Benefits of Enterprise Wide Quality Management
By Mike Jovanis VP Product Management Sparta Systems
With reports of supply quality failures making front-page headlines almost daily, business-crippling quality issues are proving disastrous for global life sciences companies and their stakeholders. For this reason, quality management has quickly moved to the forefront of priorities for both life sciences companies and their stakeholders. More than ever, global life sciences organization are required to proactively address their supplier quality issues before incidents arise that can do irreparable damage to their reputations, their businesses or – and most importantly – the well-being of the patients they serve.
With the extension of the supply chain that has resulted from expanding global footprints, companies are constantly faced with the quandary of ensuring quality in their products from the supplier and across the chain – from product development to the consumer. Executives need to take a greater role in ensuring that supplier relationships are effectively maintained and that the correct procedures are in place for gauging product quality and evaluating processes.
In order to stave off quality issues associated with production processes and procedures, centralized, enterprise-wide systems must be implemented. Enterprise software systems on the market today can provide this level of management and control, and in turn, can even improve productivity, reduce production costs, ensure compliance and ultimately reduce risk.
These tightly integrated, comprehensive systems work to evaluate changes as well as manage, track and record them to ensure product quality – not simply within siloed departments, but across the entire enterprise. They also provide the necessary level of automated communication to those people who are affected by the change, as well as those responsible for overall product quality and business objectives. With such macro-level harmonization come significant business enhancements such as higher-quality production, more robust R&D, increased operational efficiency, reduced costs, faster time to market and compliance with all necessary external requirements, both governmental and consumer-driven.
Compliance Pressures and Business Imperatives
In the wake of major product recalls, tarnished brand images and faltering corporate giants, we see perhaps stricter governmental and consumer-driven pressures than ever before to ensure quality production and adequate product safety. On the regulatory side, there are countless agencies – F.D.A. being only one example – striving to enforce quality.
While these regulatory policies are clearly designed to protect the public from any undue harm, they can also consume a life sciences organization’s precious limited resources, potentially leading to production delays, missed market opportunities, inflated costs, regulatory violations, brand pressures and lower profitability.
A centralized, enterprise-wide quality control and regulatory compliance mechanism solves many of these business challenges, ensuring that quality management drives – rather than hinders – the company’s bottom-line objectives.
Quality Management Solution Deficiencies
All large manufacturers around the world face quality and compliance issues every day, and many have already sought and deployed centralized software systems to mitigate these challenges. However, a surprisingly significant number of manufacturers across the globe still rely on homegrown, paper-based or disparate and departmentalized point solutions to serve their needs. These solutions place obvious limits on extendibility, scalability and effectiveness. From an executive standpoint, these solutions simply don’t cut it in today’s global economy.
As an organization grows, either organically or through mergers and acquisitions, so does its need for an enterprise-wide quality management solution that can scale along with it and continue to meet – and exceed – its requirements.
Many of the inadequate solutions currently in use do not provide the level of support these organizations need. Here are just some of the ways in which legacy systems fall short:
• Fail to offer a centralized view of quality and compliance across the company
• Do not integrate with other enterprise software systems within the organization to aggregate data
• Fail to automate critical business functions, thereby opening the door to costly human error
• Don’t connect directly to the company’s manufacturing processes
• Don’t provide management with a centralized, accurate view of quality and compliance across the enterprise
• Fail to ensure workflow and process consistency
• Don’t drive efficiencies in terms of managing quality and compliance, leaving less time for innovation and
product advancement
These fundamental disconnects and deficiencies are at the very core of why so many organizations face significant quality and compliance challenges that threaten their ability to successfully control quality management and compliance initiatives across the global enterprise.
Recently a major drug manufacturer was reprimanded by F.D.A. for failing to follow consistent manufacturing processes in compliance with the agency’s current Good Manufacturing Practice (cGMP) standards. These standards, designed to control quality and minimize risk in the broader manufacturing process, affect not only siloed manufacturing sites, but also the company’s reputation. Once the F.D.A. warning letter was issued, this company had to scramble to comply with the mandate as well as to control the damage from the reprimand. This should be a warning to life sciences organizations – no matter how prepared you think you may be to manage audits within your organization, problems can still arise that can significantly hurt the business and set product innovation back months, even years.
Enterprise-wide Quality Management
Adherence to quality, regulatory and consumer standards in life sciences is a business imperative that demonstrates its value by satisfying requirements, successfully powering innovation, reducing costs and driving sales. The only true means of accomplishing this enterprise-wide challenge is with a centralized, standardized and enterprise-wide quality management system. There are a number of such software systems on the market – however, organizations should be wary that all do not necessarily feature the level of support required on a global scale.
When seeking a centralized system, there are a number of factors to consider, primarily in the areas of management visibility, product improvement and process efficiencies. Such a system should ideally offer:
Visibility into trends, improvements, risks
• Consistency of processes for decision-making
• Standardize quality process workflows and escalation procedures at the corporate level while executing at the department level
• Automatically collect supplier, factory floor, and customer quality data and leverage as actionable intelligence
• Provide quality visibility across the entire value chain to improve safety and operational integrity
• Afford real-time interoperability with plant floor automation, MES, ERP, and SCM
Product improvement
• Foster best-practice quality performance through automation of quality processes: quality dashboards, workflows and audit documentation
• Build compliance and traceability into processes
Streamlined workflow
• Efficiency – shorter cycle times, less resource intensive
• Eliminate need for multiple IT systems
• Synchronize quality and manufacturing.
• Manage partners and suppliers, and monitor their quality and compliance conformance
Final Thoughts
The world of life sciences is constantly evolving, with each day seeing the introduction of new technologies, new discoveries, process enhancements, system improvements and so on. In order to take full advantage in this progressive marketplace, executives at forward-thinking organizations must constantly arm themselves with the tools necessary to leverage these innovations. Furthermore, the more these organizations expand their businesses and operations, the more enterprise-wide quality control becomes vital – to proactively identify and address the key issues affecting supplier quality management before these issues present themselves as a threat to global business growth. In the end, all parties benefit from these improvements, including the company, its stakeholders, its employees, its customers and all other constituents.
Large manufacturing companies have a litany of moving parts within the confines of their own organization that also extend to the many other companies they work with – from partners to suppliers to subcontractors and so on. In most instances these elements extend far across the globe and back again and can easily create opportunities for error – human, machine or process-based. The aid of a standardized, centralized and holistic enterprise-wide quality management program helps the company stratify, streamline and take advantage of the tremendous benefits such an array of resources can afford if managed correctly. The result comes in the form of better, more innovative products, improved quality, consumer confidence and ultimately, greater competitive advantage.
About Sparta Systems
Sparta Systems’ global quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Its TrackWise® Enterprise Quality Management Software, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in Holmdel, N.J. and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer packaged goods markets. Read more about Sparta Systems and TrackWise software on the corporate website and blog: blog.spartasystems.com.