ANSI Peer Review Report 

 

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2019 Peer Review Panel 

Evaluator Report 

For 

Agricultural Marketing Services (AMS)

National Organic Program (NOP) 

Dates of Review Panel:

December 10 - 12, 2019 

Prepared by

American National Standards Institute

1899 L Street, 11th Floor

Washington, DC 20036

Product Certification Accreditation
ANSI Evaluation Peer Review Panel

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I. TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................................................. 2

I. GENERAL INFORMATION ................................................................................................. 3

II. SCOPE ............................................................................................................................ 4

III. INTRODUCTION............................................................................................................... 4

IV. REPORT OF PEER REVIEW PANEL EVALUATION................................................................. 5

 Previous OFIs.................................................................................................................. 5

 2019 Opprotunities for Improvement.............................................................................. 8

 2019 Comments............................................................................................................ 11 

 2019 Strengths.............................................................................................................................11

V. CONCLUSION.................................................................................................................. 12
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I. GENERAL INFORMATION

Accreditation Body

Name of Reviewed Body United States Department of Agriculture

Agricultural Marketing Services (AMS)

National Organic Program 

Address 1400 Independence Avenue S.W. 

 Room 2648 South Building 

 Washington, DC 20250 

Telephone 202-720-3252 

Review

Type of Review Peer Review Panel Evaluation

On-site Review Dates December 10 to 12, 2019

Review Standard(s)

US 7 CFR Part 205, National Organic Program 

 ISO/IEC 17011:2017 Conformity Assessment – General 

requirements for accreditation bodies accrediting conformity 

assessment bodies

Review Team

Lead Reviewer: Mario Llerenas

Co-Lead Reviewer: Milan Neupane 

Technical Reviewer: Jean Richardson 

ANSI Staff: Reinaldo Figueiredo, ANSI Senior Program Director 

Elizabeth Okutuga, ANSI, Program Coordinator

Report Prepared by: 

 Milan Neupane

 Mario Llerenas

 Jean Richardson

Submitted to ANSI on: January 2, 2020 
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II. SCOPE

The NOP is establishing a peer review panel to satisfy adherence to internal and regulatory requirements. 

American National Standards Institute (ANSI) has convened this panel on July 30, 2019. 

The peer review panel is tasked to: 

• Evaluate the NOP’s polices processes and procedures for conformance to NOP regulations (7 

CFR Part 205) and ISO/IEC 17011:2017

• Focus on the updated ISO 17011:2017 standard and the revised risk-based changes to the 

standard 

• Review implementation of certification body accreditation processes through select file review

including a review of three accreditation decisions issued by the NOP - one for a certifier 

applicant, one renewal and one midterm assessment 

• The USDA oversight process

• USDA process for assessing risk in their current management system

• Area for system improvements 

The panel is reporting their findings in writing to the NOP Deputy Administrator and the National Organic 

Standards Board. The findings will be considered part of the NOP quality management system.

III. INTRODUCTION

The National Organic Program (NOP) is part of the Agricultural Marketing Service (AMS), U.S. Department 

of Agriculture (USDA), and is the organization responsible for activities relating to the development, 

implementation, and administration of the Organic Foods Production Act of 1990 (OFPA) and the USDA 

organic regulations. Key functions of the NOP include:

• Developing, reviewing, implementing and interpreting the organic standards 

• Enforcing organic production, handling, and labeling standards

• Accrediting, auditing, and training third‐party organic certifying agents

Panel Members 

Milan Neupane – 17011 Expert; Risk Assessment Evaluator; ANSI Lead Assessor. 

Jean Richardson - Professor Emerita, University of Vermont, Environmental Law and 

Environmental Studies; Independent organic inspector, IOIA qualified; NOSB 2012-2017; 

ISO/IEC trained.

Mario Llerenas, 17011 Expert (Qualified Peer Assessor); Risk Assessment Evaluator; ANSI 

Food Safety Lead Assessor. 

ANSI Staff - Elizabeth Okutuga, Program Coordinator, ANSI staff, ISO/IEC 17011 process 

knowledge and project coordinator.

