__________________________________________________________________

Marketing and 

Regulatory

Programs

Agricultural

Marketing

Service

Fruit and

Vegetable

Program

Specialty 

Crops 

Inspection

Division

AIM

Management

Series

Inspection Branch 

Internal Quality 

Management System

Review Procedures 

Guide

October 2013
BIQMS

Review Procedures Guide

This guide is specifically developed and designed by the Specialty Crops Inspection 

Division, Inspection Branch to assist Federal Program Managers and Officers in Charge to 

perform Branch Internal Quality Management System (BIQMS) Reviews.

These instructions do not establish any substantial rule not legally authorized by official 

SCI Division Policy. This publication supersedes any previously issued Review Procedures 

Guides. 

****This publication may not be duplicated without authorization from USDA. ***

This handbook replaces instructions dated July 1998

October 2013
TABLE OF CONTENTS

INTRODUCTION.....................................................................................................................1

THE REVIEWER.....................................................................................................................1

TECHNICAL EXPERTISE NEEDED BY REVIEWERS ...........................................................................1

LEAD REVIEWER..........................................................................................................................2

PERSONAL TRAITS .......................................................................................................................2

INDEPENDENCE AND OBJECTIVITY OF REVIEWERS.........................................................................3

REVIEWS AND REVIEWING................................................................................................3

AUTHORITY TO CONDUCT REVIEWS .............................................................................................3

REQUIREMENT TO MAINTAIN A QUALITY SYSTEM ........................................................................3

PURPOSE OF THE REVIEW .............................................................................................................4

ROLE OF INTERNAL REVIEWS .......................................................................................................4

DEFINITION OF THE REVIEW .........................................................................................................4

PROCEDURES, SPECIFICATIONS AND CONTRACT REQUIREMENTS ...................................................5

HISTORY......................................................................................................................................5

VERIFICATION OF SERVICE INTEGRITY..........................................................................................5

WHEN TO REVIEW........................................................................................................................5

SPECIAL CONCERNS .....................................................................................................................6

ESTABLISHMENT OF TENTATIVE REVIEW SCHEDULE.....................................................................6

OPPORTUNITIES FOR IMPROVEMENT .............................................................................................6

TYPES OF REVIEWS..............................................................................................................7

INTERNAL REVIEWS .....................................................................................................................7

COOPERATOR MANAGEMENT REVIEW..........................................................................................8

EXTERNAL REVIEWS ....................................................................................................................8

INITIAL REVIEW...........................................................................................................................8

PRESEASON REVIEWS...................................................................................................................8

UNSCHEDULED REVIEWS..............................................................................................................8

EXTERNAL AND INTERNAL PROCESS VERIFICATION ......................................................................9

VERIFICATION REVIEWS...............................................................................................................9

PERFORMING THE REVIEW...............................................................................................9

REVIEW PLAN ..............................................................................................................................9

CONTRACTUAL REQUIREMENTS .................................................................................................10

OPENING MEETING ....................................................................................................................10

THE REVIEW..............................................................................................................................10

EXIT MEETING...........................................................................................................................10

WRITTEN REPORT ......................................................................................................................11

CORRECTIVE ACTION .................................................................................................................11

FOLLOW-UP REVIEWS................................................................................................................11

REVIEW CLOSE-OUT ..................................................................................................................12

QUALITY REVIEWING TERMS, DEFINITIONS AND STANDARDS ...........................13

i
INTRODUCTION

The United States Department of Agriculture, Agricultural Marketing Service, Fruit and 

Vegetable Programs, Specialty Crops Inspection (SCI) Division and their respective cooperators 

have approved the review procedures that guide the examination of the quality systems in the 

cooperating states. The SCI Division Branch Internal Quality Management System (BIQMS) 

Quality System Service Standards (QSSS) are the “specifications” or “review standards” of the 

BIQMS program.

The cooperators provide the majority of inspection and process reviewing services within 

the growing and shipping areas of their states with oversight by the SCI Division. The future of 

the Federal-State shipping point inspection service (FSIS) depends upon ensuring that industry 

will continue to use and pay for these services. SCI Division, Inspection Branch and its 

cooperators have agreed upon this type of reviewable quality management system to ensure that 

SPI core values of honesty, impartiality, and customer service are maintained in the absence of

on–site Federal supervision.

