White Paper

Automating Electronic
Engineering Change
Management (ECM)
Systems
Reducing Compliance Risk and Improving Product Quality
 White Paper

Introduction

From medical devices to car parts to forklifts, all products undergo design changes
at some point. Manufacturers of every stripe face the common challenge of the
unexpected change. Modifications may stem from unavailability of parts, or safety
reasons, or because of government regulations. They may be minor, affecting only a
single component, or they can be complex, involving several assemblies.

Every manufacturer needs an Engineering Change Management (ECM) process for

initiating and controlling change. An effective ECM process ensures the safety and
reliability of products by using current, approved, and released documentation for a
specific change. An electronic or web-based ECM system offers reduced risk of non-
compliance and the potential of increased product quality by providing the following:

• A secure electronic login to the document control system

• A secure process of electronic approvals
• E-mail notifications to all participants
• Integrated task tracking
• A configurable automated workflow processes
• A means for attaching/linking documents to the ECM process
• Current status reports on the document in question
• A process to find/read/print documents within the database
• Electronic engineering change notice/request/order template forms
• Capability for all participants to add comments and read everybody’s input
• A process for creating external reports using current data

A change initiated from a customer complaint or through a corrective action

process that was meant to fix a simple mistake could potentially affect the design
team, the manufacturing team, suppliers, and subcontractors. A redesign in the
product itself could affect all of those people and may even include personnel
in sales and marketing, contract administration, purchasing, inventory control,
training, quality, and technical publications.

Process changes, updates in equipment, or new setups all pose challenges in

change management, but the overriding factor is usually the lack of control in
engineering and other referenced drawings, bill of material (BOM), and submission
to vendors. Keeping track of approved engineering change notice (ECN) and
engineering change requirements (ECR) can also be a major issue.

For example, a company that produces medical device XYZ finds out that a change
is necessary to fix a defective pump. The new pump, produced by another vendor,
has different mounting holes, as well as electrical connections. This single change
in the pump has affected two other assembly pieces manufactured through other
vendors. Drawings must be updated to accommodate the new pump. This change
will affect several vendors (old pump, new pump, fabrication, and electrical wiring
vendors) and entail updating instructions and BOM, installation of new pump, and
new packaging. All of these will probably mean additional costs.

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This shows how an engineering change is affected by different factors.

Manufacturers that depend on outside vendors require a higher degree of control
than those using in-house processes. Companies that run 24/7 operations could
potentially experience more issues if changes are happening every hour. In a
nutshell, dealing with an engineering change can be simple or complex. There’s
no foolproof formula for doing it, but you should consider the ECM process as an
important tool in helping you execute the change successfully.

Typical ECM Process

The ECM typically provides everything needed to set up a fast, effective, and
secure change process. There are three major components to the process
meant to ensure data accuracy, security, and consistency: Engineering Change
Notification (ECN), Engineering Change Request (ECR), and Order Change
Management (OCM).

An engineering change usually begins with either an internal or external user

report about an issue, or an update to a document or drawing or process through
ECN. The change task notification is then sent to the responsible parties through
specific routes/workflows. They use the change notification to check the issues
and/or updates and to decide on the appropriate action.

If the decision is made that an engineering change task is necessary, an ECR is

created on the basis of the change notification and both documents are linked.
The changed engineering documents are prepared. Responsible parties check all
parts and items being changed. A good ECM provides a collaboration process that
allows everybody affected to redline the changes in the document.

After everybody has approved the changes, the ECR can then be converted into an
Engineering Change Order (ECO) for the affected parts. The responsible parties
proceed to make the changes, which become effective only after they release
the ECO. The release can be made either in one step or as a general release or
through a multi-step process.

If changes are released for running production orders, the Order Change
Management (OCM) process may optionally be triggered to adopt changes in a
controlled process.

