The ability to adapt to change is critical
to the success of any business. However,
for companies that operate in FDA-regulated
or ISO-certified environments, adapting
to change and more importantly, being
able to control it, is critical to maintaining
compliance. Of course, it’s not
just regulatory agencies that are demanding
higher-quality products; today’s
more sophisticated consumers expect the
medicines, automobiles, and devices they
purchase to be safe and effective, too.
They also expect them to cost less and
be developed more quickly and efficiently.
Better, safer, faster, cheaper…it’s
a tall order for any regulated company.
Organizations that respond quickly to
increased regulation and consumer sophistication
will become inherent market leaders.
How does your company respond to change?
What is Change?
In the manufacturing environment, change refers to any modification in materials, facilities, utilities, product design, formulations, processes, packing/labeling, equipment, computer systems, as well as all associated documentation (SOPs, test methods, quality manual, etc.). A change control system may be called upon to handle a relatively minor adjustment, such as a part replacement or an updated document, or it may be expected to address an issue serious enough to shut down production.
While the regulatory requirements for change control differ by industry, the underlying message is that changes should be made in accordance with approved written company policies and procedures. The reason for this is two-fold: written policy allows for the standardization of procedures and is more reliable than passing on information verbally. Additionally, it allows organizations to maintain a history of all changes associated with the particular item or entity being changed, which is crucial for auditing purposes.
The Domino Effect of Change
Change control is a complex process. When you consider the many sources change can originate from, such as customer complaints, return, and nonconformances, as well as the number of people and/or facilities that may be involved in the change control process (e.g., suppliers, testing labs) it's difficult, if not impossible, to manage change and demonstrate compliance without an enterprise-wide change control system. Even the smallest change or deviation, if not handled quickly and correctly, can trigger a chain of cascading events, like falling dominos. 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.
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Change Control - Quality Improvements in FDA and ISO Environments
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Common Change Control Challenges and Their Solutions
What makes change so challenging? There are many factors, but let’s focus on three of the most common.
· Communication Challenges
: Communication breakdown is perhaps
the most common challenge, particularly
for companies that rely on disconnected
or paper-based tools and face-to-face
information exchanges to manage change.
Whether the breakdown manifests itself
in lack of follow up, task completion
delays or simply the relaying of
erroneous or incomplete information,
it increases the risk of noncompliance.
in an integrated change control software
solution. It will allow you to connect
users, data and processes under a
centralized system and vastly improve
communication through automatic task
assignment, routing, scheduling,
notification and escalation of overdue
tasks. You’ll want to ensure
that the system you choose is Web-based,
so third-party suppliers and off-site
employees can track, review and approve
changes from virtually anywhere.
· Documentation/Data Integrity Challenges:
Even if you’re able to avoid the
communication challenges associated
with a paper-based change control
system, you’ll have to deal
with the complicated process of updating
documentation, which is highly prone
to human error. For example, a proposed
change may be delayed when an outdated
record fails to show the correct
revision history, or testing may
be duplicated because results of
a previous test were never documented.
your documentation and reporting
functions will increase the accuracy
of your data and make it easier to
find/retrieve necessary data to support
a change. This is crucial for compliance
as FDA’s 21 CFR Part 11 requires
a time-stamped audit trail, and the
EU’s GMP Annex 11 requires
that the audit trail to be “regularly
· Turnaround Challenges:
When change issues surface,
the faster they can be resolved,
the better. Timeliness can make or
break your product’s chances
of succeeding in the market. The
legwork required to route and track
manual change submissions can slow
down the process significantly. The
problem is exacerbated when there
is an unexpected change (a deviation)
and supporting data is not generated
expediently. Solution: Automating
your change control procedures can
streamline your entire change control
process, resulting in faster turnaround.
Look for a system that will enable
you to collect and track data from
submission through project close,
assign a priority level (routine,
temporary, or emergency), and provide
real-time status reports for all
change control tasks.
· Training Challenges:
When change occurs, you are required
to train all employees who will be
affected by the change. When training
is siloed outside the change order
system, as it is in a typical paper-based
or manual system, changes in SOPs,
policies, and other documents often
fall through the cracks. Solution: An
effective change control software
solution will allow you to integrate
the change control and training control
processes. When a document change
or process change warrants new training,
tasks will be automatically assigned
upon approval of the change.
Best-in-Class Manufacturers Are Driving Change
The digital age has created more aware and demanding consumers, making customer satisfaction and continuous improvement of product quality the goal of both regulators and manufacturers. Best in class companies realize that it’s their primary responsibility—not the responsibility of an FDA inspector or ISO auditor—to determine if a proposed change could significantly affect the safety or effectiveness of a product. A well-defined process for dealing with change, as well as having the right tools to control change, can help you increase customer satisfaction and prevent costly and embarrassing product recalls and regulatory violations.
Lisa Weeks, a marketing communications specialist at MasterControl Inc., writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.