**USDA Process Verified Program**

This document can be used to help a company develop a quality manual
which addresses all of the requirements of the USDA Process Verified
Program. Page 1 includes important points to remember when developing a
quality manual. The program requirements begin on page 2.

When implementing a quality management system based on the USDA Process
Verified Program, the content of the quality manual must reflect the
Process Verified Program requirements and applicable policies, although
it does not need to match the format. A company must create a quality
manual that describes its processes and procedures.

Some important points to remember:

1.  A quality manual must describe the company's processes and
    procedures as they relate to the Process Verified Program. You can
    reference existing procedures, work instructions, forms, etc within
    the quality manual. (see #4)

2.  Say "what" you do and "how" you do it. It is not sufficient to
    simply state that you do something.

3.  Write in present tense (what are you doing) instead of future tense
    (what you will do).

4.  Use what you already have in place as long as it meets the Process
    Verified Program requirements. You can reference existing
    procedures, work instructions, forms, etc within the quality manual.
    (see #4)

5.  The Process Verified Program requires 10 documented procedures, at a
    minimum. It is easiest to reference the documented procedures within
    the quality manual and include them as attachments. When attached,
    the documented procedures can be revised as necessary without having
    to reissue the entire quality manual. If the documented procedures
    are included within the body of the quality manual, then the entire
    manual must be reissued when the procedures are revised.

6.  It is best to include the plant's name, the document\'s name, and
    the document\'s revision status on every page.

7.  Include the plant's physical location and the program contact's
    information either within the letter requesting service or in the
    quality manual.

8.  Review the ARC 1001A Policy to determine if any of the policies
    apply to your program. If they apply, insert the applicable policies
    into the appropriate sections of your program.

**USDA Process Verified Program**

# Program Requirements (Clauses 1 to 6)

Companies must submit a documented program that addresses the program
requirements as outlined in the following clauses (Clauses 1 to 6).

**1 Quality Management System**

**1.1 General Requirements**

A quality management system (QMS) must be established, documented,
implemented, and maintained which ensures that products conform to the
requirements of this Procedure and to specified process verified points.

The company must continually improve the effectiveness of the QMS in
accordance with the requirements of this Procedure.

The company must

a)  Identify the processes needed for the QMS and their application
    throughout the company;

b)  Determine the sequence and interaction of these processes;

c)  Determine criteria and methods needed to ensure that both the
    operation and control of these processes are effective;

d)  Ensure the availability of resources and information necessary to
    support the operation and monitoring of these processes;

e)  Monitor, measure, and analyze these processes; and

f)  Implement actions necessary to achieve planned results and continual
    improvement of these processes.

The company must manage these processes in accordance with the
requirements of this Procedure.

Where a company chooses to outsource any process that affects product
conformity with requirements, the company shall ensure control over such
processes. Control of such outsourced processes must be identified
within the QMS.

**1.2 Documentation Requirements**

**1.2.1 General**

The company must prepare and maintain a QMS that includes

a)  Documented statements of a quality policy;

b)  Documented statements of a quality objective;

c)  A quality manual;

d)  Documented procedures required by this Procedure;

e)  Documents necessary to ensure the effective planning, operation, and
    control of its processes; and

f)  Records required by this Procedure.

**1.2.2 Quality Manual**

The company must establish and maintain a quality manual that includes
at a minimum

a)  An organizational chart or similar document listing all personnel
    assigned to managerial positions within the program;

b)  A description of the scope of the QMS, including details of and
    justification for exclusions;

c)  The specified process verified points;

d)  Documented procedures established for the QMS;

e)  Reference to all forms, tags, and labels used to track or
    demonstrate product conformance,;

f)  A master document list that shows the most current issue of all QMS
    procedures, forms, tags, and labels used to track or demonstrate
    conformance;

g)  A description of the interaction between the processes of the QMS;
    and

h)  All other documentation as required in this Procedure.

The quality manual must be controlled and available for review at all
associated sites where activities are conducted.

**1.2.3 Control of Documents**

The company must control all documents required by this Procedure.

A documented procedure must be established to define the controls needed

a)  To control all documents required by this Procedure;

b)  To ensure that changes and the current revision status of documents
    are identified;

c)  To ensure that relevant versions of applicable documents are
    available at points of use;

d)  To ensure that documents remain legible and readily identifiable;

e)  To prevent the use of obsolete or unapproved documents; and

f)  To retain all documents for at least 1 year after the year in which
    the audit was performed.

