QUALITY MANUAL

CONTROL OF NONCONFORMING PRODUCT

Jun.15.2012

Last Revision:

FRUTH CUSTOM PLASTICS

CONTROL OF NONCONFORMING PRODUCT

QUALITY MANUAL
CONTROL OF NONCONFORMING PRODUCT

Jun.15.2012

Last Revision:

1.0 Purpose 1.1 The objective of the Control of nonconforming product process shall be to ensure that nonconforming product does not affect the quality level of delivered customer product and to maintain the effectiveness of the quality management system. 1.2 The result of the control of nonconforming product process is to ensure that all products shipped by Fruth Custom Plastic meet customer requirements and to improve the overall effectiveness of the quality management system. 2.0 Scope This procedure applies to: 2.1 Identification, segregation and disposition of suspect and nonconforming product during all stages of Fruth Custom Plastics operation. 2.4 All products manufactured by Fruth Custom Plastics 3.0 Quality Records Quality records created in this procedure are: Quality Record Nonconformance Material Report (NCMR) Material Disposition TAG (MDTAG) Monthly Nonconforming Product List 4.0 Definitions Nonconforming Product. Any item or product with one or more characteristics which depart from the requirements in the specification, drawing, or other approved product description. Rework. Reprocessing nonconforming material to make it completely conform to the drawings or specifications. Repair. Subjecting nonconforming material to an approved process designed to reduce but not completely eliminate the nonconformance. The purpose of repair is to bring nonconforming material into an acceptable condition. Repair is distinguished from rework in that the item after repair still does not completely conform to the applicable drawings or specifications. Use as Is. A disposition of material, exhibiting minor nonconformance , that is determined to be satisfactory for its intended purpose. Return to Vendor. A disposition which returns material to the procurement source. Scrap. A disposition of nonconforming material which is not usable for its intended purpose or cannot be economically reworked or repaired. 5.0 Control of nonconforming product Fruth Custom Plastics shall ensure that product which does not conform to product requirements is identified and controlled to prevent unintended use or delivery. The organization shall deal with nonconforming product in one more of the following ways: a) by taking action to eliminate the detected nonconformity. b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer. c) by taking action to preclude its original intended use or application. When nonconforming product is corrected, it shall be subject to re-verification to demonstrate conformity to the requirements. 6.0 Procedure 6.1 Fruth Custom Plastics has capability to detect nonconforming product using process-monitoring techniques including, but not limited to: Custodian Quality Leader Quality Leader Quality Leader

QUALITY MANUAL
CONTROL OF NONCONFORMING PRODUCT

Jun.15.2012

Last Revision:

6.1.1 Receiving Inspection and testing 6.1.2 In process Inspection and testing 6.1.3 First piece Inspection and testing 6.1.3 Final Inspection and testing 6.2 Upon detection of nonconforming product, when applicable, the manufacturing process will be stopped, modified and re-qualified. Nonconforming product will be processed in accordance with this procedure starting at section 6.4 6.3 Using detection methods identified in Section 6.1, nonconforming product is detected during manufacture, inspection and test. Customer shall contact Fruth Custom Plastics when nonconforming product is identified and its facility. 6.4 Nonconforming product may also be identified when a supplier determines raw material, hardware or special processes, supplied to Fruth Custom Plastics, do not meet customer requirements and specifications. 6.5 Quality Leader or Authorized personnel will be notified of nonconforming product. Notification can be in one of the following forms, but verbal only notification is not acceptable. 6.5.1 Tag 6.5.3 E-mail 6.5.3 Nonconforming Material Report (NCMR) 6.6 Upon detection, to prevent nonconforming product from being mixed with conforming product, nonconforming product shall be: 6.6.1 Positively identified 6.6.1.1 Tagged. 6.6.1.2 NCMR, as required, including: 6.6.1.2.1 Description of nonconformance. 6.6.1.2.2 Quantities. 6.6.1.2.3 Date(s). 6.6.1.2.4 Disposition 6.6.2 Separate from conforming product 6.7 NCMR form shall be initiated, as required. 6.7.1 Quality Leader or Authorized personnel will complete the NCMR form with data necessary to clearly define the nature of the nonconformance. 6.8 When appropriate, Nonconforming material will be maintained at the Fruth Custom Plastics facility. If nonconforming product is not in house: 6.8.1 Nonconforming product located off site from the Fruth Custom Plastics facility will be returned, as required 6.8.2 The Quality Leader or Authorized personnel will coordinate the return activity. 6.9 Quality Leader or Authorized personnel will assume responsibility for nonconforming product and coordinate the resolution process with Sales an Production. 6.10 Authorized personnel shall make the final determination of what actions will be taken to resolve the nonconformance. 6.11 Corrective action may include, but not be limited to: 6.11.1 Use nonconforming product as is 6.11.2 Repair nonconforming product to meet requirements and specifications 6.11.3 Rework nonconforming product to meet requirements and specifications 6.11.4 Replacement nonconforming product 6.12 When nonconforming product is dispositioned as scrap, Fruth Custom Plastics shall: 6.15.1 Identify the scrap conspicuously and segregate scrap from conforming product until rendered useless 6.13 When nonconforming product is identified as repair or rework the Quality Leader or Authorized personnel will be re-verified to ensure the product meets all applicable customer requirements. 6.14 Preventive action process will be initiated as required. Results will be used to improve processes. 6.15 All applicable quality documentation and records will be placed on the server in the QC file. 7.0 Process Flow Chart