ECM Functions

• The ECM process is inherently complex; automating the process can greatly
expedite engineering changes. Change forms, such as ECN, ECR, and ECO,
can be electronically created and routed individually or combined with a
template and attached documents for review and approval. Some e-forms
can be integrated processes in themselves – providing a form template,
background process, and an integrated document process allowing data
retrieval and record analytics that give direct feedback online. Here are some
of the main functions of ECM:

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• Routing/Change Control - The ECM process is critical in controlling routing of

drawings, specifications, formulations, process documents, etc. . . . Changes
made in certain operations may require detailed change justifications and
descriptions of changes, listing of products/processes affected, disposition
of affected product, and updates to affected documentation, personnel,
and equipment... Through the ECM process, new training courses can be
initiated using timed, notified, and dated SOPs for all affected employees.
This may include new machine setups or material handling instructions. The
ECM can also be used to track changes made to engineering drawings. The
relationships between current and previous drawings can be shown using
attached and/or linked documents

• Collaboration and Approval Steps - An ECM process may include multiple

collaboration and approval sequences. E-mail notification should be sent
automatically to members of each review/approval step. Approvals are made
based on the pre-structured routing order. Tracking is easier if members of
each step have the ability to approve and sign off electronically. Members’
review comments, approval, or rejection can similarly be tracked.

• Quality and Regulatory Control - Most quality control programs use ECM to
help meet stringent standards set forth in FDA’s 21 CFR 820 regulations and
in ISO/QS certification programs to help reduce the number of items that are
scrapped or returned.

• Engineering Audits - An ECM provides an audit trail for tracing a product

backward or forward throughout the engineering lifecycle. It’s also essential
in tracking changes in different versions of engineered parts and in comparing
multiple versions of routings and BOMs.

• Management of Change - An ECM provides the MOC a mechanism to initiate

and control the:

-- technical basis for the proposed change

-- possible impact of change on safety and health
-- modifications to operating procedures (SOP)
-- control of a necessary time period for a change
-- authorization requirements for the proposed change
-- employees affected by change that need to be informed and trained prior
to startup
-- updating of drawings, if affected
-- updating of procedures, if affected

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Controlling Change

The ECM process is crucial in maintaining the consistency of products because

it defines and controls the change task process. An effective ECM should be
flexible and workflow-process driven. It should log, record, and track the history
of all change tasks, including BOMs. All affected personnel should receive timely
communication about a change task and they should have the capability to give
input and/or approval.

The size of a manufacturer does not affect the nature of an ECM as much as the
complexity of a design change, the corporate policy on change, and the extent of
compliance requirements involved. It’s critical for a manufacturer’s ECM process
to do the following:

• Configure an effective Change Control Management process that works within

existing manual system and automate the notification and approval process.

• Prepare company processes to effectively control and document changes in:

-- Engineering drawings
-- Manufacturing processes
-- Product redesign
-- Vendor product changes
-- Other changes

• Integrate and complement manufacturer’s Change Control Management

processes to fully utilize computerized systems.

• Configure system to a variety of types of change tasks.

• Fit into different levels of change tasks (major, minor, critical)

• Decentralize the roles and responsibilities of approvers and administrators

• Provide the company with formatted templates for Change Control SOPs and
Form revisions

Advantages of Web-Based ECM Processes

Advanced ECM systems now include Web-based applications that give users access
to documents, processes, workflows, collaboration, and e-signature approvals
via the Internet. One of the advantages of a Web-based system is its ability to let
traveling or off-site employees participate in change management processes.

Many companies also take advantage of controlled Web access to improve supply
chain and customer involvement in their change management process. With
controlled Web access to ECM, suppliers and customers can be added to change
processes with limited users’ rights, such as review and approval rights.

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When organizations decide to switch from manual or hybrid to an automated

system, they start by establishing an electronic data management (EDM) process
to manage the whole engineering change process. EDM provides efficiency
and security through a controlled environment and allows a circular flow of
information within the teams. It captures the entire change process electronically.
Here are some of the things the EDM does:

• Provides pending change notifications for engineers and production personnel.

