Nonconformance Control Procedure
Nonconformance Control Procedure
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
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.
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:
Back of form
Customer(s)
affected and
communications
Fate of affected
product
Actions to
contain/separate
affected product
Employees
involved in
action and roles