Sunday, July 21, 2013
Fwd: Singing
Thursday, December 20, 2012
Thursday, October 21, 2010
Upcoming Nov. 5 Webinar: Configuring Your System for Lean Documents
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
From: Compliance Training <complianceonlinetraining@complianceonline.com>
Date: 2010/10/21
Subject: Webinar: Configuring Your System for Lean Documents
To: joseimora@gmail.com
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Friday, September 10, 2010
Thank you for making me what I am today
I am sharing it with you since I thought you might enjoy it.
Cheers!
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
--
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
Saturday, July 11, 2009
Top 10 Bad Corrective Actions
Sunday, April 26, 2009
Atzari's Accomplishments
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
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