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February 22, 2024

Change is a constant in manufacturing, and is both necessary for innovation and a significant source of risk. When uncontrolled changes occur, it can often lead to regulatory violations, product safety issues, and recalls.

In fact, from 2018-2022, change control was number eight among the top 10 U.S. Food and Drug Administration (FDA) 483 citations issued to drug companies, according to the FDA Group.

It’s not just pharmaceutical companies that need to worry about managing change effectively, however. While medical device, pharmaceutical, and food and beverage companies all have stringent change control regulations, all manufacturers face similar risks without a systematic approach to change.

In this article, we explore the importance of change control in manufacturing, covering topics such as:

  • What change control is and why it’s essential, especially in regulated industries
  • Benefits of automating change control with an enterprise quality management system (QMS)
  • Areas of your QMS to connect to change control to reduce risk

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What Is Change Control?

Change control is a systematic approach to managing changes in products, processes and systems in manufacturing. Change control is critical to ensuring product quality and safety, preventing unauthorized changes that could cause defects or deviations from quality standards.

A key element of regulatory compliance in many industries, change control protects against risks associated with unmanaged changes, so that any modifications are assessed, documented and implemented in a structured way.

The Change Control Process

The change control process provides a structured framework for reducing the risk of change, and is typically comprised of the following steps:

  • Identifying the need for a change
  • Documenting and submitting a change request, including justification for the change, scope, potential risks and benefits, and resources needed
  • Reviewing the proposed change
  • Assessing any risks it may create before approving it, rejecting it, or sending it back for modifications
  • Creating and executing a plan to implement the change across systems, documentation, and processes
  • Submitting documentation of the change to regulatory agencies as required
  • Post-change monitoring and reporting

Change Control vs. Change Management

Change control and change management are terms often used interchangeably, however, they refer to different aspects of the change process. Where change control deals with the technical details of changes, change management encompasses a broader view, looking at human and organizational aspects such as communication, stakeholder engagement, and training.

Change Control: A Medical Device Example

It doesn’t take much imagination to see how a lack of change control can lead to costly problems and even life-threatening events for consumers.

Consider, for example, a manufacturer of a Class III implantable medical device that decides, upon recommendation from a supplier, to change the design of a critical component. The proposed design change involves modifying the material composition to improve durability but is implemented without rigorous assessment or documentation.

What results is a cascade of negative consequences, both for the company and patients using the device:

  • Failure to effectively communicate the change to quality and regulatory teams means a lack of oversight into the compliance implications of the change.
  • Without a proper risk assessment, the team fails to identify potential biocompatibility issues with the new material, creating a patient safety risk.
  • Failure to validate the change means the risks go unnoticed until patient complaints start rolling in.
  • Insufficient documentation of the change, its justification, and possible impacts makes it difficult to identify the root cause of the problem.
  • Failure to follow a change control process leads to regulatory penalties, a recall and lawsuits.

The ultimate result is potentially irreparable harm to patients, and the company faces steep financial losses and brand damage that lasts decades—or worse, bankrupts the company.

Change Control in Regulated Industries

Change control and change management are a central focus of numerous industry regulations, including:

  • Pharmaceutical: Good manufacturing practice (GMP), Good laboratory practice (GLP), FDA 21 CFR Part 11, European Medicines Agency (EMA) regulations
  • Medical device: FDA 21 CFR Part 820, European Medical Device Regulation (MDR)
  • Food and beverage: FDA Food Safety Modernization Act (FSMA), Hazard analysis and critical control points (HACCP) requirements
  • Chemicals: Process safety management (PSM), Control of Major Accident Hazards (COMAH), Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH).

In addition, change control and change management appear across a number of ISO standards, including:

Why does change control appear in so many regulations and standards?

The answer is simple: uncontrolled changes pose a massive risk to public health, and companies that ignore change control do so at their own peril.

What Changes Must Manufacturers Track?

Change can come from any number of events, whether it’s to add a new product feature, change a design for compliance purposes or refine the manufacturing process.

To meet regulatory compliance and maintain certification with necessary industry standards, a rigorous review, testing and approval process must be documented anytime you make changes to:

  • Equipment
  • Product materials
  • Design specifications
  • Formulations
  • Processes
  • The QMS itself and electronic records

Benefits of Automating Change Control

Change control involves a mountain of paperwork and collaboration across diverse groups of stakeholders, from R&D to quality, engineering and operations. Is it any wonder, then, that change control problems become an issue where paper-based records and manual sign-offs are involved?

Automated change management software within a digital QMS provides several benefits over these time-consuming and error-prone manual processes. Some of the most important of these are:

  • Reduced compliance risk: A QMS built around FDA and other regulatory requirements ensures systematic documentation of changes, so that manufacturers are always audit-ready. The QMS maintains a complete audit trail of all change-related activities for full compliance during audits and inspections. It also helps protect against data integrity issues, which FDA guidance notes have been increasing in recent years.
  • Fewer errors: An automated change control process reduces the risk of mistakes such as data entry and versioning errors. An automated QMS ensures changes are correctly documented, and that people always use the most recent approved versions.
  • Streamlined collaboration: Cross-functional teams can access real-time information, collaborate on assessments and make approvals, all without in-person meetings or delays.
  • Improved decision-making: By applying a systematic approach to risk assessment as part of the change control process, manufacturers can better mitigate potential risks. Data analytics provide insights into historical trends and areas of opportunity to promote continuous improvement.
  • Efficiency gains: Fewer manual touches helps accelerate the initiation, assessment, and approval of changes, so they can be implemented faster and with less risk.

Elements of an Effective Change Control Solution

Any QMS change management solution you implement should be built around industry best practices and standards, helping to streamline compliance and processes overall. When evaluating solutions, look for functions such as:

  • Electronic signatures that comply with regulations like 21 CFR Part 11
  • Escalation rules to notify managers of overdue tasks and identify bottlenecks in the process
  • Secure, time-stamped audit trails documenting changes to electronic records, including who made the change, when, and what the changes were
  • The ability to initiate a risk assessment from a change request
  • Configurable dashboards that keep your team updated on the status of changes, pending assignments, and overdue issues
  • Workflows that can be configured to your organization’s unique process, with the ability to set due dates, approval steps, and proper routing of documents and deliverables

Integrating Change Control in Your QMS

Integration is also an essential part of automating change management with the QMS. This includes integrating change control with external systems, as well as internal QMS solutions affected by the change control process.

For example, a robust QMS will allow you to capture change requests from enterprise applications such as:

  • Enterprise resource planning (ERP)
  • Product lifecycle management (PLM)
  • Customer relationship management (CRM)
  • Laboratory Information Management System (LIMS)

From a QMS perspective, it’s important to consider how change control is interdependent with a number of other processes. These include:

Material substitutions, for instance, must be documented and communicated to suppliers, while any changes to the process should trigger new employee training requirements. Data from nonconformance reports, corrective actions, and complaints may also inform potential changes to processes or products. The ability to connect all of these to your change control process creates transparency and reduces risk, while also helping simplify regulatory filings and audits.

Conclusion

Managing change effectively is a vital part of the quality process, given that uncontrolled changes can impact many areas of the business and create hidden risks. An enterprise QMS can help reduce those risks by streamlining collaboration across multiple stakeholders, increasing visibility into potential impacts, and creating a closed-loop process to manage change across the organization.

Watch a video demo of the AssurX Change Management solution

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.

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