Category: Quality Control

What does “quality” mean?

The question of how quality is defined remains subjective, although a variety of definitions are commonly accepted. An older post reached out to our team and asked how they know quality when they see it.  Pro QC’s Managing Director was quoted as describing quality as… ‘When I think of quality, an old quote that we used to use as  kind of our slogan comes to mind: “Quality is consistent performance to clients’ expectations. To me, repeatability is quality.”

Ask us: The 5W1H of Product Quality Control

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 Why and When And How and Where and Who. Using 5W1H, we have developed a list of the most common questions we receive from inquiries regarding their product quality control initiatives.  Ask us for more information, and let us know if you have any questions …

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 around the world. 1 – Audit Potential & Existing Suppliers  To help ensure that potential or existing suppliers deliver high-quality products, operate efficiently, and support continuous improvement, process surveys and factory audits are performed. From supplier capability and qualification to process control and quality system …

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

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 processes (CGMP’s) also known as FDA 21 CFR Part 820.  FDA’s Quality System Regulation Part 820 is harmonized with ISO 13485:1996, which is based on ISO 9001:1994. According to the FDA, “The QS regulation applies to finished device manufacturers who intend to commercially distribute medical …

Engineers Week – Making a Difference

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 QC, our quality engineers are at the heart of our organization.  Mechanical, electrical, environmental and a host of other specialities are all necessary to sustain our successful global team of quality experts. The Discover Engineering website describes engineers as people who…