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Training Compliance Tips
- Ensure training provisions when employees move to other positions within the organization.
- Consider refresher training in instances where employees are cross-trained on multiple activities and there is the potential for a significant time lapse in performing them.
- All temporary/contract employees need a formal, documented training plan.
- Identify training requirements for executive management. No employee, regardless of position, should be exempt from training.
Management review, quality records, complaints, recalls, CAPA, internal audits are areas to consider for executive management training.
- Recognize that authoring a procedure does not necessarily mean that employee is qualified to train other employees, especially a large group.
- Training effectiveness verification (as required by ISO 13485) can take many forms. Consider options other than formal quizzes/exams.
- Self-study is the least effective method of training. It should be used sparingly.
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Welcome to ADVQSS
Welcome to ADVQSS website. ADVQSS is a full service consulting company specializing in the medical device industry. Its’ goal is to offer clients timely, cost-effective solutions to quality system compliance issues.
Many times, an organization’s automatic response to compliance deficiencies is to generate another piece of paper—SOP, work instruction, or form. The cumulative effect is a quality system driven by paper (or electronic documents) and an organization swimming in documents—many of which employees aren’t even aware exist.
Unlike many consultants, I do not subscribe to the “more is better” theory. I’ve seen 70 page Quality Manuals that are so generic that they do not even state the quality system scope. ADVQSS provides clients with a Quality Manual typically 8-10 pages. Other quality system documents are written in a similar fashion—succinct and appropriate for the intended audience.
ADVQSS is here to help, whatever your quality system compliance needs are.
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