change control – continuous quality improvement in fda and iso environments

8/8/2019 Change Control Continuous Quality Improvement in FDA and ISO Environments

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Compliant. Connected. Complete.

White Paper:

Change Control Continuous

Quality Improvement in FDA and ISO

Environments


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FDA & ISO Change Control Page White Pape

Introduction

Globalization of the marketplace has greatly intensied competition. It has increased the pressure on manufacturers to

develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to

meet customer demands and even quicker in adapting to changing market conditions.

The situation could not be more acute than in the FDA and ISO environments, where manufacturers must contend not

only with cutthroat competition and a dynamic market, but also stringent regulatory requirements. Consider the ercely

competitive pharmaceutical industry. Only one of every 10,000 potential medicines investigated by American research-

based pharmaceutical companies makes it through the rigorous FDA approval process, according to the Pharmaceutical

Research and Manufacturers of America. It takes about 15 years at a cost of more than $800 million before a new

medicine is approved.

The road toward product development and FDA approval or ISO certication is clearly long, arduous, and costly.

After a product is launched in the market, the manufacturer must continue to comply with regulatory requirements to stay

in business. Regulations exist to ensure the safety and reliability of products. In this context, any change that affects the

purity and effectiveness of the approved product is critical.

Denition of Change

In the manufacturing environment, change refers to any modication in equipment, manufacturing materials, facilities,

utilities, design, formulations, processes, packaging/labeling, computer systems, and all associated documentation (SOPs,quality manual, etc.).

A change may be a simple adjustment brought on by a new customer specication, or an updated document, or a part

replacement, or other production needs. It may be caused by a deviation from an approved regulatory ling or written

procedures. A change may be temporary or permanent, routine or emergency, innocuous or serious enough to shut down

production.

The fact that change is inevitable makes control a critical factor, especially in FDA and ISO-environments, where

inappropriate or uncontrolled changes could affect the safety and reliability of products and directly impact public

health and safety.

Heres an example. On Oct. 24, 2005, the FDA announced a voluntary recall of certain models of Omron instant

thermometers because the thermometer tips could potentially overheat and pose risk to young children using the device.

The FDA noted that the overheating was a result of a change in the manufacturing process. The agencys press release was

brief and did not describe the circumstances of the change that caused the quality problem, but it illustrates the critical

implications of change in the manufacture of medical devices in this case, or any other product for that matter. Whether

its a car or a computer or a pacemaker, the goal of regulatory bodies is to protect public safety by ensuring the highest

quality standards. For this reason, the concept of change control is closely interweaved with FDA and ISO compliance.

Regulatory Requirements

Change control requirements for medical device companies are outlined in FDAs 21 CFR Part 820.30 (design changes),

820.40 (document changes), and 820.70 (production and process changes). 21 CFR Part 820 requires that manufacturersestablish written change control procedures, which describe company-approved procedures.

For pharmaceutical companies, written procedures are considered part of Current Good Manufacturing Practice (CGMP)

outlined in 21 CFR Part 210-211. Any changes in production and processes must be controlled meaning recorded,

reviewed, and approved by the quality control unit. CGMP requirements are meant to prevent harm by building quality

into the development and production of medicines.


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Manufacturers certied to ISO 9000:2000 and ISO 13485 standards are required to ensure that any changes affecting the

quality management system (including product requirements, design, and development changes) should be controlled.

The underlying message in these regulations is that all changes should be made according to approved (approval implies

successful testing or thorough review/investigation) written company policies and procedures. Change control procedures

have to be written as a way of standardizing instructions. Written procedures are also more reliable compared with passing

on information verbally. Uncontrolled change in this context refers to modications made without review and approval

of the quality control unit and other departments affected by the change.

In the FDA and ISO environments, strict adherence to approved policies and procedures is key in keeping manufacturing

operations in a state of control and it is what makes change control crucial.

Elements of Change Control

Change is typically introduced by an initiator or originator. Depending on the company and industry, the initiator may

or may not be the person who will carry the change through implementation. Initiating a change usually involves lling

in a change request form, which then moves through a process or system of review and approval. Most organizations

have a change control committee or board, which may be a single entity for an entire company, or there may be one

for a companys every manufacturing site. The committee usually includes representatives from different departments

involved in production, such as quality, manufacturing, regulatory affairs, and engineering. Depending on the change, the

committee may also involve legal, sales, or marketing departments.

For pharmaceutical companies, the CGMP requires that all changes should be reviewed and approved by the quality

control unit. In these companies, there may be a change administrator, a role usually assumed by the quality unit.

Change control records usually cover: identication of the item/entity being changed, a description of the change,

identication of the affected documents, signatures of the approvers, approval date, and effective date.

In the medical device industry, each modied device, accessory, labeling, packaging, and process must be thoroughly

veried and or/validated by the appropriate department. The change control committee then reviews the test results and

other pertinent information.

Challenges

A change control system is necessary to prevent inappropriate modications. While this sounds simple, implementation

can be complex and an inadequate system can cause internal confusion, noncompliance, or worse, a product recall or a

product liability lawsuit.