A BIQMS Review is a review of the records and procedures of the cooperator made by 

Federal Program Managers (FPMs) who are not involved in the preparation of these records and 

procedures. On the basis of this examination, the reviewers obtain objective evidence to 

determine whether the cooperator’s records are accurate, the appropriate controls are maintained 

and effective, the required procedures have been followed, and whether other criteria have been 

satisfied as outlined in the cooperator’s manual.

The cooperator shall perform periodic management reviews and internal reviews to 

evaluate their quality system. This is done where there is a desire to establish a contractual 

relationship, or to verify within the framework of a contractual relationship that the quality 

system continues to meet specified requirements, and is being implemented. These reviews 

should be done periodically. In addition, reviews should be made when: 

• significant changes have been made in functional areas, for example, reorganizations and 

procedures revisions;

• safety, performance or reliability of the services are suspected to be in jeopardy due to 

non-conformities;

• it is necessary to verify corrective actions have been taken; and

• evaluating the quality management system against the QSSS.

THE REVIEWER

Technical Expertise Needed by Reviewers

This BIQMS Review Procedures Guide has been developed for individuals who have the 

technical experience for inspection of fresh fruits and vegetables and “process auditing” of 

quality systems. Individuals must have formal classroom auditor training, and good 

communication skills. This guide is to assist those individuals in performing verification reviews

1
and other limited scope reviews of a quality management system. It includes information to 

make quality systems reviews as objective as possible.

The review procedure verifies that a “quality manual” based on the QSSS is written and 

approved and the quality system defined in the manual is functioning. The review team should 

review a copy of the cooperator’s quality manual prior to the review. The reviewer(s) should 

ensure that copies of the quality manual are returned to the appropriate office at the conclusion of 

the review. Quality manuals are not for public distribution. The contents are to be treated as 

CONFIDENTIAL.

The reviewers must be perceived as competent and qualified. Confidence in review 

results depends on the reviewer’s proficiency, judgment, and professional conduct. The 

reviewer’s qualifications shall meet those established by the USDA AMS SCI Division.

The review team must have the necessary technical and managerial expertise to perform 

the review. Ideally, the knowledge of each team member complements that of other team 

members. The review criteria are only guides and reviewers should understand the subject well 

enough to identify issues and not be misled. Reviewers must be able to expand the review in 

significant areas when necessary.

Knowledge of the cooperator’s organization simplifies the review planning process. This 

knowledge exposes the FPMs to the cooperator’s program activities. This results in better 

participation in discussions of regulations, quality specifications, standards and procedures in the 

specific areas being reviewed. Identifying discrepancies among these documents and practices 

will give an understanding of non-conformities which have a bearing on the quality system 

services.

Lead Reviewer

The lead reviewer will be pre-determined if more than one person is on the team. The 

lead reviewer makes all assignments, “tie breaking” decisions, leads discussion during 

conference, writes the review report, and presents the report, findings and ratings to the 

cooperator’s management. Other team members, if applicable, may be assigned some of these 

responsibilities, but only at the direction of the lead reviewer. Reviewers shall answer specific 

questions or make specific reports to management during the exit meeting.

Personal Traits

The success of the review is largely dependent upon how reviewers present themselves. 

The credibility of the reviewer, the USDA and the SCI Division depends on the professional 

manner shown by reviewers. Reviewer selection should be made with the following attributes in 

mind:

• Ability to communicate in writing and orally, including choice and flow of speech, 

clarity of thought, and skill in listening, understanding and responding;

• Ability to plan and control an activity, with skills in organizing, initiating, observing and 

analyzing;

• Ability to lead, supervise, delegate, gain acceptance and accomplish objectives;

2
• Ability to gain cooperation between other reviewers, USDA, cooperators, and 

supervisors:

• Ability to reach decisions, separate facts from opinions, compile information and 

evidence, and compare evidence with written standards;

• Ability to administer, keep records, report, and manage budgets;

• Ability to work independently, systematically and energetically;

• Ability to acquire and use special knowledge and skills;

• Ability to adapt to changing work assignments and conditions;

• Good outward appearance and conduct;

• Intelligence, alertness, and ability to comprehend and reason;

• Stable emotions, calm, self-confident, persistent, insistent and task oriented;

• Good character, honest, reliable, constructive, helpful and diplomatic; and

• Good attitude, values, interest, work habits, initiative, carefulness, curiosity and open 

mindedness.

