QA Connect Management Consulting, LLC

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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.

10/17/2026

The Quality Policy

A quality policy must be built on integrity, so planners must be moral, ethical, just, and rational.
At best, quality management is concerned with efficiency, effectiveness, and economy.

Historically, in contrast, policies have also been used very successfully for unethical and severely immoral purposes. Some examples are South Africa's Appartheid policies, Jim Crow policies, and N**i Germany policies which were executed with supreme efficiency. This shows how strong a policy can be, and it is imperative for a policy to reflect ethics, morals, and commitment to humanity

09/29/2026

Quality Management vs. Quality Policy

The Quality Management System mandates the administrative processes in an organization, but will always be subordinate to the quality policy.

Quality Management does not make policies, it only executes them. A quality policy must be built on integrity, so organizers must be moral, ethical, just, and rational.

In contrast, Quality Management is concerned with efficiency, effectiveness, and economy.

09/25/2026

Conference in Southern California

Medical Innovation Forum
Tuesday, October 27, 2026
Irvine, California
(Irvine Marriott).

09/18/2026

"The most dangerous person is the one who listens, thinks, and observes." - Bruce Lee

09/18/2026

Ignoring Delivered Quality As a Competitive Advantage

Embedded Quality transformations led from outside the quality function tend to be focused primarily on reducing the cost of the quality function itself.

09/07/2026

AI in Quality Discussion

I recently had a long Zoom meeting with a dear friend of mine, who I also collaborate with. We are both Gen-Xers. We also both have consulting businesses in the Medical Device Industry. We had not seen each other in awhile since I'm mostly in Los Angeles now. She was amazed at my skill-set and knowledge of AI softwares such as Claude (which I use alot) and Co-pilot. She has not used AI software yet. I showed her how I utilize it in Quality. It most certainly doesn't have the full capabilities of the human brain. I showed her and pointed this out to her. I asked it to do a certain function for me, but it was limited in the delivery of what I asked. I told it - "Ok, I will just do it myself, and I will do it better than you". It responded back "Ok, let me know if you change your mind." My friend and I both had a good laugh.

She now has a better understanding and less fear of AI. It most certainly is a tool. It definitely can save a tremendous amount of time on certain tasks such as KPI metrics. But in my opinion, it will never be able to do what the human brain does because we have intuition and imagination which ties into spirituality, God, and the Universe. AI is all about logic.

"Logic will get you from A to B. Imagination will take you everywhere." Albert Einstein.

09/07/2026

Quality Initiatives

It is important to implement change control, CRB (CAPA Review Board), and quarterly KPI's for CAPAs, NCRs, Supplier Quality, and Manufacturing. These nitiatives are important for continuous process improvement, and due diligence for audits from Notified Bodies such as BSI.

audits

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 whose 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.

Address

San Leandro, CA
94578

Telephone

+15104449786

Website

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