Requirement

Document Control #:

Animal and Plant Health Inspection Service 1001B

Biotechnology Regulatory Services Version:

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APHIS BQMS PROGRAM: PROCESS AUDIT CHECKLIST Effective Date: 093010







Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.1.1 Site selection  How do you ensure access to land  4.2.3 Control of documents: the current

planning for monitoring of volunteers after procedure pertaining to site selection must

harvest? be made available at point of use

 How do you obtain knowledge of  4.2.4 Control of records: records pertaining

historical land use and topography to site selection must be readily accessible

of the selected field trial sites?  5.6 Communication: land access for

 How do you address analysis of monitoring activities must be

critical habitat for threatened and communicated to relevant internal

endangered species? personnel and external associates

7.2.1 Storage  How do you store and identify your  4.2.3 Control of documents: the current

regulated GE organisms? procedure pertaining to storage must be

 Describe how you segregate your made available at point of use

regulated GE organisms.  4.2.4 Control of records: records pertaining

 What types of containers are used to storage must be readily accessible

for storage?  6.2.2 Competence, awareness and training:

 How is access controlled to storage relevant internal personnel and external

areas? 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









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.2.2 Transport,  How are regulated GE organisms  4.2.3 Control of documents: the current

movement and moved interstate? procedure pertaining to transport,

import of regulated  How are regulated GE organisms movement and import must be made

GE organisms moved to and from field(s)? available at point of use

 If applicable, how does your  4.2.4 Control of records: records pertaining

electronic shipping/receiving system to transport, movement and import must be

work? readily accessible

 What kind of documentation is  6.2.2 Competence, awareness and training:

included with shipments? relevant internal personnel and external

 How long are shipping records kept? associates must be trained to the transport,

 How is packaging material disposed movement and import procedure in their

of or returned to use? delegated responsibilities

 How do you communicate with  6.3 Infrastructure: proper infrastructure

recipients of shipments? must be provided, established and

maintained for proper transport, movement

and import









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.2.3 Environmental  After BRS approval, what happens  4.2.3 Control of documents: the current    

release planning and next? procedure pertaining to environmental

monitoring  Explain how field release sites are release planning and monitoring must be

documented. made available at point of use

 How do you manage reproductive  4.2.4 Control of records: records pertaining

growth control? to environmental release planning and

 Show record of relevant planting monitoring must be readily accessible

equipment clean out?  5.4 Responsibility and authority: in regard

 Show records of relevant harvest to environmental release planning and

equipment clean out? monitoring must be defined

 Show records of monitoring of  5.6 Communication: training must be

volunteers conducted and communicated to relevant

 How does your organization address internal personnel and external associates

supplemental permit conditions?  6.2.2 Competence, awareness and training:

relevant internal personnel and external

associates must be trained to the

environmental release planning and

monitoring procedure in their delegated

responsibilities

 7.2.3 g Monitoring of volunteers links to

7.1.1 c provision for rights of access to land









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.2.4 Post-harvest  What happens after harvest?  4.2.3 Control of documents: the current    

handling and transfer  What happens if regulated GE procedure pertaining to post-harvest

organisms are misidentified? handling and transfer must be made

 How do you record post harvest available at point of use

equipment clean out?  4.2.4 Control of records: records pertaining

 What is the process for to post-harvest handling and transfer must

identifying/labeling harvested be readily accessible

regulated GE organisms?  6.2.2 Competence, awareness and training:

relevant internal personnel and external

associates must be trained tot post-harvest

handling and transfer procedure in their

delegated responsibilities

 6.3 Infrastructure: proper infrastructure

must be provided, established and

maintained for post harvest

 7.2.2 Transport, movement and import of

regulated GE organisms: by packaging,

verification and movement after harvest

 7.2.3 Environmental release monitoring

and planning: monitoring of environmental

release sites per notification / permit

conditions must occur post harvest

 7.2.5 Devitalization and final disposition:

proper measures to devitalize and/or

dispose and/or store regulated GE

organisms must occur post harvest





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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.2.5 Devitalization  What is your devitalization process  4.2.3 Control of documents: the current    

