Tag: audit

When do you switch suppliers?

supplier-quality-devoI’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:

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

Supply Chain Management – Webinar Review

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 broad topic. As a brief introduction, the following components are discussed:

Supplier Selection

  • Conduct a needs analysis (brainstorm and consider long-term growth expectations).
  • Conduct preliminary interviews and/or surveys.
  • Evaluate samples.
  • Perform on-site audits (general quality systems management, ISO based, social responsibility, security, etc.).
  • Use a grid analysis for objective decision making.

Supplier Evaluation (Performance)