Significant changes to QMS documentation must be submitted to the ARC
Branch for approval prior to implementation.

**1.2.4 Control of Records**

The company must establish and maintain records to provide evidence of
conformity to program requirements, to specified process verified
points, and of the effective operation of the QMS.

A documented procedure must be established to define the controls needed

a)  To control all records required by this Procedure;

b)  To store records in a manner so as to prevent loss, damage, or
    alteration;

c)  To ensure that records are legible, easily accessible, and readily
    available; and

d)  To retain all records for at least 1 year after the year in which
    the audit was performed.

**2 Management Responsibility**

**2.1 Management Commitment**

Top management must provide evidence of its commitment to the
development and implementation of the QMS.

Top management must continually improve the effectiveness of the QMS.

Top management must communicate to program personnel the importance of
meeting customer as well as statutory and regulatory requirements

Top management must establish the quality policy.

Top management must ensure that quality objectives are established.

Top management must conduct management reviews of the QMS.

Top management must ensure the availability of resources.

**2.2 Customer Focus**

Top management must ensure that customer requirements are determined and
are met with the main focus of enhancing customer satisfaction.

**2.3 Quality Policy**

Top management must ensure that the quality policy

a)  Is appropriate to the purpose of the company's program;

b)  Includes a commitment to conform to the requirements of the QMS;

c)  Includes a commitment to continually improve the effectiveness of
    the QMS;

d)  Provides a framework for establishing and reviewing quality
    objectives;

e)  Is communicated and understood within the company; and

f)  Is reviewed for continuing suitability.

**2.4 Planning**

**2.4.1 Quality Objectives**

Top management must ensure that quality objectives, including those
necessary to meet specified process verified points, are established at
relevant functions and levels within the company.

The objectives must be measurable and consistent with the quality
policy.

**2.4.2 Quality Management System Planning**

Top management must ensure that the planning of the QMS meets the
requirements given in *Clause 1.1 General Requirements*, as well as the
quality objectives.

Top management must ensure that the integrity of the QMS is maintained
when changes to it are planned and implemented.

**2.5 Responsibility, Authority and Communication**

**2.5.1 Responsibility and Authority**

Top management must ensure that QMS responsibilities and authorities are
defined and communicated within the company.

The company must have an organizational chart or similar document
listing all personnel assigned to managerial positions within the
program.

All personnel listed must have their responsibilities and authorities
outlined in an auditable method.

**2.5.2 Management Representative**

Top management must designate a management representative who,
irrespective of other responsibilities must have responsibility and
authority that includes

a)  Ensuring that processes needed for the QMS are established,
    implemented, and maintained;

b)  Reporting to top management on the performance of the QMS and any
    need for improvement; and

c)  Ensuring the promotion of awareness of customer requirements and
    specified process verified points throughout the company.

[]{.mark}

The management representative must have the authority to act on behalf
of the company at all locations where program activities are conducted.

**2.5.3 Internal Communication**

Top management must ensure that appropriate communication processes are
established within the company.

Top management must ensure that communication takes place regarding the
effectiveness of the QMS.

**2.6 Management Review**

1.  **General**

Top management must review the company's QMS, at planned intervals, to
ensure its continuing suitability, adequacy, and effectiveness.

The review must include assessing opportunities for improvement and the
need for changes to the QMS, including the quality policy and quality
objectives.

The company must maintain records from the management reviews.

2.  **Review Input**

The management review input must include information on

a)  Results of audits (internal and third party);

b)  Customer feedback;

c)  Process performance and product conformity;

d)  Status of preventative and corrective actions;

e)  Follow-up actions from previous management reviews;

f)  Changes that could affect the QMS; and

g)  Recommendations for improvement.

**2.6.3 Review Output**

The management review output must include any decisions and actions
related to

a)  Improvement of the effectiveness of the QMS and its processes;

b)  Improvement of product related to customer requirements; and

c)  Resource needs.

**3 Resource Management**

**3.1 Provisions of Resources**

The company must determine and provide the resources needed to implement
and maintain the QMS and to continually improve its effectiveness.

The company must determine and provide the resources needed to enhance
customer satisfaction by meeting customer requirements.

**3.2 Human Resources - Competence, Awareness, and Training**

Personnel performing work affecting product quality must be competent on
the basis of appropriate education, training, skills, and/or experience.

