FDA Case for Quality Voluntary Improvement Program (CfQVIP)

When the US FDA published back in 1996 the Quality System Regulations §CFR 21 Part 820, they required that "Manufacturers establish and follow quality systems to help ensure that products consistently meet applicable requirements and specifications."

The FDA believes that the requirements of the regulations are the baseline for manufacturers to produce safe and effective devices.

And all these requirements are fundamental: management commitment, having documented procedures and records, personnel competency, and periodical reviews of the quality system are good manufacturing practices that every manufacturer should follow.

Even though there is no single reference in the Quality System Regulations to "quality improvement," manufacturers have recognized the business need.

Due to the mandatory nature of the Quality System Regulations, quality became the synonym for "compliance," while improvement was led by other areas such as Business Excellence.

And even though "Lean Six Sigma" projects can be used to 1) improve quality, 2) improve revenue, and 3) reduce costs, the last two are the most common because they produce more immediate results in the bottom line.

In addition, quality improvement projects are more complicated and lengthy to implement because of compliance requirements.

For example, a product redesign might require a regulatory submission; and a change in the manufacturing process might require revalidation, rewriting work instructions, change control, and retraining personnel.?

FDA initiated the Case for Quality as a pilot in 2011

The FDA Case for Quality (CfQ) seeks to identify successful manufacturing practices that consistently produce high-quality devices to help other device manufacturers raise their manufacturing quality levels.

The FDA initiated the Case for Quality as a pilot in 2011 in partnership with the Medical Device Innovation Consortium (MDIC) .

The MDIC is a public-private partnership created to advance the regulatory science around developing and assessing medical devices.

Based on the pilot's success, the Case for Quality will transition into a permanent Case for Quality Voluntary Improvement Program (CfQVIP) program.

FDA Case for Quality Voluntary Improvement Program (CfQVIP)

Based on the pilot program's success, the FDA is currently developing a complementary policy for engaging with CfQVIP.

On May 6, 2022, the FDA issued the draft guidance:

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program .

You can submit your comments online by?June 5, 2022, at this link: Regulations.gov

The Voluntary Improvement Program uses an appraisal tool called the Medical Device Discovery Appraisal Program (MDDAP) model.

CMMI administers the MDDAP program and also certifies and coordinates third-party appraisers.

Enrollment requirements

Any facility that "designs, manufactures, fabricates, assembles, or processes a finished device" can participate.

The companies should have prior compliance history or compliance pro?le (for example, US FDA inspection or MDSAP audit), Establishment Registration, and Device Listing.

Also, the facilities must not be under Official Action Indicated (OAI) status or subject to judicial action.

Benefits for the manufacturers

Improved Quality

Participants have reported reduced defects, complaints, time to identify the root cause of issues, improved product availability, capacity, automation, and error-proofing.

Employees are included in developing solutions and recognize that quality is part of everyone's work, resulting in improved morale and turnover.

Regulatory opportunities

• Inspections: Participants benefit from a risk-based approach to FDA inspection planning and resource allocation for routine surveillance, pre-approval, and post-market inspections.
• Change Notices: Program data enables a modified submission format with reduced timeframes for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices.
• Site Changes:?Program data enables a modified submission format with reduced timeframes for PMA and HDE Manufacturing Site Change Supplements.
• Manufacturing Modules: Program data enables a modified submission format for PMA or HDE Manufacturing Modules.

Additional information can be found in:

Case for Quality | Medical Device Quality & Patient Safety | MDIC

References

fda.com

mdic.org

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