Independence and Objectivity of Reviewers

The reviewer’s independence rests on the absence of conflict of interest in organizational 

relationships and in mental attitude with respect to the review and judgments relating to the 

review. The review plan should consider this since confidence in the results of the review

depends upon the known and perceived independence of the reviewer.

REVIEWS AND REVIEWING

Authority to Conduct Reviews

Quality reviews should encompass all aspects of the quality system. With this in mind, 

the authority for conducting reviews must come from and be supported by the cooperator’s upper 

level management. Without this authority, cooperation and the value of the quality reviews are 

limited.

The written policy of the cooperator and the cooperative agreement with the USDA are 

the most common places to find authority and support for conducting quality reviews. Support 

from the highest level of management is essential for quality reviews to achieve their maximum 

benefit. Reviews required by contract or specification mean little if the requirement is not 

openly supported by management policies, statements and actions.

Requirement to Maintain a Quality System

The requirement to plan and maintain a quality program is stated in the cooperative 

agreement. The assessment of program effectiveness will be through internal cooperator reviews 

as well as external (second party) USDA reviews. This requirement can be found in the QSSS 

and the cooperator quality manual. The FPMs are responsible for establishing and developing 

procedures to identify the scope of the external reviews. These review procedures should be 

coordinated with the cooperator’s management for their concurrence and support. The reviews 

3
will provide cooperator management with reliable information while identifying opportunities 

for program improvement.

Purpose of the Review

A clear definition and policy from the cooperator’s upper level management as to the 

purpose of a quality review is critical to its success, not only to assure that senior management 

becomes involved, but so management’s support can be relied on if an impasse is reached. This 

reviewing policy is established to focus program support and to provide instructions to verify on 

a regular basis, that each segment of the program is in compliance with the QSSS and the

cooperator’s quality manual. This policy should give each cooperator assurance that the program 

services performed are maintained at an acceptable level.

Coordinating the review plan with the organization to be reviewed is critical to ensure 

understanding of the purpose of the review. The purpose of the review is not to find fault but to 

focus the attention of the management to areas where the program can be improved. 

Role of Internal Reviews

Internal reviews provide documentation of the effectiveness of a quality system. The 

USDA recognizes that the cooperator’s internal reviews provide an increased assurance that 

consistent quality services are being provided to the industry. SCI Division, Inspection Branch 

reviewers should examine the cooperator’s internal reviews and evaluate the corrective action 

taken for any non-conformity.

Definition of the Review

The review must be clearly defined and understood by both the cooperator and the 

reviewer. Most reviews are performed during the training and harvesting season. Both parties 

must understand the need to review during this time and know what the review will entail. In 

both internal and external reviews, the reviewer must assure that the cooperator’s management

understands the following:

• The scope of the review;

• When the review will be conducted and the anticipated duration;

• Who will conduct the review;

• What will be expected of the cooperator before, during, and after the review;

• Review findings are measured against the criteria found in the QSSS and the cooperator’s

quality manual; and

• How the review results will be used.

Therefore, the planning phase should include the reviewer’s preparation of an agenda notifying 

the cooperator of these considerations.

4
Procedures, Specifications and Contract Requirements

A review should start with an objective and thorough review of applicable requirements 

in the cooperator’s quality manual, procedural manuals, work instructions, contract 

specifications and regulations. Any cooperator-generated specifications or other requirements

that identify operational needs outside the cooperator’s normal, inspection or process auditing

services provided under agreement with the SCI Division Inspection Branch should be identified.

These should be used in the review planning and preparation phase if applicable.

History

An effective way to evaluate the expected usefulness of procedures and to develop a

review plan is to review a cooperator’s performance history. A thorough understanding of the 

history is important to the planning and development of the review checklist. Service integrity 

should be reviewed, and areas that could have an impact on industry acceptance of the program’s

services should be specifically added to the scope of the review. This includes verification of 

corrective actions, industry satisfaction, appeals and re-inspections, statistics, etc. Depending on 

the service, any and all of these may apply. Former problem areas need to be evaluated to ensure 

that the corrective action was effective in preventing further similar occurrences.

