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)

Leading Teams Effectively

1526430_840833672625817_5691307568455533697_nManaging teams is a core leadership subject within the CMQ/OE certification body of knowledge.  As a CMQ/OE and Education Chair of the local ASQ section in Tampa, Pro QC’s Communications Director recently instructed a webinar related to Leading Teams Effectively.  Similar training was also recently conducted for our team in China.  At Pro QC, we understand the benefits of effective teams as it relates to the delivery of value-added quality services that reduce our clients’ risks and cost.

With experience managing teams across 38 countries, our takeaways for managing effectively include:

The Right People – Selecting team members that have the right experience, skills and attitudes is critical.

Navigating Team Stages – Understand the five team development stages of forming, storming, norming and performing.  Leadership within each stage ensures smooth transitions and maximizes productivity throughout the process.

Approach to Problem Solving – Understand the team problem solving steps, but more specifically ensure that each team member is knowledgeable regarding quality tools that can be incorporated throughout the process. The Quality Toolbox is an invaluable resource here.

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:

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.

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%).