The company must provide training to all persons with QMS
responsibilities.

The company must have a documented procedure to ensure all persons
performing work affecting product quality are properly trained in
relevant aspects of the QMS.

The documented procedure must include

a)  Determining the necessary competence for personnel performing work
    affecting product quality;

b)  Determining the criteria for training;

c)  Evaluating the effectiveness of the training; and

d)  Ensuring that the persons are aware of the relevance and importance
    of their activities and how they contribute to the achievement of
    the quality objectives.

The company must maintain appropriate records of education, training,
skills, or experience, as applicable. These records must include the
scope of the training received.

**3.3 Infrastructure**

The company must determine, provide, and maintain the infrastructure
needed to achieve conformity to product requirements.

Infrastructure includes, as applicable

a)  Buildings, workspace, and associated utilities;

b)  Process equipment (both hardware and software); and

c)  Supporting services (such as transport or communication).

**3.4 Work Environment**

The company must determine and manage the work environment needed to
achieve conformity to product requirements.

**4 Product Realization**

**4.1 General**

If any program requirements within Clause 4 Product Realization can not
be applied due to the nature of a company and its product, then these
requirements may be considered for exclusion. Exclusions must not affect
the company's ability to provide a conforming product. Additionally,
exclusions do not affect the company's responsibility to provide a
conforming product.

**4.2 Planning of Product Realization**

The company must plan and develop the processes needed for product
realization.

Planning of product realization must be consistent with the requirements
of the other processes of the QMS.

In planning product realization, the company must determine the
following, as appropriate:

a)  Quality objectives and requirements for the product;

b)  The need to establish processes, documents, and provide resources
    specific to the product;

c)  Required verification, validation, monitoring, inspection, and test
    activities specific to the product and the criteria for product
    acceptance;

d)  Records necessary to provide evidence that the realization processes
    and resulting product meet the requirements.

The output of this planning must be in a form suitable for the company's
method of operations.

**4.3 Customer-Related Processes**

**4.3.1 Determination of Requirements Related to the Product**

The company must determine the specified process verified points.

The company must determine requirements specified by the customer,
including the requirements for delivery and post-delivery activities.

The company must determine requirements not stated by the customer but
necessary for specified or intended use, where known.

The company must determine statutory and regulatory requirements related
to the product.

The company must determine any additional requirements determined by the
company.

**4.3.2 Review of Requirements Related to the Product**

The company must review the requirements related to the product.

The review must be conducted prior to the company's commitment to supply
a product to the customer.

The review must ensure that product requirements are defined.

The review must ensure that contract or order requirements differing
from those previously expressed are resolved.

The review must ensure that the company has the ability to meet the
defined requirement.

The company must maintain records of the results of the review and
actions arising from the review.

The company must confirm the customer requirements before acceptance
when the customer does not provide a documented statement of
requirements.

The company must ensure that relevant documents are amended and that
relevant personnel are made aware of the changed requirements when
product requirements are changed.

**4.3.3 Customer Communication**

The company must determine and implement effective arrangements for
communicating with customers in relation to

a)  Product information;

b)  Enquiries, contracts, or order handling, including amendments; and

c)  Customer feedback, including customer complaints.

**4.4 Design and Development**

**4.4.1 Design and Development Planning**

The company must plan and control the design and development of product.

During the design and development planning, the company must determine

a)  The design and development stages;

b)  The review, verification, and validation that are appropriate to
    each design and development stage; and

c)  The responsibilities and authorities for design and development.

The company must manage the interfaces between different groups involved
in design and development to ensure effective communication and clear
assignment of responsibility.

Planning output must be updated, as appropriate, as the design and
development progresses.

**4.4.2 Design and Development Inputs**

Inputs relating to product requirements must be determined.

Inputs must include

a)  Functional and performance requirements;

b)  Applicable statutory and regulatory requirements;

c)  Where applicable, information derived from previous similar designs;
    and

d)  Other requirements essential for design and development.

Inputs must be reviewed for adequacy.

Requirements must be complete, unambiguous, and not in conflict with
each other.

The company must maintain records relating to product requirements.

**4.4.3 Design and Development Outputs**

The outputs of design and development must be provided in a form that
enables verification against the design and development input.

The outputs must be approved prior to release.

Design and development outputs must

a)  Meet the input requirements for design and development;

b)  Provide appropriate information for purchasing, production, and for
    service provision;

c)  Contain or reference product acceptance criteria; and

d)  Specify the characteristics of the product that are essential for
    its safe and proper use.

**4.4.4 Design and Development Review**

The company must perform systematic reviews of design and development at
suitable stages.

The company must perform the systematic reviews in accordance with
planned arrangements (1) to evaluate the ability of the results of
design and development to meet requirements and (2) to identify any
problems and propose necessary actions.

Participants in the reviews must include representatives of functions
concerned with the design and development stage(s) being reviewed.

The company must maintain records of the results of the reviews and any
necessary actions.

**4.4.5 Design and Development Verification**

The company must perform verification in accordance with planned
arrangements to ensure that the design and development outputs have met
the design and development input requirements.

The company must maintain records of the results of the verification and
any necessary actions.

**4.4.6 Design and Development Validation**

The company must perform design and development validation in accordance
with planned arrangements.

Validation must ensure that the resulting product is capable of meeting
the requirements for the specified application or intended use, where
known.

The company must complete validation prior to delivery or implementation
of the product, wherever practicable.

The company must maintain records of results of validation and any
necessary actions.

**4.4.7 Control of Design and Development Changes**

The company must identify design and development changes.

The company must review, verify, validate and approve changes before
implementation.

The review of design and development changes must include evaluation of
the effect of the changes on constituent parts and product already
delivered.

The company must maintain records of the results of the review of design
and development changes and any necessary actions.

**4.5 Receiving**

**4.5.1 Receiving Process**

The company must ensure that product purchased or received from outside
establishments and used in the program conform to specified receiving
requirements.

The company must ensure the adequacy of specified receiving requirements
prior to their communication to the supplier.

The company must evaluate and select suppliers based on their ability to
supply product that conforms to the specified receiving requirements.

The company must establish and implement the inspection or other
activities necessary for ensuring that product purchased or received
from outside establishments conform to specific receiving requirements.

Where the company or its customer intends to perform verification at the
supplier's premises, the company must state the intended verification
arrangements and method of product release in the purchasing
information.

The company must have a documented procedure addressing products
purchased or received from outside establishments.

The documented procedure must describe

a)  All products purchased and/or received from outside establishments;

b)  The specified receiving requirements for approval of products to be
    used in the program;

c)  The criteria and process for supplier selection, evaluation, and
    re-evaluation; and

d)  The process used to ensure that products purchased or received from
    outside establishments and used in the program conform to specific
    receiving requirements.

The company must maintain records of the results of supplier evaluations
and any necessary actions arising from the evaluation.

The company must maintain records to provide evidence of conformity to
the receiving process and of the effective operation of the receiving
process.

**4.6 Production and Service Provision**

**4.6.1 Control of Production and Services Provision**

The company must plan and conduct production and service provision under
controlled conditions.

Controlled conditions must include, as applicable

a)  The availability of information that describes the characteristics
    of the product;

b)  The availability of work instructions, as necessary;

c)  The use of suitable equipment;

d)  The availability and use of monitoring and measuring devices;

e)  The implementation of monitoring and measurement; and

f)  The implementation of release, delivery, and post-delivery
    activities.

**4.6.2 Validation of Processes for Production and Service Provision**

The company must validate any processes for production and service
provision where the resulting output cannot be verified by subsequent
monitoring or measurement. This includes any processes where
deficiencies become apparent only after the product is in use or the
service has been delivered.

Validation must demonstrate the ability of these processes to achieve
planned results.

The company must establish arrangements for these processes including,
as applicable

a)  Defined criteria for review and approval of the processes;

b)  Approval of equipment and qualification of personnel;

c)  Use of specific methods and procedures;

d)  Requirements for records; and

e)  Revalidation.

**4.6.3 Identification and Traceability**

The company must have a documented procedure to identify product (raw
materials and/or finished product) by suitable means throughout product
realization, where appropriate.

The documented procedure must describe the method for

a)  Identifying the product throughout product realization;

b)  Controlling and recording the unique identification of the product,
    including the use of the "USDA Process Verified" shield or the term
    "USDA Process Verified", if applicable; and

c)  Identifying the product status with respect to monitoring and
    measurement requirements.

