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Blog

Moving the Goalposts?

By John Henchion, April 5, 2018

Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?

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In Honor of International Women's Day: An Open Letter to my Most Inspirational Colleague

By Sarah Patterson, March 7, 2018

Have I ever told you how much I want to be just like you? I am so thankful for the opportunity to work alongside the ultimate colleague, mother, friend, partner, and party guest. You teach me to strive for the things I’ve always dreamt of and only focus on the things that actually matter. From the moment I met you, I looked up at you as a role model.

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Performance Improvement Strategies that WORK

By Daisy Chew, March 6, 2018

How Key Performer Interviews can help determine root causes for your performance issues and help you develop intentional improvement strategies that work.

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In Review: Facilities of the Future Conference

By Robert Chew, February 27, 2018

ISPE held its second Facilities of the Future conference.  The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators.  Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.  

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Data Centers are Constantly Evolving

By Jennifer Lauria Clark, February 7, 2018

Growing up, we did not have a home computer in my family until I was 11 years old. We were fortunate enough that my momma brought home an Apple desktop over the summer; my sister and I dedicated all of our computer time to Oregon Train and Number Munchers. (“Like” this post if you remember those games on 3.5 x 5 floppy disks!)

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The Low Down on a New Packaging Serialization Standard

By John Hannon, January 4, 2018

Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November 2017. This group, known as the Open Serialization Communication Standard Group (Open-SCS), advocates that PSS 1.0 minimizes customization of plant-to-enterprise interfaces (Levels 3 and 4), thereby shortening the integration process by months and improving scalability and repeatability.

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Training [Usually] Isn't the Answer

By Daisy Chew, December 5, 2017

How a knee jerk reaction can waste time, money, and leave the problem unsolved.

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Part 3 of 3: Applying Six Sigma Principles to Client Operations: The Voice of the Customer

By John Krawczyk, December 1, 2017

What is the “Voice of The Customer”? Is it only external customers? The end users? What about internal customers? Do they have a “voice” as well? Who are the “Customers” anyway?

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Part 2 of 3: Applying Six Sigma Principles to Client Operations: Waste

By John Krawczyk, November 30, 2017

Waste shows up in many forms and in all projects. This happens regardless of industry, product, or service being provided. Nothing is perfect, no matter how hard we try. That doesn’t mean that the effort to reduce waste is for nothing. Anytime waste can be removed from a product or process is a plus regardless of how big or small.

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Part 1 of 3: Applying Six Sigma Principles to Client Operations: The Cost of Poor Quality

By John Krawczyk, November 29, 2017

The principles and methodology of Six Sigma are applicable to multiple industries and processes. In all cases, the primary reason these principles are implemented is to eliminate errors, to the greatest extent possible, before they happen. The only way to accomplish this is by starting with an honest assessment of the process, locating the source of the error(s), and making needed correction(s) there. By implementing solutions upstream, where the errors occur, the client will realize much greater confidence in the quality of the final products being sent to the customer. The “quality” of the final product is what the customer is paying for. Quality in this case refers to: safety, price, availability, usefulness, and effectiveness in filling the need(s) that the customer has. All these requirements must be met for the product to be successful. If it’s not safe, why buy it? If it’s too costly or not available, alternatives will be found. If it’s not useful in solving the issue, the customer won’t want to pay for it. So, why buy it?

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How to Understand ASTM E2500