ANSI Staff - Reinaldo Balbino Figueiredo, Senior Program Director, ANSI staff, ISO/IEC 

17011 evaluator. Contract/Project Manager.
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Document Review - The review panel conducted a Document Review and completed a working 

document before the on-site evaluation.

The working document was created on November 7, 2019 and send to USDA NOP, including the 

tentative schedule of the personnel to interview during the on-site visit. The working document was 

used by the Peer Review Team for taking notes during the on-site assessment, and the findings are 

included in this report.

Assessment Plan

The on-site Assessment Plan revision 01 was issued on October 4, 2019; this version was approved and 

signed by USDA NOP in October 8, 2019; The assessment plan approved by USDA NOP is uploaded to

ANSICA, the ANSI database.

Opening / Closing Meetings

The opening meeting was conducted on Tuesday 10 of December, 2019 at 8:30 am with 5 NOP senior 

staff in attendance and the two members of the ANSI Peer Review team (Milan Neupane has a travel 

issues and arrived at 10:30am). At the end of the opening meeting, the NOP Deputy Administrator, 

Jennifer Tucker, explained the proposed changes in the organizational structure of the NOP and its 

relationship with other governmental dependencies.

The closing meeting for the on-site assessment was done on Thursday 12 of December at 12:00 pm with 

the same five NOP persons in attendance and the three assessors of the Peer Review team.

The results of the on-site assessment were discussed during the closing meeting: Six opportunities for 

improvement (OFIs) and three Comments were documented, as presented in the Section IV of this report.

Additional Comments

The Management System of USDA NOP is very well implemented and in accordance with the ISO/IEC 

17011 version 2017 and the US 7 CFR Part 205, National Organic Program requirements, with the 

exception of the six OFIs identified.

The Peer Review team was well impressed on the improvements in the organization, resources and 

accreditation process since the last Peer Review in 2018.

The NOP personnel demonstrated good knowledge in both, technical requirements and the management 

system requirements.

The NOP program management also demonstrated commitment to continuous improvement.

IV. RESULTS OF PEER REVIEW PANEL EVALUATION

1. METHODOLOGY.- The Peer Review team verified the compliance of USDA NOP to 7 CFR 205 

and ISO/IEC 17011:2017 based on the sampling of documents, interviews and records; the Peer 

Review team selected accreditation files and NOP qualified assessors in order to verify the 

accreditation process and competency. The conclusions of the Peer Review team is based on 

objective evidence collected and observed during the assessment, and is contained in this report as 

compiled by the lead and technical evaluators.

2. PREVIOUS OFIs.- The OFIs cited from 2018 were both, documented and reviewed by the Peer 

Review team during the 2019 on-site assessment in order to verify the effectiveness of the actions 

implemented by NOP. The outcome of this review is presented below:

2018 Opportunity for 

Improvement

2019 Verification of the effectiveness

2018-USDA NOP-01-OLLEM-(17011 v. 2004) 

4.2.8 

The OFI identified in 2018 was reviewed and is effective. [ref: 

2018-USDA NOP-01-O-LLEM-(17011 v. 2004) 4.2.8] 
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The NOP Organizational 

Chart does not show the 

Quality Manager position

2018-USDA NOP-02-OLLEM-(17011 v.2004) 4.3.7 

There is not documentation 

for the relationships with 

related bodies; as well, 

there is no evidence of the 

participation of the 

interested parties.

One OFI identified in 2018 was reviewed and remains open.

2018-USDA NOP-02-O-LLEM-(17011) 4.3.7

2018-USDA NOP-03-Oricj-(ISO 17011 v. 2004) 

6.1.2

The NOP does not have a 

sufficient number of 

auditors.

One OFI identified in 2018 was verified and effective.

2018-USDA NOP-03-O-ricj-(17011)6.1.2

The NOP has increased the number of Auditors to 11 total:

4 Full time Auditors; 3 Full time Auditors in Training and 6 part 

time Auditors.

In addition the NOP is in the process of hiring a full time Auditor 

Supervisor

2018-USDA NOP-05-Oricj-(ISO 17011 v. 2004) 

7.5.7.

Satellite offices of certifiers, 

especially international 

locations, are not audited 

on a frequent enough basis 

to reduce risk and prevent 

potential fraud.

