BQMS User Orientation

The repository was designed to assist BQMS Program users interested in developing a documented quality management system to facilitate compliance with the APHIS regulations for the import, interstate movement, and field release of organisms developed using genetic engineering in complying with regulations found at 7 CFR part 340.

Users may develop, implement, and maintain a BQMS within their organization to manage the environmental release, movement and field release, of regulated GE organisms. Specifically, organizations:

• Work to identify critical control points in the organization's processes for working with regulated GE organisms,
• Develop or revise standard operating procedures that address critical control points,
• Properly train personnel on standard operating procedures,
• Undergo self-certification to determine effectiveness of the organization's quality management system, and
• Become an organization participating in the BQMS Program.

Biotechnology Quality Management Support Module Templates

APHIS developed the compliance assistance modules below to better meet the needs of universities, small businesses and large companies alike in following areas:

Document Control

• Document Control (47.76 KB)
• Record Control (43.19 KB)

Internal Controls

• Competence Awareness and Training Procedure (44.7 KB)
• Management Review Meeting Form (42.1 KB)

BQMS Critical Control Points

• Site Selection Planning (37.94 KB)
• Storage (42.14 KB)
• Transport, Movement, and Import (44.11 KB)
• Environmental Release Planning and Monitoring (44.33 KB)
• Post-harvest Handling and Transfer (46.65 KB)
• Devitalization and Final Disposition (41.57 KB)
• Potential Regulatory Compliance Incidents (40.71 KB)
• Reporting Form for Potential Regulatory Compliance Incidents (37.46 KB)

Process Improvements

• Internal Audit (47.31 KB)
• Corrective Action (45.14 KB)
• Preventive Action (46.5 KB)
• CAR PAR Form (53.51 KB)