Sunday, July 21, 2013

Fwd: Singing

Singing at flag-raising event in Union City, NJ on July 20th, commemorating Colombian Independence Day.  From left to right, Colombian Consul for Newark, Dr. Christian Mauricio Rodríguez Anzola, Union City Mayor Brian P. Stack, and yours truly singing the Star Spangled Banner, followed by the Colombian National Anthem.

Photo:

Voice Recording:

Thursday, October 21, 2010

Upcoming Nov. 5 Webinar: Configuring Your System for Lean Documents

Dear Friends of Atzari,

The webinar referenced below is unlike any other I've previously presented.  It introduces new concepts in configuring ERP and Quality System software using the principles of lean documentation and lean quality systems.

This is much more than about lean documents!  It is a unique and different way of looking at managing information that is used in both ERP and Quality Systems that has never been presented before.

This is NOT "best practices" where the same ideas currently in use are re-presented and re-packaged, but rather a completely fresh and new approach to how information is configured, stored, and utilized.

I am truly looking forward to presenting this material.  This is also an opportunity for you to be one of the first to see the introduction of a new set of concepts.

Thanks and regards,


Jose I. Mora
joseimora@gmail.com

"In God we trust; all others must bring data."  - W. Edwards Deming, physicist and quality improvement pioneer


---------- Forwarded message ----------
From: Compliance Training <complianceonlinetraining@complianceonline.com>
Date: 2010/10/21
Subject: Webinar: Configuring Your System for Lean Documents
To: joseimora@gmail.com


Having trouble with this message? View it Online.
ComplianceOnline
Configuring Your System for Lean Documents
November 05, Friday 08:00 AM PDT | 11:00 AM EDT

As in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many lifescience companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner. Configuring for lean documents builds upon the principles of lean documents to bring the power of the electronic system into play.

This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance. We will builds upon the concepts of lean documents and introduces a new approach to configuring in a lean, straightforward way that let's the electronic system do what it does best while reserving the original purpose of a document.

Date: November 05, Friday 2010
Time: 08:00 AM PDT | 11:00 AM EDT
Duration: 90 Min
Instructor: Jose Mora
Location: Your office or conference room (no need to travel!)
Register Now
Note: Registration will close 48 hours before the start of the webinar

Areas Covered in the Seminar:

  • Definition of lean documents.
  • Problems with traditional document approach.
  • Applying lean manufacturing principles.
  • Basic Elements of Documented Information.
  • Relation of lean documents to basic elements.
  • Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
  • What a lean document approach would have.
  • Preparing for an electronic document system.
  • Basic elements in electronic form.
  • Basic elements applied to various quality system documents and records.

Who Will Benefit:

This webinar will provide valuable insights to design engineers, manufacturing engineers, operations managers, quality system managers, and document control managers

  • Project leaders implementing an electronic document system
  • Functional managers
  • QA managers
  • Lean Project Managers

Instructor Profile:

Jose Mora
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 24 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

Registration Information:

  • Register Online. Use your American Express, Visa or MasterCard.
  • For more than one attendee get 20% off on the price of additional attendee.
  • Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
  • Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
  • Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
ComplianceOnline

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Friday, September 10, 2010

Thank you for making me what I am today

Dear Friends of Atzari,

I posted the following verbiage below in a moment of either inspiration, exasperation, or delusion, depending on our viewpoint after jousting with a pompous knucklehead who kept questioning whether continuous improvement was possible, or even worthwhile.  

I am sharing it with you since I thought you might enjoy it.

Cheers!

THANK YOU FOR MAKING ME WHAT I AM TODAY

We have not been introduced, but I have met you many times.

You have many aliases and go by many names, but you are one and the same,

"It won't work"
"We tried that before, and it didn't work"
"If there were a better way, someone would have already found it"
"If it ain't broke, don't fix it"
"It's our policy, so don't question it"
"That's what the management wants, so just do what you're told"

You have stood in my path many times.

And, yet, I must thank you, for you have made me what I am today.

Every time you challenged, me I grew in my knowledge and profession.

For you see, the best way to get me to do something, was simply to tell me it could not be done.

You were the one who inspired me to reduce a setup time from 8 hours to 15 minutes back in 1982.

"It can't be done, we've been doing it this way for 20 years"

You were the one who inspired me to design an automatic hemostat ring polishing machine in 1983

"Don't try it, it won't work. German craftsmen have been doing this for 80 years, are you wiser than them?"

You inspired me to replace an adhesive to melt two dissimilar materials to assemble an angioplasty catheter in 1985

"Our materials experts say it can't be done, so don't waste your time."

