PROCEDURE: CONTROL

Author: PAC, UMN Approved By:

OF

NONCONFORMANCE

AMS Manual Section 8

Responsibility: Production Manager ssue !ate:

Purpose and "eneral n#or$ation

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 reali!ation.

Scope
"his procedure is applied to all nonconforming products that are either: #n site (i.e., prior to shipment and delivery #ff site (i.e., storage and$or post%delivery to customer

&re'uency
"his procedure is applied in the event of any detected nonconformance. Ne& nonconformities are evaluated at each Management 'evie&.

Re#erences
n$a

Related AMS !ocu$entation

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

Steps
(. )pon detection of any product or process that does not meet the product requirements (specified by the customer, regulations, AM*, or other&ise 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 &or+ing on the farm, or b. "he customer during inspection or follo&ing receipt of the product. ,. "he Production Manager records the details of the nonconformance in the Form Record: Nonconformance Report. "his file is considered -active. until the fate of the affected product (determined in steps belo& is met. "he active files are stored on the main computer in the folder -Nonconformance 'eports, subfolder -Active N/s..

0. "he Production Manager meets &ith top management to inform them of the problem. An action committee is assigned to plan and implement follo&%up actions. 1. "he committee determines &hat action &ill be ta+en &ith respect to the handling and final use of the nonconforming product. A plan for such actions &ill include (if applicable : a. /ontacting relevant e2ternal authorities if necessary (e.g., )*3A or AP4I* in the case of a severe pest$disease outbrea+ . b. "he means of separating the nonconforming product from product that is unaffected. c. 3etermining the fate of the nonconforming product (e.g., re%grading, identification of an alternative customer, destruction . d. /ommunications that are to ta+e place &ith the affected customers. e. /ommunications &ith relevant employees involved in the above steps. 5. "he action plan details are recorded in the active nonconformance report file. 6. )pon agreement among the top management, affected customers, and e2ternal authorities (if necessary the plan is implemented. 7. If the product is corrected and intended for delivery to a customer (i.e., re%graded, separated from problem, contract re%negotiated, or ne& customer identified the ne& requirements and$or customer are noted in the Form Record: Customer Requirements. "hus, the product must be re%tested$re%evaluated against all requirements and its release must be authori!ed prior to delivery to the customer. 8. "he Production Manager ensures that a /orrective Action 'equest is completed accordingly and the Procedure for /orrective Action is follo&ed for each individual nonconformance. 9. "he details of the actions ta+en and final fate of the product are recorded in the in the active nonconformance report file by the Production Manager or higher authority. "he file is then signed as inactive and moved to the -Inactive N/ folder on the main computer..

FORM RECORD: NONCONFORMANCE

Author: PAC, UMN Approved By:

REPORT

AMS Manual Section 8

Responsibility: Production Manager ssue !ate:

Active Record Location: #n the main computer, in the main folder named -Nonconformance 'eports.. "he active files are saved in a subfolder named - Active N/s.. :ach report is identified &ith a descriptive name and date. Record rotection: bac+ed up on /3 &ith AM* documentation Retrieval: &hen need to amend (active or revie& (inactive a nonconformance. !ompleted Record Stora"e: #n the main computer, in the main folder named -Nonconformance 'eports.. "he inactive (i.e., completed files are saved in a subfolder named - Inactive N/s.. :ach report is identified &ith a descriptive name and date. Minimum Stora"e Retention #ime: indefinite Related AMS $ocumentation: Procedure: /ontrol of Nonconformance Su$$ary o# Noncon#or$ance Prepared By: !ate: !etails:

Revie(ed by:

!ate:

Action Co$$ittee Assigned to Noncon#or$ance Control and &ollo()up

Na$e

Role

Back of form Noncon#or$ance Action Plan and $ple$entation Record Activity Co$$ittee Plan $ple$ented Activities, Notes *+ternal authorities involved and role Custo$er,sa##ected and co$$unications &ate o# a##ected product

Actions to contain.separate a##ected product

*$ployees involved in action and roles

&ollo() up chec/list Record: Customer Requirements (/rop Plan$4istory form is amended to reflect change in customer$requirements. Product (if not destroyed is re%evaluated against requirements and released for delivery to customer. "his is indicated on Record: Customer Requirements /orrective Action 'equest form is activated and corrective action

!ate

nitial

procedures are designated to relevant authority. All relevant actions to control the use and fate of the nonconforming product have been completed. "his form is no& inactive and has been moved to the -Inactive N/s. folder on the main computer.