(QMS) Competence and Training Requirements per FDA QSR and ISO 13485

FDA QSR states, “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” The corresponding requirement in ISO 13485 and ISO 9001, says, “Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience”.

An FDA Inspection or a Notified Body audit will cover the methods you established to determine competency, evaluate employees, and take actions. All of these activities require objective evidence, in the form of records, to demonstrate your QMS operation.
The webinar helps you understand the requirements and provides methods to build an effective system. The presentation defines and explains the critical competency terms: education, training, skills, and experience. These terms apply to people who affect product conformity. The presenter will use FDA Warning Letters to illustrate many of the issues. This gives you an opportunity to learn from others, so your QMS will not have the same issues.

Why Should You Attend:

Your Quality Management System (QMS) should be able to address the following questions quickly and easily. If not, then your team needs to attend this webinar!

• Can you list the competency requirements, as an example, for your Management Representative?
• Have you documented the Management Representative's appointment and created records demonstrating the incumbent is competent?
• Can you demonstrate that employees who perform validated processes are aware of the defects and errors they could meet?
• Do your job descriptions include the four elements of competency?
• Can you demonstrate that each employee is competent, based on the job description?
• Can you describe how your company evaluates training effectiveness?

Learning Objectives:

1. State the four elements of competency.
2. State the definitions and the “official” sources.
3. Describe the contents of a job description.
4. Understand the elements of a competence gap analysis.
5. Describe the content of a training record and its relationship to competency.
6. Identify jobs with special competencies.
7. Understand the concept of a “designated individual” and the qualifications.
8. Describe the elements of a training program using the ISO 10015 model.
9. Explain how to evaluate and document training effectiveness.

Areas Covered in the Seminar:

• Understanding the four dimensions of competency
  • Education
  • Training
  • Background or skill
  • Experience
• The regulatory requirements
  • FDA's QSR (21 CFR §820.25)
  • ISO 13485 Clause 6.2.2
  • The preamble to QSR
  • The QSR Manual
  • ISO/TR 14969, the ISO 13485 guidance
• Developing the job description
  • Including the competency requirements
  • Other requirements such a OSHA
• Conducting the employee gap analysis
  • How to identify gaps
  • Documenting you findings
• Training
  • Identifying training needs
  • Using ISO 10015 in a training program
  • Determining effectiveness
• Special competencies
  • People who work on verification or validation
  • ISO 14971 requirements
  • QSR requirements for a “designated individual”

Who Will Benefit:

This webinar is for people involved in design, production, purchasing, installation, servicing, document control, and human resources for medical device manufacturing.

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

• Quality Managers
• Quality Professionals
• HR Managers
• Regulatory Professionals
• Production Managers
• Risk Managers
• Project Managers
• Production Supervisors
• Process Owners
• Quality Audit Managers

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.

Topic Background:

Medical Device regulations require that manufacturers have enough people to perform all of the required tasks and that everybody is competent to do her job. The regulations also require the four dimensions of competency: education, training, background or skill, and experience.

As a medical device manufacturer, you must define the requirements for each job, evaluate the people in those jobs, develop a gap analysis for each person, and create a plan to close those gaps.

This webinar explains the competency dimensions, using the formal definitions. Many companies find confusion among these four dimensions. In addition to the formal definitions, the webinar explains the differences and illustrates them with examples.

While all four dimensions are equally important, the regulations place special emphasis on training. The manufacturer typically has the greatest control of training, especially related to the company’s policies, processes, procedures, and work instructions. As a result, ISO 13485 requires an effectiveness evaluation of training or other actions to satisfy competency requirements.

This webinar provides the information you need to assure your system is effective and complies with the regulation.

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