Up to Code: Implementing a Quality System

A quality system can be a big help or a big headache. Here are tips on how to put the right quality system in place.

A quality system can be a big help or a big headache. Here are tips on how to put the right quality system in place.

Katherine Cox

For startup executives, quality systems can be a financial drain. When poorly implemented, they can even be an impediment to product and business development. But a well-implemented quality system, on the other hand, can be an important tool for business risk mitigation. An ineffective “one-size-fits all” quality system that is poorly implemented can result in a litany of rigid rules, procedures, and mountains of paperwork, but a strategically developed quality system—carefully customized to fit a budding company—can ensure that the product or service meets the needs of the customer, the market, and the regulatory environment in a safe, effective, and cost-efficient manner.  

A comprehensive quality system that works in tandem with a good business plan provides a documented policy for ensuring that the final product meets both internal and external requirements. Such a system essentially detects and prevents defects throughout the development lifecycle. A good quality system identifies the regulatory environment; the clinical need and business case of the product or service; the customer and product requirements and risks; the development of prototypes; and, finally, the execution of product commercialization. It pushes for continuous development improvement and requires frequent feedback for process review.

Startup CEOs face two main questions: timing and level of quality.

Not surprisingly, the most cost-effective point for startups to implement a quality system is at the beginning of the product development process. Defining the company’s product development roadmap up front ensures that regulatory agency requirements are established, understood, and executed by the entire development team and then successfully met. The consequences for not adopting a quality system early in the development process could mean incomplete identification of the product’s clinical, customer (user and patient), and regulatory path needs. Moreover, failure to establish accurate product requirements, and/or failure to access product use and design risks in order to establish verifiable risk mitigation strategies, can result in significant financial costs if the product does not meet customer and market needs, if the product fails verification and validation, or if the product does not perform as intended in the field. 

Many emerging companies are often sold on a “one-size-fits-all" quality system. While compliant with international and U.S. medical device regulations, such systems typically involve a suite of binders, documents, and forms that don’t take into account a company's stage of development and that may even call out departments that don’t yet exist. These complicated systems often end up on the shelf after overwhelming a small startup team with confusing documents that don't apply to the company. On the other hand, a quality system tailored to fit the scope of a company's business operations can be strategically developed and appropriately sized to grow with the company, not the other way around.

QS development typically takes into consideration the following:

  • At the concept development phase and the engineering evaluation and development planning phases of the product development process, the quality system planning elements should include, at a minimum, processes to fulfill the ISO 13485 and the FDA Quality System Regulations, including management review, documentation controls, personnel, and design controls. 
  • As the product evolves into detail engineering design and process development planning, the quality system elements for purchasing controls, supplier controls, production and process controls, equipment calibration and maintenance processes, nonconforming product, and corrective and preventive action are added. 
  • Upon transition into pilot production for design qualification and product commercialization, customer-related processes for distribution, installation, servicing, and complaint handling are implemented into the quality system.

Depending on the company’s business strategy and regulatory path, the most effective route is to engage an experienced professional, either as a consultant or as a full-time resource, who will take into account product development needs and provide training in quality use and implementation. 

A company whose product approval path is a 510(k) for a relatively simple product design, and which utilizes contract design firms and manufacturing sources, is most likely to engage a quality system consultant throughout the entire product development process. On the other hand, a startup whose product is quite complex, requiring clinical evaluation for CE Mark or FDA PMA approval and being developed internally and externally, might initially work with a quality system consultant, but would eventually hire a permanent resource as development progresses into product realization and clinical use.

The best time to develop a quality system is before it’s needed. Delay in implementation can lead to financial and personnel resource investments in the development of a product that fails to meet market approval or adoption.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference, November 4–5, 2015.

Katherine Cox is senior director of quality assurance at Procyrion, Inc. Reach her at [email protected]

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

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