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8.2.1 Internal Audit
Quality Management Representative or position
that would be primarily responsible for this
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Master List of Documents

Disclaimer: This document provides general guidelines for the development of an internal
audit procedure. Use of this template does not guarantee conformance to APHIS BQMS
Audit Standard requirements. Auditors will seek to verify the activities described in the
procedure created from this template.
1.0

PURPOSE

1.1

This procedure describes the internal audit process used to determine: the
organizations ability to meet requirements of planned arrangements as specified in the
APHIS BQMS Audit Standard;, the organizations ability to meet BQMS requirements
established by the organization; and whether the organizations BQMS is effectively
implemented and maintained.

2.0

DEFINITIONS

2.1

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

2.2

Audit Criteria - set of policies, procedures or requirements.

NOTE: Audit criteria are used as a reference against which audit evidence is
compared.

2.3

Audit Scope - extent and boundaries of an audit

NOTE: The audit scope generally includes a description of the physical locations,
organizational units, species of regulated GE organisms, activities and processes
as well as the time period covered.

2.4

Audit Frequency - The entire BQMS must be audited at least annually, but the audit
can be broken up into sections or categories depending on time availability and the
season in which an activity takes place.
Example: You may want to audit planting or harvesting when those activities take
place.

2.5

Planned Arrangements - activities planned well in advance to ensure that the outcome
meets expectations.
NOTE: This primarily refers to section 7 of the standard, but it could also relate
to the quality objectives or specific areas being monitored or measured.

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Your Logo can go here:

Document Number:
Approved By:

Revision Details:

Address of participant headquarters can go here:

8.2.1 Internal Audit
Quality Management Representative or position
that would be primarily responsible for this
document.
Master List of Documents

3.0

RESPONSIBILITY

3.1

Please reference the relevant personnel in charge of this procedure: The Quality
Management Representative (QMR) or designee is usually the person responsible.

4.1

INTERNAL AUDIT PROCEDURE

4.2

How will your organization plan for internal audits? Planning the audit must consider:
Status and importance of the process and areas to be audited;
Results of the previous audit
Planning the audit may include:
Time availability
Time of year
Notice of when the audit plan will be sent (two weeks prior)
Whether some areas need to be audited more frequently than others

4.2

What are the audit criteria, scope, frequency and methods? The criteria of your
internal audit is the current version of the APHIS BQMS Audit Standard and your
quality manual with associated documentation.
The scope will describe the location of the audit(s), the regulated GE species, and the
element or elements that you will cover on the audit.
The frequency will be at least annually for the entire BQMS but you may audit areas
more than once if problems arise to warrant more frequent audits. The method to be
used to conduct the audit also helps determine the frequency of the audit.
The method of the audit is at the discretion of the auditor or the assigning organization.
Different methods include but are not limited to: process audit, system audit, checklist
audit, etc...

4.3

How will your organization select internal auditors? They will be selected to ensure
objectivity and impartially. This means that an auditor may not audit their own work.
Auditors should be selected on their knowledge of the regulations and of the APHIS

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8.2.1 Internal Audit
Quality Management Representative or position
that would be primarily responsible for this
document.
Master List of Documents

BQMS Audit Standard and your operation. Outside consultants or other qualified
persons may be selected to conduct internal audits for your organization.
[Suggestion: a small organization, with few personnel may need to consider outside
consultants or qualified people to ensure impartiality (knowledgeable of handling
genetic material and regulations).]
4.4

Who will take the responsibility for planning and conducting the audits? Would it be
the QMR or a designee? Even if your organization uses the services of someone from
outside the organization, there must be a person in the organization who has
responsibility.

4.5

Who will report the results of the audit? Where will the results of the audit be stored?

4.6

Who has responsibility for the follow-up activities of the internal audits including
verification that follow-up actions have taken place and that verification results have
been reported? This activity can be assigned to the person managing the area where
correction or corrective action must be taken.
[Example: The internal audit found that documentation associated with harvest
equipment cleaning was out of date and obsolete, and the field coordinator was in
charge. The field coordinator would be assigned the activity to correct the issue].

4.7

Where will records from the internal audit be kept? How long will they be stored?
Within the area being audited, management must ensure that actions are taken without
undue delay to eliminate detected nonconformities and their causes.
Your organization must review the results of internal audits during your management
review meeting.

5.0

REFERENCES

5.1

Please insert here any references that apply to this procedure

Examples would be:
5.4 Responsibility and authority
5.7 Management review

5.2

Insert here any records or forms that apply to this procedure.

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Your Logo can go here:

Document Number:
Approved By:

Revision Details:

Address of participant headquarters can go here:

8.2.1 Internal Audit
Quality Management Representative or position
that would be primarily responsible for this
document.
Master List of Documents

Examples would be:

Audit Checklist
CPAR Form

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