Change for the Better: Change Management and Quality Management

Change is common in the life science 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 due to improper procedures. This is where change management comes in. Using change management processes within an enterprise quality management system, quality becomes the foundation of every product or process throughout the product lifecycle.

An effective change management process includes the following steps: define and design; approve, plan and source; and execute and verify. The first installment of this four-part series (January/February 2009 issue of Medical Product Outsourcing) described how product lifecycle management (PLM) is a critical function that allows products to be managed efficiently, designed properly and sourced through suppliers. It also described how change management is critical to the product lifecycle and to be managed properly, it needs proper functionality. Many PLM systems lack in this area, and this is where quality management systems come in. It described the key areas in which PLM is lacking, such as flexibility, collaboration, a layered security model, and robust compliance management.
 

The second installment of this series described the elements of the first phases of a successful change management process—define and design. It outlined how these phases are initiated with the collection of information from post-market data, research and development (R&D), internal suggestions, or inspections failures and how this data is retrieved through quality management system (QMS) functions such as incident and accident management, nonconforming materials, and complaint tracking.
 

It described how integration in the change management process is made possible through the addition of a QMS and how functions such as deviations, risk assessment and documents are shared and consistently implemented across the enterprise. It also described how risk is managed throughout the process with the incorporation of risk assessment.
 

This issue’s column will discuss the next phases of the change management proc-ess—approve, plan and source.

 

Road to Quality—Approve, Plan and Source

The Approve, Plan, and Source phases include the ability to manage various elements that are involved in change. 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. This section will describe how a QMS is able to effectively manage approvals, action plans and suppliers.

 

Configurable Review and Approval Workflow

An effective change management process requires an extremely robust and configurable review and approval workflow. 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. E-mail 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.

 

Create, Implement and Track Action Plans

The planning phase of an effective change management process includes the generation of tasks or action items throughout the workflow. The ability to branch off into parallel processes that are linked to the main change management process through action plans ensures that the necessary work is kept on track and is distributed throughout the organization instead of being assigned to one person. Action items that the QMS can create and assign in parallel include feasibility analysis, training events, equipment changeovers and work orders.
 

Much like the ability to predefine approvers in the approval process, an organization also should have a predetermined set of actions that must be taken for different types of changes.
 

In setting up the change management process, the user should be able to predefine action plans that are based on the types of changes involved. Often, changes within the product lifecycle will need more than a collection of action items, and instead will need to be managed as an entire project with workflow-based dependencies between actions and the project team.
 

Integration with the QMS project control function is an important part of this phase as it 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.
 

In an organization, there are some changes that can be completed easily, and, alternately, there are complex changes that require a significant amount of tasks be completed. The QMS allows integration with project control for proper management of complex changes—such as during the process of new product design, advanced product quality planning, or the business management strategy Six Sigma—ensuring that quality is not lost in the process.

 

Sourcing Resources

The source phase of an effective change management process includes suppliers, employees, equipment and similar resources. The supplier management function is a key component of a QMS and also can be integrated with the change management process. This part of the process involves selecting the approved parts and suppliers by creating a list based on the overall supplier rating. This list is determined through the use of the QMS supplier rating and inspection feature. The ability to rank supplier qualifications allows an organization to pick the highest-rated supplier for a particular change or product. Having visibility into 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 to also rate supplied materials and inspection data. The QMS integration with supplier management provides visibility of supplier data from internal systems, third-party systems, and equipment and asset management systems.
 

The integration capabilities of a QMS don’t stop at the management of suppliers. A change also can affect an organization’s equipment, another main component of the source phase. The QMS provides integration with calibration and maintenance applications, which is beneficial to an organization because it helps keep track of changes to equipment, maintenance records, as well as equipment status.
 

Quality Management: Going Beyond PLM Functionality

The functionality of an Enterprise QMS is ideal for managing change, as everything that is managed in a change is managed in quality. An organization’s QMS is able to extend beyond PLM functionality with the use of its additional features such as calibration and maintenance, supplier rating and inspection, and project control, and its ability to integrate these functions with the change management process. An organization’s QMS is able to provide the tools that extend well beyond PLM functionality and further enable enterprise change, while keeping quality and compliance at the forefront of the product lifecycle.
 

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 [email protected].