What makes change control so challenging? There are many factors, but the following are the most common issues:

Poor Communication Lack of communication between departments, failure to follow up or escalate change

requests, and delayed or inappropriate notication of changes made by suppliers are some of the communication-

related issues that impact the change control process. Companies using a paper-based change control system

are likely to rely on face-to-face exchanges, such as change control board meetings, to discuss changes. Theeffectiveness of these meetings depends on their frequency and the availability of members to meet as emergency

changes arise.

Poor Turnaround Timeliness can make or break a products chances of succeeding in the market. Companies

that rely on a manual system to generate data and to route and track submissions and change orders are likely to

have poor turnaround for change implementation because the system requires more time and effort. The problem

becomes worse when there is an unexpected change a deviation and supporting data is not generated in a


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timely manner. Delays may also result because of failure to recognize the urgency of a change and absence of a

contingency plan for certain types of changes.

Ineffective Documentation A manual system makes it more difcult to update documentation, including

revision history, and to nd/retrieve necessary data to support a change. The proposed change may be delayed

when an outdated record does not show revision history, or testing may be duplicated because documentation has

not been updated with results of a previous testing.

Training not Integrated with Change Adequate training of personnel is a prerequisite in both FDA and

ISO environments. When training control is not connected to the rest of the quality process (such as in manual

systems), keeping training current with procedures that have changed can be difcult. Training tasks can easily

fall through the cracks if employees are not as vigilant in seeking them.

The MasterControl Solution

MasterControl Change Control is a robust solution designed to simplify the change control process by automating and

effectively managing every step of the way, from submission through actual implementation, verication, and close of

project. Heres how MasterControls powerful features address major challenges in change control:

Improved Communication Communication breakdown is likely to happen in companies that rely on tools and

processes that are not connected. MasterControl is an integrated solution that connects different departments witheach other and with data and processes under a secure and centralized system. This connectivity vastly improves

communication and increases efciency through automatic task assignment, routing, scheduling, notication, and

escalation of overdue tasks. MasterControl is Web-based, so even suppliers and others outside the company (off-

site or traveling employees) who need to participate in change control can do so from virtually anywhere.

Faster Turnaround MasterControl integrates and streamlines the entire change control process for faster

turnaround.

A pre-congured, multi-page form helps collect and track data from submission through close of project. The

form incorporates priority level by identifying the change as routine or temporary or emergency. It prompts

risk assessment by asking the initiator to evaluate the change in terms of

training, validation, and regulatory requirements.

MasterControls Organizer, similar to Windows Explorer, is an easy-to-use tool for search and retrieval of

documents. All SOPs and other documents related to a particular change can be grouped together. Users

can create virtual folders within Organizers that will automatically retrieve documents based on pre-dened

queries.

MasterControls reporting capabilities provide real-time status for all change control tasks.

Effective Documentation MasterControl automates documentation and reporting functions for increased

efciency and effectiveness.

It automatically provides revision history through the InfoCard, a MasterControl tool that provides basicinformation about a document. The InfoCard also provides the documents approval history. All changes made

to the InfoCard of every document are tracked, including reason(s) for every change.

MasterControl maintains a secure, time-stamped audit trail as required by FDAs 21 CFR Part 11. The audit

trail documents the identity of anyone who creates or modies an electronic record, when the action occurred,

and the changes made to the record.


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Integrates Training with Change Control With MasterControl, the change control process can be integrated

with training control. Any change to a document or process that warrants new training will automatically invoke

training tasks upon approval of the change. MasterControl can automate the process of distributing online exams

with the training, and even includes automatic grading.

Conclusion

In this Age of the Internet, consumers worldwide have become more aware about product quality. In response,

manufacturers are changing their business philosophy. Customer satisfaction and continuous improvement of product

quality have become the objectives not only of regulatory bodies, but manufacturers themselves. At the operational level,

the focus is moving from detection to prevention. Companies recognize that its their primary responsibility to determine

if a proposed change could signicantly affect safety or effectiveness of a product and not for the FDA inspector or

ISO auditor to spot. Manufacturers increasingly realize that effective change control is integral to continuous quality

improvement, which can ultimately help them increase customer satisfaction and prevent product recalls, product liability

actions, and regulatory violations.


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Page White PapeFDA & ISO Change Control

About MasterControl Inc.

MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. Hundreds of

companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-

211, 820, 606; ISO quality standards such as ISO 9000, ISO 13485, ISO 14000; and Sarbanes-Oxley Act requirements.

In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support,

including product training, implementation, and validation services.

For additional industry white papers about automating quality and regulatory processes, visit www.mastercontrol.com,

or call, 800-825-9117.

MasterControls integrated quality management system helps connect quality processes enterprise-wide. The solution

provides automatic triggers to ensure tasks for handling quality-related incidents dont fall through the cracks.

MasterControls integrated architecture ensures that the completion of one system process automatically launches the next

quality sub-system until the process loop is closed. Managers have analytical and reporting capabilities at their ngertips

to track and manage each quality process through completion.

2006 MasterControl Inc. All rights reserved.


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MasterControl Inc.

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change control – continuous quality improvement in fda and iso environments

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