cGMP Process

The following takes you to a list of YouTube Videos I put together to explain the current Good Manufacturing Process, or 21CFR807 and ISO 13485 processes.


cGMP Basics

cGMP Design and Development

Intended Use

Batch Records


Marketing Articles in Linkedin

Courtesy of votehemp.com
Those of you who are working hard to sell your hemp and CBD products (or any other product), if you are unsure about developing a marketing campaign, I wrote a series of articles on Linkedin that could really help you.

Remember, just because we face crisis, that does not mean you stop what you're doing.  The market is on your side, and you have a great opportunity of making a great living, as long as you're vigilant about your goals and your willingness to do what it takes to succeed.

Below are the links to, kind of, like a directory.  This way, you can use this post as a reference, a go-to place for information.

My goal later on is to produce short videos to supplement the content.  In the meantime, you enjoy it but most of all, it helps you sell more of your products!!

Each topic below will take you to a LinkedIn article I wrote in the site.


Part 9 - Case Study

Solutions

Courtesy of GPE Strategm
I was watching television and got tired of people yapping about problems with real no solution. Well, here's my two cents on what I would do if asked to help out, and a lot of you LSS folks will appreciate the last paragraphs of this article.

More Marketing More Sales: What is Marketing?


Courtesy of House Theater
I know that you would like me to get right down to the brass tacks, but in order for you to get a feel and understanding on how this marketing thing works, you’ll need a little bit of background and history.

First, I am not, by trade, a marketing guru. My specialty is continuous improvement, the same management methodology that Toyota and Motorola made it famous. Their processes not only saved trillions of dollars but made much more. Part of the paradigm that I will be using and writing on contain these philosophies and ideas.

Adjusting Patient Load


Courtesy of cbc.ca 
This blog is the second of a series of blogs will be devoted to the Health Care Community addressing long wait times and the need to test and treat the added load as a result of the Coronavirus.

In my last article, I provided a map on how doctor visits are scheduled and the general critical path following a FAT IPO (flow > accuracy > timeliness > input > process > output) paradigm.

Today, I will be addressing capacity which is the ability for a doctor clinic to adequately handle a patient load.

In severe cases, if this is not managed, the practice may have to turn away patients, which can present a problem for those with conditions that require treatment.  And this would not be good.  The alternative is to wait even longer waits in over crowded urgent care centers or hospital outpatient emergency rooms.

Health Clinic Long Wait Times

Courtesy of Oprah.com
The following series of blogs will be devoted to the Health Care Community addressing long wait times and the need to test and treat the added load as a result of the Coronavirus.

Wait times in medical clinics can be reduced by implementing the FAT IPO principles of Lean Manufacturing.  FAT IPO is an acronym for:
  • Flow,
  • Accuracy, 
  • Timeliness,
  • Input,
  • Process and 
  • Outputs.

5S in Oil and Gas

After working in manufacturing and supply chain management for nearly 15 years, I entered the realm of Lean Six Sigma Continuous Improvement process management.  Living and experiencing first hand this methodology as a subset of my job, I encountered multi-million dollar projects that saved tremendous amount of money.  On one example, I was able to lead a 10 well drilling project that saved my then company over five million dollars.  It was destined to fail; had every imaginable obstacle in front of us.  At the time, I learned and practiced several management methods, namely: Management by Objectives, eMyth, and Theory of Constraints.  A close associate of mine who consulted for Nissan Motors sent me several books, one titled:  Toyota Production Services and another white binder book with a symbol that looked like an inclined six.  After burying myself in reading for about a month, I picked up the basic concepts of Six Sigma and Lean used the combination philosophies to create a plan that systematically tackle the impossible and win a big victory for the team.

Lean Six Sigma Can Help Save Oil Field Jobs


(Reprint from 4/10/15)    

This important post affects thousands of men and women working in the oilfield industry. In days past, I’ve read articles (way too many) as key indicators in the field I work in. Lower gas prices mean lower demand and to balance this imbalance, supply is reduced. The Saudi’s and OPEC have done so with the effect of bringing prices up which we’d all complain and point fingers of blame. Now China's economy's tanking that further drives more instability in the world trade market. Regardless, production becomes less of a priority especially when drilling new horizontal fracked wells cost about $60 per barrel.

People, Technology, Culture and Process




Years ago, I worked with the Director of QA/QC and was tasked a Root Cause Failure Analysis (RCFA).  When I heard about this particular issue, I cringed thinking about how we were going to identify the cause and then fix it.  Together, along with a group of others, we spent about an hour on a white board, drawing charts and implementing the Ishikawa Fish Bone Diagram and asked the 5 Whys, affinity diagram, and multi-voting ideas -- basic Lean Six Sigma stuff.

The Need for SOPs

Reprint from my LinkedIn Post Sept. 23, 2016

To be...or not SOP, that is the question.

As I wrote in the past, the Hidden Factory is part of an organization that through action or the lack thereof, result to rework, workarounds, waste, and delays. In Lean Six Sigma, this is defined as “non-value.”  The company absorbs these mistakes by paying the added wages, raw materials, lost time on equipment use and capacity restrictions on scheduling. Some company owners and executive management dismiss it as part of it doing business with worn out phrase, “it is what it is.”

Peanut Butter SOP


A solution that companies take for granted or don't recognize as a true value is the SOP or Standard Operating Procedure. The SOP is part of a “controlled document process of policies and procedures that are used in training and daily work references. It is the most powerful tool a company has in keeping employees in line. Without it, no telling what happens in the front lines and how decisions are made. These documents provide standards and guidelines as references and strong argument for efficient flow, accountability and timeliness. SOPs are written to guide standard work, processes, and a culture of excellence.

The Kaizen Dojo

As a martial artist for many years, I was taught dojo kun.  “Hitotsu, jinkaku kansei ni tsutomuru koto” the first of five guiding rules in Shotokan Karate, one of the major martial arts systems originating in Japan, practiced worldwide, and founded by Gichin Funakoshi.  Translated it means:  Each person must strive for the completion of one's character.  When recited in the dojo after each class, it was shortened to “Seek perfection of character.”

Question is:  Can this same principle apply in a Lean Enterprise environment?

Why Lean Six Sigma? Because It Works!

Lean Sigma has proven to be an effective way in saving companies a lot of money.

If someone told me that he has ideas that could streamline my business, save money, increase profitability and that my customers implemented these ideas in their policies, I'd be interested.

Unfortunately, some don't share my enthusiastic curiosity.

Lean Six Sigma



As a trainer, I've been asked to provide a simple explanation of what Lean Six Sigma is.  When I tell people it's a science based statistical backed behavior and processed management system, I get blank looks.