Record

BQMS

Insert your organiztion's logo here (Optional) 4.2.3 Master List of Documents
Approved by:
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No. Description Title Created on: Revision Approved By File location Updates / Comments
PROCEDURES
4.2.3 Control of Documents
4.2.4 Control of Records
6.2.2 Competence, awarness, and training

7.1.1 Site Selection Planning

7.1.1a Surrounding land use and proximity to sexually
compatible species
7.1.1b Historical land use and topography of
environmental field release sites
7.1.1c Provision for rights of access to land for
purposes of monitoring for volunteers and/or
mitigation activities, for appropriate length of
time
7.1.1d Analysis of critical habitat of local threatened
and endangered species
7.2.1 Storage
7.2.1.a The method used to segregate regulated GE
organisms from other organisms
7.2.1.b Method used to marked or label storage areas

7.2.1.c The type of containers used for physical

storage
7.2.1.d Method(s) of marking, labeling, and
identification of storage containers
7.2.1.e The method used to limit access to storage
areas to authorized personnel.
7.2.2 Transport, movement and import of
regulated GE organisms
7.2.2.a The physical packaging for shipment of
regulated GE organisms to maintain
containment
7.2.2.b The method of tracking regulated GE
organisms from shipment to receipt
7.2.2.c The method(s) of marking, labeling, and
identification of shipment packages
7.2.2.d Verification of receipt, verification of contents
according to shipping record, and inspection of
physical packaging containment integrity

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 Record
BQMS

Insert your organiztion's logo here (Optional) 4.2.3 Master List of Documents
Approved by:
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BQMS Current Link

No. Description Title Created on: Revision Approved By File location Updates / Comments
7.2.2.e The disposal or return to use of packaging
material.
7.2.3 Environmental release planning and
monitoring
7.2.3a Pre-planing handling and transfer to
environmental field release sites
7.2.3.b Preparation and cleaning of planting equipment

7.2.3.c Use of physical marking and/or global

positioning system (GPS) coordinates to
identify the field release sites, including
boundaries, where applicable
7.2.3.d Documentation of environmental field release
site(s) procedure must address the
development of documented environmental
field release site maps indicating surrounding
land uses, separation distance employed and
alleys/fallow zones/border rows, where
applicable

7.2.3.e Method(s) of reproductive control (physical

separation, temporal separation, sterility, etc.)

7.2.3.f i Harvest preparation and equipment cleaning

which must address: verification of which
environmental field release site to harvest
7.2.3.f ii Harvest preparation and equipment cleaning
which must address: cleaning of relevant
equipment used for harvest on the field site
7.2.3.g i Monitoring of environmental release site(s): In-
season: 1)verification of reproductive control
effectiveness; 2)Monitorng for deleterious
effects on plants, non-target organisms, or the
environment; 3) Frequency of monitoring; and,
4) Monitoring of the environmental field
release site, including alleys, border rows and
fallow zones, for volunteer plants and/or viable
plant parts or material

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 Record
BQMS

Insert your organiztion's logo here (Optional) 4.2.3 Master List of Documents
Approved by:
Insert your organization's division/branch/unit here (Optional) (approver) Created on: month dd yy Current Revision: month dd yy

BQMS Current Link

No. Description Title Created on: Revision Approved By File location Updates / Comments
7.2.3.g ii Monitoring of environmental release site(s):
Post-harvest: 1) Communication of land use
restrictions; 2) Frequency of field monitoring;
3) Monitoring of environmental field release
site, including alleys, border rows and fallow
zones, for volunteer plants and/or viable plant
parts or material; 4) and methods to control,
devitalize and/or dispose of volunteer plants.

7.2.4 Post-harvest handling and transfer

7.2.4.a The regulated GE organisms are transferred to
storage and/or further conditioning
7.2.4.b The regulated GE organisms are contained
during transfer
7.2.4.c The regulated GE organisms are marked and/or
labeled
7.2.4.d The identity of the regulated GE organisms are
maintained while under use and/or
conditioning
7.2.4.e The identity of regulated GE organisms are
maintained during transfer to a subsequent
facility for further evaluation and/or use
7.2.4.f The equipment used for conditioning,
processing, or evaluating the regulated GE
organisms is cleaned
7.2.4.g Any misidentified regulated GE organisms are
handled
7.2.5 Devtilization and final disposition
7.2.5.a The method by which regulated GE organisms
in the field are rendered nonviable according to
relevant applicable rules, regulations, and
guidance. Records must be able to demonstrate
that devitalization and final disposition has
occurred at the field of the environmental
release

7.2.5.b The method by which regulated GE organisms

in storage and/or other means of containment
are rendered nonviable according to relevant
applicable rules, regulations, and
guidance. Records should account for the
mentod(s) of final disposition or disposal

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 Record
BQMS

Insert your organiztion's logo here (Optional) 4.2.3 Master List of Documents
Approved by:
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BQMS Current Link

No. Description Title Created on: Revision Approved By File location Updates / Comments
7.4.1 Potential regulatory compliace incidents
7.4.1.a Personnel roles and responsibilities for
ensuring regulatory compliance
7.4.1.b Personnel roles and responsibilities for
communicating and implementing resolution
activities
7.4.1.c The method of documenting the nature and
extent of the potential regulatory compliance
incident
7.4.1.d The method of communicating internal
requirements for the prompt resolution and
remediation of potential regulatory compliance
incidents
7.4.1.e The method of documenting resolution
activities used for the prompt remediation of
potential regulatory compliance incidents
7.4.1.f The method of reporting the potential
regulatory compliance incident to appropriate
regulatory authorities according to aapplicable
rules and regulations

7.4.1.g Training of relevant individuals involved in

regulatory compliace reporting requirements
8.2.1 Internal Audit
8.2.1.a The planning of an audit program, which must
consider the status and importance of the
processes and areas to be audited, as well as
the results of the previous audit