You told me that equipment maintenance could not be improved - that that was just the way it was.

"Several managers have tried, that's just the way it is. It can't be done, so don't think you're any different.

Yet after 3 years that maintenance department was rated tops by a leading regulatory agency in 1992

You told me that silicone would do what it was going to do and that the process could not be improved.

"We've been doing that for 20 years, who do you think you are, anyway?"

Yet for the first time in 20 years, after several Taguchi experiments, a defect free implant was created in 1996.

I carry your challenges like badges of honor - the purple hearts of past victories - the decals on an Ace's fuselage

So, please, "go ahead, make my day."

Tell me it can't be done. Tell me it can't be improved. Tell me that's just the way it is.

We have not been introduced, but I have met you many times. And we shall meet again ...

Your real name is old school thinking, and you are the best teacher I have ever had.

Thank you for making me what I am today.


- Jose I. Mora



Tuesday, October 6, 2009

Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

Dear Friends of Atzari,
 
This could be a very timely article!
 

--
Thanks and regards,


Jose I. Mora
Mobile: (917) 566-0965 (business)
Mobile: (786) 351-2484 (personal)
Office: (973) 206-9473
Fax: (866) 476-0426
joseimora@gmail.com

Sunday, April 26, 2009

Atzari's Accomplishments

Dear Friends of Atzari,

Many of you enjoy and are amused by our anecdotes, platitudes, analogies, and theoretical discussions.

But for the more serious utilitarians among you, I'm sure the question has crossed your mind, "That's all well and good, and even entertaining, but what have you folks actually accomplished?"

We are happy to provide you with an abbreviated list of our past and recent accomplishments.
  • Design, creation, and validation of a world-class lean cleanroom manufacturing facility
  • Lean kanban supply-chain management pull system
  • Lean transformation at a top 20 pharmaceutical company's tablet and capsule manufacturing operations
  • Design and creation of a participative hands-on simulation game for lean kanban pull systems and constraint management
  • White Paper: Searching for the Lean Document Ideal
  • Value stream mapping and process mapping for pharmaceutical companies
  • Due diligence and environmental assessment for holding company
  • Turnkey washer-disinfector, sterilization, and supply-water purification system for loaner surgical instruments and implants
  • Cleanroom validation per ISO 14644 and ISO 14698
  • Transformation of a failing Maintenance and Facilities Department into a world-class operation rated as "tops" by the British Department of Health and Social Services (DHSS) over a campus of 9 large buildings with over 50 maintenance personnel
  • Design and implementation of spare parts kanban system for maintenance and PM
  • Implementation of the DIN "Do It Now" Squad for Emergency Maintenance Services
  • Process development and optimization of symmetrical and asymmetrical PTA balloon blow molding
  • Implementation of 5S visual workplaces for manufacturing, lab, and individual processes
  • Insert mold development and process optimization for PTA catheter manufacturing
  • Development of PTA proximal heat-seal process for dissimilar materials
  • Re-design of tooling and equipment for guiding catheter fusing, braid-welding, and assembly
  • Critical cleaning and cleaning validations
  • Process development, optimization, and validation of new header bag for surgical kit manufacturer
  • Configuration of EQMS CAPA and Audit systems using six-sigma DMAIC as framework
  • Design and development of lean quality system and documentation
  • Corporate and local ISO and cGMP audits
  • Transformation of company-wide tooling fabrication and control system
  • Introduction of Taguchi DOE methodology at facilities of three major companies
  • Successful track record using Kepner-Tregoe Problem and Decision Analyses
  • Automated process for polishing the outside rings and shanks of hand-made stainless steel surgical hemostats
  • Lab optimization including HPLC process
  • Redesign of change-control, CAPA, and document control process at biotechnology companies as well as medical device companies
  • Re-design of process validation program and multi-plant medical device manufacturer
  • Complete re-design of surgical scissor manufacuring, reducing the process from 27 steps down to 9 and reducing changeover time from 8 hours to less than 30 minutes
  • Development of universal adjustable tooling for hemostat and surgical scissor manufacturing
The list goes on.   As you can see, behind all the talk and passion, there is also a solid record of achievements in the lifesciences.

Thanks and regards,


Jose I. Mora, Principal Consultant
Atzari Consulting, L.L.C.
Mobile: (917) 566-0965 (business)
Mobile: (786) 351-2484 (personal)
Office: (973) 206-9473
Fax: (866) 223-5813 (business)
Fax: (866) 476-0426 (personal)
www.atzari.com
jmora@atzari.com, joseimora@gmail.com