Personnel performing work which may affect product quality must be competent on the basis of education, training, skill and experience.

Job Descriptions

In order to sure this is adequately documented a written and approved job description must be established. Each person performing work which may affect product quality should have a training record including a job description and a copy of the resume or curriculum vitae (C.V.).

Written Training Plan

In addition each job title should have a written training plan. A training plan is simply a table of procedures and training requirements (typically in the rows) and job titles for a given department (typically in the columns) with an annotation as to whether or not the process is required training optional or not required.

Establishing Competence and Ensuring Awareness

The organization must provide the process for establishing competence and ensuring awareness of personnel. The process for ensuring competence may vary depending on the nature of the work and how that specific process might impact product quality. For example, some training may simply be “read and understand”. This may require the personnel responsible to read the document and sign a training record stating they understand and feel trained on the process. Another process may have a simple multiple choice quiz, or it might require “on the job training” (OJT), which is documented and performed under supervision.