How the Quality Management System Streamlines the Change Process

Change is the only constant in the business world; there is always a need for it in the product or process lifecycle. The reasons vary from product upgrades to correcting defects, and the process leading up to change execution is often complicated and requires effective management in order to achieve positive results.

When factoring in design centers, suppliers, manufacturing facilities, and testing labs, for example, coordination is critical to success. With all these factors in play, especially considering that product lifecycles can be short, change management is necessary to get things right the first time. By incorporating a Change Management system, quality design failures are easily noticed from the start—with risk mitigation set in place to reduce failures in the field.

Inevitably, an organization will need to change a process or product during some point in its lifecycle. Quality and change management come into play in order to keep up with the increasing market demand and pace with current competition.

Change management is complex: It involves employees, equipment, various departments, suppliers, and much more. It also requires multiple levels of planning, sourcing, and collaboration with internal and external sources. Increasing speed and complexity within the change management process demands more effective process management.

The Quality Management System (QMS) seamlessly guides an organization through the necessary phases of the change management process, which comprises:

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 a corporate initiative. This data often originates in quality management functions such as complaint handling, incident and accident management, and nonconforming material returns, and may ultimately feed into the corrective and preventative action (CAPA) system. CAPA, in many cases, is the catalyst for change—we see a problem, fix it, and adapt to mitigate the risk. While not typically linked to the change management process, CAPA often drives the change management function. However, 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. Coupled with the fact that increased competition and new technology advances shorten the product lifecycle, managing a product or process 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 an organization to manage action plans, approvals, suppliers, maintenance, and any operational areas with ease.

Execute and Verify: These crucial 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. Even as the product is rolling out the door, the QMS collects market feedback, initiating corrective actions and preparing and collecting data for the next version.

Let’s expand on some of the functionality that helps to successfully manage these phases:

Corrective and Preventative Action: The post-market data necessary to determine feedback is retrieved through functions such as complaint tracking, nonconforming materials, and audits. It is then filtered through the QMS Corrective Action system, which is the catalyst for change initiatives. This determines the root cause and the necessary steps to correct adverse events. Ideally, changes are made to the initial concept using the data from the Corrective Action system to recognize areas for improvement.

Deviation Management: Before a change is requested, it must be determined whether there is an acceptable deviation plan in place, and for how long. Otherwise, the executed change may cause unnecessary duplication of effort. The ability to integrate with QMS software and discover any unplanned deviations is critical. Integration with the change management process ensures that all deviations are defined, and then removed once a long-term change is set in place.

Document Control: The ability to reference critical documents involved in the change is another important step of the process. Documentation such as design files, specifications, work instruction, job descriptions, and procedures will need to be changed alongside the product or process.

Risk Assessment: Before an organization can continue forward with a process, it must determine if the change has been effective. A QMS Risk Assessment module analyzes risk to gauge the change’s effectiveness before moving forward in the process. This provides quantifiable evidence that the new change will successfully determine the outcome with the lowest risk level possible.

Project Control: Integration with the QMS 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—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.

Employee Training: A product or process change is only successful if employees are knowledgeable about executing it. All involved employees must successfully complete training on product or process changes. Integrating change management with Employee Training applications and Document Control systems provides a seamless link in knowledge transfer to those affected by the change. Documentation 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 upon the change’s completion. It also ensures that employees are trained on new procedures, work instructions, and similar requirements.

Complaint Handling: Once a change is complete, the next product lifecycle begins. Organizations continually receive post-market feedback in the form of inquiries, returns, or complaints. The QMS traditionally collects 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 also provides decision tree analysis and captures data, with trend reporting for visibility of change and new design effects. Integrating change management with complaint handling closes the loop on the process and enables visibility of post-market data when defining and designing the next change.

Audit Management: While post-market feedback can be a catalyst for change, so can internal reviews of the products and processes. Through use of continuous improvement initiatives such as audits, organizations can bring about change internally. Using a QMS Audits tool integrated with change management provides a link from audit findings to potential product or process changes. Not only can the Audits tool schedule and track multiple audit plans with various question and checklist profiles, it can also trigger other processes based on audit findings. This could be a CAPA or the need for a new change to the product lifecycle. Integrating audits with change management enables audit data to be used when defining and designing a new change.

In addition to providing integrated modules, fortifying the change management process with technology facilitates different points in the process. Change management is complex, rapidly evolving, and involves various elements:

• Flexibility: Every change management process is different. The QMS is flexible enough to adapt to individual processes; the right QMS provides extensive configuration options and business rules. A flexible Web-based designer tool enhances the process further by simplifying the design process with the ability to configure workflows, forms, and reports, ultimately enabling personal adaptation.
• Scalability: The change management process consists of various process owners. A QMS with a distributed administration model allows for local control of set groups, users, keywords, reports, and security measures. Change management should not be confined to one area of the organization because it should allow for both internal and external elements. Scalability lets both the company and the software grow; groups can be created and necessary documents filtered accordingly. It limits access to documents based on organizational criteria and provides multi-level security.
• Localization: As stated before, change management spans the entire enterprise in many cases. The right QMS can translate specific configurations to avoid software and language barriers. Creating a specific “look into location” technology enables translations of all design elements including keywords, error messages, homepage, action button names, and form fields.
• Integration: During change management, information must be exchanged within production systems. The need for an integrated system enables assimilation with third party business systems and other profiles.

QMS change management solutions efficiently guide organizations through each step of the change process. It provides functionality inside and beyond change management—linking outside systems, personnel, and mitigating language barriers. Further, users can fully adapt to the look and feel of their systems by personalizing them.

Conclusion
The QMS is best suited to provide flexibility, security, enhanced visibility, and workflow process for an organization, enhancing the change management process. QMS solutions such as CAPA, complaints tracking, audits, and more can eliminate the need for manual processes, reducing the possibility of mistakes due to human error.

Managing processes of change is important; an organization must be able to prove that all elements involved in the change are effective. QMS helps ensure that all employees are knowledgeable on changes and fully trained. Integration with the QMS helps enhance the change management process and all components that accompany it. QMS tools help to further the methods of change by allowing a company to grow and make judgments on future moves, while also learning from post-market data.

There are many complex processes throughout the product lifecycle that serve several different functions, and one small defect can affect many subsequent steps. It is important to have a solution in place to account for this and ensure a positive outcome. Ultimately, this creates a better future for the business, and helps organizations build and maintain a high quality brand. 

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Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com