8.2.1.b The audit criteria, scope, frequency, and

methods
8.2.1.c The selection and conduct of auditors, which
must ensure objectivity and impartiality of the
audit process (auditors must not audit their own
work)

8.2.1.d The responsibilities for planning and

conducting audits
8.2.1.e The reporting of results
8.2.1.f The follow-up activities (follow-up activities
must include the verification of the actions
taken and the reporting of verification results)

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 Record
BQMS

Insert your organiztion's logo here (Optional) 4.2.3 Master List of Documents
Approved by:
Insert your organization's division/branch/unit here (Optional) (approver) Created on: month dd yy Current Revision: month dd yy

BQMS Current Link

No. Description Title Created on: Revision Approved By File location Updates / Comments
8.2.1.g The maintenance or records
8.4.2 Corrective action
8.4.2.a Reviewing nonconformities with its BQMS as
well as non-compliance with regulatory
requirements communicated by APHIS or other
regulatory agencies
8.4.2.b Determining the root causes of
nonconformities with its established BQMS
8.4.2.c Evaluating the need for action to ensure that
nonconformities with its BQMS do not recur
8.4.2.d Determining and implementing action(s)
needed
8.4.2.e Recording the results of actions taken
8.4.2.f Reviewing corrective action taken to determine
its effectiveness
8.5 Preventive action
8.5.a Determining potential nonconformities and
their causes
8.5.b Evaluating the need for action to prevent
occurrence of nonconformities
8.5.c Determining and implementing action needed
8.5.d Recording the results of action taken
8.5.e Reviewing preventive action taken to
determine its effectiveness
DOCUMENTED STATEMENTS, LISTS,
CHARTS, AND OBJECTIVES
4.2.1.b Quality policy and objectives
4.2.3 Master list of documents
5.4 Organizational chart

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Number Form Created on:
1 Form 009 Summary of Regulatory Officials Visit enter creation date
2 Form 014 Agreement of Compliance Certification enter creation date
3 Form 015 Cancellation of Trial enter creation date
4 Form 016 Receipt of Planting Seed enter creation date
5 Form 017 Plot Location Map enter creation date
6 Form 018 Plot Design Map enter creation date
7 Form 019 Confirmation of Plant Conditions (Pre-Plant Checklist) enter creation date
8 Form 020 Seven Days Notice of Planting enter creation date
9 Form 022 Verification of Cleaning of Equipment Prior To and After Plant enter creation date
10 Form 023 Field Observations enter creation date
11 Form 024 Seven Days Notice Harvest-Destruct enter creation date
12 Form 026 Verification of Cleaning of Equipment Prior To and After Harv enter creation date
13 Form 027 Disposition of Post Harvest Seed enter creation date
14 Form 028 Monitoring for Volunteers enter creation date
15 Form 029 Unintentional Release of Regulated Material-Field enter creation date
16 Form 035 Field Manager's Record for Field Testing of Regulated Materia enter creation date
17 Form 040 Certification of Training of Field Technician enter creation date
18 Form 041 Harvest Checklist enter creation date
19 Form 042 Movement of Regulated Material Checklist enter creation date
20 Form 043 Storage Checklist enter creation date
21 Form 044 Planting Procedure Checklist enter creation date
22 Form 045 Field Test Observations Checklist enter creation date
23 Form 046 Monitor for Volunteers Checklist enter creation date
24 Form 047 Plot Location Map Checklist enter creation date
25 Form 048 Inspection Checklist enter creation date
26 Form 059 Notice of Replanting enter creation date
27 Form 060 Notice of Acres Planted enter creation date
28 Form 063 Landowner Checklist enter creation date
29 RGD 002 Packaging Regulated Material for Shipment enter creation date
30 RGD 003 Receiving and Storing Regulated Material enter creation date
31 RGD 004 Field Test Site Selection enter creation date
32 RGD 005 Field Plot Location and Detailed Plot Maps Preparation enter creation date
33 RGD 006 Planting Procedure & Planter Cleanout enter creation date
34 RGD 007 Disposition of Seed Not Intended for Future Use enter creation date
35 RGD 008 Harvester Clean Out enter creation date
36 RGD 009 Seed Transporter Selection and Clean Out enter creation date
37 RGD 010 Post Harvest Monitoring and Subsequent Crop Production enter creation date
38 RGD 011 Storage of Regulated Seed - Container Selection and Celanout enter creation date
39 RGD 012 Unintentional Release of Regulated Material into the Environ enter creation date
40 RGD 013 Procedures for Government Inspections enter creation date
41 RGD 014 Field Test Site Observations by BASF Plant Science Employees enter creation date
42 See revelant release application to USDA APHIS, BRS enter creation date
43 Design Protocol [for specific crop species] enter creation date
44 Regulatory Compliance Incident Reporting and Resolution enter creation date
45 See revelant PPt Presentation enter creation date
46 Records in G Drive enter creation date
47 Training flow chart enter creation date
48 6.2.2 Competence, awareness and training enter creation date
49 4.2.4 Control of Records enter creation date
50 4.2.3 Control of Documents enter creation date
51 8.2.1 Internal Audit enter creation date
52 8.4.2 Corrective Action enter creation date
53 8.5 Preventive Action enter creation date
54 Appendix A enter creation date
55 4.2.1 Document Status Form enter creation date
56 5.7 Management Review Meeting enter creation date
57 Compliance Training Attendance Form enter creation date
58 Training Quiz template enter creation date
59 Reg Compliance Sign-Off Form enter creation date
60 Appendix B Glossary enter creation date
61 Field Compliance Training agenda enter creation date
62 8.4.2 Corrective Action Form enter creation date
63
64
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