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Pharmaceutical Quality: Our Platform's Not Burning, It's Leaking!

William Botha, Sensei, Interlean
Monday, February 25, 2013 00:05 EST

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ALM at Global B2B
ALM at Global B2B  
6/14/2013 9:45:09 AM
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lean in Japan
This commemoration of Japanese pharma in today's news--

http://www.kantei.go.jp/foreign/96_abe/actions/201306/09yakuzaishikai_e.html

makes me wonder if in the land where spc and kaizen etc were born that pharma industriy is somehow ahead ?  Does anyone have data on this?

Jack Carroll
Jack Carroll  
3/3/2013 3:13:36 PM
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Re: Change needed, but lean is difficult
Girish,

Sorry for the late reply. I think that you have captured the QbD situation so well that I plan to use it in my upcoming QbD/Analytical Technology course. Thank You!

William Botha
William Botha  
2/28/2013 11:12:57 AM
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Re: not for everyone, or everything
Hi Angelo,

I couldn't agree with you more about ill-informed novices trying to blindly install something they know very little about, even although they have attended a three-day workshop and are now allowed to term themselves some or other hue of belt.

However The Toyota Production System was an artifact of Toyota's need to satisfy their customer, who in their world is also the end-user.  They have proven to have done a great job at it, haven't they?  Their products have remained at the top of the automotive quality pile for a very, very long time.  This quality ascendency caught the attention of the American market which triggered the MIT team's mandate to find out how they are doing it, which in turn spawned Womack's book ("The Machine...") and the term 'Lean' was born.

Isn't regulations' mandate to try and ensure that the patient (end-user) is satisfied (protected)?  Why do we need this oversight?  Is it maybe because the industry lacked the quality 'temper' required to consistently produce safe products?

We could, of course, shutter our minds to the possibility of learning from anyone outside of our hallowed halls, but somehow it makes perfect sense to try and learn from others who have overcome similar quality issues.  Wouldn't the patient benefit?

I, and several other knowledgable, experienced and knowledgable leaders have deployed TPS/Lean very effectively in the cGMP realms and we don't have to 'imagine' it,  It is real, it is practical and it is effective.  Very, very effective to the tune of hundreds of millions of real dollars, and one hundred percent customer satisfaction indices in very short spaces of time.

angelodp
angelodp  
2/27/2013 8:50:41 AM
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not for everyone, or everything
Lean, etc. were originally designed for manufacturing that had little regulatory oversight. Imagine deploying them under GMPs ("No-one has suffered a viral illness after taking our product so let's cut out the virus filtration step"). These techniques show their weakness when lumped together under the label "operational excellence." In reality these OpEx initiatives take on a life of their own. I had a client who spent about $50,000 worth of company resources analyzing, identifying, blah-blah to iniitiate changes that any mid-level manager could have implemented in five minutes, and which resulted in a savings of $700 per year. ROI, anyone?

Paul Marshall
Paul Marshall  
2/26/2013 8:04:38 PM
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The principles work - but must encompass a culture
 

William has again distinguished himself as a true leader in this field.  The relentless pursuit of excellence works, but needs to be cultural.  It all fits - Quality Systems that people can work within, good CAPA and advance problem solving, eliminating waste in all 7 forms, drive variation down, establish EH&S systems based upon ISO 14000 and OHSAS continuous improvement, value improvements, yield improvements. The word is Relentless.  It's a frame of mind.  Processes, systems, etc... must work every time.  If they don't, people need empowerment, a management expectation AND an improvement program to work within to constantly make it better. It can and has been done in our industry but only in small nuclear plants or working groups.  If it's not a "flavor of the month" but rather an expectation of "how to do business", a business can thrive.

Hedley Rees
Hedley Rees  
2/26/2013 10:30:34 AM
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Lean has been totally misunderstood by the West...
I think it is helpful to set aside the T = Toyota and focus on the words 'production' and 'system'. In fact, there is historical evidence that the Japanese phenominum emerged from Industrial Engineering's (IE) focus on improving production systems. Deming's SPC and approach to variation elimination came from IE and techniques such as 5 S were based on the work of the Gilbreth's (famous IE's) and their Therbligs. Similarly the 7 production wastes.

IE looks at complex, interrelated systems bringing products to market. It doesn't matter what you are making. If you have people using equipment, facilities and other assets to bring products to customer markets, it is the same. So call it what you will, the production system approach is absolutely applicable in Pharma......

