Six Sigma Methodologies—Part2

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DMAIC (Define, Measure, Analysis, Improve, and Control) method

As I introduced with two basic methods of Six Sigma, with very simple example I will explain the difference between the two.

If you want to prepare TEA but you don't know how to prepare then how you proceed this is given by DMADV method and if you know how to prepare TEA but you are not able to prepare good quality TEA (or you want to improve the quality of TEA) then which way you should proceed this is given by DMAIC method.

Six Sigma method deals with a strategy of Customer origin to customer end. Means, process starts from customer and ends with customer.

First step of DMAIC1-3 method is define the improvement in the existing process which should be able to reach the satisfactory level of customer as well as compatible enough for manufacturers in all aspects.

What one should define????

Customer is the best source from where one can take practical problems associated with the existing method. This can be taken by identification of customer of interest (means group of customers which can give proper information)

E.g. In General, if you want the information regarding any pharmacy college, best information you can get from students, staff, other people working in near premises or pharmacy related people studying or working nearby area or other pharmacy college and not from any engineering or B. Sc. Student studying elsewhere. So, identification of proper source is most important step in Defining, followed by taking opinion or suggestions from customer (voice of customer), identify some critical and important parameters or suggestions. After collection, then chart out points of improvement in process by considering some previous cases as well as some other similar cases and objective behind the process, and then figure it out time duration and financial details. By this way you have to define some above mentioned parameters for process.

Measure step comes thereafter. Here we have to start developing system for our process by study deeper to component level from system level.

E.g. As our drug delivery system going more and more specific day by day, if you take an example of vaccines initially (first generation) developed by using whole microorganisms either dead or alive then in second generation use of some components out of total microorganisms which required had been used for development and now third generation vaccine can be developed by using only protein/peptide/ DNA/ RNA etc only.

What I wish to tell you, measure step involves the study where step by step one will determine specific thing which should be modified or point where one should focus.

Data which has been collected (either in continuous or discrete form) from this study should be analyse for compatibility and capability of process.

Analysis is always an interesting and important step for every process........... As in our pharmaceuticals we verify the how our modification in process works out? We are checking the relationship between the modification done and improvements in process along with other risk factors like impurity and else. Similarly, in this step we have to verify and validate the relationship between cause and effect, means whether different factors under consideration of improvement of process are co relating properly with each other or not, if they are deviating, how much extent? What are the risks associated with the factors or process as a whole, how far this process is capable of meeting goal etc should be estimated.

Improve step is have its own importance like you know about FIVE PANDAVAS; everyone has its own characteristic feature (Yudhistir: A symbol of truth, bheema: had power of 100 elephants, Arjuna: finest archer and very keen learner; best student, Nakula: extremely handsome and intelligent too and Sehdeva: excellent swordman).

Here we are validating the every important parameter which is considered during previous steps for their applicability and consistency. One can use various experimental designing methods for validation and simultaneously find out the further required improvement. Improvements also have been done whatever maximum extent possible in this step. In this step, your improved process is ready but one more thing is remaining there............... ......

That is control, as an extremely fast horse if not in control, will not able to win race. Similar manner, if developed process is not in a perfect control will not produce fruitful results. As six sigma process eliminate defect, this step check the capability of process to give defect free product.

This is an overview of DMAIC method. In this method, various statistical and logistic tools are been used in every step which I didn't include because each and every tool, one has to study separately. As a primer of six sigma first one should have basic idea.

References:

  1. Nunnally BK, McConnell JS. six sigma in the pharmaceutical industry. CRC press, London. 2007: 154-161.

This blog does not contain any plagiarized matter

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About the Author

Amol Malpani's picture
Author: Amol Malpani

Comments

TK Indira's picture

Very well explained in a simple way.Good work.

T.K. Indira. http://www.pharmainfo.net/tkindira

-- "Our greatest glory is not in never falling, but in rising every time we fall..." Team 'Char'minar.

Amol Malpani's picture

Dear Indira, Thanks a lot for your kind support and comments. Regards,

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