Continuous Improvement – QMS

Continuous Improvement Graphic- Plan, Do, Check, Act

One of the essential elements of a quality management system (QMS) is continuous improvement. It is the process of making ongoing improvements to products, services, or processes through changes that occur incrementally or all at once. Continuous improvement enables organizations to sustain high performance, meet customer expectations, and adapt quickly to changing market conditions.

Regulatory bodies like ISO outline procedures for monitoring, measuring, and analyzing the processes that support a QMS. Similarly, the Medical Device Single Audit Program (MDSAP), which is governed by the FDA and other regulatory bodies across the globe, has published a continual improvement procedure. It provides organizations guidance for evaluating operational performance and identifying areas that need adjustment.

Many of today’s continuous improvement methods stem from Walter Shewhart’s Plan-Do-Check-Act (PDCA) cycle. Using this approach, an organization’s senior management team establishes specific goals and objectives for improvement (Plan). Next, employees implement changes to meet the defined targets (Do). The performance of the changes is measured to determine their effectiveness (Check). If the changes are deemed successful, they are implemented as a standard practice (Act). If the changes are ineffective, the organization will repeat the cycle.

Here, we further explore the various tools and methodologies for measuring performance and driving continuous improvement across your organization.

Additional Resources

MEASURING AND MONITORING QMS PERFORMANCE

Companies must determine the different areas and business processes that require monitoring. Additionally, they must implement effective measurement tools to gather valid results that ensure continuous improvement. To comply with industry regulations and reach their business targets, manufacturers focus on monitoring processes that support their quality objectives. These processes are typically tied to areas like product development, operational efficiency, safety, delivery, and customer service.

Key factors to consider:

Which employees/functional areas are responsible for monitoring?
What is the appropriate timing/cadence for monitoring?
What measurement tools should be used?
Can the organization consistently produce measurable and repeatable results?
What key performance indicators (KPIs) will be used to measure performance?

Widely used monitoring and measurement tools include:

Control chart – A statistical diagram that enables organizations to view how manufacturing processes change over time. By comparing current data to upper and lower control limits that are gathered from historical data, teams can draw conclusions about whether process variation is consistent or out of control (unpredictable).
Six Sigma – This set of statistical methods and tools enables teams to identify the problems or issues that are associated with a particular process. Teams measure the initial performance of the process to create a benchmark. From there, they pinpoint a series of inputs that may hinder performance. Next, each input is isolated and tested to determine if it might be contributing to performance failures.
Cause and effect (fishbone) diagram – This visual analysis tool helps teams explore all possible causes of a particular problem. Causes are usually grouped into categories like method, machine (equipment), people (manpower), materials, measurement, and environment. These categories are narrowed down until the root cause is identified and teams agree on the necessary corrective action(s).
Pareto analysis – Using this technique, organizations assign a numerical value to identified problems or issues based on their level of impact to the business. The higher the score, the greater the impact. The issues are then grouped into different categories (e.g., customer complaints, technical issues, product defects, shipment delays).
Customer survey – This methodology uses a series of questionnaires and/or rating scales to gather customer feedback. It provides organizations with a real-time snapshot of how customers perceive their products and services and helps them identify opportunities for improvement. Metrics such as customer satisfaction score (CSAT), net promoter score (NPS), and customer effort score (CES) can be used to gauge customer loyalty, retention, and engagement.
Customer complaint report – This report highlights the problem that a customer is experiencing with a product, service, employee, or internal process. By monitoring customer complaints, organizations can readily detect product or service issues and identify bottlenecks in the customer experience.
Nonconformance report (NCR) – This record documents any discrepancies between the actual condition/behavior of a product or service and the expected condition that is defined in the company’s quality objectives as well as applicable regulatory requirements. NCRs are commonly associated with manufacturing, production, and operations. By maintaining NCRs, issues can be easily audited and addressed to ensure compliance with quality and safety standards.
Internal audit – Through routine assessments of internal processes, organizations can readily detect flaws in their quality management system and implement corrective measures to mitigate compliance risks. As part of their assessment, internal auditors review and compare training records, CAPAs, design controls, and other critical areas of the QMS against applicable regulatory standards.

ANALYZING DATA TO IDENTIFY OPPORTUNITIES FOR IMPROVEMENT

Once the appropriate information and data has been gathered, organizations can start to evaluate the effectiveness of their QMS as well as the conformity of their products, services, and supply chain partners to applicable regulations and standards.

Some enterprise product lifecycle management (PLM) and QMS solutions include analytics tools to help organizations readily assess their product and quality data. Convenient dashboards with preconfigured KPIs and reports can be leveraged to gain deeper insights into:

Product development processes (e.g., engineering change order [ECO] cycle time, requirements management)
Manufacturing processes
Supply chain collaboration
Customer service/complaint resolution
Product/material nonconformities
Corrective and preventive action (CAPA) resolution
Employee training
Environmental compliance
Product costing

With access to this information, teams can readily identify areas for process improvement and address business risks and opportunities.

IMPLEMENTING IMPROVEMENT INITIATIVES

As prescribed in the PDCA model, senior management should establish an action plan for implementing improvements based on the results of the analysis. This plan, along with the expected outcomes, should be documented and clearly communicated to all impacted teams.

Improvements may involve retraining employees, changing certain processes, or adding resources (e.g., equipment, staff, new technology). After a set period, employees should evaluate the performance of any changes to verify that they are meeting their defined targets. In addition, controls should be established to keep process variation within acceptable limits.

UPDATING THE QUALITY MANAGEMENT SYSTEM

Once improvement initiatives are deemed successful, organizations can update the supporting QMS documentation. This may include standard operating procedures (SOPs), work instructions, assembly instructions, customer requirements, approved supplier/vendor lists (ASLs/AVLs), and training records. Having a centralized system like Cloud PLM and Cloud QMS solutions automates the management of product information and quality processes so that organizations can better track and control changes that are made over time and demonstrate compliance.

AN ONGOING PROCESS

As the term implies, “continuous improvement” is an ongoing practice that requires routine monitoring, evaluation, and refinement of products, services, and processes. Having the proper tools and resources to regularly assess your performance and make incremental improvements will ensure that you reach your business targets and gain a competitive advantage.