and final disposition in the field? procedure pertaining to devitalization and

 What happens to regulated GE final disposition must be made available at

organisms that is harvested and point of use

stored?  4.2.4 Control of records: records pertaining

 What happens after seed cleaning to devitalization and final disposition must

or conditioning? be readily accessible

 How do you record the method of  6.2.2 Competence, awareness and training:

devitalization? relevant internal personnel and external

 How is the regulated GE organism associates must be trained to devitalization

used if it is not devitalized or and final disposition in their delegated

disposed of, if applicable? responsibilities

 6.3 Infrastructure: proper infrastructure

must be provided, established and

maintained for devitalization and final

disposition









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.2.6 Regulatory  How does your self reporting  4.2.3 Control of documents: the current    

compliance reporting process work? procedure pertaining to regulatory

and resolution  What are the roles and compliance reporting and resolution must

responsibilities in terms of reporting be made available at point of use

compliance incidents?  4.2.4 Control of records: records pertaining

 How is a potential compliance to regulatory compliance reporting and

incident tracked from report to resolution must be readily accessible

closing?  5.4 Responsibility and authority: in regard

 How do you communicate potential to regulatory compliance reporting and

compliance incidents internally and resolution roles must be defined

externally?  6.2.2 Competence, awareness and training:

 What kind of training is provided to relevant internal personnel and external

ensure that relevant personnel are associates must be trained to compliance

aware of potential compliance reporting and resolution in their delegated

incident reporting requirements? responsibilities

 6.3 Infrastructure: proper infrastructure

must be provided, established and

maintained for compliance reporting and

resolution









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



7.3 Management of  How do you manage external  4.2.3 Control of documents: the current    

external associates associates? relevant procedures must be made

 In regard to your external available at point of use for external

associates, who is trained? associates

 4.2.4 Control of records: relevant records

must be readily accessible

 5.4 Responsibility and authority: roles must

be defined

 5.6.1 External communication:

management of external associate requires

proper communication.

 6.2.2 Competence, awareness and training:

relevant internal personnel and external

associates must be trained to compliance

reporting and resolution in their delegated

responsibilities









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



4.2.1 (b) Quality  What are your organization’s quality  5.1 Management commitment:    

policy and objectives objectives? commitment is demonstrated through the

 How do you measure your quality development and implementation of the

objectives? quality objectives

 5.7 Management review: quality objectives

are reviewed and revised during the

management review for continued

suitability with regard to data

 8.2.1 Internal audit: quality objectives are

reviewed for evidence of effectiveness

during the internal audit

 8.3 Analysis of data: the measurement of

quality objectives generate data that is

analyzed for suitability and effectiveness

 8.4.1 Continual improvement: quality

objectives are the foundation of continual

improvement









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



4.2.2 Quality manual  How is your quality policy  4.2.3 Control of documents: control    

communicated within your notation must be updated if any revisions

organization? are made to the quality manual and

associated documents

 5.1 Management commitment:

commitment is demonstrated through the

development and implementation of the

quality manual

 5.6.2 Internal communication – internal

personnel has access to and understands

the quality manual

 5.7 Management review – quality manual is

reviewed and revised during the

management review for continued

suitability



4.2.3 & 4.2.4  How does your electronic document  5.6 Communication: ensures that internal    

Document and record control system work? (if applicable) personnel and external associates have

control  How are your procedures access to current and relevant

distributed and controlled? documents/records

 What is your records retention

policy?

 How do you control obsolete

records/documents?









