Role Based Training Best Practices - UL Compliance to ... Based Training Best Practices Scott Barnard – Practice Leader, Advisory Services Knowledge Summit - 2013 June 5-7, Philadelphia,

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Knowledge Summit - 2013

June 5-7, Philadelphia, PA

Role Based Training Best

Practices

Scott Barnard – Practice Leader, Advisory Services



Agenda

Role Based Training

Break

How Best Practices Drive Enhancements

2013 Roadmap



DOJ Expectations: GMP Focus

Deputy Assistant Attorney General Presentation at

CBI Pharmaceutical Compliance Congress (1/29/13):

“… We will be taking an especially hard look whenever patients are

placed at an unacceptably high risk of harm by those violations of

current good manufacturing practices.”



Deputy Attorney General Speech During 2013 CBI

Pharmaceutical Compliance Congress:

“What is the DOJ looking for?

I urge you to also focus on

people. People are at the heart of

what you do, and it is the failures

of people — often the combined

failures of a number of people —

which result in noncompliance.”

“Therefore, in our

investigations, we are looking

at people to determine

responsibility. And for this

same reason, we urge you to

look at people.”




Deputy Attorney General Speech During 2013 CBI

Pharmaceutical Compliance Congress:

“1. Do we have the right

people?”

“You need people with the right

training and expertise to

recognize problems that can arise

when manufacturing

pharmaceuticals.

People are not fungible,

especially when it comes to the

complex and highly technical

issues that arise in a

pharmaceutical production line.”




The ROLES Based Training Formula



ROLES : Review Your Training Matrix



ROLES : Review Your Training Matrix

• Review for gaps in your current training

matrix

• Fill gaps using a risk based approach

• Start slow and build with consistency



ROLES: Organize Training Into Curricula

• Manageable size

• Control due dates, retraining periods, and

quizzes by role

• Sequencing training items in your curriculum

• Define your process for approving &

maintaining curricula



ROLES: Organize Training Into Curricula

Role-based Approach Manages the Issues of Over

Training and Under Training



ROLES: Organize Training Into Curricula:

A Risk Based Approach

Elevate Training Programs to Better Manage Risk

• Categorizing

Assignments by

Risk Level

• Currently

involves

building Risk-

Level User

Groups in

ComplianceWire



ROLES: Leverage Automated User Groups

• User Groups are “Containers” for Users

• Automate Membership With Custom Field Criteria

• HRMS Feed Provides Further Automation

• Manually Manage Exceptions (limit when possible)

• Use Smart Forms for Assigning Group Membership

and Automating Assignment Workflow




13




User Group “Mfg

Material Handlers”

User Group “Weighing

Operators”

ROLES: Employ Rule Based Assignments

15



Ultimate Goal…

ROLES : System Maintenance

• Define Your Governance Model

• Create a Procedure for System Governance

• Standardize Nomenclature and Other Meta Data

• Create Targeted Custom Security Roles

• Train Your Administrators

• Decentralize System Administration Appropriately

• Monitor the System Through Standard Reporting

• Practice Continuous Improvement



ROLES: Qualification Reporting



ROLES: Compliance Dashboard



Implementation Based on Defined Requirements

Managing Organizational Behavior and Performance Dashboards & Metrics

Biometrics Web Portal Integrations

Targeted Content (Visual Job Aides,

CBT…)

Extended Reach

MES & Op Cert Integrations

Resource Planning Suppliers & Other

Third Parties

Improved efficiency and value Added Return on Investment

Single Sign-On (SSO) & Self Registration

EDMS Integration HRIS Integration

Base Implementation

ComplianceWire

(with, CICS, Quiz Creator, Forms, etc.)

Training Matrix & Recurring Assignments

Thank You!

Questions?