• Tracks approvals for changes.

• Provides engineering changes to in-process work orders for manufactured parts.

• Prevents certain transactions against in-process work orders when changes

are pending.

• Maintains a comprehensive audit trail of changes and approvals.

• Allows secure manufacturing repeatability

• Allows traceability of ECN/ECR/ECO documents

• Maintains drawing and product specification revisions

• Maintains parts and materials lists

• Provides product change notifications

• Provides flow charts

Automating the ECM Process

The initial review process can be automated in a number of ways. For example, an
engineer could initiate an ECN by getting an electronic copy of the document that
needs to be changed (e.g., a drawing or specification). ECNs (Engineering Change
Notifications) may be improvements - not a full-scale revision - to a previously
approved specification. After proposed changes are made to the document, it
could be sent on a collaboration route to those who need to review it and/or
provide feedback.

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In initiating ECRs (Engineering Change Requests), the workflow drives the

users directly to the associated documents and their markups. ECRs define the
acceptance of an engineering change notification that is approved. An automated
system allows the recipient to collaborate with the originator and resolve
questions immediately. The recipient can easily check out the document for
changes, make the changes using the native application, and then check in the
revised document. When the changes are complete, the work can be automatically
routed to the designated participants for review and approval and the continuing
release process.

After all the responsible parties have approved the changes, the ECR can be
converted into an Engineering Change Order (ECO). Only then can the physical
change of the affected parts be made. The ECM process could also include
implementation steps to ensure that approved changes are incorporated,
documents are released, training has been completed, bill of materials (BOM) has
been updated, etc. Implementation steps ensure that the original intent of the
approved ECR has been effectively followed through.

Conclusion

An effective engineering change management system is critical to maintaining

quality standards and ensuring FDA and ISO compliance. Companies that rely on
a “work- around” — an alternate process used when problems arise — may get
the job done, but runs the risk of compromising product quality. By using a work-
around, it is easy for employees to break rules and policies. The result: an entire
organization’s product quality may be jeopardized.

Implementing a Web-based ECM not only allows manufacturers to streamline

workflow processes, but establishes control over these processes. An
electronic ECM sets a standard for the workflow, so enforcement is not the sole
responsibility of the manager. The entire system (not just the manager) will ensure
that every step of the process is performed accurately and consistently.

When choosing a Web-based software solution, find a system that’s flexible

enough to configure a variety of change tasks and decentralize the roles and
responsibilities of approvers and administrators. It should be able to automate
the notification and approval processes, tracking, reporting, and provide a secure
audit trail. Select an integrated system that will connect all of your quality data,
processes, and teams to ensure compliance

Glossary

• Engineering Documents - Documentation relating to the design,

manufacture, procurement, test, inspection (if applicable), of an item or
items or system as well as procedures that may be required to support the
program’s hardware procurement, build, test and site delivery phases.

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• Released - Released engineering documentation is data that has been

reviewed and approved by project review process.

• Effective - Effective engineering documentation is data that has been

released and approved and is available to all users.

• Expiration - Expiration engineering documentation is data that has met a

defined archive date and/or is replaced by a newer revision.

• Approval - Program designated members review and approve, engineering

documentation, and changes thereto, prior to use in procurement,
manufacture, assembly, installation, test, or inspection of an item or system
intended to be delivered to a site or retrofit or repair an item or system
previously delivered to a site.

• Redlines - The markup of drawings to show how portions of the engineering

documentation are to be revised. These markups may be made on hardcopies
of the drawings and electronically scanned and linked to Web ECO
documentation package. Markups may also be done electronically with Adobe
Acrobat and other such Web markup/viewing programs for CAD and word-
processed documentation.

• PDF Format – A document-viewing format (portable document format)

that may be viewed and printed with its original appearance preserved with
Acrobat Reader (Adobe Systems Incorporated). It is available free from their
Web site. An Adobe Acrobat application may be purchased which includes
modules that allow a user to electronically markup a document in the PDF
format, and then distribute it for viewing and printing on any system, to
streamline workflow.

