FDA Outlines Critical Quality Measures

Case for Quality is an initiative launched by FDA to shift focus from compliance to quality in medical device design and production. In an OMTEC 2015 presentation, representatives from FDA’s Center for Device and Radiological Health (CDRH) outlined the steps to Critical to Quality (CtQ) measures—one component of Case for Quality—and other initiatives of particular importance to orthopaedic device manufacturers.

FDA launched Case for Quality in 2011 with three core components: focus on quality, enhanced data transparency and stakeholder engagement. CtQ is a priority of component one, with FDA working with stakeholders to promote practices that correlate to higher-quality outcomes. The Agency also seeks to use these practices to streamline inspections.

Specifically, CtQ measures refer to key characteristics and features of a device that relate to overall quality based on manufacturing, design, supplier control, etc., according to William MacFarland, Director of the Division of Manufacturing and Quality within the Office of Compliance.

CtQ began as an inspection pilot in which FDA built CtQ information documents by combining technical information for a particular type of device with inspectional guidance, then sharing this information with investigators and firms willing to volunteer in inspections. This was completed in 2014.

“Our focus was not to change the method for an inspection,” MacFarland said. “The Quality System Inspection Technique (QSIT) still applies, but we wanted to promote more engagement with quality itself. Feedback from investigators suggested that this did promote more discussion of quality. One possible downside is that when we write this information and call it inspectional guidance, there is the perception that this is the test for the inspection.”

Rather than serving as the inspection test, CtQ helps the investigator get up to date on a particular device, gaining clarity on critical characteristics and features, MacFarland said.

“We wrote it in such a way that the investigator knows it doesn’t replace QSIT, but just interfaces with it,” he said.

Currently, FDA endeavors to make 13 documents public on CtQ inspections.

“Going forward, you’ll see more CtQ information documents, but don’t assume that the intent is inspectional in nature,” MacFarland said.

Further, FDA is determining how to use the concept of CtQ in a Premarket Approval (PMA) and will soon announce a PMA CtQ pilot.

“Rather than a normal pre-approval inspection to approve the PMA, we will confirm the CtQ information, confirm the controls with CtQ and defer everything else normally associated with a pre-approval inspection to post-approval. Expect to hear more from that soon,” MacFarland said.

To illustrate how CtQ documents are created, Nazia Rahman, a biomedical engineer in the Physical Medicine, Orthopaedics, Neurology and Dental Devices Branch of the Division of Manufacturing and Quality within the Office of Compliance, walked through the four-step process that reviewers will use.

1.  Identify top 10 key characteristics for the device.

“We’ll look at the device and its background, identifying the user, end user and key failure modes of the device,” Rahman said. “Then we’ll use those key failure modes and how they affect the device to identify those characteristics that are important to the device.”

2.  Identify how these characteristics are controlled in design and manufacturing.

“We observe documents such as essential design outputs, supplier agreements and acceptance testing to learn what firms use to ensure that these key characteristics are meeting their key specifications,” she said.


3.  Draft CtQ indicators.

Rahman provides an example of a spinal implant, with key characteristics being sphericity and surface finish of the endplates. After pinpointing key characteristics, reviewers then evaluate the impact of failure. In this case, conformity of either of these characteristics can lead to excessive wear, which can lead to pain, metal debris inside the end-user’s body or the need for revision surgery. Then, reviewers talk about the controls.

“Sphericity is primarily an output of the CNC turning, CNC milling and deburring processes performed by the contract manufacturer,” Rahman said. “The contract manufacturer is key because when we reference 21 CFR 820.50, we’re referencing purchasing controls. That gives the investigator an indication that they should really look at the purchasing controls for this key characteristic. We also reference the quality system inspection technique, specifically production and process controls with respect to number two, [identifying the controls used in design and manufacturing] which is also tied into acceptance testing and supplier control.”

4.  When possible, validate the document with technical stakeholder input.

The fourth step is the most critical, as it assists FDA and the stakeholder in closing the perception gap on quality.

“We’ll go back to industry and make sure we’re on the same page—that the key characteristics we identified are also what they think is key,” Rahman said.

FDA recently launched a webpage for its Case for Quality Stakeholder Forum. The site highlights  projects that encourage operating above the quality system regulatory baseline, as well as a forum for engaging on this topic.

The forum, spearheaded by the Medical Device Innovation Consortium, allows stakeholders to discuss the latest quality measures and models. Meetings are held regularly to discuss the latest research and discourse on quality maturity models and quality measures.

Other initiatives on which MacFarland advised orthopaedic device manufactures to stay abreast include:

FDA Library of Quality Practices

FDA is working with stakeholder organizations, from standards organizations to industry membership organizations, to pinpoint quality best practices that firms should incorporate into design stages in order to take quality beyond baseline regulatory requirements.

“We’re getting away from the fundamental quality system concept and into the tools that can be used, so look for more on this concept in 2015,” MacFarland said.

Quality Measures Project

Recently, FDA completed a quality measures project with Xavier University to identify key indicators of product quality related to pre-production, production and post-production.

The results are now in the hands of the Medical Device Innovation Consortium, to further industry’s case for quality projects.

“Now they are taking all of that information from this effort over the last year and boiling it down to three measures of product quality,” MacFarland said.

Data Transparency

FDA seeks to ensure that information on product quality and quality system compliance is readily available for manufacturers. FDA has been working with third-party organizations to determine what data the Agency has, and what data should be made available to industry.

FDA representatives encourage industry to stay tuned for more announcements and information on these upcoming initiatives.