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