The reviewer should be aware that bias and pre-judgment can occur when, in planning 

the review, the focus is on the former problem areas and corrective actions.

Verification of Service Integrity

A verification review is performed to verify the adequacy of services provided by the 

cooperator. Any non-conformity found should lead to improvements to meet employee and 

industry expectations more reliably. The primary purpose of documenting non-conformities 

during a review is to identify services that can be improved. A verification review is performed 

when specific areas of concern are identified or when reliability needs to be confirmed. This 

type of review should occur at various times during the service activity. First and middle level 

managers should cooperate to avoid unnecessary conflicts. This cooperative support is a positive 

step in any review and the success will depend on how these managers view the review function.

When to Review

The quality management system should identify non-conformities as early as possible 

through the timely reviews. This early detection allows management to implement corrective 

action before non-conformities actually affect delivery of services. It should also prevent

recurrence of the non-conformity.

The frequency of reviews is determined by the complexity and scope of a particular 

cooperator’s program. Larger and more complex programs may require more reviews in order to 

provide full confidence that all parts of a program are being serviced adequately. Review 

frequency is also influenced by the number of commodities inspected, process auditing services 

provided and the number of offices a cooperator has under its program. The quality, frequency 

and findings of the cooperator’ internal reviews should also influence the number of reviews 

performed by SCI Division Inspection Branch reviewers.

5
All cooperators shall be treated equally, proportionate to the complexity and scope of the 

particular program.

Special Concerns

Quality systems require internal reviews, especially when service problems or customer 

complaints are encountered. Often these concerns can be documented by a well-planned review. 

The problem areas could be detected from records control, excessive rejections in receiving 

inspections, a reduction in productivity, personnel problems or industry concerns. These reviews 

normally receive maximum visibility and usually are directed by upper management. Caution 

should be taken to avoid overly frequent reviews in the same area as this could lead to the review 

function losing the sense of urgency and cooperation from middle management.

Establishment of Tentative Review Schedule

Federal Program Managers shall make a tentative review schedule for each cooperator’s 

program based on the types of services provided under USDA oversight, the number of 

commodities, when the commodities are in season, and the location and number of offices within 

the program. There should be a minimum of one BIQMS review annually for each different 

segment of a cooperator’s the program. Reviews for a specific segment of the program could be 

considered “targeted” in the respect that the FPMs may identify a narrower review scope of “PLI 

procedures,” or “equipment,” for example. In these cases, the subject area is targeted in order to 

determine how a cooperator controls that area throughout their program

Reviews should be scheduled to cause the least amount of disruption to both the reviewer

and the service delivery. Production schedules, vacations, unusually heavy workloads, etc., 

should be considered. Establishing a tentative time agreeable to the cooperator can help foster a 

good relationship with the cooperator. However, sometimes reviews must be performed during 

busy production and servicing times. Even then they should be planned to cause as little 

disruption as necessary.

Opportunities for Improvement

A review generally encompasses every aspect of the service provided by the cooperator 

and industry acceptance of that service. One objective of the review is to determine if the 

program has kept up with advancements made within the industry. A review of a specific 

operation within the program (i.e., limited scope review) is a prime example of an evaluation that 

may identify opportunities for improvement.

Reviews may reveal that procedural processes need to be evaluated. Sometimes a

cooperator’s inspection or process auditing program cannot be understood due to lack of 

instructions. Other times too many procedures address the same subject and confuse the issue. 

Cooperators understand the economics of their operation, so when a more economical method 

can be suggested through a review report, its value to the cooperator will be recognized and 

management support will increase.

Observations during the review which are not considered serious enough for immediate 

attention, should be recorded on the review report under the “General Comments” or 

6
“Observations that may lead to Non-Conformities” sections and be discussed during the exit 

meeting. This should result in program improvement. Reviewers should use caution not to use 

the “General Comments” section to the extent that is detracts from the central purpose and scope 

of the review.

TYPES OF REVIEWS

Internal Reviews

The internal reviews are conducted by the cooperator to verify whether the various 

elements in their quality system are implemented effectively and are achieving the quality 

objectives as defined by management. It is especially important to assure that the services 

provided are being maintained to meet USDA requirements and that the services meet or exceed 

levels as outlined in the cooperator’s quality manual.

Reviews are performed in accordance with the cooperator’s quality manual which 

establishes the frequency of the reviews. This frequency is based on the status and importance of 

the activity being reviewed. Therefore, in areas where problems exist, or in areas which are 

more critical to the quality of the services provided, more frequent reviews are likely to be 

carried out. In addition these reviews are performed when specific program needs are identified. 

Even though past reviews may indicate an acceptable service delivery, future reviews should be 

scheduled because people, places and situations affecting a cooperator’s operation change over 

time.

Four factors are essential for any review system to be effective.

1. The cooperator must select and assign trained competent quality systems personnel to 

review each segment of their program functions.

2. The review must be performed against defined and documented criteria such as the 

QSSS, the cooperator’s quality manual, program instructions, a customer’s contract 

and/or other formal requirements. Without a clear set of defined criteria, variability and 

subjectivity will be introduced into the process as each review may be influenced by the 

biases and personal work experience of the reviewer.

3. Clear, accurate and complete review records must be maintained. Details of these 

records will include: the scope of the quality system that was examined; positive

observations and negative findings; and verification that effective corrective actions were 

implemented to deal with the root cause of problems (if/when non-conformances are 

identified).

4. A report of the review must be sent to management.

The review plan for an internal review should include a complete review of recent nonconformity reports and corrective actions as well as review of facilities, equipment, and 

personnel training that are within the scope of the review.

7
Cooperator Management Review

An internal management review program is vital to assure cooperator management that 

its program is accomplishing their quality objectives and maintaining the services delivered to 

industries they serve. This type of review should be conducted upon initial implementation of a 

quality system, process, or procedure, and periodically thereafter. Lower level supervisory visits 

should be reviewed by management to assure adherence to the cooperator’s quality manual.

The dynamics of change is constant. Cooperators need to prepare themselves for any 

adverse effects of change. Management decisions may be made to address changes. A regularly 

scheduled internal verification review of their quality program keeps management abreast of the 

following possible circumstances:

• Licensees may become lax in procedural rules and regulations.

• Licensees may transfer or quit, putting less experienced people into a position, sometimes 

without adequate training.

• Licensees may develop more efficient methods and training without documentation.

• Changes in specifications may not always be communicated effectively.

• Shortcuts may be taken.

External Reviews

An external review is performed by the FPMs on a cooperator’s program to evaluate the 

quality of services provided on behalf of USDA, as outlined in the quality manuals. This 

requirement is based on the QSSS.

Initial Review

An initial review affords the opportunity to identify strengths and weaknesses of a 

service, process, or product. This review is then used to initiate improvements aimed at assuring 

the future integrity of the program. The initial review also establishes a baseline that may be 

used to evaluate and measure future progress. Planning should be thorough and include all 

functions or elements of the quality system, and should be performed as early as possible. This 

can apply to both internal cooperator reviews as well as external USDA BIQMS reviews.

Preseason Reviews

The preseason review should be performed before program services begin. Planned 

inspection or other service (process reviewing) requirements, if appropriate at this time, should 

be made to assure that all aspects of the program have been considered.

An advantage of the preseason review is that there is an opportunity to review personnel 

needs, calibration systems and measurement and test equipment prior to performing the service. 

The preseason reviews often show that equipment and personnel needs are met, however they 

must be evaluated periodically to assure continuous quality service is provided.

Unscheduled Reviews

Reviews should be planned and coordinated in advance when possible but there are 

situations that may require unscheduled reviews. In most cases, an reviewer can find a nonconformity if one exists. In the case of suspected wrongdoing, if prior notification could allow 

8
the opportunity to hide the “real information,” significantly jeopardizing the reliability of the 

review judgment, then the review should be unscheduled.

Unscheduled reviews are usually sensitive and require a great deal of diplomacy. This 

type of review may be necessary if intentional unethical or illegal practices or procedure 

violations are suspected. This type of review should be used sparingly as the “got you” kind of 

interface it may produce could cause many hard feelings.

External and Internal Process Verification

Process verification is achieved through the cooperator’s internal supervisory checks and 

by external BIQMS reviews performed by FPMs. These reviews consist of observing the 

product and observing the licensee performing the service to determine if their actions are in 

compliance with the specified requirements. Observations should include conditions such as 

work site, rules as applied to industry employees, safety regulations, use of current 

specifications, etc. The review should determine if inspectors require special training, education, 

experience, or certification.

