Successfully Managing ChangeWith Quality Management

Quality must be at the forefront of manufacturing & included in the product life cycle.

Brenda Percy

In the orthopedic device industry, products require innovation, quick turnaround and an exceptional level of quality. Given the critical nature of most medical devices, there is no exception to these requirements. Change ensures that products remain current with market expectations in order to satisfy customer requirements and to keep pace with the competition.

In an industry such as orthopedics, product life cycles are short and change is necessary to keep up with the rapidly increasing pace of the market. Processes of change management are necessary to ensure a successful change in each product, each and every time.

Product life cycle management (PLM) always has been considered the driver for change because it manages data and processes; however, the increasing speed and complexity within change processes demands more effective process management.

The quality management system (QMS) effectively serves as an extension of PLM, enhancing its functionality greatly and effectively heightening the level of quality and compliance in the overall product or process.

During product development, quality should be in the forefront of creation and incorporated into every aspect of the product life cycle. It is imperative to successful product outcome that quality be incorporated from the very early stages of product design. This, however, often is not the case.

Quality is too often an afterthought, taken into consideration with the end product. In order for an organization to achieve compliance the first time around, change management is necessary, as it enables organizations to make adjustments quickly and effectively while mitigating risks.

This is possible because change management processes result in faster innovation, assistance in keeping pace with shortened product life cycles, as well as greater overall quality in the finished product.

Change management is critical to the product life cycle; however, product change is not as simple as switching to a new design and running the production line. It 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.

Many PLM systems fall short in this area. This is where the QMS comes in.

The Intersection Between Quality Management, PLM

Quality management is ideal as a PLM function as it is rooted in the automation of workflows and enabling efficient processes, and serves as a workflow-centric system that is adept at managing complex issues, whether identifying and correcting defects or responding to customer complaints.

The QMS also provides integration, an invaluable addition to the change management process, because the QMS serves as a hub, feeding data to and from outside systems and ensuring that vital information is not “siloed” in individual systems where it cannot be shared. QMS processes that are integral to change management 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.

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 a successful change.

Quality management’s robust security model mitigates any risk of external resources seeing information beyond what is required. Additionally, the ability to enforce regulatory requirements, such as those set forth by the U.S. Food and Drug Admin-istration, including 21 CFR Part 888 and ISO 13485 is a strong point of an automated QMS. This compliance layer to regulatory standards promotes a uniform standard of operations, rates supplier qualifications and performance and provides a level of compliance unmatched by any other system.

Change Management and Quality Management Linked

In most change management activities, there is inherent core methodology that increases efficiency in the process. These steps include collecting requirements through complaints and research; determining feasibility through costs and benefits; approving and planning the change and sourcing through supply chain management; executing the change through manufacturing, testing, documenting, and product release; and verifying the change to determine effectiveness and feedback. The QMS seamlessly guides an organization through the phases of an effective change management process.

Define and Design

The define and design phases begin with the collection of the information from postmarket data, research and development, 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 postmarket data.

The postmarket data often is retrieved through QMS functions such complaints, audits, and nonconforming materials.

The integration capabilities of the QMS allow visibility into existing 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 the data from the CAPA 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’ 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 phase 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.

The risk assessment tool provides visibility into the impact the change will have by analyzing the risk not only in the CAPA system, but also through other processes such as the production parts approval process and environmental health and safety processes such as job safety analysis, and aspects, objectives and targets. These tools track 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.

Approve, Plan, and Source

The approve, plan and source phases include managing the various elements that are involved in a change. Change management is complex and involves many departments, suppliers, and various levels of approval and planning. It involves not only executing change internally, but extending to outside sources, such as suppliers, OEMs and contract manufacturers. 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. 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.

The planning phase of the change management process includes the generation of all action items throughout the workflow. The ability to branch off parallel process 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 analyses, training events, equipment changeovers and work orders.

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—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.

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, ensuring 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 to 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 and maintenance records, as well as equipment status.

Execute and Verify

In the execute and verify 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 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 trained on new procedures, work instructions and similar requirements. This ability to manage and track affected documents related to the change, as well as schedule or require training on documents, ensures that information is distributed, used and understood by employees.

Once a change is complete, the next product life cycle begins. Organiz-ations must be able to capture postmarket data in order to collect the necessary data 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. It also provides decision tree analyses on adverse events, aides in decision-making and captures data with trend reporting for visibility of change or new design effects.

Benchmarking Quality With a “Compliance Dashboard”

Quality is often seen as a postmarket event; however, quality is inherent in everything—design, production, supplier, and market—and should be incorporated accordingly. The key is to manage and measure quality during the product life cycle, not just after product completion. QMS provides an environment for tracking quality throughout the product life cycle in providing an enterprise environment to view all quality and compliance data in the organization. This concept of a compliance dashboard provides a top-level view of all quality and compliance benchmarks—effectively reviewing the state of quality within the product.

It is important for quality and compliance to be benchmarked at every step in the change management process. The compliance dashboard concept provides business intelligence in tracking quality throughout the process in a singular view. Essentially, implementing a compliance dashboard enables organizations to measure quality and compliance, and take actions on quality issues, fixing them prior to their release and reducing nonconformities in finished products. It also facilitates the creation of reports on completed projects, complete with compliance benchmarks associated with the documented change process.

Through use of a compliance dashboard, organizations can ensure that the change management process is kept on track and streamlined. In addition, it can look for bottlenecks and time-consuming phases in the process, as well as where the change management process can be improved, resources streamlined and the change overtime shortened, resulting in quicker cycle time, error and cost reduction and product recall risk mitigation.

Quality Management as a Total Solution

The QMS is best suited to provide flexibility, security, enhanced visibility and workflow process for an organization and enhance the scope of PLM functionality for each organization’s unique change management process. With solutions such as CAPA, 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 life cycle.

Many products in the orthopedic device industry serve the purpose of preserving functionality for those who depend on them. Many of these devices cannot be taken off at the end of the day and put away—they are internal and used daily; therefore, they must be depended upon to withstand the daily wear and tear that comes with even the most miniscule motions. In the orthopedics device industry, high product quality is essential to a high quality of life. Processes of change management ensure that orthopedic devices are created with quality as the foundation to help ensure success in every change, every time, while quality management provides a total quality solution for further enhancing the change management process.

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].