Tag: audit
We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits. Who? Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform. Quality auditors must be professional, ethical and objective. They …
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 …
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 …
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); …
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 …
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 …
Our Tampa office worked with the local ASQ section and Hillsborough Community College’s Institute for Corporate and Continuing Education and coordinated and instructed a series of webinars that will run through this month. The webinar scheduled for today discusses Supply Chain Management, which many in our industry recognize is a …
