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?