Unlike the traditional audit approach where employees are instructed to address only questions asked and refrain from volunteering any extraneous details, the new FDA appraisal model relies on collaboration with employees to discover what’s happening inside the organization relative to best practices. The interactions take place between the appraisal team and “doers” who are responsible for work products. These are simple and direct conversations with no artifacts to review.
The goal of FDA’s Case for Quality Pilot is continuous improvement that goes above and beyond compliance. In a facility appraisal, employees are asked to be transparent and descriptive about how their work is done. The outcome of an appraisal is to identify improvement opportunities using best practices as a guide. It’s all designed to make a positive impact on the business. This differs substantially from the outcome of a traditional medical device facility inspection, which is the identification of FDA Form 483 findings with negative business impact.
FDA’s changing regulatory approach prompted one program participant to remark, “This feels like a parallel universe.”
In the table below is a comparison of the new and old compliance models.
Comparison of Resource Allocation: CMMI vs. FDA Inspection
|CMMI Appraisal||FDA Inspection|
|Capability maturity model appraisal of business practices and processes.||Inspection of quality system procedures and records.|
|Focused on eleven (11) CMMI Model practice areas.||Focused on 21 CFR Part 820 (or other) requirements.|
|Appraisers conduct group interviews of ‘doers’ responsible for work products.||Inspectors interrogate Quality leaders, process experts, and record owners.|
|Appraisers engage in discussions to truly understand how the business operates relative to best practices.||Inspectors review procedures, records, storyboards looking for evidence of noncompliance to regulations.|
|Many participants outside of QA||Few participants outside QA.|
|Minimal disruption to site resources and no need for Back Room / Front Room.||Large support team with Back Room / Front Room, streams, scribes, etc.|
|Weaknesses are opportunities to improve business process.||483s require escalation to CAPA and formal agency response.|
|Be open in answering questions and it’s ok if you’re not 100% sure.||Only answer questions asked. If you don’t know the answer, don’t guess.|
|It’s OK to volunteer information that may be tangentially related to the question.||Don’t volunteer information that doesn’t pertain to question asked.|
|Highlight improvements made over time, as well as plans, if appropriate.||Don’t discuss improvement opportunities or future plans.|
|Explain other systems and tools used to do your work. For example, PLCP, Business Essentials, VIPs, CI Boards, etc.||ODon’t deviate from what is documented the quality system, i.e. policies, procedures, records, etc.|
|No need to prepare for questions. Just respond as best you know based on you experience and perspective.||Be prepared to speak to any pertinent documentation. Facilitators will ensure the right people answer questions.|
|Do not bring your laptop, exhibits, or documentation to your interview. Is it just an open discussion?||Bring in procedures and records as appropriate. A laptop may be needed to view certain electronic files.|
In the tables below are a large medical device company’s comparison of resource allocation, showing a maturity model appraisal takes 340 hours, 25% of the 1,370 hours it takes for a traditional FDA inspection/ software validation.
Comparison of Resource Allocation: CMMI vs. FDA Inspection
|CMMI Appraisal – 5 Days|
|Site Coordinator||80 hours||20 hours||100 hours|
|Participants||60 hours||180 hours||240 hours|
|Total||140 hours||200 hours||340 hours|
|2-day FDA Inspection||1370 Hours|
EQMS built on the Salesforce.com platform can enhance this new appraisal process because it brings the power of social networks into medical device quality organizations, improving connections and knowledge among coworkers.
Salesforce Chatter is a private and secure social network for businesses. Everything that matters — from the status of a specific non-conformance, to corrective and preventive actions or change in customer information — gets delivered to all relevant stakeholders through their Chatter feed. With the connectivity provided by the Salesforce Chatter functions employees will be more informed and better able to participate in an appraisal.
EQMS Built on Salesforce Offers a Bridge to Quality 4.0
Considering the radical change ushered in by FDA’s new regulatory environment for medical device organizations, a 100% cloud- based EQMS built on the Salesforce platform may deliver increased benefits over the long term. It is still the early days of this new regulatory paradigm and more change is essential as need grows for compliance solutions not yet envisioned.
In addition to preparing for the new regulatory paradigm, 100% modern cloud EQMS can help the medical device industry move into the future world of operating known as Quality 4.0, which includes the digitization of quality but also examines the impact of this digitization on quality technology, processes and people.
Leading the way are companies like ComplianceQuest, the fastest growing, 100% modern cloud (EQMS) natively built and run on the Salesforce platform. Delivering best- in-class out-of-the-box solutions, Compliance Quest fast-tracks an organization’s efficiency, safety, and overall performance by combining enterprise quality, compliance, collaboration and communication across the product value chain. Suitable for emerging growth companies and scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate, and use. Its team of domain experts is committed to innovation, product excellence and to the success of its customers especially those embracing transformation as part of FDA’s Case for Quality.
The vision at ComplianceQuest is to transform quality and compliance into a strategic advantage for our customers through experience, expertise and passion. ComplianceQuest is an innovative, 100% cloud based Enterprise Quality Management System solution company. We provide an enterprise grade solution that streamlines quality, compliance, content and collaboration management initiatives and strategies across diverse, globally based supply chain networks.
For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today.