The method for identifying the product must

a)  Be unique to the Program. When applicable, animals must be
    identified with ear tags or other permanent identification; and

b)  Be such that the identification will transfer through all phases of
    product realization, from receipt into the Program through
    production to delivery;

The company must maintain records of all products as identified and
records of all changes of identities.

**4.6.4 Customer Property**

The company must exercise care with customer property while it is under
the company's control or being used by the company.

The company must identify, verify, protect, and safeguard customer
property provided for use or incorporation into the product.

The company must report to the customer and maintain records of any
incidences where customer property is lost, damaged, or otherwise found
to be unsuitable for use.

**4.6.5 Preservation of Product**

The company must preserve the conformity of product during internal
processing and delivery to the intended destination.

The preservation must include identification, handling, packaging,
storage, and protection. It must also apply to the constituent parts of
a product.

**4.7 Control of Monitoring and Measuring Devices**

The company must determine the monitoring and measurement to be
undertaken to provide evidence of conformity to product requirements.

The company must determine the monitoring and measurement devices needed
to provide evidence of conformity to product requirements.

The company must establish processes to ensure that monitoring and
measurement can be conducted and is conducted in a manner that is
consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment must

a)  Be calibrated or verified at specified intervals, or prior to use,
    against measurement standards traceable to international or national
    measurement standards; where no such standards exist, the basis used
    for calibration or verification must be recorded;

b)  Be adjusted or re-adjusted as necessary;

c)  Be identified to enable the calibration status to be determined;

d)  Be safeguarded from adjustment that would invalidate the measurement
    result; and

e)  Be protected from damage and deterioration during handling,
    maintenance, and storage.

The company must assess and record the validity of the previous
measuring results when the equipment is found not to conform to the
requirements. The company must take appropriate action on the equipment
and any product affected.

The company must confirm the ability of computer software to satisfy the
intended application when used in the monitoring and measurement of
specified requirements. This must be performed prior to initial use and
reconfirmed as necessary.

The company must maintain records of the results of calibration and
verification.

**5 Measurement, Analysis, and Improvement**

**5.1 General**

The company must plan and implement the monitoring, measurement,
analysis, and improvement processes needed

a)  To demonstrate conformity of the product;

b)  To ensure conformity of the QMS; and

c)  To continually improve the effectiveness of the QMS.

This must include determination of application methods, including
statistical techniques, and the extent of their use.

When statistical methods are used to control product quality or
integrity, the basis for those procedures must be clearly defined.

**5.2 Monitoring and Measurement**

**5.2.1 Customer Satisfaction**

The company must monitor information relating to customer perception as
to whether the company has met customer requirements. This information
must be reviewed as a performance measurement of the QMS.

The company must determine the methods for obtaining and using this
information

The company must maintain records relating to customer perception.

**5.2.2 Internal Audit**

The company must conduct internal audits at planned intervals.

The internal audits must determine whether the QMS

a)  Conforms to the planned arrangements, to the requirements of this
    Procedure, and to the QMS requirements established by the company;
    and

b)  Is effectively implemented and maintained.

The company must have a documented procedure which defines

a)  The planning of an audit program, which must consider the status and
    importance of the processes and areas to be audited, as well as the
    results of the previous audit;

b)  The audit criteria, scope, frequency, and methods;

c)  The selection of the auditors and conduct of auditors which must
    ensure objectivity and impartiality of the audit process (Auditors
    must not audit their own work.);

d)  The responsibilities for planning and conducting audits;

e)  The reporting of results;

f)  The follow-up activities (Follow-up activities must include the
    verification of the actions taken and the reporting of the
    verification results.); and

g)  The maintenance of records.

Within the area being audited, management must ensure that actions are
taken without undue delay to eliminate detected non-conformances and
their causes.

The company must review the results of internal audits during management
reviews.

The company must maintain records of the internal audits.

NOTE: Prior to initial approval of a program, the company must conduct
an internal audit and submit those results to the ARC Branch as part of
the application for service.

**5.2.3 Monitoring and Measurement of Processes**

The company must apply suitable methods for monitoring and, where
applicable, measurement of the QMS processes.

These methods must demonstrate the ability of the processes to achieve
planned results.

When planned results are not achieved, correction and corrective action
must be taken, as appropriate, to ensure conformity of the product.

**5.2.4 Monitoring and Measurement of Product**

The company must monitor and measure the characteristics of the product
to verify that product requirements have been met. This must be
conducted at appropriate stages of the product realization process in
accordance with the planned arrangements.