Verification Reviews

Verification reviews are generally scheduled. Review frequencies should be varied from 

one review to the next so as not to develop a predictable pattern. Cooperators may be contacted 

to get information pertaining to their service delivery schedule. If the reviewer arrives to 

perform a review and there is no activity, the scope of the review can be limited, for example, to 

records review. This is an option that should be used sparingly.

PERFORMING THE REVIEW

Review Plan

The scope of the review must be determined and if necessary, narrowed to a specific area. 

The reviewer must research data and develop an organized checklist. The Review should be 

planned so that it is organized and follows a systematic review path.

The development of the checklist is a part of the review planning process. If standardized 

checklists are used the reviewer may develop follow-up questions that apply to the specific scope 

of the review. The source from which each question or item on the checklist is derived should be 

identified. A note can be made that the item is from procedures, regulations, contract 

requirements, or quality objectives, etc. This adds credibility and is useful in referencing nonconformity reports.

A sampling plan that ensures effective representation must be based on the services

provided as well as knowledge of previous reviews and the corrective actions or current 

problems. When the cooperator has implemented preventive actions as the result of a review, the 

adequacy of those actions should be evaluated. It is vital that reviewers be aware of preventive 

actions taken so they may prepare for the current review criteria.

An integral element of the review planning is an awareness of a possible need for followup. The reviewer should allot sufficient time at a future date to perform a follow-up review 

regarding any findings made during the current review.

9
Contractual Requirements

Two key elements to understanding review requirements are the cooperator’s contract 

review process and the communication of the contract requirements to internal and external 

parties. When contracts or requests for service specify certain information, the internal review 

system must address those items. The internal reviews should determine whether or not the 

cooperator’s employees have complied with the services required or requested in the 

“contract/request for service” or “application for service”. The reviewer must recognize the 

requirements of the contract. Non-conformities in contract services during a review should be 

corrected with a great sense of urgency; otherwise the potential for loss can be considerable.

Opening Meeting

Every review must have an opening meeting regardless of the type or scope of the 

review. At a minimum, the opening meeting will be attended by the reviewer and a 

representative of the cooperator. Additional management personnel and representatives may be 

invited to attend by the cooperator. Occasionally the opening meeting may be by telephone.

The meeting should be scheduled in advance and upper level management should be 

notified. The meeting is useful in affirming the type and scope of the review to be performed, 

the expected duration of the review, what facilities will be reviewed and what the reviewers’

needs are. The opening meeting times and persons present must be documented in the review 

report.

The Review

Reviewers must know their particular assignment as well as the products and program 

areas being reviewed. Each concern or issue identified during a review should be confirmed 

before leaving the area where it was detected. The responsible supervisor of the affected area 

should give confirmation as to the non-conformity. During the review, the reviewer should 

observe the program and document any observations or findings that may be contrary to the 

quality management system. Positive observations of processes and procedures should also be 

noted. Any notes or other documentation will become part of the review working papers. The 

cooperator’s management should be notified if the review process leads outside of the 

predetermined scope of the review.

Exit Meeting

Every review must have an exit meeting attended by the reviewer and a management

representative. The exit meeting allows the cooperator’s management to understand and ask 

questions concerning review observations and findings. If management wishes to rebut findings 

they should be allowed time during the exit meeting. The reviewer should be prepared to justify 

any findings or non-conformities with a rating standard from one of the cooperator’s documents 

or the QSSS. The cooperator may present information that satisfies the findings or nonconformities of the review. A successful exit meeting results in the management being in a 

position to begin corrective action, if needed. Information brought up during this meeting may 

10
also affect the formal written report. The time and attendees of the exit meeting must be 

documented.

Written Report

The product of a review is a written report. While the format of the report may vary, it 

should follow the USDA SCI Division procedure for conducting reviews. The report should 

include the cooperator’s responses to the findings and incorporate them into a final summary for 

distribution. The value of such an approach is that it provides cooperator management with 

corrective and preventive actions along with review findings. Regardless of the format used, the 

review report should identify who has responsibility for an action and should provide a date 

requiring a response plan for corrective and preventive actions.

