Tag Archive: audit

Jun
25

On-Site: What’s a C-TPAT Security Audit?

security-audit

I’ve recently returned from a visit to our offices in China where I was able to attend a C-TPAT audit with our Supplier Development Manager, Jean Champlain. A C-TPAT audit isn’t quite as common as a general QMS or ISO 9001 evaluation, but the information generated has significant value when you understand the scope. “C‐TPAT …

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May
28

When do you switch suppliers?

supplier-quality-devo

I’ve never heard the process of switching suppliers described as easy.  People may say that it “went smoothly” or “could have gone worse,” but the reality is that it’s not easy.  Because of this, many organizations delay the process and experience increased costs and consumer dissatisfaction as a result. Questions to consider: Do you know …

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Mar
27

Ask us: The 5W1H of Product Quality Control

5W1H_PQC_QC

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
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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