Life science organizations must keep up with the industry’s high demand for innovation by constantly changing products and processes to remain competitive. Organizations using change management processes can execute change more effectively than others, delivering change faster and with less risk. Product life cycle management (PLM) systems often are used to manage change. However, PLM systems fail to provide the functionality needed in today’s fast-paced and highly regulated markets. A quality management system (QMS) picks up where PLM leaves off by comprehensively automating the change management process with the flexibility, collaboration, security, and compliance management necessary to compete effectively.

This series of columns has reviewed the phases of an effective change management process. The define and design phases set the foundation for the change by collecting and prioritizing internal research and customer market data to identify the requirements, scope, and impact of the change. The approve, plan and source phases describe the benefits of using a robust and configurable review and approval process to accelerate and control change and to support continuous collaboration along the way. This installment will look at the final phases of the change management process, execute and verify, to answer some critical end-of-process questions: When is the change process complete? Has the change been communicated effectively? Was the change effective?

 

The Road to Quality—Execute and Verify

It is imperative that the right people are delivering on the change and are trained and knowledgeable prior to the change becoming effective. During these phases, involved parties need to collaborate on the change in real time using electronic distribution of change notifications to enhance communication. Before change completion, all affected parties must be fully trained. The QMS manages and tracks training, with all training materials linked to the change process. Furthermore, quality concerns must be resolved, ensuring low risk before rolling out the change to customers. The QMS manages and tracks quality processes to ensure timely completion before the change process is completed.

Proper Employee TrainingFosters Effective Change

A product or process change is only successful if involved employees are trained and knowledgeable on executing that change. Integrating change management with employee training applications and document management systems provides a seamless link in transferring knowledge to those affected by the change. Documentation that was created or revised during the change will be stored in an integrated document control system linked to an employee training system. These tools provide the capability to schedule, require, and track training, ensuring the change is implemented effectively and all affected employees are knowledgeable on new procedures, work instructions and similar requirements upon change completion.

Collecting Postmarket Feedback

Once a change is complete, the next product life cycle begins. Organizations continually receive postmarket feedback in the form of inquiries, returns or complaints. Quality management systems traditionally collect this data through a complaint handling application. An integrated QMS complaint handling function identifies adverse events, analyzes feedback and collects customer requirements for future changes. It provides decision tree analysis on U.S. Food and Drug Administration reporting and captures data with trend reporting for visibility of change and new design effects.

Audits Improve Quality, Drive Change Management Process

While postmarket feedback can be a catalyst for change, so can internal reviews of the products and processes. Using continuous improvement initiatives such as audits, organizations can bring about change internally. Using a QMS audits tool that is integrated with change management provides a link from audit findings to potential product or process changes. Not only is the audits tool able to schedule and track multiple audit plans with various question and checklist profiles, but it also can trigger other processes based on audit findings. This could be a corrective and preventive action (CAPA) or a need for a new change to the product life cycle. Integrating audits with change management enables audit data to be utilized when defining and designing a new change.

Compliance Dashboard Concept

The goal of integrating quality management to the change management process is to ensure that changes are executed efficiently and with quality at the forefront of the change. During a change management process, it is important to benchmark and report on quality and compliance at every step of the process. This ensures that quality or compliance issues can be resolved during the change as opposed to afterwards. Many organizations are exploring the concept of a compliance dashboard to create visibility into quality within the product life cycle. This compliance dashboard concept tracks quality and compliance throughout the organization in a unified view. As a change is executed, the compliance dashboard displays the change timeline and benchmarks quality and compliance at each phase.

Using this dashboard, quality and compliance events are clearly visible and the appropriate corrective actions can be taken immediately. This real-time dashboard view allows managers to fix quality events during the change process instead of at the end, thereby reducing nonconformities in finished products and costly field repairs. Furthermore, the compliance dashboard can generate reports on completed projects, with compliance benchmarks associated with the documented change process. The compliance dashboard also ensures that change processes are kept on track and streamlined. It looks for bottlenecks and time-consuming phases in the process, identifying where the change process can be improved and, over time, shortened. This results in quicker cycle times, fewer errors, reduced costs, and lower risk of product recalls.

Quality Management—ChangeManagement’s Total Solution

This series has described the high-level phases of an effective change management solution and provided insight into how the robust functionality of a QMS can be leveraged in change management proc-esses. It has described how change management requires much more flexibility, security and workflow process than PLM can provide to automate processes and manage change, as well as the ability to provide proper visibility into the effects of the change.

The QMS is best suited to provide these functions and enhance the scope of PLM abilities for each organization’s unique change management process. With integrated tools including complaint handling, nonconforming materials, CAPA, project control, supplier management, document control, training, reporting and audits, the QMS is able to automate all aspects of the change management process and mitigate quality and compliance risks. In addition, through the compliance dashboard concept, the entire change management process is benchmarked and each phase is tracked to ensure quality and compliance risks are mitigated. In the end, quality management provides a total quality solution for enhancing the change management process.

As shown in this four-part series, the road to quality begins with embedding quality into the product life cycle from start to finish. Throughout the phases of an effective change management process, benchmarking and addressing quality challenges leads to enhanced visibility into all areas of the product life cycle and producing compliant products the first time.

However, the process does not end there. Once a product has undergone a successful change, market demand or continuous improvement will drive the need for change, once again beginning the change management cycle. Integrating quality management systems into the change management process will ensure success in every change, every time.

Brenda Percy is the product marketing analyst for EtQ Inc., headquartered in Farmingdale, N.Y. Prior to EtQ, Brenda was a marketing communications analyst at STG Inc., where she specialized in corporate research and reports with respect to advances in technology and compliance capabilities. At EtQ, Percy is responsible for communicating overall technology trends and compliance initiatives to the market, and has extensive background in information, food and bev-erage and medical device technologies. EtQ Inc. specializes in enterprise quality and compliance management software for iden-tifying, mitigating, and preventing high-risk events through automation. She can be reached at [email protected].