Decrypt quality management system

Evolving product manufacturing, challenges within organizations and a dynamic global business environment are driving different industries to change product and process quality, as well as pay close attention to supplier quality. Market pressures remain intense, whether in highly regulated industries such as life sciences, medical devices and food and beverage, or in industries such as automotive and industrial manufacturing. These pressures drive businesses to pursue the highest levels of quality in all aspects of their operations.

In manufacturing, the application of a quality management system (QMS) provides the basis for implementing quality policies and processes across the enterprise. Organizations often use the system to optimize management and achieve operational goals, such as improving product quality, maintaining business efficiency, and bringing products to market faster, while using QMS to meet regulatory and compliance requirements. A mature QMS can play a significant role in enhancing shop floor manufacturing operations, product and process quality performance, and overall organizational performance.

Addressing quality process and application challenges

Most manufacturers fail to take a holistic view of quality or which quality functions are centralized, outsourced, localized, or shared across the enterprise No consensus has been reached. Most manufacturers also do not have an enterprise-wide governance system; instead, each business unit has the authority to set a budget, with varying emphasis on quality. In order to coordinate quality across the enterprise, top management must assign an executive directly responsible for quality improvement across all functional areas of the enterprise.

Quality processes must be integrated to take full advantage of data in applications that manage quality. An integrated quality system builds a culture of cross-functional teamwork; for example, the Production Part Approval Process (PPAP) requires the involvement of not only purchasing and quality, but also external suppliers and close collaboration.

Over the years, organizations have built various decentralized applications to manage quality control processes at all levels across the enterprise. These siloed applications—including home-grown apps, spreadsheets, and applications based on outdated technology—are often not integrated and cannot perform broader functions to support the business.

Most applications are highly customized and unintuitive; in addition, even the same application is often used differently across business units and regions, and organizations sometimes Use different applications to manage the quality of the same process both internally and externally. No single application is universal, and many applications have little or no integration. This fragmented, incomplete, and inconsistent state results in operational inefficiencies, increased costs, and dissatisfied end users.

To compound the problem, organizations often require multiple applications to manage closely related areas such as audit management, non-compliance (NC) handling, and corrective and preventive action (CAPA). This forces users to manually manage the association between audit findings and their corresponding CAPAs.

Organizations struggling with duplicated quality functions and complex processes in legacy systems often try to simplify and consolidate applications into standardized platforms, eliminating unnecessary The management system is an essential strategic capability of the enterprise in the future.

As millennial workers enter the workforce, these tech-savvy, mobile, socially Organizations also have to have a minimum digital capability in order to address quality issues in a targeted and effective manner, and the bar for this digital capability continues to rise at an ever-increasing rate. The new, digital-centric world also requires companies to adopt enterprise-level quality management systems.

Choosing a QMS: Executive Decisions

With a minimum of data or experience, business leaders need to assess whether and how the QMS they are considering provides the following capabilities:

Escalation and visibility optimization of operational quality issues

Capability to respond to potentially dangerous operational trends

Adapt to regulatory changes and corresponding business plans

The ability to influence the quality procedures of each business unit or site

Coordinate quality control of suppliers and their partners

Investments in a QMS should consider the following factors:

Capability to close process gaps

Simplification of existing technology environment, adoption of new technology

Effort and benefit

Sunk investment

Growth Strategy and Business Objectives

Based on these factors, business leaders should assess current process and application gaps to identify opportunities for quality improvement. In seizing these opportunities, practical constraints, current and future needs, business continuity and the organization's ability to respond to change must also be considered.

Assessing QMS Applications

As an enterprise-level QMS centralizes various functions (eg, audit management, non-compliance handling, etc.) Regional and cross-departmental quality management. This enables organizations to create a single platform for cross-functional communication and collaboration, synchronizing and consolidating quality across the value chain.

Companies are re-examining their quality strategies and have begun to centralize the quality function. QMS vendors are beginning to embrace social networking, real-time analytics, and mobility elements for their next-generation products, where they leverage:

Cloud-based technology with dramatically reduced cost Potential

Building a modular platform that can accelerate return on investment (ROI) before full implementation

Digital transformation

There are many companies active in niche markets and Independent businesses provide quality management systems, and many enterprise system providers are incorporating quality management systems into enterprise resource planning systems (ERP), product lifecycle management (PLM), and manufacturing execution system (MES) application suites.

