Change is common within the life sciences industry, where a product may be designed only once but change occurs often throughout the product lifecycle. An organization’s ability to incorporate quality into every aspect of a change results in overall product quality with less chance of recall. This is where change management comes in. Using the enterprise quality management system’s (QMS) automated change management process, quality becomes the foundation of every product or process throughout the product lifecycle.
While product lifecycle management (PLM) is typically considered the driver for change because it manages data and processes, the increasing speed and complexity within change processes demands more effective process management. The QMS effectively serves as an extension of PLM, enhancing its functionality and effectively heightening the level of quality and compliance in the overall product or process.
While change management is critical to the product lifecycle, product change is not as simple as switching to a new design and running the production line. Change management involves in-depth data analysis, which defines what will be changed, the parties involved, suppliers to use, materials to purchase, how to calibrate machinery, packaging, marketing, departmental approvals, and other factors. Change management is complex and, to be managed efficiently, needs the proper functionality. This is where the QMS comes in.
To create a streamlined and efficient change management system, flexibility is needed to adapt to dynamic changes in products and markets. QMSs are well suited for this purpose, with their flexible workflow and routing capabilities. In addition, the ability to coordinate and collaborate across multiple areas and external resources is key to a successful change.
An Overview of the Change Management Process
In most change management activities, there is inherent core methodology that increases efficiency in the process. The QMS seamlessly guides an organization through the phases of an effective change management process, as laid out in the sections that follow.
Lay the Foundation: Define and Design
The define and design phases begin with the collection of the information from post-market data, research and development (R&D), 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, product non-conformance, a result of audit findings, and various other post-market data.
The post-market data is often retrieved through QMS functions such as complaints, audits, and nonconforming materials. The integration capabilities of the QMS allow visibility into existing enterprise resource planning (ERP) systems and allows an organization, for example, to use nonconforming materials software to determine which lots need to be put on hold, enabling them to mitigate the risk of product recall, and then make corrections using their change management process.
It is then filtered through the corrective and preventive action (CAPA) system, the catalyst for change initiatives, which determines the root cause and the necessary steps to correct adverse events. Ideally, changes are made to the initial concept using data from the corrective action system to recognize areas for improvement. 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. Integrating the QMS’s planned deviations function with change management ensures that all deviations are defined and then removed once a long-term change is put in place.
A crucial part of the define and design phases is to analyze the impact of the change. Using quantitative risk assessment utilities, organizations can analyze multiple dimensions of risk to gauge the overall impact the change may have on the business before moving forward in the process. 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. It also enables companies to build risk portfolios for each individual product line, allowing the enterprise to leverage past risk assessments.
Ensure Collaboration: Approve, Plan, and Source
Change management is complex and involves many departments, suppliers, and various levels of approval and planning. It involves executing change not only internally, but extending to outside sources, such as suppliers. It also involves the process of multiple approvals across operational areas and integration through various QMS functions.
An effective change management process requires an extremely robust and configurable review and approval workflow. The QMS provides a centralized resource for managing and executing change, and has proven workflow methodologies that can provide a venue for managing change. The approval phase ensures that the appropriate people in each step of the process approve the change. Email alone is not sufficient for collaboration of this level because in many cases there is a need for electronic signatures. Business rules must be built directly into the workflow so that durations and due dates can be set for different stages of the workflow, which is important if a variety of people are being notified, and ensures work is kept on track.
The planning phase of the change management process includes the generation of all action items throughout the workflow. The ability to branch off parallel processes that are linked to the main change management process through action plans ensures the necessary work is kept on track and is distributed throughout the organization instead of being assigned to one person. Action items the QMS can create and assign in parallel include feasibility analyses, training events, equipment changeovers, and work orders.
Integration with the QMS’s project control function allows an organization to create, track, and control projects by identifying the project stages, allocating tasks to individuals, and tracking the progress of each task. The QMS allows integration with project control for proper management of the more complex changes—such as during the process of new product design; advanced product quality planning (APQP); or the business management strategy, Six Sigma—ensuring that quality is not lost in the process.
The source phase of the change management process includes suppliers, employees, equipment, and similar resources. Supplier management integration is a key component of the QMS. With multiple suppliers and logistics, securing the proper suppliers is a critical function of change. This part of the process involves selecting the approved parts and suppliers by creating a list based on the overall supplier rating. This supplier rating list is determined through the use of the QMS supplier rating and inspection feature.
Ranking supplier qualifications enables an organization to pick the highest rated supplier for a particular change or product. Visibility of supplier qualifications and ratings is extremely important during the change management process, and the supplier rating and inspection function should be able to not only rate suppliers, but also rate supplied materials and inspection data. Supplier management integration provides visibility of supplier data from internal systems, third party systems, and equipment and asset management systems.
A change also affects an organization’s equipment. To mitigate this risk, the QMS provides integration with calibration and maintenance applications to keep track of changes to equipment, maintenance records, and equipment status.
Check Your Work: Execute and Verify
In these phases, all involved parties collaborate on the change through real-time, electronic distribution of change notifications, enhancing communication throughout the process. Prior to final shipment or change completion, all affected parties will become notified and fully trained. The QMS manages and tracks training, with all training materials linked to the change process. Furthermore, quality concerns are tracked and resolved, ensuring the least amount of risk before change completion.
Organizations need to ensure that the necessary employees are trained and knowledgeable prior to release. Integration with employee training applications within the QMS provides this with scheduled or self-training and identification of employees who still need training. All training documentation that is attached to the change management process will be fed into a training system that tracks employee training, ensuring that all parties are versed in new procedures, work instructions, and similar requirements. This ability to manage and track affected documents related to the change as well as scheduling or requiring training on documents ensures that information is distributed, used, and understood by employees.
Once a change is complete, the next product lifecycle begins. Organizations must be able to capture post-market data in order to collect the necessary information from the consumer, whether inquiries, requirements, or complaints. Integration with the QMS complaints handling function identifies adverse events, analyzes change feedback, and collects customer requirements for future changes.
The quality management system is best suited to providing flexibility, security, enhanced visibility, and workflow processes for an organization and enhancing the scope of PLM functionality for each organization’s unique change management process. With solutions such as corrective action, complaints tracking, nonconforming materials and audits, the QMS is able to eliminate the need for manual processes, reducing the possibility of mistakes due to human error. Additionally, the concept of a compliance dashboard has the ability to track and benchmark quality through the change management process, which is of paramount importance in the product lifecycle.
Throughout the phases of an effective change management process, benchmarking and addressing quality challenges leads to enhanced visibility into all areas of the product lifecycle 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.