Category Archive: Uncategorized

Mar
27

Ask us: The 5W1H of Product Quality Control

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One of the most commonly used quality tools is 5W1H, “a method of asking questions about a process or a problem taken up for improvement.” This socratic questioning method is said to be rooted in Rudyard Kipling’s poem: I keep six faithful serving men (They taught me all I knew); Their names are What and …

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Mar
18

Five Ways to Ensure Quality Manufacturing – Sourcing Success

Whether you’re sourcing abroad, or from a manufacturer down the street, similar issues with product quality, shipment delays, cost and safety concerns, etc. still apply.  To mitigate the quality risks and cost involved in sourcing, we recommend five actions that have been proven successful throughout the three decades of experience we have working with clients and suppliers …

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Mar
12

Investing in Sustainability & Social Responsibility

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A recent TED Talk that caught our attention includes Chris McKnett making a solid case for investing in sustainability.  In fact, several TED related talks focus on this topic and do an exceptional job demonstrating the benefits of this long-term strategy. In McKnett’s talk, he highlights three additional components to sustainable investing that add to the …

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Mar
05

Are ISO 13485 and FDA 21 CFR Part 820 audits the same?

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Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.  A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. Food and Drug Administration regulates current good manufacturing …

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Feb
25

Engineers Week – Making a Difference

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This week recognizes engineers, and in support we are encouraging our partners and teams to share their experience, knowledge and passion with others. Engineers are changing the world all of the time. They dream up creative, practical solutions and work with other smart, inspiring people to invent, design, and create things that matter. At Pro …

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