One OFI identified in 2018 was verified and effective.

2018-USDA NOP-05-O-ricj-(17011) 7.5.7

With the increase in number of staff available to conduct audits, 

both domestically and internationally there is now a Schedule of 

planned visits in place for more frequent auditing of Satellite 

offices.

2018-USDA NOP-06-Oricj-(ISO 17011 v. 2004) 

7.7.2. 

Procedures for residue 

sampling are not clearly 

understood or followed by 

international CAB and 

satellite offices.

One OFI identified in 2018 was verified and the Peer Review team 

has the following comment:

2018-USDA NOP-06-O- ricj-(ISO 17011 v. 2004) 7.7.2. 

Procedures for residue sampling are not clearly understood or 

followed by international CAB and satellite Offices.

In response to this OFI from 2018, the NOP, in February 2020, will 

be conducting a training on residue sampling procedures at 

BIOFACH, and there will be a training module developed for 

residue sampling in the Organic Integrity Learning Center. This is 

scheduled.

2018-USDA NOP-08-Oricj-(ISO 17011 v. 2004) 

6.1.1.

There is insufficient NOP 

personnel to handle the 

number of complaints and 

enforcement actions 

required of the C&E 

division.

One OFI identified in 2018 was verified and effective.

2018-USDA NOP-08-O-ricj-(17011) 6.1.1

The total number of NOP staff has increased to accommodate the 

growth in the Complaints program. Presently there are 45 total 

NOP staff, with a goal of increasing to at least 59 positions in the 

next few months. This staff increase includes additional Auditors.

The Compliance and Enforcement Division has added six new 

FTE which has allowed a much more streamlined procedure with 

procedures in place. 
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A tiered system of complaint handling (3 tiers) is now in place and 

is quickly seen to be allowing for a streamlined approach to 

complaints resolution in a very timely manner. The newly updated 

system in place also includes the use of external contractors, 

other divisions of USDA and other Federal and international 

agencies.

2018-USDA NOP-09-OCADS-(17011)

NOP should establish 

stronger quantitative 

objectives and key 

performance indicators for 

effective measurement and 

monitoring to achieve the 

Administration's goals.

One OFI identified in 2018 was verified and effective.

2018-USDA NOP-09-O-CADS-(17011)

The NOP has documented 2020 objectives and measurable goals:

1.- Deepen risk-based Organic Control Systems, leading to trusted 

people, processes, and rules

2.- Expand Farm to Market Traceability, increasing supply chain 

integrity around the world

3.- Protect Organic Integrity through Robust Enforcement, creating 

a consistent and fair market for all organic participants

4.- Support the existing organic standards and collaborate with 

organic stakeholders

5.- Support AMS-wide initiatives to facilite agricultural marketing

6.- Increase communication and efficiency of compliance and 

enforcement mission

2018-USDA NOP-10-OCADS-(17011) 5.3 

Several documents were 

found to be out of 

compliance with the 

document control 

procedure.

The OFI identified in 2018 [ref: 2018-USDA NOP-10-O-CADS-

(17011) 5.3] was reviewed and the Peer Review team has the 

following comments:

Following improvements are noted during on-site peer review:

a) NOP 1006 Document Control Master List has been updated to 

Rev.57.

b) National Organic Program Handbook: Guidance and 

Instructions for Accredited Certifying Agents and Certified 

Operations has been updated (e.g. NOP 5611 National list 

Sunset Dates – a regulation has been updated on 11/22/2019 

and approved by NOP Deputy Administrator).

c) All Guidance documents, Policy Memos, and Instructions 

undergo Office of General Counsel review as part of the 

review process. 

d) The NOP 4000 series of quality management procedure is 

under review, which focuses on Compliance and Enforcement 

topics. 

e) NOP procedures are referred in NOP 1000 Quality Manual, 

Rev. 04.

f) The Quality Manager has demonstrated commitment in 

continued oversight and active facilitation of the quality 

management system improvement. 
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2018-USDA NOP-11-OCADS-(17011) 7.9.4 

The accreditation certificate 

does not identify all 

premises from which one or 

more key activities are 

performed and covered by 

the accreditation and the 

physical addresses 

associated with the 

certification body.

One OFI identified in 2018 was verified and the Peer Review team 

has the following comment:

2018-USDA NOP-11-O-CADS-(17011) 7.9.4

The NOP is developing a mechanism with the accreditation 

database to accommodate the necessary additional information. 

This is not yet fully complete.

2018-USDA NOP-12-OCADS-(17011) 8.3.2 

There is an opportunity for 

NOP to provide further 

protections for its USDA 

Organic seal.

One OFI identified in 2018 was verified and is effective:

2018-USDA NOP-12-O-CADS-(17011) 8.3.2

The NOP has the added support of the Custom & Border 

Protection (CBP) on the control of the USDA Seal.

3. 2019 Opportunities for Improvement.- During this on-site assessment, the Peer Review team 

identified six opportunities for improvement. The following are the 2019 opportunities for 

improvement (OFIs) made by the review panel:

Requirement Opportunity for 

Improvement

Evidence

17011:2017

4.4 Impartiality requirements

4.4.5 The accreditation body 

shall document and implement a 

process to provide opportunity 

for effective involvement by 

interested parties for 

safeguarding impartiality. The 

accreditation body shall ensure 

a balanced representation of 

interested parties with no single 

party predominating.

4.4.6 The accreditation body 

shall have a process to identify, 

analyse, evaluate, treat, monitor 

and document on an ongoing 

basis the risks to impartiality 

arising from its activities 

including any conflicts arising 

from its relationships or from the 

relationships of its personnel.

2019-USDA NOP-01-OLLEM-(17011) 4.4.5 and 

4.4.6

The NOP can improve their

risk identification and 

analysis process. The NOP 

does not document the 

process for identification, 

analysis, control and 

mitigation actions for all 

potential risks.

There is no evidence of a

documented and 

implemented structure with 

participation of the interested 

parties.

1) NOP demonstrated to have the 

impartiality controls implemented; 

however, NOP can improve the risk 

identification and analysis process 

for the assessors conducting 

assessments of International 

certifiers. NOP should document 

the process for identification, 

analysis, controls and mitigation 

actions for all potential risks.

2) The Quality Manual NOP 1000 

dated December 18, 2017 clause 

3.3 Impartiality, states the NOP has 

documented and implemented a 

structure to provide the opportunity 

for effective involvement by 

interested parties. The NOP 

ensures a balanced representation 

of interested parties with no single 

party predominating; however, 

there is no evidence of the 

documented and implemented 

structure with participation of the 

interested parties.
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ISO/IEC 17011:2017, section 

5.6

The accreditation body shall 

document the duties, 

responsibilities and authorities 

of top management and other 

personnel associated with the 

accreditation body who are 

involved in the accreditation 

process.

ISO/IEC 17011:2017, section 

5.7

The accreditation body shall 

identify the top management 

having overall authority and 

responsibility for each of the 

following:

i) provision of adequate 

resources;

k) safeguarding of impartiality.

2019-USDA NOP-02-ONEUM-(17011) 5.6, 5.7

The NOP has an opportunity 

to complete the 

documentation of 

responsibilities and 

authorities of NOP positions 

in its quality system as part 

of the expanded 

organizational structure.

The responsibilities and authorities 

of all NOP positions of the 

explanded organizational chart are 

not yet addressed in the NOP 

quality system documentation for all 

positions. For example:

a) AMS Trade Systems Director

b) Standards Assistant Director

The responsibilities and authorities 

of Executive Management for 

safeguarding impartiality and 

provision of resources (other than 

financial resources) are unclear in 

the quality system documentation 

(ref: NOP 1002).

ISO/IEC 17011:2017, section 

9.3 Document control.

The accreditation body shall 

establish documented 

procedures to control all 

documents (internal and 

external) that relate to its 

accreditation activities. The 

procedures shall define the 

controls needed:

a) to approve documents for 

adequacy prior to issue;

b) to review and update as 

necessary and re-approve 

documents;

c) to ensure that changes and 

the current revision status of 

documents are identified;

d) to ensure that relevant 

versions of applicable 

documents are available at 

points of use;

e) to ensure that documents 

remain legible and readily 

identifiable;

f) to prevent the unintended use 

of obsolete documents, and to 

apply suitable identification to 

them if they are retained for any 

purpose;

g) to safeguard, where relevant, 

the confidentiality of documents.