To choose the right QMS means, companies need to understand the current state of QMS and their specific needs.

Once a PLM investment has been made, a PLM-based quality management system can be an advantage. In general, a PLM-based quality management system is best suited for organizations that focus on time-to-market and design complex products. PLM helps integrate the functions of quality from design to manufacturing; this approach ensures that feedback from sources such as non-compliance and corrective actions is passed to the engineering function to help resolve quality issues. Combining PLM with model-based development and simulation allows organizations to better utilize visualization and variance analysis, greatly improving quality and reducing the cost of quality. In this case, the organization should integrate and establish an independent quality management system to take full advantage of these advantages.

If the organization is deploying ERP, an ERP-based quality management system [rough end] can work. The main advantage of an ERP-based quality management system is that it utilizes a single platform, so there is no need to maintain multiple systems and costly integrations. For larger organizations, an ERP-based quality management system is often deployed as part of a larger ERP.

An MES-based quality management system [rough end] is best suited for an organization that has a high focus on manufacturing and has achieved operational excellence; it has teams responsible for continuous improvement efforts that continually seek to improve quality processes and manufacturing performance and achieve a harmonious unification of the quality control process. Many MES vendors complement their solution collections by including QMS capabilities. The best-of-breed QMS applications offered by niche-focused companies [rough end] often represent a manufacturing company's unique need for quality. Compared to specialized PLM and ERP systems, their solutions generally result in shorter time-to-value, lower costs and greater flexibility.

Business leaders need to assess the strengths and weaknesses of different types of solutions from a long-term strategic perspective to develop a business case and predict whether the quality management system should be built or sourced, and the resulting Impact. Application types can be categorized as node-level and enterprise-level applications.

Node-level applications are typically custom off-the-shelf (COTS) or out-of-the-box (OOTB) and are used to address specific needs, such as production part approval processes (PPAP) or audit management; are pressing issues within a functional area of the organization. In contrast, enterprise applications address cross-departmental, cross-functional requirements and include more than one solution. Such applications are scalable, configurable, and flexible enough to meet the future needs of the quality management system.

Selecting the most suitable enterprise-level QMS

Common challenges faced by enterprises in selecting a quality management system include:

Selecting the necessary basic design to get it right The overall quality management system challenge

Keeping the quality management system lean, simple, and agile so that the right information is delivered to the right employees at the right time

Ensuring that the quality management system is fully compliant Regulatory requirements, and reduce non-compliance issues

When selecting applications, companies first need to develop a long-term vision related to their quality management system strategy. In the short term, node-level applications often seem to be the most viable and cost-effective option; however, organizations with long-term goals for quality need to ensure that the solution can evolve to meet the needs of the organization as it grows.

Enterprises typically invest in multiple node-level applications over time; however, the associated costs (maintenance and support, training, licensing, etc.) are often more than expected due to the need for customization. Ultimately, organizations move to enterprise-wide applications, and the time, effort, and money invested in node-level solutions are forfeited. When choosing the type of application, organizations should weigh the following parameters:

Functionality

Industry fit

Ability to interact with the organization's internal systems, as well as with the organization's customers, Internal systems integration for partners and suppliers

Scalability and flexibility

Software pricing/licensing models

Seller's ability to deliver service and support across geographies

Ease of use

[Copyright] Original text with permission, adapted from Decoding Quality by Amit Joshi, Kalpesh Agarwal and Hardik Kansupada in Cognizant 20-20 insights, October 2015 Management Systems" article. Cognizant registered copyright in 2015. Translated by Qin Ling.

Amit Joshi is a Senior Consulting Manager in the Engineering and Manufacturing Group at Cognizant Business Consulting. Kalpesh Agarwal is a Consulting Manager in the Engineering and Manufacturing division of Cognizant Business Consulting. Hardik Kansupada is the Director of Engineering and Manufacturing at Cognizant Business Consulting.