Control of Nonconforming Product By: Neal Stiemert One of the requirements of the ISO 9001:2000 standard is control of nonconforming product. This month, I will provide you with some ideas to satisfy the requirements for this element of the standard. ISO Requirement:   8.3 Control of Nonconforming Product (Key requirements are in bold) The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or 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) or by taking action to preclude its original intended use or application. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. 1. Nonconforming and/or suspect product must be visibly identified. 2. Your procedure must state the functions within your company that have the responsibility and authority to disposition nonconforming product. 3. You must have a documented procedure for control of nonconforming product. 4. You must identify the dispositions that you allow. 5. You must have records. 6. If you re-work product, it must be re-inspected. 7. If your customer accepts nonconforming product on concession (waiver), get approval in writing. 8. If you have shipped nonconforming product, you should quarantine the remainder of the product and notify your customer of the nonconformance. Section from the Widget Company Quality Manual 8.3 Control of Nonconforming Product The Widget Company ensures that product which does not conform to requirements is identified and controlled to prevent unintended use or delivery. These activities are defined in a documented procedure. Widget deals with nonconforming product by one or more of the following ways: - by taking action to eliminate nonconformity; - by authorizing its use, release or acceptance by concession by a relevant authority and, where applicable, by the customer; - or by taking action to preclude its original intended use or application. Records of nonconformities and any actions taken, including concessions obtained, are maintained. When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to requirements. When nonconforming product is detected after delivery or use has started, Widget takes action appropriate to the effects, or potential effects, of the nonconformity. Sample Procedure: The Widget Company Operating Procedure Title: Control of Nonconforming Product No.  XXX Approved By:     Johnny Quality                           Date:     5/19/04                 SCOPE: This procedure applies to identification, segregation and disposition of suspect and nonconforming product during all stages of the Widget Company operation. 1.0   IDENTIFY SUSPECT PRODUCT Suspect product may be identified by anyone in the Widget Company organization during any stage in the process, including: - receiving inspection and testing - in-process inspection and testing - final inspection and testing - customer returns Suspect product is segregated from other product identified with: - Hold tag: for suspect, damaged and nonconforming product and for product returned from customers awaiting disposition. - Rejected tag: for damaged and nonconforming product. 2.0   INITIAL REVIEW An initial review of suspect product is made by Quality Assurance to determine if the product is nonconforming. 3.0   NONCONFORMING ? Yes - go to 3.1 No - go to 4.0 3.1   NONCONFORMING PRODUCT REVIEW AND DISPOSITION Nonconforming product is moved to a nonconforming material area and Quality Assurance issues a Material Reject Notice (MRN) number from the MRN Log and a Material Reject Notice is issued. Quality Assurance and any other appropriate Widget Company personnel reviews the information on the MRN and determines the disposition which is recorded on the MRN Form. Nonconforming product may be dispositioned as follows: - rework - accepted by the customer on waiver (see note 1) - return to supplier - other (the reason must be documented on the MRN form) Dispositioned nonconforming product is identified with: - A Rework Tag for product being reworked - A Rejected Tag for damaged and nonconforming product 3.2   FILE RECORDS Material reject notices are retained by Quality Assurance as quality records and become inputs for management review and supplier performance information. If the nonconformance is due to a supplier nonconformance, a copy of the material reject notice is sent to Purchasing to be used for supplier performance information. 4.0   RELEASE If the product is determined acceptable, all tags are removed and the product is released for use. Notes: 1.   Product accepted on waiver must be identified and accepted in writing by the customer. Records of product accepted on waiver are maintained by Quality Assurance. 2.   Product requiring rework is reworked and re-inspected in accordance with the Widget Company rework and process control procedures. Reworked product shall be inspected by Quality Assurance prior to shipment back to the customer. Note: If this document is printed out from the network, it is the responsibility of the user of this document to verify the correct revision status prior to use. If this document is marked "CONTROLLED," Document Control maintains the revision control and the user does not need to verify the correct revision status prior to use. End of Document Here are copies of the various Nonconforming Product forms in PDF format:   Control of Nonconforming Product Sample Procedure   Material Reject Notice   Material Reject Notice Log I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Neal Stiemert President Independent Quality Consultants, Inc. About the Author In fond memory - Neal Stiemert - 1948-2006 Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ certified quality engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article