You Can be Great If You Really Want To

Life science companies experience no lack of quality system ideas, quality system conversation, quality system arguments, quality system implementation methods, etc.

After all, even the required systems of quality management such as the FDA’s GMP, GCP and GLP regulations and guidelines are specified to a certain extent but still don’t determine all of the whens, hows, whys and whats of in-house quality system management. As a result, life science companies are left with a few decisions to make:

1) On what system(s) should a quality system be based?

2) How will the quality system’s data be managed?

3) How will the quality system’s documentation be managed?

4) What will be the KPIs (key performance indicators) of the quality system?

5) How will a need for improvement be justified?

Note: The first of these questions will be the focus of this article although questions #2 and #3 will also be discussed as auxiliaries to discussion regarding #1.

What Quality System is the Right Quality System?

First of all, it is essential for life science companies to realize that every quality system is nothing more than stated limits of discipline and a successful quality system is made of stated limits of discipline that are followed. Those stated limits of discipline however must originate from a specific mentality or template for a “starter quality system.” The quality system that a life science company selects will of course continue to evolve but upon the initiation of a new or revised quality system it is important to choose the “quality system mentality” best suited to any given company.

This can be difficult.

After all, some say lean manufacturing must be adhered to; others vouch for PAT and still others Six Sigma. Some say a combination of these systems work best and all of them are probably (at best) only partially right. So, how will pharmaceutical companies make the best decision for the unique needs of their own company?

Could Six Sigma be the right starter quality system?

This article posits the idea that as a starter quality system, Six Sigma is ideal for the pharmaceutical industry. This position does not exclude lean manufacturing or PAT systems of management, but instead recommends Six Sigma as the initial system of practice. Why? For starters, Six Sigma ideals are based on intense statistical analysis and serious data collection, and the pharmaceutical industry just happens to have colossal amounts of data and documentation. This data and documentation, with the appropriate amount of time, could be analyzed according to Six Sigma methods and then used to adjust less-than-stellar aspects of the quality system. The Six Sigma system also focuses on the near obliteration of deviation or nonconformance events which for pharmaceutical companies falls exactly into line with regulatory standards and quality management goals.

Easier Said Than Done

Any reader may easily volley this article’s position by stating that Six Sigma is difficult to implement and that most pharmaceutical companies don’t want to change anyways. According to an online source1 however the benefits of making the right changes within the very wealthy pharmaceutical industry are staggering. The online article states that “the potential worldwide cost savings from efficiency improvement could be as high as $90 billion.” This article still acknowledges however that the reader is correct in saying that Six Sigma is difficult to implement; Six Sigma implementation requires know-how and the appropriate instrumentation. That know-how and instrumentation will vary greatly since it is likely that a very small percentage of Six Sigma black belts would be even remotely qualified to cross the pharmaceutical threshold (an intelligent in-house manager might do well simply studying up on Six Sigma principles).

Six Sigma tools may vary as well. After all, the “Six Sigma mentality” doesn’t specify tools (the Six Sigma calculator wouldn’t necessarily even be a required purchase) but does specify the principles of data collection, analysis and a decrease in deviation.

What tools can be used for the implementation of Six Sigma?

A vast variety of software solutions might be able to help provide the needed Six Sigma success but should be chosen carefully. For most pharmaceutical companies it seems likely that management tools/software for data collection (data and document management software) and tools for any type of deviations or nonconformance management could be valuable. Since small amounts of deviation usually depend on the speed of information distribution within a company (although even that assumption could be subjected to Six Sigma analysis), an automated training solution triggered by changes in SOPs, work instructions, etc. might also be of great value.

Conclusion

Essentially the keys of Six Sigma are rigorous data collection, analysis and a decrease in deviation, principles which would seem to attract the naturally rigorous pharmaceutical industry.

1 http://www.contractpharma.com/articles/2007/10/lean-practices-in-a-life-sciences-organization

Related Blogs

• 75 PR/Article Submission Sites to Generate Inbound Links | Search Engine Journal
• Article: The Use Of Handheld Mobile Devices: Their Impact And Implications For Library Services « ResourceShelf
• A Designer’s Article Marketing Menu | Unmatched Style

Signum is really a relatively simple, but high tech solution, that the client can set up for live production quickly and after just five days, the client can be in position to achieve almost instant ROI through efficient application of real time supply chain collaboration and consumption-based replenishment.  Clients use the Datacraft Solutions’ SaaS tool for reliable and cost effective communication of the demand to suppliers and can receive the same pull-based usage from their customers.  Signum has an array of features and functions that can be used in an assortment of combinations that lead to very creative application to the particular challenges that face our customers who represent diverse industries.

Ron Van Nostrand, CPIM, MBA, is the Services Project Manager for Datacraft Solutions.  According to Van Nostrand, “Companies with lean initiatives move from card kanban to e-kanban and the impact on their enterprise is dramatic.” Van Nostrand addresses the specific benefits of moving to an electronic or digital kanban environment.

Signum automates the administration and execution of electronic replenishment to reduce overhead costs for key operations personnel and to improve supply chain collaboration across a client’s supply network
Signum enable suppliers to gain visibility to our client on-hand inventory and consumption of their products which enables them to accurately anticipate the requirements of our clients (key to improving supplier on-time delivery performance and order fill rates)
In some cases, clients have realized reductions in inventory and the occurrence of inventory stock-outs far exceeding their wildest hopes
Clients have used the additional purchasing resource time freed up by Signum to embark on strategic purchasing initiatives including formal supplier development programs

Datacraft Solutions (www.datacraftsolutions.com) delivers a revolutionary digital kanban process of automation solutions to lean manufacturers through a secure Internet gateway, eliminating the need to install and maintain a complex IT infrastructure. The company has experienced significant growth in the past two years by eliminating complicated, expensive, time-intensive software implementations as well as extensive training regimens and the need for internal support. Datacraft Solutions’ replenishment supply chain digital kanban system allows customers to access and utilize powerful lean benefits immediately for a low, predictable monthly fee. Services are scalable so manufacturers can design an appropriate digital kanban solution.

Datacraft Solutions

www.datacraftsolutions.com

Sonja Foust

sfoust@datacraftsolutions.net

800-819-5326

We live in paradoxical times…at the same time our country has been instilled with a new sense of hope; every day we hear more bad news of our growing economic downturn. If we have not lost a job or a retirement plan, we know someone who has. We try to be optimistic but many of us feel a growing sense of anxiety as we wonder what will happen next. Some of us even wonder whether we, our loved ones, or even our country will survive.

Several years ago, on a trip to Chicago, I went to a jazz club where I listened to a very good band. One particular song caught my attention. It was called System of Survival. Besides getting my dancing feet going, the song really got me thinking.

Do we each have a System of Survival?

Is it intuitive or learned?

Can we put it in place before we need it?

I believe that we each have our own System of Survival. We use it intuitively and we learn new ways to survive each time life presents us with a new use for it. From experience, I know you can put your system in place before you need it and that it’s worth the effort to do so.

Survival – I don’t usually use that term. While to survive emotionally is a positive experience, just surviving doesn’t seem good enough to me. Realistically though, I know that there are times when all we can do is survive the moment. We each have our own unique system to do so. Depending upon our life circumstances, many of us have used it often. At some point, we all will have a use for one. It makes sense to me to take some time now to examine your own System of Survival. After doing so you could decide whether you have the necessary means to put it in place when it is needed and ascertain whether you need to develop it further.

I’ll give you a few examples from my system (in no particular order) to get you thinking about yours:

Friends and Family – I’ve learned through the many crises I’ve experienced that friends and family are imperative to survival. My first husband died after six years of illness. You can be sure there were many crises during that period. I don’t know what I would have done had I not had several best friends, many good friends, and my extended family to count on. As I examine the shape of my present System of Survival, I realize that this area needs some work. I remarried and moved to the Kansas City area several years ago. While the friends of my past are still in my life, because of work and school, I’ve yet to develop the Kansas City friendships necessary for my system to work. This is something that needs my attention.

Faith – Each of us has our own spiritual and/or religious beliefs. What works for me may not even make sense to someone else. It is important to me to have a clear understanding of my beliefs so that I can take comfort in them when necessary. There is nothing like a crisis to shake the very foundation your beliefs are built upon. The more you have knowledge of them, the easier they are to rely on. There have been times in my life when I’ve been in the questioning mode. I’ve learned that for me that is good and that even the questioning keeps me in touch with my spiritual self. The more I’m in touch, the more my faith is there for me when I need it.

Appreciation – My life motto is, Make the Moment Count. I take it very seriously (in a fun kind of way!) My System of Survival requires me to store up a backlog of magical moments because I know there are times when life isn’t so magical. During those hard times, I can feel confident that not only did I appreciate the good times in the past, but I can also use those memories to get me through the bad. The way I make the moment count is I make a conscious effort to put myself in situations that have the best possible chance of providing one of those magical moments. When I do experience one, I purposely choose to not only acknowledge my gratitude but to build a memory.

A quick example: During the trip to Chicago I mentioned above, I had my first opportunity to goon a sailboat. It was some sailboat too! It looked like a modern day tall ship. The captain used an engine to get us out into the lake. When he and his crew unfurled the sails, he turned off the motor. That first moment when the wind filled the sails was magical! Without getting too poetic, I can tell you that the sun, cloudless blue sky, cool breeze, silence, and floating sensation of sailing brought tears to my eyes. It also gave me another magical moment to savor and save.

Stress Management – My System of Survival is dependent on stress management techniques that work for me. I’ve learned through the years which ones I can depend on and how to push myself to use them. I know that listening to music can change my mood, talking out loud to myself keep away the scary mind talk, moving around gives me an outlet for the extra adrenalin, and crying releases my tension.

There are plenty more things in my System of Survival. What about yours? I encourage you to set aside some time to take an inventory of your own survival techniques. By taking my inventory, I now know that there are things I must put in place to be ready for the next crisis. Even in my busy everyday life, I know I must make my system a priority. I can’t imagine how I would function in crisis without it.

Sometimes people in crisis feel hopeless, powerless, depressed, or even have panic attacks. If this happens to you, it may help if you seek out a qualified counselor or psychotherapist who can help you figure out your system. Seeking counseling does not mean you are crazy or have a mental illness. In fact, seeking counseling or therapy is an example of a healthy behavior.