By Lisa Weeks, Marketing Communications, MasterControl Inc.
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.
This article is related to the Whitepaper: Change Control - Quality Improvements in FDA and ISO Environments To get the full details, please download your free copy.
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. Solution: Invest 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. Solution: Automating 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 reviewed.”
· 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.
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