Requirement of the BQMS Audit Standard Suggested Guidelines Example interrelationship(s) with BQMS requirements Y N N/A Description of Evidence Provided 7.1.1 Site selection planning How do you ensure access to land for monitoring of volunteers after harvest? How do you obtain knowledge of historical land use and topography of the selected field trial sites? How do you address analysis of critical habitat for threatened and endangered species? 4.2.3 Control of documents: the current procedure pertaining to site selection must be made available at point of use 4.2.4 Control of records: records pertaining to site selection must be readily accessible 5.6 Communication: land access for monitoring activities must be communicated to relevant internal personnel and external associates 7.2.1 Storage How do you and identify your regulated GE organisms? Describe how you segregate your regulated GE organisms. What types of containers are used for storage? How is access controlled to storage areas? 4.2.3 Control of documents: the current procedure pertaining to storage must be made available at point of use 4.2.4 Control of records: records pertaining to storage must be readily accessible 6.2.2 Competence, awareness and training: relevant internal personnel and external associates must be trained to the storage procedure in their delegated responsibilities 6.3 Infrastructure: proper infrastructure must be provided, established and maintained for proper storage
7.2.5 Devitalization and final disposition What is your devitalization process in the field? What happens to regulated GE organisms that is harvested and stored? What happens after seed cleaning or conditioning? How do you record the method of devitalization? How is the regulated GE organism used if it is not devitalized or disposed of, if applicable? 4.2.3 Control of documents: the current procedure pertaining to devitalization and final disposition must be made available at point of use 4.2.4 Control of records: records pertaining to devitalization and final disposition must be readily accessible 6.2.2 Competence, awareness and training: relevant internal personnel and external associates must be trained to devitalization and final disposition in their delegated responsibilities 6.3 Infrastructure: proper infrastructure must be provided, established and maintained for devitalization and final disposition
5.7 Management review When will your management review be conducted? What is your management review frequency? 8.2.1 Internal audit: internal audit will be reviewed during the management review 8.4.1 Continual improvement: continual improvement will be reviewed during the management review 8.4.2 Corrective action: corrective action(s) will be reviewed during the management review 8.5 Preventive action: preventive action will be reviewed during the management review 6.2.2 Competence, awareness and training How do you measure the effectiveness of your training program? How do you ensure that those associated with regulated field trials are trained? How is competency addressed? Do you train external associates? How is training delivered? 5.6 Communication: training must be conducted and communicated to relevant internal personnel and external associates 8 Monitoring, Analysis and Improvement: training program(s) are monitored, analyzed and improved effectiveness and suitability 6.3 Infrastructure How would you describe your organization’s infrastructure? How are resources provided to achieve conformance? 7.2 Critical control points and procedures: proper infrastructure must be provided, established and maintained for the implementation of critical control points and procedures
8.3 Analysis of data What data are you going to analyze? How are to use this information? If applicable, what will be the frequency of surveys? 4.2.1 General: data produced from measurable quality objectives should be analyzed 5.7 Management review: data collected may be presented at management review 8.4 Improvement How has the implementation of your BQMS improved your organization? Tell us about specific improvements that were made to your management system. Tell us about your corrective action procedure and how it is used? How are you determining effectiveness of the corrective actions? 5.7 Management review: corrective action and continual improvement will be used as input into management review meeting 8.2.1 Internal audit: corrective action may be a result of an internal audit 8.5 Preventive action Can you explain the difference between your corrective and preventive action procedures? 5.7 Management review: preventive action will be used as into management review meeting 8.2.1 Internal audit: preventive action may be a result of an internal audit