...just the West has converted it all erroneously, firstly into JIT, then Lean and now Lean six sigma....andf the reason why Toyota, Nissan, Honda, Matsuishita were all masters of production systems? Because the executive leaders lived and breathed it.....and tha's what it needs in Pharma - IMHO

 

Bikash Chatterjee
Bikash Chatterjee  
2/26/2013 4:02:31 AM
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Re: Change needed, but lean is difficult
As a lean practitioner and SSMBB I must say that lean and Six Sigma can be very successful in the Pharma enviroinment if properly deployed. Unlike industrial industries, the quality and regulatory constraints of improvemnt must be defined in the chartering phase of lean exercise. Couplingthese withe entitlement opportunity will ensure that the objectives are consistant with the business needs of the organization. The projects where we have been most successful with Lean have been in the laboratory where assay velocity through the lab can be controlled and measured, reduction in the clinical supply chain timeline and in the pilot plant operations with their constanytly changing demands can also benefit from basic Kazen and 5S activities.  In terms of the CAPA discussion I have never run into an organization that willfully tried to delay a CAPA investigation. In fact most organizations (including hte ones you mentioned) have metrics they ar emeasured by against pother manufacturing sites in terms of CAPA closures and Deviation closures. The problem more often is, the investigation is poorly conducted and the CAPA reoccurs. I can understand the perception of delay as often the CA for the CAPA requires a change control to implement and most pharma companies change control systems are broken. We should not abandon the basic principles of lean as unimplementable. It requires a solid understanding of compliance as a predicate component to improvement but within this construct Lean can be very effective.

William Botha
William Botha  
2/25/2013 6:10:46 PM
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Re: Change needed, but lean is difficult
Hi Jayvee, and Rodney,

Thanks for sharing your concerns and views on the post - it is always refreshing to hear from edcuated and interested industry leaders.

Could you illustrate why there would be a concern with the speed of a CAPA response, or the validity of a proper TPS/Lean approach to the Quality Systems of a cGMP manufacturer?

I have in the past encountered the 'mindset' that slow is somehow better and with a little digging have found that what is being sought is actually a rigorous, effective, methodical approach, which is both fair and reasonable.  Well, most leaders are fine with that as long as the time taken does not include idle time.

CAPA demands an immediate corrective action - so speed is of the essence in that step, no?  An example may be to stop the process.  This immediate corrective action must be followed up with a corrective action such as quarantining those lots that have passed through that machine since the last validation or maintenance.  This also needs to be done fast, so that your company doesn't waste more input on a product that may no tmake it to market, or contaminate machinery downstream.  Aren't these drilled actions that require standard work so that mistakes are not made in the lot tracking tree?

What needs thorough analysis and deliberation is the preventative action phase where we need to find a way or ways to prevent a recurrence of the deviation.  And who says that needs to take months?

How long does it take to visit the gemba and observe the facts and interview the staff who were involved in the process?  How long does it take to get a sample tested - the longest one I am aware of is a mere 14 days.

The misconception about the PDCA (Shewhart) cycle is this;  that it starts with a Plan.  Not always true, and in the case of CAPA is never true! 

CAPA starts the PDCA cycle with the discovery of a deviation in the CHECK phase of the cycle.  You then ADJUST with immediate and normal corrective actions and then you PLAN to prevent the reoccurrence of the event using the most appropriate methodology; Six Sigma if its a yield issue or TPS/Lean if someone mixed up the hoses on the tank!  TPS/Lean has a specific concept to assist you in this team problemsolving phase - it's called Jishuken!

Finally you wrap up this cycle with DO; you rewrite the SOP, train, practice and install the new practice.  And you continue the performance management cycle by CHECKing the numbers again!  So it is the CAPD cycle, not the PDCA cycle!

One way to address the risk-aversion of senior leadership teams to TPS/Lean is education.  TPS/Lean has worked miracles for senior leadership teams who have immersed themselves in it, and have committed to its delivery. 

"One learns by doing the thing, for though you think you know it, you have no certainty till you try."  Sophocles 470 BC

Girish Malhotra
Girish Malhotra  
2/25/2013 5:04:20 PM
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Re: Change needed, but lean is difficult
Jack:

Some one had to sell the elixir as the cure all for every ill. Well without having the understanding of cause and effect no one tweaked the elxir. Poor patient is still sick and needs help. We have the knowledge to cure the disesae but are stll focued on the elixir. 

Jayvee
Jayvee  
2/25/2013 5:00:12 PM
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Re: Change needed, but lean is difficult
Well put, Rodney. I agree, entirely.

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