This article discuss about a risk-based approach to qualifying, managing and auditing third party providers.
Supplier qualification processes aren't just recommended precautions to guard against compliance issues, they're a regulatory requirement for most FDA-regulated manufacturers.
"Qualifying" a supplier, in this case, should be thought of as a kind of quality system within a quality system.
Candidate suppliers and vendors should be thoroughly evaluated against your own quality requirements, compared with other options, physically evaluated, and reevaluated on a regular basis to ensure compliance both now and in the future.
Although most drug and device manufacturers have a supplier qualification process in place already, one company's approach can look much different than another's.
Before you can assess a supplier’s ability to address your needs, you need to define and document those requirements thoroughly. Although each situation is unique, consider the following areas when putting together your list:
- Manufacturing/production capabilities
- Quality standards and certifications
- Regulatory and compliance requirements
- Technological capabilities
- Customer service standards
- Delivery and cycle times
- Product lifecycle management
In most cases, the change control system is the appropriate place to document this information. Avoid relegating this duty to just one person or a small team. Experts from each of these areas should be engaged in creating questions.
Supplier qualification is just one component of a larger supplier quality management system.
You can download, The Complete Guide to FDA-Regulated Supplier Qualification & Quality Management, to learn more about protecting yourself from supplier-related compliance issues.
TABLE OF CONTENTS
1. Outsourcing under greater scrutiny
2. Regulatory requirements for supplier management
3. Qualifying suppliers, vendors & other contractors
4. Writing an effective quality agreement
5. Managing supplier quality: a risk-based approach
6. Maintaining quality and improving supplier performance through auditing