2019-USDA NOP-03-ONEUM-(17011) 9.3

The NOP has an opportunity 

to improve the effectiveness 

of its implemented document 

control procedure.

PART I:

a) The NOP ́s quality system 

documents are maintained as 

unlocked word documents. Users

can make unintentional changes or 

unauthorized modifications to the

documents.

b) The procedure for the control of 

documents from external origin is 

not specified in NOP 1010.

c) The NOP Records File Plan and 

Disposition Schedule (NOP XXXX, 

dated Dec 6, 2016) is still a draft 

document and not yet approved.

PART II:

1) The reference to NOP 1010 

Quality Management System 

Document and Record Control 

Procedure under NOP 1000 Quality 

Manual, section 4

appears to have the incorrect title.

2) The NOP ́s quality system 

documents reference older versions

of standards or normative 

documents, such as ISO/IEC

17011:2004 and ISO 19011:2011).

3) Reference to NOP Records File 

Plan and Disposition Schedule is 

missing in the NOP 1000 Quality 

Manual.
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ISO/IEC 17011:2017, section 

9.5 Nonconformities and 

corrective actions.

The accreditation body shall 

establish documented 

procedures for the identification 

and management of 

nonconformities in its own 

operations. The accreditation 

body shall also, where 

necessary, take actions to 

eliminate the causes of 

nonconformities in order to 

prevent recurrence. Corrective 

actions shall be appropriate to 

the impact of the problems 

encountered. The procedures 

shall cover the following:

b) determining the causes of 

nonconformity;

2019-USDA NOP-04-ONEUM-(17011) 9.5 b)

The NOP has an opportunity 

to record the identification of 

the root cause when

addressing corrective 

actions.

As a result of 2018-2019 internal 

audit a corrective action report was

generated addressing findings

identified during the internal audit. 

However, the identification of root 

cause was not recorded while 

developing the corrective action 

plan as per NOP 1020 Corrective 

and Preventive Action Procedure 

(Rev03), Section 4.2.

ISO/IEC 17011:2017, section 

9.7.1

The accreditation body shall 

establish documented 

procedures for internal audits to 

verify that the accreditation body 

conforms to the requirements of 

this document and that the 

management system is 

implemented and maintained.

ISO/IEC 17011:2017, section 

9.7.4

The accreditation body shall 

ensure that:

a) internal audits are conducted 

by competent personnel 

knowledgeable in accreditation, 

auditing and the requirements of 

this document;

ISO/IEC 17011:2017, section 

6.3 Personnel records.

The accreditation body shall 

maintain records, including 

qualifications, training, 

competence, results of 

monitoring, experience, 

professional status and 

professional affiliations for 

personnel managing or 

performing accreditation 

activities.

2019-USDA NOP-05-ONEUM-(17011) 9.7.1, 9.7.4, 

6.3

The NOP has an opportunity 

to ensure standard audit 

checklist and reporting 

templates are used while 

conducting internal audit, and 

relevant records are 

maintained as per NOP 

1030.

a) NOP 1030-3 Internal audit report 

template and NOP 1030-2 Internal 

Audit Checklist were not used for 

the 2018-2019 internal audit, as per 

NOP 1030 Internal Audit Procedure 

(Rev04).

b) The record of the internal 

auditor ́s training on ISO/IEC 

17011:2017 and ISO/IEC 

17065:2012, as per NOP 1030, 

section 2.1, was not available 

during the peer review.
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ISO/IEC 17011:2017, section

9.8.2 

Inputs to management reviews 

shall include, current 

performance and opportunities 

for improvement related to the 

following:

c) participation in international 

activities, where relevant;

d) safeguarding impartiality;

e) feedback from interested 

parties;

i) the status of actions to 

address risks and opportunities;

2019-USDA NOP-06-ONEUM-(17011) 9.8.2

The NOP has an opportunity 

to include additional agenda 

items into its management 

review procedure to comply 

with the updates in ISO/IEC 

17011:2017.

NOP 1040 Management Review 

procedure, section 2.2 defines the 

requirements for inputs to the 

management review. However, it 

does not include the following 

inputs as per ISO/IEC 17011:2017, 

section 9.8.2:

1. Participation in international 

activities, where relevant;

2. Safeguarding impartiality;

3. Feedback from interested parties 

(except Feedback from accredited 

certifying agents, as it is included 

as an input item)

4. The status of actions to address 

risks and opportunities.

None of the above agenda items 

were discussed during the

management review for 2018.

2019 Comments.- In addition to the Opportunities for Improvement, the Peer Review team

documented three comments for USDA NOP to consider:

NOP PROCESS COMMENTS

Impartiality:

Obligations of the 

accredited CBs

The NOP should encourage the certifiers to comply with the Impartiality 

Risk Analysis evaluated by an independent mechanism requirement of 

the ISO/IEC 17065 (ref. ISO/IEC 17065 clauses 4.2 (Management of 

Impartiality) and 5.2 (Mechanism for safeguarding impartiality).

Competence of Personnel: 

6.1.2.1

The NOP does not use IAF MD 20:2016, Annex 1, which is mandated 

for 17011. However, the detailed criteria used in hiring competent staff 

and evaluating them as required in the USDA ́s performance plans and 

processes for appraisal, as verified from completed documents reviewed 

during sampling, indicates that the present USDA/NOP system appears 

to contain the elements covered in the IAF MD20: 2016, Annex 1.

7 CFR 205.670

Procedures for residue sampling are not clearly understood or followed 

by international CAB and satellite offices. In response to this OFI from 

2018, the NOP, in February 2020, will be conducting a training on 

residue sampling procedures at BIOFACH, and there will be a training 

module developed through the Organic Integrity Learning Center. This is 

scheduled.

2019 Strengths.- The Peer Review team identified positive processes and activities during the 

2019 on-site assessment. The following are the strengths identified by the team:

NOP PROCESS COMMENTS

2018 Peer Review 

responses and actions 

taken

The NOP has made a serious analysis of the findings documented in 

2018 by the ANSI team elaborating an action plan.

During this on-site assessment, the NOP demonstrated the 

implementation of the actions in accordance with the action plans 

(several actions already implemented and some of them in process).
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2020 Objectives and 

Goals

The NOP developed Objectives and Goals for 2020. The document lists

six general objectives including the measurable Goals related to each 

objective.

These goals are part of the Performance Task and Appraisal document 

created for NOP staff person.

NOP Resources The NOP has more resources (both, financial and personnel), appointed 

a Quality Manager, and is creating the Accreditation Assessment team, 

with three qualified auditors, and five in training at the time of this Peer 

Review.

Training The creation and implementation of the Organic Integrity Learning

Center is an improvement. Some training courses are still in 

development but the Learning Center is working and supporting the 

knowledge and calibration of the NOP personnel.

Complaints Complaint and Enforcement introduction to a new complaints process

with additional personnel. Additional improvements include data 

analysis, complaints classification, electronic complaints management 

system, and the pasture surveillance audit team. In addition, NOP 4001 

is in revision for finalization.

Publicly Available 

Information

The NOP web-site contains more public information in comparison to 

other Accreditation Bodies. The NOP demonstrates transparency in the 

public information domain.

V. CONCLUSION

This completes the work of the 2019 ANSI Peer Review for the USDA NOP accreditation body. The 

review covers NOP’s compliance with ISO/IEC 17011:2017. The report covers review of NOP’s 

accreditation procedures and decisions, and conformance with ISO/IEC 17011:2017 and 7 CFR Part 205.

The Peer Review Panel members conclude that USDA NOP and staff operate in conformance with 

ISO/IEC 17011:2017, 7 CFR part 205, and NOP’s own policies and procedures with the exception of the 

Opportunities for Improvement identified and documented above in this Report. 

During this on-site assessment, NOP management consistently demonstrated their commitment to 

improvement to the Peer Review team. 

The Peer Review team would like to express appreciation to USDA NOP personnel for their cooperation 

and hospitality during the Peer Review assessment.

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