Equipment Calibration in FDA QSR - Regulations and Warning Letters

Why Should You Attend:

Managing your calibration program is a key element in delivering good products and services. You must satisfy the QMS requirements but first you need to understand them. You need to know when a piece of equipment needs to be in the calibration recall program and when you can identify it as “no calibration required”.

Your Quality Management System (QMS) should be able to address these questions about your Inspection, Testing, and Measurement (IM&TE). If not, then your team needs to attend this webinar!

• Is your IM&TE suitable for its intended purposes and is capable of producing valid results?
• Do you have procedures for handling, preservation, and storage of IM&TE?
• Do you understand the meaning of accuracy and precision?
• Have you established remedial actions when the equipment doesn't meet limits for accuracy and precision?
• Do your calibration records include the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date?

This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The webinar defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability. With these concepts in hand, the webinar moves to an analysis of FDA requirements and ISO 13485 requirements.

Areas Covered in the Seminar:

• Metrology requirements of FDA QSR.
• Metrology requirements of ISO 13485 and ISO 9001.
• Understanding metrology terms.
  • Accuracy
  • Precision
  • Traceability
• Chapter 7 of the FDA's Quality Systems Manual.
• ISO 10012:2003 requirements.

Who Will Benefit:

This seminar is for people involved in the metrological aspects of medical device manufacturing and design. The principles are larger in scope than medical devices, and apply to all manufacturing processes. Attendees should understand the concepts of manufacturing processes from the design or production view.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Professionals
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners

Instructor Profile:

Daniel O'Leary, 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 holds an APICS certification in Resource Management.

Topic Background:

Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72, while the ISO 13485 requirements are in Clause 7.6.

Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to understanding accuracy and precision.

The FDA issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations.

ISO 10012:2003 Measurement management systems – Requirements for measurement processes and measuring equipment, a document in the ISO 9000 family, specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.

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