04 - Compliance Review (Standards)
Compliance Review requires appropriate allocation of resources to review current applicable national and international standards. It includes especially the review of requirements of government agencies, including the U.S. Food & Drug Administration, Health Canada, and the European Union’s ‘General Product Safety Directive.’
What do we look for?
- No or substandard review of compliance with codes, standards and regulations
- Requirements of regulations are not fulfilled
- No or inadequate resources for compliance review
- Employees with responsibility for product safety compliance are not adequately trained and equipped.
- Proactive, comprehensive and ongoing review of compliance with codes, standards and regulations,
- Comprehensive safety risk analysis.
- Good resources for product safety issues
- Good documentation of products safety compliance processes.
Risk improvement ideas
- Define a person or a team which is responsible for the compliance review.
- Set compliance review as mandatory part of the development process which is also substance of the product safety approval procedure.
- Increase awareness of management’s responsibility for product safety compliance.