trainees need — which is brevity, clarity and relevance.

It doesn’t have to be this way. The gist of it is this: you can cater to both trainees and auditors by putting the essence of the training right up front.

The truth about trainings

The first step to writing better trainings is to embrace the facts:

On the one hand, quality system documents often must be lengthy and chock full of dense details and boring language. That’s what regulations demand and auditors expect, and you can’t necessarily change that.

On the other hand, your team members must truly read and understand trainings not just for compliance-sake, but also to create products that are safe and effective.

This is complicated for several reasons:

• Productive team members are too busy to read all of their read and understood docs.
• Even if they do read the trainings in full, they won’t retain most of the details. When it’s something they do all the time, it might be more resonant, but still unlikely that they’ll remember every last instruction.
• While it would be nice to develop interesting training materials for each topic, it’s not realistic.
• Read & understood trainings are a proven way to comply with regulatory requirements.

With all of that in mind, it makes sense to decide what you can realistically expect from an effective read and understood experience. This boils down to awareness, whereby your trainees either realise a procedure on a given topic exists and is there for them as needed, or if it’s a daily task, they can quickly spot what’s new.

Putting these core objectives into the heart of your documentation practices can dramatically increase the effectiveness of your training program and of your processes as a whole.

There are several writing habits you can adopt, which will increase the effectiveness of your read and understood trainings (and stay tuned to this blog to read them all!). Our  #1 favorite is to craft a short, concise gist section.

What is a gist section?

If you understand that a typical trainee will spend a minute or less reading a given document, then the best way to convey the essential aspects of the training is to place an informative paragraph, potentially called “Gist,” somewhere very close to the top of the document.

While traditional opening sections such as “Purpose,” or “Scope” are usually aimed at auditors and are full of complicated regulatory language, the Gist section is written solely for trainees.

The gist section answers the following questions:

• How does the information apply to the trainees? What’s in it for them, and how does it change or improve their daily workload?
• When should this document be used?
• Why this new version/update?
• Are there any timelines, and are they clearly highlighted? e. in a Complaints procedure, you would include something like, “If you ever encounter a situation where our device has put someone in danger, contact the COO immediately, as we need to move fast.”

Examples of gist sections

The following examples give you an idea of how to craft an effective gist section:

For a CAPA Process

The CAPA process is used when things are not up to par. For example: If we see that our customer shippings are missing the deadlines too frequently, then we will initiate a CAPA for this. We’ll involve everyone who can help us figure out why this happens and fix it. Anyone can initiate a CAPA if they think something needs improving in our system. This new version reflects the recent organizational changes and assigns responsibilities to the current roles.

For a Software Development Life Cycle Procedure

We explain here how we develop and ship the XYZ App. All the documents we need and the tools we use are also explained here. If you are involved in the development of our App, make sure you are familiar with this document. Appendix A includes a summary table, which can help you get started. This new version reflects the update to the Jira tooling we use to manage the product requirements.

Get the gist? If you have questions about how to simplify your training process while at the same time strengthening it, please feel free to contact us.

A successful eQMS project is not simply about replacing a legacy tool with a shiny, cool new one. It’s also not solely about achieving regulatory compliance. While those are positive outcomes, they’re not the point of evolving your quality system.

Just like smart phones weren’t only an upgrade of the dial telephone and commercial flights weren’t merely a faster version of ships, your new eQMS needs to go far beyond its old-school counterpart. The significant time, effort and resources that  go into building and maintaining your eQMS should translate into a 10x impact on your business. 

Be bold: A reimagined eQMS can unlock the future of your business, so do not settle for  merely a better version of your past system.

Frame your eQMS project as a game changer

The goal of a eQMS transformation project should be seen within the context of your overall business strategy and designed so it effectively addresses your biggest challenges.

Each organisation will have its own variant, so here are a few examples:

Example 1: A high-growth business is challenged by scale and consistency. Onboarding a large number of new hires and ensuring that all are quickly and thoroughly educated about the company’s values, approaches and quality standards is a difficult task.

The right eQMS will evolve the business in several important ways.

• Significantly shortens onboarding and training processes for new staff and even for whole teams (i.e. when work is outsourced or in M&A  scenarios). For example, consider how much time, budget and resources are saved when a new team member is fully productive in one month vs. three months.
• Supports consistent cross-team performance.
  For example,  sprawling global support teams, who are empowered to perform consistently with the one operating out of corporate headquarters.
• Increases the quantity and quality of documented knowledge, and the dissemination and usage of that knowledge.
  Imagine how much more productive and effective employees are when they have easy access to information critical to job performance.

Example 2:  An innovative med tech company wants to accelerate and improve the update release cycle for their medical devices.