• Database - An SQL data management application that maintains data and

generates reports about parts, bill-of-materials, drawings, software code,
files, and specifications used in the SMA project. Users may search this
information system and produce reports that may be viewed with a web
browser and printed.

• Drawing Library - A hierarchical computer filing system where all

electronic files of engineering drawings, software code, and documentation
are stored.

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The MasterControl Solution

The MasterControl™ quality management software solution offers a holistic

approach in improving the ECM process. It interconnects data, processes,
and people to promote efficiency across an organization. MasterControl’s
integrated software modules are configurable, easy to use, and designed to
help companies maintain compliance by effectively managing change control,
training control, audits, corrective/preventive action (CAPA), and other forms-
based quality processes under a single Web-based platform. MasterControl
offers comprehensive technical and customer support, including product training,
installation, implementation, and full-cycle validation services.

• MasterControl Portal™ – Provides a Web-based foundation for all

MasterControl applications. It offers easy access through the Internet for
all authorized users. It ensures security through encrypted passwords,
automatic password expiration, intruder lockout, and dual signatures for
login and approval.

• MasterControl Documents™ – This core module within the MasterControl

suite provides control for all types of documents regardless of the software
used to create them. It also offers capabilities for: revision control to ensure
current version of a document is used, advanced routing, automatic e-mail
notification, time-based escalation of tasks, secure and time-stamped audit
trail, tracking, reporting, and business analytics.

• MasterControl Forms™ and MasterControl CAPA™ – These closely related

applications offer out-of-the-box configurations that can be used as is or
customized to help manage forms-based quality processes such as audits,
out of specifications, nonconformances, deviations, customer complaints,
and corrective/preventive action (CAPA).

• MasterControl Training™ – This innovative module provides the tool for

managing role-based training requirements that are critical to compliance.
It allows deployment of simple or extensive training courses that will
require users to learn their duties and demonstrate their proficiency
through exams. When integrated with MasterControl Documents, it can
trigger training tasks related to engineering change or any modification in
SOPs, policy, and other quality-related documents.

• MasterControl Collaboration™ – A solution that connects people and

teams, regardless of their location. MasterControl Collaboration is an
effective tool for sharing ideas. It allows users to view everybody’s input
to avoid duplication of corrections. This module simplifies teamwork and
strengthens collaborative initiatives.

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• MasterControl Submissions™ – This product has all the necessary

features for submission of electronic records and signatures to ensure
compliance with FDA 21 CFR Part 11. It offers templates that conform
to formats approved by various FDA centers. With just a click of a mouse,
you can format submissions for New Drug Applications (NDA), Biologic
Licensing Applications (BLA), Common Technical Document (CTD), and
Investigational New Drug (IND).

Other MasterControl White Papers

In addition to this white paper, other complimentary papers can be downloaded by

contacting MasterControl Inc. at 800-825-9117. A few of these include:

• Corrective and Preventive Actions (CAPA) – Does your CAPA system need
a CAPA?

• Automating Paper-based Document Control and Change

Management Processes

• Automating Paper-based Training Control Processes

• Validating Software Systems in FDA GxP Environments

Related Acronyms Used in the Engineering Industry

ATD Available-to-Deliver
ECO Engineering Change Order
ATO Assemble-to-Order
EDM Electronic Data Management
AVL Approve-Vendor List
EDMS Electronic Data Management Systems
BOM Bill of Materials
EDMS Engineering Document Mgmt System
BTP Build-to-Order
EIM Enterprise Information Management
CAD Computer-Aided Design
EMD Engineering, Manufacturing, Design
CAE Computer-Aided Engineering
FCO Field-Change Order
CBT Computer-based Training
MCAD Mechanical Computer-aided Design
CGMP Current Good Manufacturing Practices
MOC Management of Change
CM Configuration Management
MRP Materials Requirements Planning
COTS Commercial Off-the-Shelf
OCM Order Change Management

