Category: Quality Control

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 to add.

5W1H_PQC_QC

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 audits, there are a wide range of options.

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 devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.”

CFR – Code of Federal Regulations Title 21

Engineers Week – Making a Difference

2015_Engineers Week_Horizontal

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…

What is APQP?

Advanced Product Quality Planning, APQP, exists to ensure suppliers and manufacturers produce products that meet or exceed customer expectations. It is considered a structured approach to the design and development of new products and manufacturing processes.

As part of Pro QC’s Supplier Development services, APQP incorporates the Deming Cycle, or PDCA.

Plan – Technology & Concept Development

Do – Product/Process Development & Prototype Development

Check – Confirmation Product & Validation Process

Act – Continuous Improvement

With APQP, upfront planning and output review work together to support continuous improvement. Suppliers understand the requirements of all parties, and an approved product design reflects this.

The process includes: