Tag: audit

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)

ISO 13485:201X Preparation (Medical Device Audits)

iso13485ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.”

Every few years, ISO issues standard revisions with 13485 originally scheduled for release this year.  However, due to the high volume of comments received by the ISO Technical Committee, the 13485 revision is planned for early 2016. It is currently referred to as ISO 13485:201X, or DIS (Draft in Standard).

The proposed revisions are significant, and it is important for medical device organizations to start preparing now.  Three changes that are speculated include:

1) Due to to the increasing complexity of the international regulatory environment for medical devices, it is expected that ISO 13485:201X will incorporate EN ISO 13485:2012 elements and reflect more current requirements by the EU.

How well are your suppliers performing?

03b46b56-b77c-4008-9e90-9ad4cfd1f3cfIn a recent post, we discussed several New Year’s goals that we frequently hear from clients and prospects around this time of year.  One of the most common is evaluating and improving supplier performance.

We know that suppliers may appear qualified at first and then fail to deliver the required quality after time and money have been invested in project development. Other suppliers have many of the desired capabilities for your projects but are inconsistent in quality and performance. Supplier switching costs can be very high and risks to quality and delivery unacceptable.

Juran describes the process of supplier evaluation as:

  • The evaluation of product samples
  • The evaluation of the supplier’s manufacturing process

So, how well are your suppliers performing?