Agenda

Role Based Training

Break


2013 Roadmap

February

[2012]

Release

Products and Enhancements

1. Standard Manager Field

• Email notifications and Reporting

2. Key Enhancements

• CV Security Update – Enhanced Security

• Historical Forms Completions

• Exam Player Enhancements – Max Attempts & Lock Out

• Reference Material – Supports Content Hosting

• Training Item Version – Default to Re-training

• Assignments – Default to Recurring

• User Group Criteria Search Fields

Application Architecture

1. SCORM Training Item Management

• Item Properties, Logs, Course Uploads

2. Data Center Updates

• Load Balancer Upgrade

• HTTPS Protocol

• Additional Web Server

February 2012 Release


June 5-7, Philadelphia, PA Page

February Release: Standard Manager Field

User Profile will contain a new standard field for ‘Manager’

Must select a valid User ID in the site

The manager field can be used as report criteria and can be displayed in User, Assignment and Completion reports

Cannot be used as criteria for User Group Membership

Used for company wide notification settings including :

• Assignment Notices

• Overdue Assignment Notices

• Reminder Email


June 5-7, Philadelphia, PA Page 25

February Release: Exam Creator Applies to those Licensing Exam Creator

Aligns with the functionality of Quiz Creator

Maximum Attempts

• Maximum number (up to 25) learner attempts

• After exceeding max attempts, user is locked out of the exam until additional attempts are granted

Additional Icons

• Visible from the ‘To Do List’ that identify ‘locked’ courses

Page 26

February Release: Admin Experience

Add Assignments (Recurring) – New Default

Training Item (Require Re-Training) – New Default

User Group Criteria – Search Fields

Page

February Release: Hosted Reference

Material

Applies to those Licensing Content Hosting

Aligns with the functionality of CICS Hosting

Use the ‘Browse’ option to locate a file and upload

Available on Course reference material and Classes reference material

May

[2012]

Release


1. LS Course Infrastructure (EduFlex)

2. Custom Certificates

3. SmartCurricula

4. Customizable To-Do List

Infrastructure

1. Company MetaData

2. SQL Replication Enhancements

May 2012 Release



May Release: Introducing EduFlex

Allows course creation in a managed data structure with XML schema and provides greater long-term efficiency and flexibility in content editing and reuse.

Courses delivered in the EduFlex format will be delivered with cutting edge web technologies such as HTML5, CSS3 and Java Script.

Learners will be able to access a course from any device, browser or operating system.

Clients who implement courses in this format will be able to bolster their training strategy as it pertains to mobile devices and advanced interactivity.

UL EduNeering will be working to integrate this format as we develop courses going forward.

Look for the ‘Welcome To ComplianceWire’ course in the EduFlex course format in the Preview environment.

Allows course creation in a managed data structure with XML

schema and provides greater long-term efficiency and

flexibility in content editing and reuse.

Courses delivered in the

EduFlex format will be delivered

with cutting edge web

technologies such as HTML5,

CSS3 and Java Script.

Learners will be able to access

a course from any device,

browser or operating system.

August Release – Added the

Offline Player



May Release: SmartCurriculum

Training items that are part of a curriculum will now be able to have

event-based rules assigned (similar to a Smart Form).

Upon completion of a training item within a curriculum, for example, a

rule can be added that will add/remove the learner to/from another User

Group.

Curriculum, training items, etc. that are assigned to the User Group

would then apply to this learner.

Multiple training items within a curriculum can be assigned such rules.

No additional cost for this functionality – available to all Clients



May Release: SmartCurriculum

When SmartCurriculum tools are used in conjunction with training

item sequencing rules (within curriculum), assigning SmartCurriculum

rules to the last item in the sequence can be used as an effective way

to move from one curriculum to another.

