Quality Creates Perspective

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Audits in the Time of Coronavirus

Travel is restricted, companies have moved to virtual work wherever possible, and the world is attempting to maintain some normalcy in the face of a global pandemic. While the long-term economic impact on supply chains has yet to be seen, there is still an obligation on the part of companies to attempt to maintain supplier quality activities, especially audits.

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A Formula for Food Safety: HARPC = CCP + PRP + OPRP [Podcast]

There continue to be many questions around Hazard Analysis and Risk-based Preventive Controls (HARPC) and how a company’s food safety program will need to change to meet the new Food Safety Modernization Act (FSMA) requirements. Through FSMA, the FDA has basically stated that Prerequisite Program (PRPs) are now considered of equal importance as Critical Control Points (CCPs), clumping them all together and calling them preventive controls.

By ETQ on December 29, 2015
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3 Tips for Communicating Effectively with Your Suppliers (Podcast)

Communication…it is the key to all relationships. Good communication can inspire partnership and trust. Bad communication can result in confusion and doubt. How you communicate both in your personal and professional life will determine how successful you are. There are a number of examples of how businesses have crumbled due to bad communication. Therefore, it is critical to consider how you are communicating with your external partners such as suppliers, co-packers and vendors, to ensure mutually beneficial, trusting and successful partnerships.

By ETQ on March 31, 2015
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Risk Assessment: Creating a Risk Matrix

In this day and age, Risk is the biggest buzzword in the compliance industry.  We've talked about it, you can't go anywhere without hearing about it, and everyone's got a Risk-Based solution. We can no longer rely purely on "gut instinct" to execute on events, whether Quality, Financial, Social or similar areas.  The world moves too fast, and one misstep can make or break you as a business.  Risk provides the objective metric to help the decision-making process.  But, you need to know how to use risk.

By ETQ on March 4, 2011
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HACCP for Medical Device and Pharmaceuticals

I recently was speaking to a group of folks on the different ways to mitigate risk.  While this may not seem like "exciting" dialogue, it actually provoked an interesting thought - while many organizations interpret Risk factors differently, it seems that from one industry to the next, they tend to use a singular method.  One group uses FMEA exclusively, another uses HFACS or some human error risk, another uses HACCP, and so forth.

By ETQ on December 20, 2010
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