Benchmarking StudyComplianceWire®

2015 Trends | 2016 Forecast

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ForewordIn this report, UL Compliance to Performance presents the results of our annual “Quality and Compliance Learning Trends’ benchmarking survey, as well as critical knowledge projects with more than 400 life science companies in 2015.

Not only do we analyze the results of the survey and compare that data to the feedback we receive from ComplianceWire deployments, we also look at specific annual usage data within ComplianceWire, in which more than 37 million training completions were recorded in 2015. That was an increase of 12% over 2014 completions.

We look at global regulatory trends, such as ongoing efforts to harmonize enforcement among multiple global agencies. We also meet regularly with officials at US FDA’s Office of Regulatory Affairs, which uses ComplianceWire and FDA-authored eLearning content as part of their investigator training program.

Our benchmarking study has been conducted since 2008, and we believe these findings can help shape our clients’ learning and compliance best practices for the coming year. This year, we focused on the training content development process and what our clients consider to be the most effective training modes within their organization. Understanding the type of training that impacts employee performance is critical as these quality and learning teams evaluate and map out their 2016 strategies.

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Making Learning More Effective2015

The top priority for our clients in 2015 was “Measuring Training Effectiveness,” which correlated with a growing number of FDA observations in 2014 that cited either “lack of procedures” or “procedures not being followed.”

2016

The top priority in 2016 continues to be “Measuring Training Effectiveness,” and the training type that will get the most attention is SOP and policy “read and sign” training. FDA and other agencies continue to ask about effectiveness, and “procedures not followed” continue to appear on warning letters and 483s.

• Audit Readiness

• Validated System

• Defined Curricula

• Role-Based Qualifications

• OJT Checklists

• Learner Assessments

• Business Performance

• Talent Growth and Retention

• Skills and Competency

• Performance Management

Forecast

Clients have told us that building more effective training content is a critical goal in 2016. While SOP training represented 65% of the training types in 2015, we believe clients will shift from “read and sign” training for high-risk topics related to GxP, ethics and skills development topics.

Our learning projects in 2015 cemented the fact that “effectiveness” and content development will be a major focus within organizations this year. For example, we see operational excellence teams that are working closely with HR, QA, Operations, and Learning & Development to include “business outcome” programs, skill development programs and business productivity programs. This progress aligns with our Quality-Based Learning Maturity Model, shown below.

When we introduced this model in our 2014 paper, we outlined the multi-year process that many of our clients take to continually improve their training management and talent management programs.

Initially, a new client is seeking to automate training management. When that’s achieved, the client takes the next step: mapping role-based qualifications to gain efficiencies, and provide visibility for auditors and senior managers.

Our clients’ top learning priority continues to be “Training Effectiveness,” and at this stage clients are challenged to shift from low effective to high effective training types. Only then can a training or development program have measurable impact on key performance indicators, including manufacturing output, employee satisfaction, and compliance risks.

The Quality-Based Learning Maturity Model

BusinessOutcome

TrainingEffectiveness

TrainingRecord

Management

SOP Role-BasedManagement

4Talent

Management

LMSS

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The Shift from “Read and Sign” to Effective Types“Training Effectiveness” continues to be both a compliance and “skills development” issue. Life Sciences companies must show that employees are trained on key procedures and work instructions; they must also show that employees have the core skills and competencies related to their job function. For example, an employee is trained on an SOP related to a QC lab procedure. Does that mean the individual is now a high-performing lab professional? What are the limitations of the SOP?

For the second year in a row, “Failure to Follow SOPs or Other Documentation” was the most cited observation by internal and external auditors. Given these findings, how can organizations improve SOP training to address this observation?

We believe that “Read and Sign” procedure and policy training needs to shift to a more effective training type. In addition, we believe more clients in 2016 will add a new step to their qualification process -- assessing an employee to determine their current skill sets, beyond simply what’s outlined in an SOP.

In our survey, we asked clients what they thought was the most effective training type used in their organization. “Classroom Events” was most cited at 69%, “Mentoring” was ranked second at 64%, and “eLearning (developed in-house) was ranked third at 55%. And yet, according to our completions data, these types represent about 25% of total completions in ComplianceWire.

In the same vein, we asked which training type was preferred in specific areas of learning and development.

This helped us gain visibility into the “training” make-up of our clients’ programs, and what type was most popular within each program. The goals of the training program shaped the training type choice, but there were several other factors, such as budget and resources. Also, several clients told us that “training time” per employee had been restricted in 2015, and this constraint may have factored into the preferred type noted here.

What Are the Most Preferred/Effective Training Types?

Most Effective Training Types

Most Preferred Training Types

Our Takeaway Why not build more classroom events or mentoring activities for SOP training?

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In 2016, UL Compliance to Performance will develop solutions that help our clients shift “Read and Sign” training to highly effective learning types. This includes collaborative learning development platforms that enable a company’s SMEs to begin the eLearning development process, in a methodology that resembles the SME building slides in PowerPoint.

As noted on the next page, UL Compliance to Performance is expanding our blended “classroom training” programs that empower both SMEs and targeted groups within the company.

