QP1030 Control of Non-Conforming Outputs

Policy: Harrington Signal Inc. shall ensure that outputs that do not conform to requirements (e.g., finished products, parts, manufacturing tools/aids) are identified and controlled to prevent its unintended use or delivery.
Purpose: To describe the process of identifying, segregating, and dispositioning nonconforming outputs to prevent inadvertent use.
Scope: This procedure applies to all nonconforming outputs found by Harrington Signal Inc. during production, inspection, testing, verification, or outputs returned by customers.
Responsibilities: The Quality Manager, the Manufacturing Manager and the Purchasing Manager are responsible for determining the disposition of nonconforming products.

All Employees are responsible for identifying nonconforming or suspected nonconforming product or outputs and notifying management of the nonconformance.

Definitions: Nonconforming (NC) Outputs – That which does not meet specifications (i.e., one or more characteristics does not meet specified requirements). Nonconforming output is typically found during verification, inspection, test activities or outputs returned by customers.

NCR – Nonconformity (or nonconformance) report.

RMA – Return materials authorization; giving a customer expressed permission to return outputs that do not satisfy customer’s needs.

Procedure:

1.0     Identification and Segregation

1.1       Nonconforming outputs shall be identified by a “Red” nonconforming tag attached to the item or, in the case of some outputs (e.g., small pieces, liquids, gases), their containers.

1.2       The Red nonconforming tag should include the following information, at a minimum:

  • Date of Nonconformance
  • Part number;
  • Quantity rejected;
  • Work order number, or Purchase Order number, as applicable;
  • Description of nonconformance; and
  • Initials of the person putting a “hold” on the item after completed a red tag.
  • 1.3       The person putting a “hold” on output or designate shall segregate the nonconforming output by placing it in a designated HOLD location. If this is not possible, nonconforming output must be clearly separated/segregated from conforming outputs and conspicuously identified as HOLD to prevent it from being accidentally used or shipped as acceptable product. The Quality Manager should then be notified about the nonconforming product.

2.0     Nonconformance Corrective Action (CAR/RMA/MRBA) database

2.1       The information from the red nonconforming tag will correlate to a record in the CAR/RMA/MRBA REPORT DATABASE. Each CAR/RMA/MBRA report entry shall contain the following information:

·     Date NC identified

·     CAR/RMA/MRBA number

·     Part number

·     Quantity not conforming

·     Work order, purchase order, or

RMA number

·     Name of person who will disposition the nonconforming output

·     Description of nonconformity

·     Unit price of nonconformity

 

2.2       Proper disposition of the output may be determined once the CAR/RMA/MRBA. Proper disposition shall be determined within a reasonable amount of time by a Manager.

2.3       Once dispositioned of nonconforming product is determined, the appropriate Manager shall enter disposition into the CAR/RMA/MRBA database.

3.0     RETURNED MATERIALS

3.1       Upon being notified by the customer of its intent to return materials, the Manufacturing Manager shall notify Purchasing to prepare a RETURN GOODS AUTHORIZATION. An RMA number will be assigned or generated and this will be given to the customer, to identify the product upon its return.

3.2       If the RMA is for a defective product, the complaint should also be logged in the CAR/RMA/MRBA database (see QP1190 CUSTOMER SATISFACTION).

3.3       All items received will be inspected, counted, and recorded on this form. The individual responsible for receiving the items shall sign and date the form.

3.4       Receiving shall place the returned product in a designated “HOLD” area, with RMA reference attached for identification, and notify Quality and/or Test to analyze, verify, and report on the identified nonconformity.

4.0     NONCONFORMANCE Disposition

4.1       The Manufacturing Manager, Operations Manager, or Quality Managers, at a minimum, shall review nonconforming items and dispose of them in one of the following ways:

SCRAP (S) Unsuitable for use; cannot repair or is not cost effective to repair
REWORK (RW) To meet specified requirements
USE “AS IS” (UAI) Accept as is by concession (i.e., customer approval must be obtained)
RTV Return to vendor/supplier for replacement or credit
HOLD Hold for further evaluation

4.2       Persons determining/authorizing disposition shall enter data in the CAR/RMA/MRBA NONCONFORMANCE record in the appropriate area.

4.3       For items that can be reworked or repaired, Purchasing shall complete and authorize rework/repair instructions and ensure their correct implementation.

Reworked or repaired items must be re-inspected in accordance with Harrington Signal’s inspection procedure and customer, regulatory, and other pertinent requirements.

4.4       For items that might be used “AS IS”, the customer should be contacted and an authorization for acceptance under concession or customer waiver should be obtained.

5.0     Corrective Action

5.1       While determining product disposition, the Quality Manager or relevant department manager shall review CAR/RMA/MRBA Nonconforming Database and take the severity of the nonconformity into account to determine if corrective action is required to prevent recurrence of the nonconforming condition. Corrective actions shall be carried out in accordance with procedure QP1040 NONCONFORMITY AND CORRECTIVE ACTION.

5.2       The Management Team should also review CAR/RMA/MRBA Nonconforming Database periodically (e.g., weekly, monthly, each 6 months) to identify and analyze nonconformity trends. Trends sometimes indicate a need for corrective action (see procedure QP1040).

 

Effectiveness Criteria:

  • No nonconforming product reaches customers.
  • No nonconforming product is further processed until proper disposition is determined.
  • Documented Information provides evidence of effective implementation.