PROCEDURE: CONTROL OF NONCONFORMANCE

Procedure: Control of NonconformanceAMS Manual

Section 8

Author: PAC, UMNResponsibility: 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/aRelated AMS DocumentationForm Record: Nonconformance ReportForm Record: Corrective Action RequestProcedure: Corrective ActionSteps

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.Form Record: Nonconformance reportAMS Manual

Section 8

Author: PAC, UMNResponsibility: 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

NameRole

Back of formNonconformance Action Plan and Implementation Record

ActivityCommittee PlanImplemented 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 checklistDateInitial

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.