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CRB Change Review Board

PCM Product Change Management
DM Document Management
PLM Product-lifecycle Management
DMS Data Management System
PDM Product Development Management
ECM Engineering Change Management
PSM Process Safety Management
ECR Engineering Change Request
SOP Standard Operating Procedure
ECN Engineering Change Notice
TQM Total Quality Management

Typical Flow Processes for ECM

These flow diagrams represent two typical scenarios that can be used in the
Web-based ECM system environment, the first is an e-document control flow,
with or w/o e-collaboration and the other is using an integrated e-forms process
that consolidates all of the interactions within the process, where departments,
vendors, and linked revision changes are managed within the document system via
a closed controlled work flow process. Here, forms are filled on-line, attachments
and linked revisions become part of the final forms data collection and
recordkeeping. Both have major advantages over paper documentation with the
e-forms having the most attributes and advantages. This is where the true power
of e-forms works to control every step of the ECM process.

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Start - Originator Launches Template Start - Originator Launches Start - Originator Launches Template
ECN From to ECM Collaboration Collaboration Process on ECN ECR Form to ECM Collaboration
Process along with ECN Revisions Revision Document Process along with ECN Revision

ECN Form Completed NO

Form Collaboration by Leader - First Reject - No ECN -
Team #1 - Feedback Redline Markup Returns to Originator
Complete by Leader

YES

Step 1 Collaboration
Complete - Leader
Dispositions Final Redline
w/Team #1 Feedback

ECR Form Completed

Form Collaboration by Leader - First
Team #2 - Feedback Redline Markup
Completed by Leader

YES

Step 2 Collaboration
Complete - Leader
Dispositions Final Redline
w/Team #2 Feedback

E-Mail Notification to
Training Invoked on New Approval Process Begins -
Affected Vendors, Possible ECO Issued to
Production Process, SOP or E-Signatures and Finalized
Engineering Groups and Vendors or Production Floor
Change of Vendor Revisions
Manufacturing

Finalize Documentation

Start - Originator Launches Template

ECN/ECR Form through Revision
Form Template Route #0001

Step 1 Originator Completes

ECN and Attaches Revision
Document Showing Redline
Markups

E-Approvers Review and

Step Reject - Correct ECN NO Sign-Off to Next Step NO Final Reject - No ECN -
and/or Revision Document w/comments Returns to Originator
and Re-Attach Modify Next Step
Participants

YES

Step 2 Chosen Team Reviews

ECN and Completes ECR
Re-Attaches Updated
Revision Document

YES

E-Approvers Review and

Step Reject - Correct ECN NO
Sign-Off to Next Step Option to Start an ECO and
and/or Revision Document Notify Affected Parties
w/comments
and Re-Attach
Modify Next Step
Participants

Step 3 Chosen Team Reviews

ECR and/or Completes the
ECO Form for Revision
Document

Step Reject - Correct ECN NO E-Approvers Review and

and/or Revision Document Final Sign-Off w/comments
and Re-Attach or Final Reject to STOP
PROJECT

Replace the Revision

Document w/Approved
Version and Attach all
ECN/ERC/ECO Documents
to Original Document for
Separate Approval Process

Finalize Documentation
Approval

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About MasterControl

MasterControl Inc. creates software solutions that enable life science and other
regulated companies to deliver life-improving products to more people sooner.
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by
automating and securely managing critical business processes throughout the
entire product lifecycle. More than 1,000 companies worldwide, ranging in size
from five employees to tens of thousands, rely on MasterControl cloud solutions
to automate processes for new product development, clinical, regulatory, quality
management, supplier management, manufacturing and postmarket surveillance.
MasterControl solutions are well-known for being scalable, easy to implement, easy
to validate and easy to use. For more information, visit www.mastercontrol.com.

© 2019 MasterControl Inc. All rights reserved.

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