Tag: manufacturing

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

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:

Quantifying the Importance of Quality in 2015 (US Market)

Quality Magazine recently posted an article related to the importance of quality and other interesting observations regarding their 15th Annual Spending Survey.

The article indicates a positive increase in spending where quality is concerned, along with other key indicators showing support and acknowledgment of the importance of quality.  Two highlights worth noting include:

1) About half (49%) said the importance of quality has increased compared to a year ago.

Quality_Importance

2) The top three spending categories were general test, measurement and inspection equipment (69%); gages and gaging systems (65%); and test and inspection services (53%).

Global Supply Chains are Changing Fast & Creating New Quality Challenges

Our latest newsletter featured an article written by Pro QC’s VP/Americas, Michael L. Hetzel.  In the article, Michael expands on the ideas he presented in a recent interview with Awarely regarding trends in logistics and supply.  The original article is posted below.
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“Finally, product simplification/modularization/mass customization will dictate short supply chains and inventory reductions. Manufacturing in proximity to each market becomes the lowest cost option.”
The above quote is from an article I wrote that was published in the January-February, 2007, issue of Mexico Now magazine, titled; ‘Avoid Strategic Overshoot©: Consider All Elements Before Moving Production Outside the U.S.’ This has been a theme in my articles and lectures ever since.

It took a while for the trend to accelerate and gain prominence, but this prediction is coming true at an increasingly rapid pace and getting catchy names like “reshoring” and “nearshoring” from the pundits.

Simplified 5S: What is it & why is it important?

a-place-for-everything

What is 5S?

5S is a lean manufacturing approach to “A place for everything, and everything in its place” based on the Toyota Production System.

Qualitymanagement has compiled definitions from a variety of sources worth referencing here:

1. 5S definition of Wikipedia.com

Sort, straighten, shine, standardize, sustain: a workplace discipline used to ensure reliable work practices and a clean working environment, now used in the West but originally from Japan.

2. 5S definition of Thequalityportal.com

Seiri (sort), Seiton (set in order), Seiso (shine), Seiketsu (standardize), Shitsuke (sustain); application in manufacturing, in office.