The review report and any non-conformity reports should be transmitted to the SCI

Division Inspection Branch, Federal-State Inspection Management Section when the review is 

complete. An electronic or a hard copy of the review report should be given or transmitted to the 

cooperator’s representative as soon as possible after the conclusion of the review. The FPMs 

shall maintain a file of review reports with original signatures. The file should include all the 

review working papers.

Corrective Action

The primary purpose of the review is to verify compliance, or when non-conformities of 

the program are noted, to require corrective action. When criteria are identified as needing 

correction, the reviewer should document the findings and the related criteria on a nonconformity report (NCR). The corrective action should be proposed by the cooperator on a 

corrective action report (CAR). The reports may be combined on one page. It is appropriate to 

request in the review report that a formal corrective action plan be prepared by the cooperator 

describing the cause of the problem(s), the actions that will be taken, who will take them, and 

when the action will be effective.

An appropriate corrective action plan corrects the specific non-conformity, identifies the 

root cause of the non-conformity, and schedules the action to prevent a recurrence. Correcting a 

specific non-conformity may be easy; identifying the root cause is often difficult. Successful 

identification of the root cause increases the likelihood that a corrective action will prevent 

recurrence of a non-conformance. The corrective action plan submitted by the cooperator will be

evaluated by the FPMs and SCI Division Inspection Branch.

Follow-Up Reviews

The need for a follow-up review is determined after submission and acceptance of a 

corrective action plan. This must always be included in the review schedule. Not allowing time 

for follow-up reviews creates a hardship for the reviewer and hinders the value of future reviews.

A non-conformance will require follow-up to verify the corrective action’s effectiveness 

and adequacy. Records must reflect follow-up on non-conformities particularly when the 

cooperator is subject to external reviews.

11
If the planning for the next verification review incorporates checks on previous nonconformities or findings, then a specific follow-up review may not be necessary. However, with 

some shipping seasons so short, follow-up should be planned and completed within 5 days so the 

reviewer can confirm whether or not the corrective action was put in place and effective prior to 

the season ending.

Review Close-Out

There is a tendency to consider the review complete when the review report is issued. 

However, the review is not complete until the reviewer is confident that the actions needed to 

correct the non-conformities have been implemented and are effective. Therefore, review closeout should take place only after documentation of appropriate follow-up action.

12
QUALITY REVIEWING TERMS, DEFINITIONS AND

STANDARDS

ANSI/ASQC Q90, Quality Management and Quality Assurance Standards 

ANSIIASQC Q1, Generic Guidelines for Reviewing Quality Systems 

ANSI/ASQC A3, Quality Systems Terminology 

ANSI N45.2.10-1973, Quality Assurance Terms and Definitions

CAN3-Q395-81, Quality Reviews 

ISO 8402 (1987), Quality Vocabulary 

Assessment An estimate or determination of significance, importance or value of 

something.

Cooperator An organization to be reviewed.

Certification The procedure and action, by a duly authorized body, of determining, 

verifying, and attesting in writing to the qualifications of personnel, 

processes, procedures, or items in accordance with applicable 

requirements.

Characteristic A property that helps to identify or to differentiate between entities and that 

can be described or measured to determine conformance or non 

conformance to requirements.

Client The person or organization requesting the review. Depending on the 

circumstances, the client may be the reviewing organization, the 

cooperator, or a third party.

Compliance An affirmative indication or judgment that the supplier of a product or 

service has met the requirements of the relevant specifications, contract, or 

regulation; also the state of meeting the requirements.

Conformance

Conformity

An affirmative indication or judgment that a product or service has met the 

requirements of the relevant specifications, contract, or regulation; also the 

state of meeting the requirement.

Contractor Any organization under contract to furnish items or services; a vendor, 

supplier, subcontractor, fabricator, and sub-tier levels of these, where 

appropriate.

Convention A customary practice, rule or method.

Corrective action Action taken to eliminate the root cause(s) and symptom(s) of an existing 

undesirable deviation or non-conformity to prevent recurrence.

Critical Control 

Point

A point or operation, beyond which if not controlled, non-conforming 

services will be produced.

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Deviation A non-conformance or departure of a characteristic from specified product, 

process, or systems requirements.

Finding A conclusion of importance based on observation(s).

Follow-up review A review, the purpose and scope of which is limited to verifying that 

corrective action has been accomplished as scheduled and determining that 

the action prevented recurrence effectively.