The company must ensure that the planned arrangements have been
satisfactorily completed prior to product release and service delivery,
unless otherwise approved by a relevant authority and, where applicable,
by the customer.

The company must maintain records to verify evidence of conformity with
product requirements. Records must indicate the person(s) authorizing
release of product.

**5.3 Control of Non-conforming Product within the QMS**

The company must ensure that non-conforming product (raw material and/or
finished product) is identified and controlled to prevent its unintended
use or delivery.

The company must have a documented procedure that defines

a)  The identification of non-conforming product;

b)  The controls used to ensure the segregation of non-conforming
    product; and

c)  The related responsibilities and authorities for ensuring the
    segregation and disposition of non-conforming product.

The company must handle non-conforming product by one or more of the
following methods:

a)  By taking action to eliminate the detected non-conformity;

b)  By authorizing its use, release, or acceptance under concession by a
    relevant authority and, where applicable, by the customer;

c)  By taking action to preclude its original intended use or
    application.

When non-conforming product is corrected, it must be subject to
re-verification to demonstrate conformity to the requirements.

The company must take appropriate actions when non-conforming product is
detected after delivery or use has started.

The company must maintain records of all non-conforming product and any
subsequent actions taken, including concessions obtained.

**5.4 Analysis of Data**

The company must determine, collect, and analyze appropriate data to
demonstrate the suitability and effectiveness of the QMS.

The company must evaluate where continual improvement of the
effectiveness of the QMS can be made. This must include data generated
as a result of monitoring and measurement and from other relevant
sources.

The analysis of data must provide information relating to (1) customer
satisfaction; (2) conformity to product requirements; (3)
characteristics and trends of processes and products including
opportunities for preventative action; and (4) suppliers.

**5.5 Improvement**

**5.5.1 Continual Improvement**

The company must continually improve the effectiveness of the QMS
through the use of the quality policy, quality objectives, audit
results, analysis of data, corrective and preventative actions, and
management review.

**5.5.2 Corrective Action**

The company must take action to eliminate the cause of non-conformance
in order to prevent recurrence.

Corrective actions must be appropriate to the effects of the
non-conformances encountered.

The company must establish a documented procedure which defines the
requirements for

a)  Reviewing non-conformances including customer complaints;

b)  Determining the causes of non-conformances;

c)  Evaluating the need for action to ensure that non-conformances do
    not recur;

d)  Determining and implementing action needed;

e)  Records of the results of action taken; and

f)  Reviewing corrective action taken to determine its effectiveness.

The company must maintain records of the results of any actions taken.

**5.5.3 Preventative Action**

The company must determine action to eliminate the causes of potential
non-conformances in order to prevent their occurrence.

Preventative actions must be appropriate to the effects of the potential
problems.

The company must establish a documented procedure which defines the
requirements for

a)  Determining potential non-conformances and their causes;

b)  Evaluating the need for action to prevent occurrence of
    non-conformances;

c)  Determining and implementing action needed;

d)  Records of results of action taken; and

e)  Reviewing preventative action taken to determine its effectiveness.

The company must maintain records of the results of any actions taken.

**6 Promotional Materials**

**6.1 Control of Promotional Materials**

The company may use the "USDA Process Verified" shield or the term "USDA
Process Verified" in promotional and advertising materials, which
includes all labels, packaging, and other marketing materials.

The company must request the use of the shield or term within the QMS.

When applicable, the company must establish a documented procedure for
promotional and advertising materials that

a)  Addresses the development of the materials;

b)  Ensures the specified process verified points are accurately
    represented in the materials;

c)  Ensures the use of the "USDA Process Verified" shield or the term
    "USDA Process Verified" in direct association with a clear
    description of the specified process verified points in the
    materials;

d)  Provides for the proper control and use of the shield or term on
    labels, packaging, and other marketing material on which it may
    appear.

All materials must be reviewed by the ARC Branch prior to use.

**Appendix A - Definitions**

Conforming Product -- product within the QMS that meets, and can be
verified as meeting, the product requirements. Such product may be
identified and/or labeled as meeting the requirements of the USDA
Process Verified Program.

Corrective Action -- action to eliminate the cause of a detected
non-conformance.

Correction -- action to eliminate a detected non-conformance.

Customer Satisfaction -- customer's perception of the degree to which
the customer's requirements have been fulfilled.

