Is Product-Centric QMS Right for You?
Most product quality problems are fixed by changing the product record—the product design and the documentation that describes how to manufacture, test, and package the product. In today’s fast-paced product development environment, traditional document-centric quality management systems (QMS) often fall short. These systems manage quality issues separately from the product record, leading to slow resolutions, disconnected audits, and missed opportunities for improvement.
A product-centric QMS integrates quality processes directly with product records, enabling faster issue resolution, better compliance, and a culture of continuous improvement. This approach is especially vital for industries like medical devices, where complexity, regulation, and global collaboration are the norm.
What Is Product-Centric QMS?
Product-centric QMS manages your product information, based on a complex bill of materials (BOM) that specifies all the components, subassemblies, and associated documents to speed the design, testing, and production of high-quality products. A product-centric QMS is a system that manages quality processes in tandem with the product record, which includes:
- Bill of materials (BOM)
- Design documentation
- Change management
By linking quality issues directly to the product record, companies can:
- Resolve problems faster
- Ensure traceability for audits
- Improve cross-functional collaboration
Working through new product introduction (NPI) processes while navigating FDA regulations and ISO standards requires an integrated approach. Traditional document-centric QMS systems have a major blind spot when it comes to managing the product record. A product-centric QMS streamlines product development, management of quality issues, and the resolution of design issues to accelerate delivery of compliant products.
A BRIEF COMPARISON: PRODUCT-CENTRIC VS. DOCUMENT-CENTRIC QMS
Which Companies Need Product-Centric QMS?
Regulated companies that deal with one or more of the following challenges require a product-centric QMS approach:
High Product Complexity
Products with mechanical, electrical, and software components require synchronized design tools and vaults. A product-centric QMS ensures all teams are aligned.
Note: Product-centric QMS solutions are designed for highly regulated companies that design, produce, and deliver complex products. Companies that provide services, like insurance agencies, banks, or restaurants, will get good results from standard, document-centric QMS systems.
Production Sourcing
Global supply chains introduce communication and quality control challenges. Product-centric QMS enables secure data sharing and real-time updates with supply chain partners, so you can ensure everyone is on the same page and apply their specialized knowledge and experience into product improvements.
An example of production outsourcing support: If you release a revised sterilization standard operating procedure (SOP), your partner gets notified and uses their valid credentials to download that information immediately. An activity log shows you that the partner has downloaded the most recent version of the SOP.
Corporate Growth and M&A
Mergers and acquisitions demand standardized processes. Product-centric QMS supports integration, design reuse, and scalable quality management.
For corporate mergers and acquisitions, use product-centric QMS to standardize, normalize, integrate, and scale quality and product processes. For example, the customer complaint process in product-centric QMS is integrated, transparent, and accelerated. All stakeholders understand the benefits of keeping customer service high during an often-tumultuous time.
Aggressive Operational Goals
To meet revenue and cost targets, companies need systems that support faster launches, lower costs, and better quality—all achievable with product-centric QMS.
For revenue gains, product-centric QMS accelerates time to market for new products and new features. Product-centric QMS is an integrated system that offers streamlined processes and enhanced communication. A product-centric QMS, unlike a traditional document-centric QMS, is architected for easy integration with systems like CAD and ERP.
For cost savings, product-centric QMS helps purchasing and manufacturing realize measurable savings. Purchasing gets early access to parts and subassemblies that need to be sourced to begin finding the best supplier. In addition, procurement aggregates forecasted demand for standard parts and uses that information to negotiate lower prices based on higher volumes. Manufacturing has instant access to the latest, released revision of instructions and procedures, such as assembly instructions and test procedures.
The improved product quality from streamlined, integrated quality processes dramatically saves costs due to fewer rework orders, recalls, and field replacements.
Conclusion
Building a Culture of Quality
A product-centric QMS is more than a tool—it’s a strategic approach to quality. By embedding quality into every stage of the product lifecycle, companies can:
- Deliver better products
- Respond faster to market demands
- Maintain compliance with standards like FDA and ISO
- Foster innovation through collaboration
For more information about product-centric QMS, read the “7 Principles of Product-Centric Quality Management” ebook.