Guidelines Documented instructions that are considered good practice but are not 

mandatory.

Independence Freedom from bias and external influences.

Inspection Activities such as measuring, examining, testing, and gauging one or more 

characteristics of a product or service and comparing these to specified 

requirements to determine conformity.

Internal review A formal evaluation by top management of the status and adequacy of the 

quality system in relation to the quality policy and new objectives resulting 

from changing circumstances.

Non Conformance

Non Conformity

The non-fulfillment of specified requirements.

Objective evidence Verifiable qualitative or quantitative observations, information, records, or 

statements of fact pertaining to the quality of an item or service or to the 

existence and implementation of a quality system element.

Observation An item of objective evidence found during a review.

Procedure A document that specifies the way to perform an activity.

Process quality 

review

An analysis of elements of a process and appraisal of completeness, 

correctness of conditions, and probable effectiveness.

Product quality 

system

A quantitative assessment of conformance to required characteristics.

Qualification The status given to an entity or person when the fulfillment of specified 

requirements has been demonstrated; the process of obtaining that status.

Quality All the features and characteristics of a product or service that bear on its 

ability to satisfy stated or implemented needs.

Quality assurance All those planned and systematic actions necessary to provide adequate 

confidence that a product or service will satisfy specified requirements for 

quality.

Quality review A systematic and independent examination and evaluation to determine 

whether quality activities and results comply with planned procedures and 

whether these procedures are implemented effectively and are suitable to 

achieve objectives.

Quality control The operational techniques and activities that are used to fulfill 

requirements for quality.

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Quality documents Documents that form part of a cooperator’s quality system, including 

manuals, written procedures, organizational charts, work instructions, 

plans, designs, drawings, specifications, test methods, job descriptions, preprinted forms, tags, labels, and all kinds of records related to the quality 

system.

Quality 

management

The aspect of the overall management function that determines and 

implements the quality policy.

Quality manual A document stating the quality policy, quality system, and quality practices 

of an organization. A document produced by a cooperator to describe the 

quality system in operation that satisfies the specifications of the quality 

assurance system.

Quality plan A document setting out the specific quality practices, resources, and 

activities relevant to a particular product, process, service, contract or 

project.

Quality policy The overall intentions and direction of an organization regarding quality, as 

formally expressed by top management.

Quality surveillance The continuing monitoring verification of the status of procedures, 

methods, conditions, products, processes and services and the analysis of 

records in relation to stated references to ensure that requirements for 

quality are being met.

Quality system The organizational structure, responsibilities, procedures, processes and 

resources for implementing quality management.

Quality system 

review

A documented activity performed to verify, by examination and evaluation 

of objective evidence, that applicable elements of the quality system are 

suitable and have been developed, documented, and effectively 

implemented in accordance with specified requirements.

Record Any written or printed findings or results pertaining to design, inspection, 

testing, reviewing, surveying, reviewing or other observations related to the 

quality system.

Review A planned, independent, and documented assessment to determine whether 

agreed-upon requirements are being met. An review.

Review program The organizational structure, commitment, and documented methods used 

to plan and perform reviews.

Review standard The authentic description of essential characteristics of reviews that reflects 

current thought and practice.

Review team The group of individuals conducting a review under the direction of a team 

leader.

Reviewer The individual who carries out the review. A person who is trained and 

designated to perform reviews of documented quality assurance systems. 

An reviewer.

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Reviewing 

organization

A unit or function that carries out reviews through its employees. This 

organization may be a department of the cooperator, a client, or an 

independent third party.

Survey An examination for some specific purpose; to inspect or consider carefully; 

to review in detail. (Note: some authorities use the words “review” and 

“survey” interchangeably. “Review” implies the existence of some agreedupon criteria against which the plans and execution can be checked. 

“Survey” implies the inclusion of matters not covered by agreed-upon 

criteria.)

Testing A means of determining an item’s capability to meet specified 

requirements by subjecting the item to a set of physical, chemical, 

environmental or operating actions and conditions.

Traceability The ability to trace the history, application, or location of an item or 

activity and like items or activities by means of recorded identification.

Verification The act of reviewing, inspecting, testing, checking, or otherwise 

establishing and documenting whether items, processes, services, or 

documents conform to specified requirements.

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