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



5.1 Management  Who is considered top management  4.2.2 Quality manual: management    

commitment in your organization BQMS? commitment will be stated in the quality

manual

 5.4 Responsibility and authority:

management defines and communicates

the roles and responsibilities of relevant

personnel

5.3 Quality planning  How does internal communication  4.2.3 Control of documents: quality    

work with changes are made to your planning could lead to the revision of

BQMS or procedures? documents

 How does relevant information flow  5.4 Responsibility and authority: the

through your organization? primary function of top management is

quality planning

 5.6 Communication: results of quality

planning needs to be communicated

 5.7 Management review: the primary

function of quality planning is

demonstrated in the management review

meeting









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



5.6.1 External  How do you communicate with  4.2.3 Control of documents: external    

communication external associates? associates must have access to current

 Who is responsible for relevant documents

communication with external  4.2.4 Control of records: external associates

associates? may temporarily store and must have

access to current relevant records

 5.4 Responsibility and authority:

responsibility delegated to external

associates must be communicated

 6.2.2 Competence, awareness and training:

external associates must be trained in

relevant aspects to their delegated

responsibilities

 7.2 Critical control points and procedures

(all, where applicable): relevant aspects of

critical control points and procedures must

be communicated to internal personnel and

external associates









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



5.6.2 Internal  How do you communicate with  4.2.3 Control of documents: internal    

communication internal associates? personnel must have access to current

relevant documents

 4.2.4 Control of records: internal personnel

must store and have access to current

records

 5.4 Responsibility and authority:

responsibility delegated to internal

personnel must be communicated

 6.2.2 Competence, awareness and training:

internal personnel must be trained in

relevant aspects to their delegated

responsibilities

 7.2 Critical control points and procedures

(all, where applicable): relevant aspects of

critical control points and procedures must

be communicated to internal personnel and

external associates









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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



5.7 Management  When will your management review  8.2.1 Internal audit: internal audit will be    

review be conducted? reviewed during the management review

 What is your management review  8.4.1 Continual improvement: continual

frequency? 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,  How do you measure the  5.6 Communication: training must be    

awareness and effectiveness of your training conducted and communicated to relevant

training program? internal personnel and external associates

 How do you ensure that those  8 Monitoring, Analysis and Improvement:

associated with regulated field trials training program(s) are monitored,

are trained? analyzed and improved effectiveness and

 How is competency addressed? suitability

 Do you train external associates?

 How is training delivered?

6.3 Infrastructure  How would you describe your  7.2 Critical control points and procedures:    

organization’s infrastructure? proper infrastructure must be provided,

 How are resources provided to established and maintained for the

achieve conformance? implementation of critical control points

and procedures







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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



8.2.1 Internal audit  Who is involved in resolving  4.2.3 Control of documents: the current    

corrective actions for your BQMS? procedures must be made available for

 What is your corrective action internal audit

process for your BQMS?  4.2.4 Control of records: relevant records

 Who can initiate a corrective action? must be readily accessible pertaining to the

 What is your internal audit internal audit

frequency plan?  5.4 Responsibility and authority: roles must

be defined for the internal audit

 5.7 Management review: a report

pertaining to the internal audit must be

given at the management review meeting

 8.4.2 Corrective action: corrective action(s)

may be initiated during the internal audit

 8.5 Preventive action: preventive action(s)

may be initiated during the internal audit

8.2.2 Monitoring of  How do you monitor your BQMS  8.2.1 Internal audit: processes are    

process processes? monitored/measured during the coarse of

the internal audit

 8.4.2 Corrective action: corrective action(s)

may be initiated at any time and/or during

the internal audit

 8.5 Preventive action: preventive action(s)

may be initiated at any time and /or during

the internal audit







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Requirement of the Example interrelationship(s) with BQMS

Suggested Guidelines Y N N/A Description of Evidence Provided

BQMS Audit Standard requirements



8.3 Analysis of data  What data are you going to analyze?  4.2.1 General: data produced from    

 How are going to use this measurable quality objectives should be

information? analyzed

 If applicable, what will be the  5.7 Management review: data collected

frequency of surveys? may be presented at management review



8.4 Improvement  How has the implementation of  5.7 Management review: corrective action    

your BQMS improved your and continual improvement will be used as

organization? input into management review meeting

 Tell us about specific improvements  8.2.1 Internal audit: corrective action may

that were made to your be a result of an internal audit

management system.

 Tell us about your corrective action

procedure and how it is used?

 How are you determining

effectiveness of the corrective

actions?

8.5 Preventive action  Can you explain the difference  5.7 Management review: preventive action    

between your corrective and will be used as input into management

preventive action procedures? review meeting

 8.2.1 Internal audit: preventive action may

be a result of an internal audit









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