Quality management, if we’ve learned anything, is a central factor in any manufacturing organization. What’s most compelling is the evolution during the past decade of our perception of quality management. Once thought to be a compartmentalized system in an organization’s infrastructure, quality management systems (QMS) have evolved into a central point of prominence in defining how products and processes are executed.
In many industries, compliance is the word of the times; compliance encompasses so many facets within an organization. Compliance to regulatory standards, compliance to good manufacturing processes, compliance to governance and risk—compliance is everywhere in the organization. In order to remain competitive, organizations not only must adhere to the consumer’s demand, they must also ensure that compliance is met throughout. Whether it’s in design, supply chain, production, or post-market, compliance is the underlying force that drives competitive advantages over others in the market.
The challenge is how to manage compliance across these varying operational areas, ensure there’s a consistent and viable way to collaborate, and also ensure quality and compliance is met at all levels of the process.
Organizations generate a bill of materials when creating a production process, and organizations take a similar approach to compliance. The bill of materials provides the different operational areas with the list of materials, design specifications, procedures, work instructions, and related data to help ensure the production is correct and consistent. The bill of compliance operates in a similar way, but instead of creating consistency in production, it strives to create consistency in compliance from one operational area to the next.
The QMS operates as a “hub” for all business systems by feeding compliance data, organizing and analyzing the data, and creating a level of visibility into quality operations that cannot be achieved with each system individually. A QMS is the key to a successful bill of compliance.
“The bill of compliance, like a bill of materials or bill of process, provides a persistent structure (a metadata definition), that defines bindings for master and operational data elements (these could be stipulated regulatory documents, material safety data sheets, assay results, raw material specifications, and training certifications) required to demonstrate product and process compliance for material sources and destinations by region, industry, or even customer,” says Simon Jacobsen of Gartner Research in the report, “EQM Hubs Unite Quality Management IT Systems Across the Value Chain.” Simon goes on to say that “...the EQM [enterprise quality management] hub provides the master data management processes needed to maintain the bill of compliance over its life cycle, and provides a single version of the truth with respect to compliance requirements for all other enterprise systems involved in conversion processes.”
If we start to look at the QMS as a hub for the organization, we can then broaden the scope for which we view quality in an organization. A standardization of compliance across the organization can lead to many great things:
• Common platform for compliance. One single view of the truth in an organization on quality and compliance enables management to view compliance in a broader light.
• Quality’s reach is extended to the supply chain, production, design, environmental health and safety, governance, and more. All these areas are now connected to quality more than ever before, and quality becomes ensconced within every aspect of the business.
• The view from the top is clearer than ever. Decision making is improved when compliance risks are visible. The more we can see, the better decisions we can make.
Although these concepts are a fairly recent perspective on our way of thinking about quality, many organizations are already employing them in some form or another. Quality by design, supplier quality, and even environmental health and safety activities are being tied to QMS. As more systems begin to integrate with quality, the closer we come to a true quality hub. As you begin to evaluate your business systems and explore your options for improving your compliance visibility, look to quality to provide you with the hub that will house a bill of compliance. This level of compliance has proven effective for many organizations in leading the charge to put quality and compliance at the forefront of the operation.