• Criteria Based UG

• Curricula w/ sequenced Training

• Last Training item triggers Smart Curricula rule

Level I

Training

• Smart Curricula puts User into Level 2 UG

• New Curricula w/ sequenced Training

• Last Training Item triggers Smart Curricula rule

Level 2 Training • Smart Curricula puts

User into Level 3 UG

• User Completes final Curriculum

Level 3

Training

May Release: To-Do List – Customized View

System Administrators will now have the ability to customize the

end user (learner) experience for the system’s To-Do List feature:

Select/Deselect Columns to be visible

Custom View Assigned at the Organization Level

Learners will not be able to override the Administrator’s column

selections

No additional cost for this functionality – available to all Clients



August 2012 Release

August

[2012]

Release


1. Forms Enhancements

• WYSIWIG Editing

• Responses Sequencing

• Responses Types

• Approvers

2. Other Key Enhancements

• Multi-Curricula Assignments

• Recurring Assignments Enhancements

• Meta-Group Homing

• User Upload Tool – Manager Field

• Multi-Lingual Comments

• EduFlex Offline Player Support

Infrastructure

1. Company MetaData



August Release: Forms Enhancements WYSIWYG Editing

Change the way the text in a form appears using the Editing Tools.

Change the font size, style, color and insert HTML links.

Only Forms Questions (text) can be formatted. Responses cannot

have formatting options applied to them.

Applies to those Licensing Forms



August Release: Forms Enhancements Response Sequences

Use when creating questions with Single Responses and/or Multiple

Responses

List the Responses in the Box

Use the check box next to the option ‘Display responses in the order

they were entered’ (default is by alphabetical order)




August Release: Forms Enhancements Response Types

To change to the ‘Dropdown List’ response type, check the box option

that appears below the response entry box:

The dropdown list will appear in the response area on the form like this:



August Release: Forms Enhancements Approvers - Assigned User Groups

Designate specific authorized form approvers OR choose one or

more existing User Groups.




August Release: Forms Approver Training Item Report Details

Form approver information can now be added to the Training Item

Report.



August Release: Recurring Assignments

This enhancement allows you to issue recurring assignment –

regardless of a valid completion.

Subsequent reassignments will follow the retraining rules that

currently exist. In this example, if assignment is made for this item

after 7/16 – the completion requirement is not ignored.

Use the ‘Ignore previous completions’ option to assign the training

item to all designated users, regardless of previous completions.



August Release: Meta-Group Homing

Meta Groups were restricted so that the groups can only be ‘homed’

in a company’s top level organization.

This presented a challenge to System Administrators who did not

have access to the organization’s top level.

This feature will allow Meta Groups to be homed at any organization

level.

The criteria for Meta Groups will be that they must be comprised of

user groups in the same organization as the Meta Group or below

the Meta Group’s home organization.



November 2012 Release

November

[2012]

Release


1. Expanded Custom Fields

2. Quiz Rules for Control Documents

3. Hosting Multi‐Lingual CICS Documents

4. Access to eRoster Through Knowledge Center

5. Functionality Enhancements:

• New EduConnect Licensing Model



November Release: Expanded Custom

Fields

Expands the maximum number of custom fields from 15 to 50

All existing client sites and all new client sites will still be restricted to

15 CF’s unless specifically requested.

New custom fields and data associated to user records could impact

user group management, reporting, data feeds and user group

criteria.

UL Client Services will be able to set the expanded number of

custom fields, but additional effort will be needed to modify

integration and other functionality.

Clients who need additional data fields added to data feeds and/or

reports should discuss with their Account Director in order to assess

the impact of this enhancement on their instance of

ComplianceWire.



November Release: Quiz Rules for Control

Documents

Allow Administrators to apply ‘Quiz Rules’ to disable (or “decouple”)

quizzes from Training Items, either by Curriculum (“Globally”) or by

Individual Training Items within a Curriculum.

Aligns with the Role Based Training philosophy of managing the

behavior and/or requirements for the role at the curriculum level

(e.g. Initial Due In, Retraining Due and Retraining Period

November Release: Hosting Multi-Lingual

CICS Applies to those Licensing CICS and Content Hosting

Allows users with Content Hosting to upload content for all

languages of a multi-lingual CICS training item



November Release: Access to e-Roster

The eRoster has been made

accessible via the Knowledge

Center tab to allow for user

signoff on a number of

browsers, including mobile

ones.

Allows for better adoption of the

e-roster through the use of

mobile devices.



