AMS Manual

PROCEDURE: CONTROL OF NONCONFORMANCE

Section 8
Author: PAC, UMN Responsibility: Production Manager
Approved By: Issue Date:

Purpose and General Information

All nonconforming products must be controlled according to this procedure in order to
prevent, or respond to, unintended delivery to the customer. A nonconformity is defined
as a product and/or process which fails to meet the requirements specified by law,
customer(s), and/or the requirements of this AMS. It is the primary responsibility of the
Production Manager to ensure reporting and control of all nonconformities as soon as
they are detected. Nonconformities (against the product requirements) may be detected in
the product itself, or in the process used in its realization.

Scope
This procedure is applied to all nonconforming products that are either:
On site (i.e., prior to shipment and delivery)
Off site (i.e., storage and/or post-delivery to customer)

Frequency
This procedure is applied in the event of any detected nonconformance. New
nonconformities are evaluated at each Management Review.

References
n/a

Related AMS Documentation

Form Record: Nonconformance Report
Form Record: Corrective Action Request
Procedure: Corrective Action

Steps
1. Upon detection of any product or process that does not meet the product
requirements (specified by the customer, regulations, AMS, or otherwise) the
problem is immediately reported to the Production Manager (indicated in the
header of this documented procedure). Nonconformities may be reported by:
a. Any staff/contract personnel working on the farm, or
b. The customer during inspection or following receipt of the product.

2. The Production Manager records the details of the nonconformance in the Form
Record: Nonconformance Report. This file is considered active until the fate of
the affected product (determined in steps below) is met. The active files are stored
on the main computer in the folder Nonconformance Reports, subfolder Active
NCs.
3. The Production Manager meets with top management to inform them of the
problem. An action committee is assigned to plan and implement follow-up
actions.

4. The committee determines what action will be taken with respect to the handling
and final use of the nonconforming product. A plan for such actions will include
(if applicable):
a. Contacting relevant external authorities if necessary (e.g., USDA or
APHIS in the case of a severe pest/disease outbreak).
b. The means of separating the nonconforming product from product that is
unaffected.
c. Determining the fate of the nonconforming product (e.g., re-grading,
identification of an alternative customer, destruction).
d. Communications that are to take place with the affected customers.
e. Communications with relevant employees involved in the above steps.

5. The action plan details are recorded in the active nonconformance report file.

6. Upon agreement among the top management, affected customers, and external
authorities (if necessary) the plan is implemented.

7. If the product is corrected and intended for delivery to a customer (i.e., re-graded,
separated from problem, contract re-negotiated, or new customer identified) the
new requirements and/or customer are noted in the Form Record: Customer
Requirements. Thus, the product must be re-tested/re-evaluated against all
requirements and its release must be authorized prior to delivery to the customer.

8. The Production Manager ensures that a Corrective Action Request is completed

accordingly and the Procedure for Corrective Action is followed for each
individual nonconformance.

9. The details of the actions taken and final fate of the product are recorded in the in
the active nonconformance report file by the Production Manager or higher
authority. The file is then signed as inactive and moved to the Inactive NC folder
on the main computer.
 AMS Manual
FORM RECORD: NONCONFORMANCE REPORT
Section 8
Author: PAC, UMN Responsibility: Production Manager
Approved By: Issue Date:

Active Record Location: On the main computer, in the main folder named
Nonconformance Reports. The active files are saved in a subfolder named Active
NCs. Each report is identified with a descriptive name and date.
Record Protection: backed up on CD with AMS documentation
Retrieval: when need to amend (active) or review (inactive) a nonconformance.
Completed Record Storage: On the main computer, in the main folder named
Nonconformance Reports. The inactive (i.e., completed) files are saved in a subfolder
named Inactive NCs. Each report is identified with a descriptive name and date.
Minimum Storage Retention Time: indefinite
Related AMS Documentation: Procedure: Control of Nonconformance

Summary of Nonconformance
Prepared By: Date: Reviewed by: Date:
Details:

Action Committee Assigned to Nonconformance Control and Follow-up

Name Role

Back of form

Nonconformance Action Plan and Implementation Record

Activity Committee Plan Implemented Activities, Notes
External
authorities
involved and
role

Customer(s)
affected and
communications

Fate of affected
product

Actions to
contain/separate
affected product

Employees
involved in
action and roles

Follow- up checklist Date Initial

Record: Customer Requirements (Crop Plan/History form) is amended
to reflect change in customer/requirements.
Product (if not destroyed) is re-evaluated against requirements and
released for delivery to customer. This is indicated on Record:
Customer Requirements
Corrective Action Request form is activated and corrective action
procedures are designated to relevant authority.
All relevant actions to control the use and fate of the nonconforming
product have been completed.
This form is now inactive and has been moved to the Inactive NCs
folder on the main computer.