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2020 ANAB Peer Review Report

For 

Agricultural Marketing Services (AMS)

National Organic Program (NOP)

Dates of Review Panel:

September 15 - 17, 2020

Prepared by

ANSI NATIONAL ACCREDITATION BOARD 

1899 L Street, 11th Floor

Washington, DC 20036

Document: 2020-USDA-PeerReviewPanel-1-0-LLEM
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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

 2020 Opportunities for Improvement .............................................................................. 8

 2020 Strengths.................................................................................................................................8

V. CONCLUSION................................................................................................................... 9
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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 September 15 to 17, 2020

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

Technical Reviewer: Susan Ranck

Technical Reviewer: Jean Richardson

ANSI Staff: Reinaldo Figueiredo, ANSI Senior Program Director

Elizabeth Okutuga, ANSI, Accreditation Manager

Report Prepared by:

 Mario Llerenas

Jean Richardson

 Susan Ranck

Submitted on: October 22, 2020
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II. SCOPE

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

ANSI National Accreditation Body (ANAB) convened this panel on August 12, 2020.

The peer review panel is tasked to: 

• Evaluate the NOP’s policies, processes and procedures for conformance to NOP 

regulations 7 CFR Part 205 and ISO/IEC 17011:2017.

• Focus on the updated ISO/IEC 17011:2017 standard and the revised risk-based 

changes to the standard 

• Review implementation of certification body accreditation processes through 

select file review

• Include a review of three accreditation decisions issued by the NOP 

• Review the USDA NOP oversight process

• Review the NOP accreditation division process, focused on sections 6 and 7 of 

the ISO/IEC 17011 standard

• Identify area(s) 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

Susan Ranck – Risk Assessment Evaluator; ANAB Technical Expert Assessor in Food 

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; ANAB

Food Safety Lead Assessor

ANAB Staff - Elizabeth Okutuga, Accreditation Manager, ANAB staff, ISO/IEC 17011 process 

knowledge and project coordinator.

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

17011 evaluator. Contract/Project Manager.

Document Review - The review panel conducted a Document Review and completed a working 

document before the remote evaluation. The working document including the tentative schedule of 

the personnel to interview during the remote assessment was created on September 4, 2020 and 

sent to USDA NOP. The Peer Review Team used the working document for taking notes during the 

remote assessment, and the findings are included in this report.

Assessment Plan

The Remote Assessment Plan was issued on September 3, 2020; this version was approved and signed 

by the Quality Manager of USDA NOP. The assessment plan approved by USDA NOP is uploaded in

ANSICA, the ANAB database.
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Opening / Closing Meetings

In accordance with the assessment plan, an opening meeting was conducted on Tuesday, the 15th of 

September, 2020 at 11:00 am with five NOP senior staff in attendance and the members of the ANAB

Peer Review team. At the end of the opening meeting, the NOP Deputy Administrator, Jennifer Tucker, 

explained the key changes in the organizational structure of the NOP, the accreditation process, and its 

relationship with other governmental departments.

The closing meeting for the remote assessment was conducted on Thursday, 17th of September 2020 at 

4:00 pm with six NOP persons in attendance and the three assessors of the Peer Review team. The 

results of the remote assessment were discussed during the closing meeting: Two new opportunities for 

improvement (OFIs) were documented and three OFIs remain open from the 2019 Peer Review as 

presented in the Section IV of this report

Additional Comments

The Management System of USDA NOP is very well implemented and functions in accordance with 

ISO/IEC 17011:2017 and US 7 CFR Part 205, National Organic Program requirements with the exception 

of the OFIs identified.

The Peer Review team was very impressed by the improvements in the organization, resources and 

accreditation process since the last Peer Review in 2019. Significant improvements have been 

implemented since the last Peer Review in both the QMS and the Accreditation Process.

The NOP personnel demonstrated sound knowledge in both management system and technical 

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 

Part 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 are 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 2019 were both documented and reviewed by the Peer 

Review team during the 2020 remote assessment in order to verify the effectiveness of the actions 

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

2019 Opportunity for 

Improvement

2020 Verification of the effectiveness

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.

The OFI identified in 2019 was reviewed and remains open:

2020-USDA NOP-01-O-LLEM-(17011) 4.4

The NOP is updating its Quality Manual including the Risk 

Analysis Methodology in accordance with the ISO/IEC 17011:2017 

requirements; however, these documents were not completed at 

the time of this Peer Review.

The NOP ́s revised Quality Manual NOP 1000 is in the process of

being finalized and states in the section 4.4 “The NOP identifies, 

evaluates, mitigates and documents potential risks to impartiality 

including conflicts of interest arising from its relationship and the 

relationships of its personnel on an ongoing basis. The NOP 

records identified perceived risks to the impartiality of the NOP’s 

operations and accreditation activities, in NOP 1009 Risk 

Mitigation Table”

The draft of the NOP 1009 Risk Mitigation Table was reviewed.
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NOP should finalize the new version of the Quality Manual as well 

as the Risk Mitigation Table.

ANAB recommends for NOP to review the ISO 31000 Risk 

Management – Principles and Guidelines for improving the 

creation of the Risk Mitigation methodology.

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

One OFI identified in 2019 was reviewed and remains open:

2020-USDA NOP-02-O-LLEM-(17011) 5.6

The NOP is in the process of updating the Quality Manual and 

several documents related to the management system; However, 

at the time of this Peer Review, the responsibilities and authorities 

of all NOP positions of the expanded organizational chart (NOP 

1001 May 28, 2020) are not consistent with the current document 

NOP 1002.

During the revision of the Quality Manual and other QMS 

documents, the NOP is archiving and combining some documents 

in order to have a more efficient QMS documentation. One of the 

documents to be archived is NOP 1002 Duties, Responsibilities 

and Authorities.

NOP should finalize the revision and release of the new QMS 

documents, verifying that the duties, responsibilities and 

authorities are consistent with positions in the Organizational 

Chart.

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

The NOP has an 

opportunity to improve the 

effectiveness of its 

implemented document 

control procedure.

One OFI identified in 2019 was verified and remains open:

2020-USDA NOP-03-O-LLEM-(17011) 9.3

The Peer Review Team reviewed the drafts of the new version of 

the Quality Manual and NOP 1010 Document Development, 

Review and Distribution Process, and both of these are still in 

process and not yet completed.

The control of the documents was improved and now the 

documents are in PDF files.

The draft version of NOP 1010 includes the Control of Records 

and External documents; however, this section is not yet finalized. 

NOP should finalize NOP 1010 new version and complete the 

release process.

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.

One OFI identified in 2019 was verified and is effective:

2019-USDA NOP-04-O-NEUM-(17011) 9.5 b)

As a result of the QMS documental revision, NOP has archived

the NOP 1020-1 Corrective and Preventive Action Work Plan and 

the NOP 2010-2 Corrective and Preventive Action Summary.

NOP 1020 Corrective Action Procedure section 4, clause 4.2 

states the NOP will determine the cause of each nonconformance 

or OFI.

Closed
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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.

One OFI identified in 2019 was verified and is effective:

2019-USDA NOP-05-O-NEUM-(17011) 9.7.1, 9.7.4, 6.3

The new procedure NOP 1030 Internal Audit Procedure Rev05 

(dated July 30, 2020) addresses the policies and procedures for 

internal audits conducted by the National Organic Program (NOP) 

of its accreditation activities.

The implementation and effectiveness of the new NOP 1030 

Internal Audit Procedure was verified during remote review.

All records of the last Internal Audit are in accordance with the 

NOP policies and procedures and complies with the ISO/IEC 

17011 requirements.

Closed

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.

One OFI identified in 2019 was verified and effective.

2019-USDA NOP-06-O-NEUM-(17011) 9.8.2

The new procedure NOP 1040 NOP Management Review Rev06 

(July 29, 2020) addresses the policies, procedures, and 

responsibilities for conducting NOP management reviews. 

NOP 1040 requires that the NOP conducts a management review 

at least once each calendar year to ensure its continuing 

adequacy and effectiveness in satisfying the requirements of the 

USDA organic regulations, ISO/IEC 17011, and the NOP’s stated 

policies and objectives. 

The agenda is included in the new version of the Quality Manual 

NOP 1000.

The inputs and outputs are also included in the new version of the 

NOP 1040 and are according to the ISO/IEC 17011 requirements.

The records of the last Management Review were evaluated 

during this Peer Review and found to be in accordance with the 

NOP procedure and the ISO/IEC 17011 requirements.

Closed

3. 2020 Opportunities for Improvement. During this remote assessment, the Peer Review team 

identified two opportunities for improvement. The following are the 2020 opportunities for 

improvement (OFIs) documented by the review panel:

Requirement Opportunity for 

Improvement

Evidence

17011:2017

7.6

The accreditation body shall 

have documented procedures 

for describing the assessment 

techniques used, the 

circumstances in which they are 

to be used and the rules for 

determining assessment 

durations. The procedures shall 

2020-USDA NOP-05-ORANS-(17011)7.6

The accreditation body does 

not have a documented 

policy/procedure for the 

timely completion of 

assessments.

File reviews and discussion with the 

management staff indicate there is 

no formal policy for the completion 

of assessment activities. This lack 

of definition makes it difficult for the 

organization to determine adequate 

resources to meet assigned 

deliverables.
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include how the accreditation 

body will report the assessment 

findings to the conformity 

assessment body.

ISO/IEC 17011:2017, section

7.4.7

The accreditation body shall 

develop an assessment plan to 

cover the activities to be 

assessed, the locations at which 

activities will be assessed, the 

personnel to be assessed where 

applicable and the assessment 

techniques to be utilized 

including witnessing where 

appropriate or applicable. The 

accreditation body shall justify 

where witnessing is not 

appropriate or applicable.

2020-USDA NOP-06-ORANS-(17011)7.11.2

The organization does not 

have a defined process for 

completion of certifier 

satellite offices as part of the 

accreditation cycle.

There is no formal policy for 

satellite office visits as part of the 

accreditation cycle. A tracking 

document was presented as an 

historical illustration but was not 

currently in use.

2020 Strengths. The Peer Review team identified positive processes and activities during the 

2020 remote assessment. The following are the strengths identified by the team:

NOP PROCESS COMMENTS

2019 Peer Review 

responses and actions 

taken

The NOP made a complete analysis of the findings documented in 2019

by the ANAB Peer Review team and presented an action plan.

During this remote assessment, the NOP demonstrated the 

implementation of the actions in accordance with the action plans. 

There are three OFIs from 2019 where the actions are not yet 

completed; however, the action plan appears to be adequate to avoid 

the recurrence of the findings.

Organic Integrity 

Learning Center

Records indicate a high level of attendance at training sessions

conducted by the Organic Integrity Learning Center (OILC) established 

in May 2019. Data indicates 3144 persons presently enrolled in the 

OILC. This includes certifier staff and inspectors worldwide. Additional

training modules will be developed in 2021 to improve competency of 

inspectors and certifiers.

Auditors The NOP has addressed the need to conduct audits worldwide in a 

timely manner through the restructuring of the Accreditation Division to 

include both Accreditation Managers and Auditors. With additional

resources, the NOP has been able to eliminate the outsourcing of 

Auditors to QAD, and move to a group of in-house, full time Auditors with 

the goal of increasing to 8 full time Auditors in the next fiscal year. 

Residue Sampling The NOP has taken actions to address the issue of inconsistencies in 

residue sampling in different countries around the world through training

and a new course in the OILC. Previous Trainings were well attended by 

all except 4 of the 77 certifiers. The trainings will continue to be available 

and be updated as necessary.

Materials Review The NOP seeks to assure consistency in materials review including inert

materials and is in the process of hiring a Materials Specialist for the 
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Standards Division. The NOP plans to hire two additional Materials 

Specialists in the next fiscal year.

ACCREDIT System The NOP has established a system to ensure ease of access for all staff 

to documents remotely. Evidence indicates that this system is 

streamlining work and eliminating inconsistencies.

Documentation and 

Control of Documents

The NOP has worked over the last three years to update its document 

control system.

At this time, the documentation of the Quality System remains under 

revision. The new Quality Manual in accordance with ISO/IEC 17011 is 

the key document in the QMS remains in draft form, but is very well 

documented. 

Adittionaly, several documents were archived and/or combined, an 

action that will lead to more effectiveness in the system

Complaint Process The NOP demonstrated a sound improvement in handling complaints.

The Compliance & Enforcement Division acts in a more robust manner 

and the effectiveness of the complaint process has been improved.

V. CONCLUSION

This report completes the work of the 2020 ANAB 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, 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 remote 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 commitment during the Peer Review assessment.

--------------------------------------------- END OF REPORT ----------------------------------------------