March 2013 Release

March

[2013]

Release


1. SCORM – Multilingual Courses

2. SCORM – Scores & Results View

3. Reporting Solution – New Optional Functionality

4. EduFlex – Schema Versioning Support



SCORM – Multi Lingual Courses

Overview

• Multi Lingual training items are supported for UL developed Computer-Based-Training (CBT)

modules, Critical Information Control Systems (CICS) documents and Forms.

• This enhancement will support multi lingual SCORM courses in a similar way.

To assign multiple languages to a SCORM training item:

1. Access the SCORM training item (use the search functionality, etc.)

2. Select the ‘Languages’ option on the left side of the screen.



SCORM – Score & Results Views

Overview • ComplianceWire will be enhanced so that SCORM course properties can be set to display the

score in place of the completion status.

• The final score will appear in completion reports and other locations where proficiency is

displayed.

• Company Preference and SCORM courses must be configured to display numeric scores.

• ComplianceWire will continue to determine pass/fail as it does now (by reading directly from the

SCORM course response).

To Set ComplianceWire – Company Preferences: 1. From the ‘Options’ tab, select Classroom Options/Company Preferences




To Set ComplianceWire – Company Preferences (continued):

2. It is necessary to set the Completions option so that it indicates ‘Display numeric scores, if applicable’.




SCORM Registrations Quick Report

Details relating to the assessment responses and other data preserved in the SCORM

suspend variable are now accessible to view in the SCORM Registrations Quick Report.

To Access the SCORM Registrations Quick Report

1. While viewing the General Information for a

SCORM training item, select the option for

reports on the left.






52


To Access the SCORM Registrations Quick Report (Continued)…

2. Choose the link for SCORM Registrations to display runtime registration data for users who

have launched this SCORM course (under General Reports).

3. A Runtime Log is provided for each user registration.




53


To Access the SCORM Registrations Quick Report (Continued)…

4. Click on the Runtime Log link to open the report for that user/registration. Here is an example of the data that is

contained in the Runtime Log. You can copy/paste the data, but there is no ability to export or parse the data in the

log.

New Reporting Solution Overview - Features

Next generation Reporting Solution

Separate component from

ComplianceWire

Able to be launched from

ComplianceWire

Leverages replicated database

Near real-time data replication of

ComplianceWire Data

Ability to draw extensive data sets based

on pre-determined base reports.

Quick Access to Most Popular Reports a

User Has Run Over Time

Filters & Sorting – Provide Customization

CW

Replicated Database

UL Base Reports

Duplicate, Edit & Save

Filter, Sort & Group

Report Results

Reporting Solution Overview - Feature Comparison

Feature Description

ComplianceWire

Reporting

Reporting

Solution

Multi-Select a Single Filter Parameter Limited

Special Date Field/Queries Limited

Desktop or Mobile

Ability to Show/Hide Report Columns

Ability to Save Copy of Report

(for future reference without the need to recreate the report query)

Report Scheduling

Report Publishing

Report Email

Separate Reporting Database

Clone and/or Edit Saved Reports

Ability to Email Reports to Non-ComplianceWire Users

Single and Multiple Column Sorting

Qualification Matrix Report

(Premium Reporting Solution)



Reporting Solution – NEW Optional Functionality

Next generation ComplianceWire Reporting Tool

Leverages replicated SQL database – Near time data replication

Quick Access to Most Popular Reports a User Has Run Over Time

Access to UL Base Report Library

NOTE: Due to its unique architecture leveraging data replication, the Reposting Solution will not be available for

testing as part of the Preview site for the March Release. For details about a Trial Period (to be scheduled after

April 8th), or for pricing information on the Premium Reporting solution, please contact your Account Director.



Agenda

Role Based Training

Break


2013 Roadmap



Agenda

Role Based Training

Break


2013 Roadmap



Domain Security



Assignment Questionnaire



Curriculum Versioning & Approvals



Data Upload Tools



New Reporting Tool

Thank You!

Questions?