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                       Document Number:                      7.2.4 Post-Harvest Handling and Transfer
                           Approved By:                      Quality Management Representative or position that
                                                             would be primarily responsible for this document.
                             Revision Details:               Master List of Documents

Disclaimer: This document provides general guidelines and suggestions for the development
of a procedure for post-harvest handling and transfer. Use of this template does not
guarantee conformance to APHIS BQMS Audit Standard requirements. Use of this template
does not guarantee compliance with APHIS regulations. BQMS auditors will seek to verify
the activities described in the procedure created from this template.

1.0         PURPOSE

1.1         This procedure describes the controls for post-harvest handling and transfer of regulated
            GE organisms; the methods employed to maintain the identity of regulated GE
            organisms; the way in which the process is monitored; and whether the monitoring and
            verification, as well as any changes in those activities, are effective. The species of
            regulated GE organism addressed in this procedure is [species name].

            [If this clause or any of the sub-clauses are not applicable, please state that in the Scope
            of the quality manual.]

            [Existing SOPs may be referenced within this procedure or in the quality manual as a
            substitute for this procedure.]

2.0         DEFINITIONS

2.1         Insert any terms, acronyms or reference to a glossary here that may apply to this
            procedure.

3.0         RESPONSIBILITY

3.1         The roles and responsibilities of the personnel involved in this procedure must be
            defined. This may be achieved through the use of an organizational chart or defined
            directly in the procedure. Please reference the relevant personnel in charge of this
            procedure: The Quality Management Representative, field supervisors, trainers, or
            someone else with appropriate training and authority.

4.0         POST-HARVEST HANDLING AND TRANSFER PROCEDURE

4.1         Describe the way in which regulated GE organisms are transferred to storage and/or
            further conditioning after it has been harvested. Are the harvest personnel and drivers (if
            applicable) informed of what they are transporting? Is there any paperwork that
            identifies the material? In the event of a loss of containment during transfer, how is that
            handled?

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                  Your Logo can go here:                     Address of participant headquarters can go here:

                       Document Number:                      7.2.4 Post-Harvest Handling and Transfer
                           Approved By:                      Quality Management Representative or position that
                                                             would be primarily responsible for this document.
                             Revision Details:               Master List of Documents

4.2         Describe the containment of regulated GE organisms during transfer. Are there specific
            containers? Do you have specifications for containers?
4.3         Describe how regulated GE organisms will be marked and/or labeled during transfer. Is
            there anything different about this labeling process than any of your other labeling
            processes? (i.e.; 7.2.1 Storage and 7.2.2 Transport, Movement and Import of Regulated
            GE Organisms)

4.4         Describe the way in which the identity of regulated GE organisms is maintained while
            under use and/or conditioning. Explain how your operation identifies GE organisms and
            the method used to maintain the identity after it is harvested. Does the material ever pass
            from your organization's direct control? What method is used to inform, instruct, and
            monitor the handlers who are not your own personnel?

4.5         Describe the way in which the identity of regulated GE organisms is maintained during
            transfer to a subsequent facility for further evaluation and/or use. Explain how your
            operation identifies GE material and the method used to maintain the identity after it is
            harvested. Does the material ever pass from your organization's direct control? What
            method is used to inform, instruct, and monitor the handlers who are not your own
            personnel?

4.6         Describe the cleaning process for equipment used for processing/conditioning and/or
            evaluation of regulated GE organisms. If material is dried or cleaned, describe the
            process that ensures identification and segregation. If the material passes from direct
            control of your organization, how do you ensure identification and segregation?

4.7         Describe the handling of any misidentified regulated GE organisms.

            [Suggestion: You may reference other procedures here, such as 7.2.5 Devitalization and
            Final Disposition or 7.4 Regulatory Compliance Reporting. If you have other methods,
            they should be thoroughly explained here.]

4.8         Describe how your organization monitors and verifies the effectiveness of the above
            planned activities and of any changes to those activities.

            [When determining suitable monitoring methods, it is advisable that your organization
            consider the type and extent of monitoring or measurement appropriate to each process
            in relation to its impact on compliance with APHIS regulations and on the effectiveness
            of your BQMS.]

4.9         Describe how relevant personnel receive training applicable to their defined roles and
            responsibilities.
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                  Your Logo can go here:                     Address of participant headquarters can go here:

                       Document Number:                      7.2.4 Post-Harvest Handling and Transfer
                           Approved By:                      Quality Management Representative or position that
                                                             would be primarily responsible for this document.
                             Revision Details:               Master List of Documents

4.9.9          Records will be kept on all the above activities.

5.0            REFERENCES

5.1            Insert here any references that apply to this procedure.
               Examples would be:
                      4.2.3 Control of Documents
                      4.2.4 Control of Records
                      6.2.2 Competence, Awareness and Training
                      6.3 Infrastructure
5.2            Insert here any records or forms that apply to this procedure.
               Examples would be:
                      Master List of Documents
                      Training record(s)




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(***For BQMS Program document control, this may be deleted by user. BQMS_Template_Procedure_7.2.4 Post Harvest Handling and Transfer_v3.0)

								
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