Change and quality management are necessities for businesses.
Change management is a necessity for businesses today. Without it, companies cannot adapt to market trends, improve products or processes, or remain competitive.
Processes of change management enable companies to make adjustments within their organizations quickly and effectively, while mitigating the risks involved. Effective change management will result in faster innovation, shorter product lifecycles and greater quality in the finished product.
In addition, there are quality management processes within an organization that must be integrated into the change management process to ensure quality is a key player throughout the design, pre-production and production phases of the product lifecycle.
An effective change management system integrates quality to provide a real-time quality benchmark at every step of the process. The double-edge sword is that everyone fears change because it is risky—especially when product lines, revenue and company stability are at stake.
The Intersection Between Quality Management, PLM
Product lifecycle management (PLM) is a critical function of any business. To meet ever-growing market demands, companies must ensure their products are managed efficiently, designed properly, sourced through suppliers and released with no compliance issues. Similarly, external factors—whether competition, customer demand, or design improvements—can influence the decision to undergo a change.
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, it needs proper functionality—many PLM systems fall short in this area. This is where a QMS comes in.
Quality management is rooted in the automation of workflows and enabling efficient processes. Quality management is a workflow-centric system that is adept at managing complex issues, whether it is identifying and correcting defects or responding to customer complaints. The use of a QMS to provide change management functionality lacking in PLM is the next level of advancement in improvement and quality in the product lifecycle.
To create a streamlined and efficient change management system, flexibility is needed to adapt to dynamic changes in products and markets.
Quality management systems are far better suited for this purpose, with their flexible workflow and routing capabilities. Furthermore, the ability to coordinate and collaborate across multiple areas and external resources is key to successful change.
As the change management process extends beyond a company’s building, the ability to keep data and intellectual property secure is critical. Quality management has a robust security model that mitigates any risk of external resources seeing information beyond what is required.
Finally, the ability to enforce regulatory requirements set forth by the U.S. Food and Drug Administration such as 21 CFR Part 11, is a strong point of an automated QMS.
This compliance layer to regulatory standards promotes uniform standards of operations, rates supplier qualifications and performance and provides a level of compliance unmatched by any other system.
Managing the Core Change Process
In many cases, there are other processes that are not necessarily related to the change, but are affected by its results. QMS has the ability to not only manage the core change process, but also to cross-reference any related quality, environmental or health and safety processes, and link them to the core change. For example, incorporating employee training, environmental aspects and job safety analyses are critical functions of the business that may be affected by a change, but are not part of the core change process. By linking these peripheral processes from the start, it’s possible to effectively address these issues during the change, as opposed to afterwards or too late.
The Supply Chain Adds Complexity
Supplier selection is a huge part of change, and it adds a degree of complexity to the product lifecycle. With multiple suppliers, logistics and supplier quality, ensuring the proper suppliers is a critical function of change. Quality management systems often have a supplier rating function that provides visibility into which suppliers’ products are able to meet a company’s expectations. Quality management also has the performance to support consolidated, centralized deployments through an integrated security model, which is designed to improve efficiency by limiting supplier access to the system. It protects intellectual property without impeding supplier collaboration in the change management process.
Steps of the Change Management Process
With most business processes, there are certain best practices that will ensure a successful outcome the first time, and change management is no different. The following essential steps will ensure an effective change management process:
• Define and Design: These are the first steps to a successful change management solution. Before making a change, there must be a reason, whether it is customer-driven, demand-driven or corporate initiative. This data often originates in quality management functions such as complaint handling, incident and accident management, and nonconforming material returns (NCMR) and may ultimately feed into the corrective and preventive action (CAPA) system. CAPA, in many cases, is the catalyst for change—we see a problem, we fix it and we adapt to mitigate the risk. While not typically linked to the change management process, CAPA often drives the change management function—yet very few companies integrate the two.
• Approve, Plan and Source: These next stages lie in the ability to manage the various elements involved in the change. Change management is a complex dance, involving many departments, suppliers, and various levels of approval and planning. That, coupled with the fact that increased competition and new technology advances shorten the product lifecycle, managing a product or process change can become a daunting task. The ability to coordinate and effectively “choreograph” this dance requires a robust workflow and project control. Quality management applications are especially adept at this, and integrating a QMS into the change process will enable you to manage action plans, approvals, suppliers, maintenance, and any operational areas with ease.
• Execute and Verify: These crucial final pieces rely on the “then-what” factor. Once the change is set in motion, automated and streamlined, the cycle does not stop. In many demand-driven markets, the product lifecycle never stops—data is continually collected and analyzed for the next iteration of the product. A change is made, but then what? Integration of the QMS training system ensures employees are trained and knowledgeable. Most importantly, even as the new product is rolling out the door, the QMS is collecting market feedback, initiating corrective actions and preparing and collecting data for the next version.
This is the first installment in a four-part series that will uncover the various phases in companies’ change management lifecycles and how a quality management system (QMS) can effectively streamline the elements of change. The next installment, to be published in the March issue of Medical Product Outsourcing, will take a deeper look into the define and design phases and will focus on where change begins, where to get data that initiates that change and how the corrective and preventive action system is the catalyst for 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 email@example.com.