COVID-19 forced the FDA to accept remote quality auditing more quickly than originally intended, and in the process all parties have quickly learned more about the significant benefits and inherent risks of the process.
Today, OEMs, contract manufacturers, and key suppliers must become uncommonly good at both “giving” an d “receiving” Remote Quality Audits.
Remote Quality Audits Are Beneficial When . . .
Internal Quality Audits and/or Supplier Quality Audits are behind schedule
The risk of performing in-person audits is too high
You’re undergoing a company reorganization to improve effectiveness and efficiency
Lowering your Cost of Quality is a company mandate
Delta Consulting Alliance utilizes a predefined, proven, Remote Quality Audit System that ensures strict confidentiality, maximizes the benefits, and mitigates the inherent risks of Remote Quality Audits.
With Delta, you have a team on your side with decades of experience in compliance, quality, and risk management, whose goal is to provide you with the knowledge and insight to improve your processes and reduce your risks.
AUDIT
PLANNING
While planning and preparing for remote quality auditing is more time consuming than for on-site audits, it is time well spent. All parties are more prepared and efficient.
Confidentiality:
We maintain the confidentiality of your audit information from the very beginning to the very end of the process.
Team:
One key individual from Delta is designated as your Audit Leader, responsible for the Delta team of 1 to 3 auditors.
Audit Plan:
An audit plan is established collaboratively with you, including production schedules, availability of key people, existing audit schedules, document and media storage, technology tools, and a “Plan B” for technical glitches.
Desk Audit:
A desk audit is performed on your Key Manuals, Policies, Procedures, Work Instructions, and Records, to determine in part if current audit procedures will require revision in order to properly support the Remote Quality Audit.
Statement of Work (SOW):
The formal and final output of the planning process.
AUDIT
PERFORMANCE
Initial Opening Meeting:
This 60-minute, “all hands” meeting communicates the audit process and addresses any questions/concerns you may have.
Start of Day Meetings:
30-minute meetings highlighting the planned audit actions for that day, including any changes to the original plan.
Interviews:
Because one-on-one internet meetings are more taxing then face-to-face meetings, we limit them to 60-minutes. This ensures your team members maintain their energy and focus for their regular responsibilities.
End of Day Meetings:
30-minute meetings summarizing the day’s accomplishments, including any nonconformities found.
strong>Procedures:
TYour Internal Audit Procedure or Supplier Audit Procedure and associated forms and checklists are used, unless specified otherwise..
Nonconformities:
When discovered, nonconformities are communicated immediately, and if possible, prior to the End of Day Meeting. Initial reporting /discussion is with the SME and his/or immediate supervisor.
Recommendations / Suggestions:
Only provided if agreed upon per the SOW.
Final Audit Report:
Provided within 3 business days of audit completion. The report format complies with your Quality Audit Procedures or applicable IMDRF guidance, as specified in the SOW.
AUDIT
FOLLOW-UP
At Delta Consulting Alliance, we believe follow-up is the most important part of any quality audit. We will perform follow-up activities, unless otherwise specified. Components of Quality Audit Follow-up:
We invite you to schedule a custom consultation to discuss your specific FDA compliance issues.
We can help you determine what to do, how much it will cost, and how long it will take to make that 501(k) go away.
SCHEDULE YOUR