Brenda Percy03.04.09
Quality Perspectives: Integrating Change and Quality Management
Brenda Percy
In the medical device field, where lifecycles are short and competition is fierce, a change management system that starts at the beginning of the product lifecycle and incorporates quality into each step of the change process is the key to success. Using a quality management system (QMS) to automate the change management process makes this possible.
The previous article in this series described the key functionality of product lifecycle management (PLM) and highlighted its key shortcomings. For example, PLM houses all the information about the product and how to build it; however, the process of product creation involves much more than initial product design and specification.
A field as competitive as medical devices involves constant change. The difficulty is that an effective change management process is never static. It is constantly evolving and continually improving; it’s always in motion. Integrating change management with quality management ensures that change initiatives keep up with this rapid pace without losing quality in the process.
The last installment touched on how a QMS effectively can replace PLM to automate and streamline the change management system. It also described how quality management supports the change management process to increase a company’s ability to adapt, collaborate and maintain compliance.
It identified the elements that quality management incorporates into the change management process—specifically flexibility, collaboration, a layered security model and robust compliance management. It also defined the phases of an effective change management process —define and design; approve, plan and source; and execute and verify.
The define and design segments set the foundation for quality throughout the organization. This article will delve further into these first two phases.
Road to Quality—Define and Design
The define and design stages start with the collection of the information from post-market data, research and development (R&D) and internal suggestions or inspection failures that help to identify and initiate the need for change. This process is initiated in any number of ways—from a customer complaint, a product nonconformance, a result of audit findings and various other post-market data. This data can be retrieved through QMS functions such as complaint tracking, incident and accident management, nonconforming materials, and audits. It is then filtered through the corrective action preventive action (CAPA) system—the catalyst for change initiatives—to determine the root cause and steps to correct adverse events. Ideally, changes are made to the initial concept using the data from the CAPA system to recognize areas for improvement.
An automated QMS has all of the capabilities to manage the change management process effectively while ensuring consistent quality. For example, this first phase involves QMS modules with lookups to pull in all of the related master data on products, suppliers, customers and the equipment or production line to determine which elements of the product lifecycle are affected by a change.
The ability for the user to be able to look up data, as opposed to manually entering it, is critical to consistency, as chance for human error is substantially decreased. Truly automated change management systems are able to integrate data from multiple sources, such as complaints, adverse events and nonconformances, allowing vital information to be shared across the enterprise. This integration of systems increases visibility of all processes across the enterprise and ensures consistent change procedures with nothing left out of the quality loop.
Integration Through Quality Management
Integration is an invaluable addition to the change management process that is made possible by using a quality management system. The QMS serves as a hub, feeding data to and from outside systems, ensuring that vital information is not “siloed” in individual systems where it cannot be shared. QMS processes that are integral to the change management process, such as deviations, documents and risk assessment, will be shared and consistently implemented across the enterprise, ensuring that the change management process is not involved in one of these “silos.” This ability is paramount where change procedures are involved.
For example, the ability to integrate with the QMS to discover any planned deviations is critical. Before a change is requested, it must be determined whether there is an acceptable deviation in place, and for how long—otherwise, the executed change may cause unnecessary duplication of effort. Integration with the change management module ensures that all deviations are defined and then removed once a long-term change is put in place.
Another example is the ability to reference critical documents that are involved in the change. Documentation such as design files, specifications, work instructions, job descriptions and procedures will need to be adjusted as the product or process is changed. The ability to link these documents to the overall change management process and issue multiple-document change requests is critical in monitoring and tracking all the information needed to design an effective change.
The next crucial part of the define and design phases is to analyze the impact of the change up to this point through the use of a risk assessment. Risk needs to be analyzed, and severity needs to be determined in order to gauge the effectiveness of the change before taking any further steps—this is made possible through the QMS’ integrated risk assessment module.
Managing Risk Throughout the Entire Process
The key question to address in implementing a risk-based change management process is, “What will be the overall risk of the change?” If the risk is too high, then further diligence is required. The ideal change management process provides the organization with quantifiable evidence that the new change will successfully alter the product at the lowest risk level possible.
Incorporating risk assessment helps to calculate risk and guides decision-making. This is an essential piece of the quality puzzle as risk assessment at each point in the change management process decreases the probability of a change for the worse and aids in making good decisions.
For example, an effective risk management system allows companies to build risk portfolios for each individual product, even allowing the enterprise to leverage past risk assessments, all the way back to product design. This tool allows companies to quickly identify appropriate risk levels and resolutions for quality and FDA compliance events. It also provides visibility into the impact the change will have by analyzing the risk not only in the CAPA system, but also through modules such as the production parts approval process and environmental health and safety modules, such as job safety analysis and aspects, objectives and targets. These modules are tracking information that could be affected by the product or process change. Risk assessment does this effectively by going through the process and quantifying the impact of change.
Quality Management in the Cycle of Change
Change is an endlessly accelerating cycle in any organization, but even more so in the medical device industry. The increasing pace in time to market pressure and the high demand for innovative products have made change a critical part of the production process in order to remain competitive.
A product in today’s business environment, in a sense, is never complete. It goes through stages—it needs to be constantly refined to meet current market expectations. Once those expectations change, the product must change, too. Quality management is an ideal hub for these change processes. It ensures that change is managed effectively while maintaining compliance with important quality, environmental and health and safety requirements.
Editor’s note: The next installment of this four-part series will continue on to the next phases of change management—the approve, source and phase segments. It further will show in what capacities quality management is able to extend beyond PLM functionality. It also will focus on the execution of the change management process and the QMS workflow methodologies that provide a venue for
managing change.
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 beverage and medical device technologies. EtQ Inc. specializes in enterprise quality and compliance management software for identifying, mitigating, and preventing high-risk events through automation. She can be reached at bpercy@etq.com.