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REMOTE QUALITY
AUDITS

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Also called Electronic Quality Audits or Virtual Quality Audits, Remote Quality Audits are playing an increasingly vital role in our current and post pandemic world.

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 . . .

Remote Quality Audits

Internal Quality Audits and/or Supplier Quality Audits are behind schedule

Remote Quality Audits

The risk of performing in-person audits is too high

Remote Quality Audits

You’re undergoing a company reorganization to improve effectiveness and efficiency

Remote Quality Audits

Lowering your Cost of Quality is a company mandate

510(k) Premarket Notification Background 510(k) Premarket Notification

Our Process

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.

KEY COMPONENTS OF OUR PROCESS:

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.

Remote Quality Audits

Confidentiality:
We maintain the confidentiality of your audit information from the very beginning to the very end of the process.

Remote Quality Audits

Team:
One key individual from Delta is designated as your Audit Leader, responsible for the Delta team of 1 to 3 auditors.

Remote Quality Audits

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.

Remote Quality Audits

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.

Remote Quality Audits

Statement of Work (SOW):
The formal and final output of the planning process.

AUDIT
PERFORMANCE

Remote Quality Audits

Initial Opening Meeting:
This 60-minute, “all hands” meeting communicates the audit process and addresses any questions/concerns you may have.

Remote Quality Audits

Start of Day Meetings:
30-minute meetings highlighting the planned audit actions for that day, including any changes to the original plan.

Remote Quality Audits

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.

Remote Quality Audits

End of Day Meetings:
30-minute meetings summarizing the day’s accomplishments, including any nonconformities found.

Remote Quality Audits

strong>Procedures:
TYour Internal Audit Procedure or Supplier Audit Procedure and associated forms and checklists are used, unless specified otherwise..

Remote Quality Audits

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.

Remote Quality Audits

Recommendations / Suggestions:
Only provided if agreed upon per the SOW.

Remote Quality Audits

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:

  • Review of the Corrective Action Plan before the action is completed.
  • Review of the Corrective Action Taken, including objective evidence.
  • Advising management if corrective action taken is not adequate.
  • Monitoring and reporting to management on the timeliness of the Corrective Action.
  • Re-auditing a specific function or process if determined to be necessary and agreed upon by management.

Custom Consultation

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.

calend SCHEDULE YOUR
CUSTOM CONSULTATION