Many clients told us in 2015 that they would prefer to build more training programs using the most effective learning types, but resources and time were barriers. In our survey, we wanted to drill down in this issue. What’s preventing clients from shifting critical SOPs to more effective learning types?

Not surprisingly, “eLearning” was the most cited learning type in the two “50% and up” ranges. eLearning took more than half of the “learning development” time for 20% of respondents. Clearly, time and resources are the barriers that prevent companies from shifting learning from “read and sign” to the highly effective learning types.

For many clients, a learning and development team may be a small team, serving many areas of the manufacturing and QA functions. The eLearning development backlog occurs when five or six SMEs require courses or programs from this team. For most of our clients, the ability to create an eLearning course sits with those individuals that have training backgrounds, instructional design skills, multimedia skills and content authoring skills.

Identify high-risk SOP topics warrant highly effective learning types

Identify the learning type best suited to the topic: workshop, mentoring or eLearning, and time and resources required to shift to this learning type

Determine if an “internal” SME has the knowledge needed or if a third-party expert is required

Review content from SME and customize to the chosen highly effective learning type

Add the critical scenarios, examples, visuals and other instructional elements to the instructional material

Compare instructional material to actual SOP content, review and approve

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The Learning Shift From “Read and Sign”

UL Compliance to Performance’s Response in 2016

Steps for Shifting from “Read and Sign”

Percentage of Time Developing Training

*20% of clients spend more than half of their time developing eLearning.

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Clients continually ask us for programs that will help them demonstrate how to put quality and compliance principles into everyday processes and activities.

UL Compliance to Performance will continue to add new courses and tools in 2016. For example, medical device clients have asked for ISO 14971 “Risk Management” workshops and mentoring programs, so that a company can drive deeper, real-world education to their teams. We are exploring programs that extend beyond our eLearning courses, but also provide these key benefits:

Clients gain knowledge and best practices directly from the same experts who maintain our eLearning courses;

Clients will gain access to tools to integrate their own proprietary content within our standard eLearning courses;

Clients can use these collaborative tools to build their own skills development and professional development eLearning programs, helping to capture proprietary knowledge and deliver advancement opportunities to the workforce.

Providing Global Learning Programs

Top Ten Languages used in ComplianceWire Global Usage Continues to Increase

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Introduction to GMPs

Principles of Good Documentation

Orientation to GMP Compliance

GMP Principles of SOPs

Handling an FDA Inspection

Change Control

DEA Compliance

Awareness of FDA Inspections for Pharmaceutical Manufacturers

Batch Record Reviews

Principles of Sterilization

Introduction to the Quality System Regulation (QSR)

An Introduction to ISO 13485 -- The Quality Management System for Medical Devices

A Guide to ISO 13485 – The Quality Management System for Medical Devices

QS Regulation 1: Overview and General Provisions

Complaint Management for Medical Device

Failure Investigations for Medical Device Manufacturers

QS Regulation 2: Requirements

QS Regulation 9: Records

Complaint Management for Medical Device Manufacturers

QS Regulation 1: Overview and General Provisions

Bloodborne Pathogens -- General Industry

Hazard Communication

Personal Protective Equipment

Fire Extinguishers

Electrical Safety

Hearing Conservation

Walking and Working Surfaces – Affected Person

Lockout/Tagout -- Affected

Ergonomics: Body Mechanics and Fitness

Access to Employee Exposure and Medical Records

Standard eLearning Courses - Top Ten List

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Top 2015 GMP Pharmaceutical CoursesTop 2015 Medical Device GMP/QSR Courses

Top 2015 Environmental, Health & Safety Courses

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Conclusion:

In 2016, we believe that companies will take proactive steps to ensure training effectiveness. Among the steps taken will be to shift SOP “read and sign” training activities to one of the three highly effective learning types: classroom events, mentoring, and eLearning.

As we discussed in last year’s paper, the commitment to “skill development” has progressed very slowly among clients. These competency management programs, in which skill gaps are identified and individual skills assessments are delivered, are either in place or planned in 2016 for 60% of our clients, according to our 2015 survey.

In response to these trends, UL Compliance to Performance is committed to assist clients as they proactively shift from “read and sign” to more effective learning types:

• Continue to expand on our competency management solutions that include applications and advisory solutions to define technical skills related to key topics: CAPA, QC Labs, Data Integrity, etc.

• Focus on targeted blended learning programs that include both eLearning and workshops, so clients can bring the expertise right into their facilities

• Expand our reporting tools so that managers gain high-level visual dashboards that point to critical indicators that may require action

Top Ten Languages used in ComplianceWire Global Usage Continues to Increase

ULCompliancetoPerformance.com

About UL Compliance to Performance

UL Compliance to Performance provides knowledge and expertise that empowers Life Sciences organizations globally to accelerate growth and move from compliance to performance. Our solutions help companies enter new markets, manage compliance, optimize quality and elevate performance by supporting processes at every stage of a company’s evolution. UL provides a powerful combination of advisory solutions with a strong modular SaaS backbone that features ComplianceWire®, our award-winning learning and performance platform.

UL is a premier global independent safety science company that has championed progress for 120 years. It’s more than 12,000 professionals are guided by the UL mission to promote safe working and living environments for all people.

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