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

Fwd: The Spirit of Atzari

Dear Friends of Atzari,

Call us naive, hopeless romantics, or incorrigible optimists.   We believe that, in spite of all that one can find wrong with the world, good will eventually prevail, truth does find its way, and principles do matter.

To the cynics, many of the compliance tasks and requirements are part of a game one must play - as part of the price of entry.  

We see things very differently.

If you truly can't make the case for a robust process, then how can you claim to have one?

If you truly haven't designed a clean room to meet your own requirements, how can you convince others that you did?

If you can't produce the pedigree of your great product's design history, then what is to say there is one?

Having said that, why, when challenged, do you then create a complex system born out of panic from the auditor's unfavorable spotlight?

Why not create a logical, less-intrusive, user-friendly system when you have the time to do it right and at a reasonable expenditure?

When approaching many potential clients, we are reminded of an old Cuban joke about rationing of food in Castro's Cuba.   Plan "Camarioca" - When there is some, it's not your turn.  Plan "Guanajay" - When it's your turn there isn't any.  The joke only rhymes in Spanish, but you get the idea.

When we examine a client's operations and quality system, the response is often that they haven't had a problem, therefore there is no need to improve.  Translation: Plan Camarioca.

When the client is under a warning letter and a consent decree, they want 30 consultants "yesterday" and enthusiastically agree to almost any draconian imposition and gridlock - just to be able to stay in business.  Of course, by then they must hire a "recommended" firm of ex-regulators and pay $225-$500 per hour plus expenses just for the privilege of placing their business in a chokehold.  Translation: Plan Guanajay.

We believe there is a third option -and that is to build a system that works well together and also happens to be compliant.

We believe in doing it right because it is the right thing to do, not because of some external imposition.   It is much easier to plant and nurture the sapling to grow straight than to have to do major surgery on a crooked tree.

But, then again, what do we know?  We're just some hopeless romantics who happen to know exactly how to do this.

José Ignacio Mora,
Principal Consultant,
Atzari Consulting, L.L.C.
www.atzari.com