Setting and Measuring Quality Objectives

Duration: 90 Minutes
The Quality Objectives, derived from the Quality Policy, must be measurable. Good metrics have characteristics that make them clear and understandable. This presentation describes three types of metrics, illustrates how to use them for the Quality Objectives, and provides examples developed using Excel. One of the metric types, related to cycle time, has a particularly interesting graph type available in Excel.
Measuring Quality Objectives
Instructor: Daniel O'Leary
Product ID: 501634
One of the most important communication elements for a Quality Management System (QMS) is the Quality Policy and Quality Objectives. Together, they set the company's direction and help demonstrate the most essential quality aspects from management. In addition, implementation is a QMS requirement from FDA's QSR, ISO 13485:2003, and ISO 13485:2016.

Poor implementation can both diminish communication and create problems with regulators. A well-structured Quality Policy, with the required elements, provides the framework for the Quality Objectives. In QSR, the policy and objectives become part of the Quality System Record.

Management reviews the policy and objectives on a regular basis. The standard approach includes this as an element in the Management Review.

Objectives of the Presentation
  • Explain the QSR requirements for the Quality Policy and Quality Objectives
  • Describe the methods an FDA Investigator uses to verify compliance
  • Identify the additional requirements from ISO 13485:2003 and from ISO 13485:2016
  • Provide example for Quality Policies illustrating the requirements
  • Describe the methods to develop Quality Objectives from the Quality Policy
  • Provide a description of the three types of metrics
  • Show how to use Excel to develop a graphical approach to the metrics
Why Should you Attend
Medical device manufacturers have received Warning Letters for not implementing or communicating the Quality Policy and Quality Objectives. In addition, management can set the quality expectations and continuous improvement intentions through these management tools. Attending this presentation provides the tools and knowledge to develop an effective program.

Who will Benefit
The presentation focuses on the Quality Policy, the Quality Objectives, and the associated metrics. This is of particular interest to:
  • Quality Managers
  • Management Representatives
  • Management Review attendees
  • Managers of QMS processes
  • Continuous Improvement Specialists
  • Quality Engineers
  • Production Managers
Bonus Material
A checklist to help ensure your system is prepared for your next FDA Inspection or Notified Body audit.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
View More