QA Connect Management Consulting, LLC

QA Connect Management Consulting, LLC Internal, supplier, GMP and Remote Audits supporting (ISO 13485: 2016, ISO 22716. Assembly Line Audits, Backlog projects (Recalls, complaints), FMEA Audits.

Six Sigma and Kaizen focused for medical device, cosmetic companies, and start-ups.

08/06/2026

Why are daily Quality huddles (or Quality Circles) important?

They are important because they ensure work priorities stay consistent and on track. They also help keep track of metrics, and any important changes and problems that may come up. Meeting huddles should be brief (10-15 minutes) and all cross-functional departments (manufacturing, design engineering, quality, and supply chain), should give updates.

07/28/2026

"Surround yourself with people who will lift you higher." Oprah Winfrey

Young entrepreneurs (and older ones), it's imperative to stay away from toxic, negative, low vibrational people who lives are steeped in depravity. Remember trash will ALWAYS vibrate at the level of trash. It is absolutely amazing what happens in your life when you remove the trash!!
Incredible good people, opportunities, and love will enter your life in abundance. ❤️

07/23/2026

Verification of Effectiveness (VOE) Plans for CAPA Closure

Closure of implementation activities alone does not constitute effectiveness. It is important to know that post-implementation data collected against a pre-defined acceptance is required.

It is very important to have four things:

1) Effectiveness metrics that defines a specific, measurable indicator i.e. Cpk, NCR occurance rate etc.

2) Monitoring Period such as 90 days, 2 internal audit cycles based on output.

3) Acceptance Criteria which states the pre-defined pass/fail threshold.

4) Actual Data/Results -Summarize raw data, trend charts.

07/17/2026

Dreamers vs. Visionaries

I love working with young Millenial talent in medical devices. My current teams are just great. Their innovative ideas, humor, excellent tech and AI knowledge always makes me smile and brings me joy.. There are two particular very talented team members who always go the extra mile. They have realistic goals, great attitudes, work ethics, commitment, and are firmly based in reality. They will one day be visionaries. I have no doubts whatsoever! I can always tell the ones who are going to achieve great things, and the ones who aren't.

"The difference between a dreamer and a visionary, is that a dreamer has his eyes closed, and a visionary has his eyes open." Martin Luther King Jr.

07/17/2026

5 -Whys for Bottlenecks in Quality processes.

The 5-Why process can be very use in removing roadblocks, delays, and inefficiencies in Quality.
Specifically, with delays for NCR's, CAPA, and complaints.

#5-Whys

07/07/2026

Backlog projects in Quality

Whether its backlog complaints, CAPAs, or NCRs - these projects cannot and will not succeed without team goals and the support of Executive Leadership. It's also imperative for Executive Leadership to attend meetings to understand the ins and outs, complexities, and bottlenecks that are deeply rooted in previous incompetency.

06/26/2026

'When you do the uncommon things in life in an uncommon way, you will command the attention of the world." George Washington Carver

Happy Father's Day to all the amazing fathers and grandfathers! There are some amazing alpha male, high vibrational wond...
06/21/2026

Happy Father's Day to all the amazing fathers and grandfathers! There are some amazing alpha male, high vibrational wonderful men who are doing excellent jobs. We celebrate you today! I am so blessed and grateful to know and honor you.

Happy Juneteenth!
06/19/2026

Happy Juneteenth!

06/17/2026

"To be successful in business, spot the possibilities, not the problems". -R. Sharma

Address

San Leandro, CA
94578

Telephone

+15104449786

Website

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