Measurement -- the actual determination of a value. Requires the use of
a device to determine the numerical value of a product characteristic or
process parameter at a given time.

Monitoring -- a general term implying oversight over time. (Examples:
normal process observation by employees, daily supervision by managers,
automated alarms, etc.)

Non-conforming Product -- product within the QMS that does not meet, or
can not be verified as meeting, the product requirements. This includes
raw materials and finished products. Non-conforming raw materials must
be excluded from use within the program; and non-conforming finished
products must be excluded from delivery. Additionally, the company must
take appropriate actions when non-conforming product is detected after
delivery or use has started.

Objective evidence -- data supporting the existence or verity of
something.

Planned Arrangements -- arrangements that have been pre-determined.

Preventative Action -- action to eliminate the cause of a potential
non-conformance.

Procedure -- a specified way to carry out an activity or a process.
Procedures can be documented or not. The Process Verified Program
requires 10 documented procedures.

Process Verified Points -- the specified requirements of the product
which are achieved through the implementation of a quality management
system.

Process -- a set of interrelated or interacting activities which
transforms inputs into outputs.

Product -- a raw material or a finished good. The type of product
depends upon where it is within product realization. A product is the
result of a process.

Product Realization -- the process of developing a product from initial
acceptance of the raw materials into the program through production to
delivery to the customer.

Product Requirements -- includes, but is not limited to, the
requirements of this Procedure, the requirements outlined in the QMS,
the customer requirements, and the specified process verification
points.

Quality Policy -- the overall intentions and direction of a company
related to quality and formally expressed by top management.

Quality Objective -- something sought, or aimed for, related to quality.
These are generally based on the quality policy and specified for
relevant functions and levels in the company.

Record -- a document that states results achieved or provides evidence
of activities performed. The Process Verified Program requires 20
records.

Top Management -- a person or group of people who direct and control the
company at the highest level.

Validation -- confirmation, through the provision of objective evidence,
that the requirements for a specific intended use or application have
been fulfilled.

Verification -- confirmation, through the provision of objective
evidence, that specified requirements have been fulfilled.

**Appendix B -- Documentation Requirements**

1\. Clause 1.2.2 -- Quality Manual

2\. Documented Procedures

2.1 Clause 1.2.3 -- Control of Documents

2.2 Clause 1.2.4 -- Control of Records

2.3 Clause 3.2 -- Training of Personnel

2.4 Clause 4.5.1 -- Receiving of Product from Outside Sources

2.5 Clause 4.6.3 -- Identification and Traceability

2.6 Clause 5.2.2 -- Internal Audits

2.7 Clause 5.3 -- Control of Non-conforming Product

2.8 Clause 5.5.2 -- Corrective Action

2.9 Clause 5.5.3 -- Preventative Action

2.10 Clause 6.1 -- Control of Promotional Material

3\. Records

> 3.1 Clause 2.6.1 -- Management Reviews
>
> 3.2 Clause 3.2 -- Human Resources - Competence, Awareness, and
> Training
>
> 3.3 Clause 4.2 -- Planning of Product Realization
>
> 3.4 Clause 4.3.2 -- Review of Requirements Related to the Product
>
> 3.5 Clause 4.4.2 -- Design and Development Inputs
>
> 3.6 Clause 4.4.4 -- Design and Development Review
>
> 3.7 Clause 4.4.5 -- Design and Development Verification
>
> 3.8 Clause 4.4.6 -- Design and Development Validation
>
> 3.9 Clause 4.4.7 -- Control of Design and Development Changes
>
> 3.10 Clause 4.5.1 -- Receiving Process (2)
>
> 3.11 Clause 4.6.3 -- Identification and Traceability
>
> 3.12 Clause 4.6.4 -- Customer Property
>
> 3.13 Clause 4.7 -- Control of Monitoring and Measuring Devices
>
> 3.14 Clause 5.2.1 -- Customer Satisfaction
>
> 3.15 Clause 5.2.2 -- Internal Audit
>
> 3.16 Clause 5.2.4 -- Monitoring and Measurement of Product
>
> 3.17 Clause 5.3 -- Control of Non-conforming Product within the QMS
>
> 3.18 Clause 5.5.2 -- Corrective Actions
>
> 3.19 Clause 5.5.3 -- Preventive Actions

4\. Any other documents necessary to ensure the effective operation and
control of the QMS.