To remain competitive and avoid downstream legal headaches and costly recalls, manufacturers must understand, accept and deliver quality and regulatory compliance at levels that not only satisfy their customers but government and regulatory commissions. A strict adherence to industry and regulatory requirements benefits companies by putting emphasis on auditing processes that can translate to increased revenue, profits, and customer satisfaction.
While adhering to a growing number of government and industry regulations and requirements complicates the business of designing, producing and selling new products, compliance efforts also keep consumers safe and protect the environment. Though many manufacturers view regulatory compliance as a necessary evil to doing business, implementing effective compliance and quality management processes can translate to increased sales, manufacturing and service strategies.
According to a study conducted by the Small Business Administration’s Office of Advocacy, federal regulation is estimated to cost more than $1 trillion annually, and U.S. manufacturers will pay a hefty portion ($162 billion) of the $648-billion total cost for environmental, economic, workplace, and tax-compliance regulation. In fact, last year the National Association of Manufacturers continued congressional lobbying efforts to reduce the regulatory burdens on U.S. manufacturers, which it views as “critical to the country’s economic recovery.”
While complying is often expensive and time-consuming for organizations, non-compliance with industry data standards such as ISO9100 or those imposed by the FDA, regulations can have even more dire and costly consequences. Regulatory non-conformance at its worst can lead to product recalls or expensive litigation that can have a disastrous financial impact to a manufacturer as well as loss of confidence among consumers.
Automated solutions aid compliance efforts
A host of automated software tools help organizations comply and maintain quality standards more easily than ever. Let’s take a look at a few best practices for improving your organization’s compliance efforts and how automated quality management tools can help.
Overhaul processes. The beginning of the year is a great time to re-evaluate or re-define supply chains, production processes, and quality-assurance procedures to identify problems and cut bottlenecks out of existing processes. By performing internal audits and implementing new ways to measure quality and compliance, manufacturing teams gain better insight into what processes are under-performing and why.
Take a closer look at your suppliers. Maintain a high level of supply chain quality standards to ensure that your suppliers are consistently meeting your needs and ultimately the needs of your customers. Automated tools enable manufacturers to tie inspections and audit data back to supplier rating results. By defining the processes that interlink inspection and audit to supplier ratings, manufacturers can encourage each supplier to implement specific improvement strategies.
Be proactive, not reactive. Error detection and prevention is often key to avoiding future non-compliance headaches. Compiling accurate records of corrective actions is crucial to preventing the reoccurrence of defects. Automated tools provide a vital closed-loop mechanism for initiating, implementing, and verifying the effectiveness of changes resulting from the non-compliance process.
Integrate quality and compliance data. When manufacturers rely on manual processes to control quality and compliance efforts, that information often becomes fragmented and useless on an enterprise-level. Automating the process enables the integration of fragmented databases, data sets, historical performance data, supplier audit results, non-conformance history, and corrective-action reports. Once a single compliance system of record is established, manufacturers can effectively define and execute quality management strategies.
Make compliance forethought, not afterthought. Because speed to market is imperative to gaining a competitive advantage today in most markets, it’s important to closely link the regulatory group with product development efforts from early strategy and concept development stages. This enables the regulatory function to identify and include regulatory requirements for new markets into product development plans early and avoids the reactive scramble and design changes when country-specific requirements are identified after the early design is completed.
Turn compliance into competitive advantage. Instead of focusing on clearing the next regulatory hurdle, look at regulatory compliance as an opportunity to more clearly define how you can make your product quality and product compliance strategies more in line with customers’ needs. When regulatory compliance requirements are fulfilled within the context of market- and customer-driven quality initiatives, both the manufacturer and the customer wins.
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