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

Dear Friends of Atzari,

 

This could be a very timely article!

 

http://www.qualitydigest.com/inside/quality-insider-column/ten-signs-your-ceo-still-has-no-idea-about-iso-9001-and-lean.html

--
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

Top 10 Bad Corrective Actions

Dear Friends of Atzari,

This one is too good not to share...

http://www.taproot.com/wordpress/2009/07/10/friday-joke-top-10-bad-corrective-actions/

Enjoy!

Jose

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

Fwd: The Sounds of Your Future

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

---------- Forwarded message ----------
From: "Jose Mora" <joseimora@gmail.com>
Date: Mar 18, 2009 5:36 pm
Subject: The Sounds of Your Future
To: undisclosed-recipients:;

[?]Dear Friends of Atzari,

I have a challenge for you. Blindfold me, and let me walk through your
workplace, and I will tell you if it will be there in a few years.
Actually, you can do this yourself. Walk around your operation and tell me
what you hear. You will find your "fortune" in the table below:

What Old School Sounds Like
(you may want to start updating your resume [?])

What New School Sounds Like
(I see a very good future for you [?])

We tried that before and it didn't work

The last time we tried that, we didn't consider "X." Let's look at this in
a different way

If it ain't broke, don't fix it

There is always a better way

The information is available on a "need-to-know" basis

You can't manage what you can't see

Everything is a priority

If everything is a priority, then nothing is. We must relentlessly focus on
the vital few and on our constraints

Multi-tasking is just a fact of life. That's just how long it takes, when
you have all these interruptions.

Let's focus and get this thing done

It really isn't a problem, just a nuisance

We don't live with problems. We prioritize and work to eliminate them.

We have to do it because the boss said so

Here is why this is the right thing to do...

We'll bring it up at the next meeting

Let's get this resolved right now

We need more space

What do we do with all this extra space?

We need more people

Is it okay for people to seem idle?

We need more tables, bins, hoppers, shelves, conveyors, etc.

What will we do with all these extra tables, bins, hoppers, shelves,
conveyors, etc.?

It finally works! Don't touch it!!!

If we don't understand our process window, and where it fails we don't know
what we're doing.

What can we do with the resources we have?

What will it take to get this done?

We've never had a problem, so why do we want to measure that now?

You can't manage what you can't measure

That's not my job

What do I need to do to resolve this?

No one has ever complained about our products

We need to actively engage our customers for how we can improve their
experience with our products

Larger lot sizes leverage set-up times and rejects

We must relentlessly expose and drive out defects and waste in our system

That's just how long it takes

How can we improve this?

We're not trying to be the best, just good enough

If we aren't the best in what we do, our customers will eventually find the
one who is

Where does it say we need to do that?

What else do we need to do to be world class?

I need to put a buffer at the end of each project step, just in case...

I need to move as quickly as possible to expose the unknowns in my
project. Time
is precious. I only have one buffer and that is for the entire project - I
must manage it like a bank account.

We need extra inventory just in case

Inventory hides defects and problems. We need to move product quickly
through the shop floor

Our FMEAs are a legal work product. We can't let anyone know if our product
might fail!

Our FMEAs are a vital tool for continuous improvement. We must be
transparent and strive to minimize or eliminate the major risks

Our customers are satisfied.

We must achieve intense customer loyalty and keep our customers excited
about using our products

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: How to really cut costs - myth vs. reality

---------- Forwarded message ----------
From: Jose Mora <joseimora@gmail.com>
Date: Thu, Feb 26, 2009 at 6:45 AM
Subject: How to really cut costs - myth vs. reality
To:

Dear Friends of Atzari,

We've all been there.  We're working on our project, making strides, and along comes the assertive "business guy" that tells you its time to cut costs.  He has the right gravitas, the right presence, and the right body language, all to intimidate you into taking precisely the wrong actions to what your business really needs.  We also know him as the "old school" guy.

This so-called business-guy is coming at you from a cost-accounting viewpoint.  He measures costs in terms of local efficiencies, absorption, and other jargon that seem to make him a true business believer.  

The problem?  

What he is proposing will be the exact opposite of what will cut operating expenses for the enterprise.

Myth: Larger lot sizes will improve efficiencies, reduce the cost per unit, therefore the overall cost.

Reality: You can't measure what you can't see, and you can't cut costs if you have masked the inefficiencies.  Larger lots create excess work in process, hide inefficiencies, and defeat the quality feedback system.  In fact, they end up resulting in much larger operating expenses (the true measure of cost).  Throughput Accounting can mathematically prove the fallacy of unit-based cost accounting.  The only unit that counts is the enterprise, not a unit of product.

Myth: Across the board cuts are the fairest and surest way to reduce costs

Reality:  Cutting costs at the constraint and choking the constraint will reduce the overall throughput of the system and hurt business.  It is far better to invest in protecting your constraint while cutting expenses dedicated to non-constraints.  Protecting the constraint also means having a buffer before and after the constraint.  Unless you know what these are, you really can't just cut across the board and know if you're helping or hurting your business.

Myth: By inspecting early and often, we eliminate defective product while its unit costs are still cheap.

Reality: Units have no value to a customer until they are usable finished units.   you cannot inspect quality in, you must build it in.  Having a reliable lean process, with small lot sizes, the units will travel quickly to their finished stage, at which time defects and corrective action can be put in place.  Frequent inspections, on the other hand, actually slow the process and may also interfere with the quality feedback loop.

Myth: You must first eliminate the "rocks" before lowering the water level.

Reality: Many so-called "rocks" are mirages of light distorted by excess inventory.  Until you reduce lot sizes and WIP inventory, you won't see your real inefficiencies.

Myth: Let's lean each area individually and later connect them.

Reality: Efficiencies at a non-constraint are a mirage.  Unless you view the entire process and identify the constraint, you may actually end up hurting the process.

So, how do you really cut costs:

(1) First and foremost, you need to reduce your lot size.    I don't know your product, so I don't know what is a good lot size.  As a rule of thumb, you should be able to complete an entire lot in a few hours or at least within a day.   If it takes longer, you may have lot sizes that are too large.  There are exceptions, but we know how to deal with those.  

(2) Once you have lowered your lot size, the true constraint(s) in your process will become obvious.  Apply TOC to protect the constraint.  Everything else that is not a constraint or a buffer to protect the constraint is fair game for cutting operating expenses - or eliminating altogether.

(3) Do not be afraid of "lowering the water level."  If you approach it carefully and truly engage the problem, the answers will reveal themselves.  There is always a way to "remove the rocks" or at least minimize their effect.

Controversial?  Yes, but if there is a time to shed cost-sapping myths, that time is now.

Did I step on some toes?  Probably.  But unless we want to see our jobs exported, or eliminated, we must begin to challenge these myths and become truly lean.  The biggest obstacle to a lean transformation is not found in our production floor, but in the way we think and in the myths we continue to embrace.

Lean isn't a luxury, it is a necessity.  We either believe in it or we don't.  If we REALLY want to cut costs, its time to stop the posturing and really get to the heart of the matter.

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