The right eQMS supports getting newer versions of products out faster and more frequently, and impacts quality processes in a few important ways:

• It becomes the backbone of the Agile+DevOps cycle, embedding the regulatory considerations as part of the iterative process. 
• It provides the tools necessary for integrating design-controls directives into shorter version cycles.
  This means a new version of a given device can be released daily vs. monthly or even annually.
• It provides an easy way to control the release at a glance.
  By utilizing a central dashboard that consolidates all the bits of information in one place, team members can quickly and easily assess statistics and spot discrepancies. This pain-free approach also supports full documentation, making it a snap to sign off on the release with confidence. 

Example 3: A life sciences company with several popular products receives a flood of post-marketing data.

The right eQMS can open the door to new opportunities culled from critical marketing analysis, surveillance and vigilance:

• The right eQMS will listen on all incoming channels — including support calls, auto-generated analytics and crash reports on end devices — and consolidate the intelligence into a data lake.
  By tracking, analysing and aggregating this crucial data, new opportunities and challenges will swiftly surface.
• Market insights allow you to better understand your customers, align with their needs and proactively serve them.
  Your brand will grow to be synonymous with quality and empathy.

Remember when you first started reading this post and were thinking of your eQMS as just a good way to save forests by cutting out paper use or as solely a way to stay compliant?

By devising and delivering an eQMS project using this new, bolder definition of success, you’ll find that the benefits are far more profound than you may have ever imagined.  When you take a company-level view that is much more strategic, you can save time, money and resources and significantly impact your company’s bottom line. 

Read & Understood trainings are known both for what they do well — demonstrate compliance to auditors — and also for what they do not do so well: truly train employees. The truth is there’s no reason that you can’t achieve both goals by making it quick and easy for trainees and auditors alike to access key information.
We’ve already explored how to craft a short and sweet gist section as a top way to increase the effectiveness of your Read & Understood documents. Because many trainings are procedures, work instructions or guidance focusing on a complete business process, it also makes sense to focus on writing better rule-based docs.

For example: A management review procedure should include all the vital details such as:

• Overview of your company’s approach to the review process
• Frequency of reviews
• How to conduct a review, including topics to cover
• How to determine next steps

While it would be great if the managers knew everything about the company review process, the reality is that people will automatically scan for what impacts them directly. So, for example:

• A service manager will need to know the timing of a management review so she can have the service data ready.
• A risk officer needs to know that he will be asked about the Vigilance records.
• An operations manager must know when to be ready to submit manufacturing data.

To improve any process, it behooves QA pros to make it simple to scan dense documentation. Here are two tried and true ways to level up your role-focused writing.

Technique 1 for Role-Focused Writing: Table of Contents (TOC)

Start by writing “sections per role.” The heading of a role section should explicitly state which position it addresses, so that team members can scan the TOC to find the sections that directly apply to them.

For example, the TOC may look like this: (Note: Bold & italicized sections are specific to role holders.)

Title: Management Review SOP

1. 1. Gist
   2. Scope & Purpose
   3. Overview

1. 1. 1. 1. Logistical organisation by the Quality Manager
         2. Inputs by role holders:
         3. Production Manager
         4. Customer Support Manager
         5. Risk Officer
         6. R&D Manager
      2. Meeting agenda
      3. Forms

A split second later, your role-holders are able to take in what applies, and skip the rest.

Technique 2 for Role-Focused Writing: SEARCH friendly

If it’s difficult to break up the document to fit neatly into a TOC, then you can use this less structured approach:

Close to the top of the document, perhaps as part of the Gist section, list the participating roles. This list should then determine the terminology you use in the document. In this way, you ensure that the SOP is friendly to automatic search.

For example:

Gist
Management Review is the occasion where the management team formally reviews performance in critical areas. We review data and metrics collected from across the business, discuss the future, and decide what we can do to further our quality and business goals.

Participating Roles:
Quality Manager, Production Manager, Risk Officer

Procedure

Inputs to the management review will be prepared by each respective manager:

• Production Manager will present production data and trends.
• Risk Officer will present status of Risk Management and Vigilance.

The important point here is consistency. If you decided to use the term, “Production Manager,” then do not use “Production Lead” or “Head of Production” in its place. Also, avoid using a blanket statement like, “all contributors”. Instead, be sure to list the position titles of all contributors so that it’s easy for each person to find the sections that apply to them.

Test Your Work

Finally, regardless of which technique you choose, I highly recommend that you test your document so you can be sure the training is as easy to follow as you think. Ensure your Read & Understood documentation is good to go takes no time and involves good old fashioned human communication:

• Choose one or two people who have the most involved roles in the training.
• Give each one three minutes to review it.
• Ask them what they understood.
• Use the information to improve your document.
• Release the document only when you are satisfied with what you hear.

Because in the end, your Read & Understood docs are there not only for compliance, but also to truly improve your team’s performance. If you have questions about how to simultaneously streamline and strengthen your Read & Understood trainings, please feel free to contact us.