QUALITY MANUAL
CONTROL OF NONCONFORMING PRODUCT

Jun.15.2012

Last Revision:

Suppliers

Fruth Custom Plastics

Nonconforming product is identified Nonconforming product is positively identified and separate from conforming product Nonconforming product is placed under control of QC Department Documentation is originated to gather information concerning the nature of the nonconformance A cross functional team reviews nonconformance Nonconforming product is dispositioned: Use as is, Repair, Rework or Scrap Nonconformance condition is addressed (repaired) and only conforming product is remain Only conforming product is shipped to the customer All nonconformance documentation and records are processed to completion, re-verified and the nonconformance closed out Quality records store on the FCP-server in the QC file Customer input Inspection documentation Authorized Personnel NCM R Tag

Customers

NCM R Tag

NCMR and / or Deviation request

Customer & Supplier

Dispose of scrap

Corrective Action response as required

8.0 Responsibilities

QUALITY MANUAL
CONTROL OF NONCONFORMING PRODUCT
8.1 Responsible personnel, Fruth Custom Plastics: 8.1.1 Review nonconformance 8.1.2 Suggest recovery options 8.1.3 Identify and separate nonconforming product 8.1.4 Complete required quality documentation and quality records 8.2 Quality Leader 8.2.1 Manage nonconforming product process 8.2.2 Review quality records 8.2.3 Issue and control documents, as appropriate 9.0 Record Retention

Jun.15.2012

Last Revision:

9.1 All NCMRs, quality documentation and quality records will be maintained on the server in the QC file. 9.2 All Quality records associated with this document will be retained for a minimum of one year. 9.3 As appropriate, all quality records associated with this document are available for customer.

QUALITY MANUAL
CONTROL OF NONCONFORMING PRODUCT
10.0 Nonconformance Material Report and Material disposition TAG

Jun.15.2012

Last Revision:

FRUTH CUSTOM PLASTICS

Nonconformance Material Report
NCMR No. Material / Product: Issue Date: Initiated By: Amount Rejected:

Description of Nonconformance / Reason for Rejected

Review and Disposition

A. B. C. D. E. F. Scrap Rework Repair Use as is Return to vendor Other Note: No product can be Use as is if it compromise the quality of the product.

Disposition :

Approved By:

Date:

QUALITY MANUAL
CONTROL OF NONCONFORMING PRODUCT

Jun.15.2012

Last Revision:

FRUTH CUSTOM PLASTICS

Material Disposition TAG
Date: Quantity: Material/Product: Problem:

Nonconformance Source:
A. B. C. Customer Production Vendor

Material Disposition:
D. E. F. Scrap Rework Repair D. Use as is E. Return to Vendor G. Other

QCI Name: