Written by admin on 07 January 2010
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
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Tags: Fda, Gcp, Glp, Gmp, Lean Manufacturing, Life Science Companies, Pharmaceutical, quality system, Six Sigma, Six Sigma Tools
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Written by admin on 04 January 2010
Medical device companies manage their respective quality systems not with the goal of “staying busy” but with the ideal of producing high-quality, innovative products that don’t jettison a trail of product recalls and process deviations along the way. Every medical device designer, manufacturer or quality control representative would likely agree that medical device companies should standardize a process that gives birth to high quality products and simultaneously attacks every deviation, nonconformance or customer complaint with the speed and vigor of Spartan warriors.
Simple enough?
It would seem so but even with all the combined brain talent of designers, manufacturers and quality control personnel this ideal bionic process still seems like nothing more than a medical device nirvana. In fact, current quality system management habits within most medical device companies emulate Isaac Newton’s first law by remaining “in a state of uniform motion…unless an external force is applied…”1The External Force for Medical Device Quality Systems
The external force that should be applied to most medical device quality systems is the force that is inevitably required by almost every industry. That force is technology. The right technology can help medical device companies create the streamlined and automated quality system processes that WON’T vary under any circumstances unless confirmed and logical data points to evidence-based deviations, nonconformances, customer complaints, etc.
That’s one reason for medical device companies to start automating their quality systems with the right quality system management technology. Listed below are 4 more:#2: The FDA is Moving along the Automation Pathway
Let’s face it. The FDA rules the U.S. regulatory roost and every medical device company that wants to produce or sell products in the U.S. has to conform to its quality system regulations. Conforming with FDA regulations becomes easier when FDA requirements are duly anticipated by medical device companies. For example, a recent FDA News bulletin states that, “FDA-mandated electronic Medical Device Reporting (eMDR) could happen in a soon as 18 months,” which means that medical device submissions will soon have to be submitted electronically and medical device submissions are far easier to submit electronically when they are consistently managed electronically with an automated quality system solution.#3: Decrease Quality System Breakdowns
George Bernard Shaw once said that “The problem with communication … is the illusion that it has been accomplished.”3 The illusion that information is being communicated or that employee morale is “fine” is often the sign of communication breakdown. Communication breakdowns are catalyzed by tedious paper-based routing procedures, capsulated quality processes that disconnect product lifecycles, customer complaints that never reach the investigations department, approvals that are too numerous to complete quickly, possible deviations that can’t be backed with proof, etc., etc.
Once medical device companies automate document control, information routing, approvals, quality data connections (customer complaints to CAPA investigations, etc.) and provide tracking and reporting features that help readily identify deviations and nonconformances, REAL communication suddenly engenders results—not illusions.#4: Uniting Quality Systems Across Geographic Barriers
When a medical device company begins to expand or continues to do so, automated software that is web-based becomes the pot of gold at the end of the rainbow. Web-based solutions for instance allow companies to expand on a national or global level and still stay abreast of salient information. Medical device companies (depending on their current situations) are also likely to benefit from a software provider that allows medical device companies to select from various networking options (shared licences, EFP replication, etc.).#5: Help Make Quality an Aspect of Every Department
For many medical device companies, quality system management is in the hands of the quality control team. Although this establishment of responsibility has worked in the past, quality system management now must move faster and more efficiently to meet increased demands for quality products. The truth is that much of a quality system can be managed bit by bit and employee by employee when training is automated and a quality management system (plus associated information) is available quickly for the right employees in the right departments.
Medical device companies also need to search for a training software solution that can be automatically triggered by essential document changes and that can control GLP, GCP and GMP training tasks (plus other training tasks) across a company wide spectrum.
Curt Porritt, VP of Marketing at MasterControl says the following in his article entitled Adopting Technology in the Life Science Industry: Why Is It Taking So Long? states and paraphrases the following:
“…according to Life Science Insights, an IDC company, over 60% of survey respondents cited GMP/GCP/GLP processes as the main driver for increased IT spending. In this same survey, 62% of respondents said they intended to spend more on electronic data integration tools. When asked why they intended to spend more, their main reasons (in the order cited) were: increased collaboration, regulatory compliance requirements, reduced time for one or more processes, and reduced costs for one or more processes.”5 Conclusion
Mary Collins, director of regulatory and industry relations for
Image Solutions Inc. says the following in regards to the implementation of electronic software solutions:“No matter how you get started [implementing electronic solutions], you [must] get started now. Over the next 10 years, you will see the different regions of the world come closer together and harmonize more on electronic requirements, and, to some extent, their regulatory requirements.” 4
For medical device companies, the advice remains the same. Staying connected with quality system technology will help med device companies keep pace with changing quality system standards.
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References
1 csep10.phys.utk.edu/astr161/lect/history/newton3laws.html (Retrieved Jan. 24, 2008)
2 FDA News email (Received Jan. 24, 2008)
3 wisdomquotes.com/cat_communication.html (Retrieved Jan. 24, 2008)
4 mastercontrol.com/newsletter/feature/adopting_technology_1007.html (Retrieved Jan. 24, 2008)
5 http://209.85.173.104/search?q=cache:4Vn3H0TV2O0J:www.parexel.com/pdfs/e-solutions%2520in%2520clinical%2520trials%2520-%2520R%26D%2520Directions%25207.07.pdf+E-Solutions+in+Clinical+Trials:+Digital+Dilemma+Michael+D.+Christel+pharmalive.com&hl=en&ct=clnk&cd=1&gl=us (Retrieved Jan. 24, 2008)
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Tags: customer complaint, Fda, medical device companies, nonconformance, process deviations, product recalls, quality control, quality system
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