Quality System Implementation
Predictive Quality Assurance

An organization can address quality issues such as inconsistent supplier performance, inconsistent outcomes, low process compliance and chronic customer complaints by developing standards based on customer and regulatory requirements, formulating a practical quality system and developing organizational competencies.  This will enable organizations implement a quality system that enhances organizational effectiveness & efficiency.

This approach utilizes extensive implementation experience and will reference standards such as ISO 9000, Food & Drug Administration 21 CFR 820 Quality System Regulation and 21 CFR 211 Current Good Manufacturing Practice.

The methodical and systematized approach enables organizations to interpret requirements into practical applications that enhance process effectiveness and efficiency.

The Approach

1. Identify customer, industry and regulatory requirements
2. Develop the organization Quality System Plan
3. Build organization competencies
4. Develop Quality Policy Manual
5. Develop, train and coach implementation of Quality System procedures
6. Develop, train and coach implementation of Department-level procedures
7. Develop, train and coach implementation of Work Instructions, if necessary