Procedure Number QSP 8.3-1

[Company Name] / Procedure Number
QSP 8.3-1
QUALITY SYSTEM PROCEDURE / Page
1 of 1
Subject: / Date Issued
10/01/02
CONTROL OF NONCONFORMING PRODUCT / Supersedes
None
Written by: Approved by: / Review/Approved Date

1. Purpose:

The purpose of this procedure is to define the steps that [Company Name] follows to document, segregate, evaluate, and dispose of material/product that is suspect or does not conform to specified requirements as a means of ensuring that such material is prevented from inadvertent use or delivery.

2. Scope:

This procedure applies to any personnel involved in or responsible for identification, documentation, segregation (when practical), evaluation and disposition of nonconforming materials and products, and for the notification to the functions concerned.

This procedure applies to clause 8.3 in ISO/TS 16949 and Section 8.3 in [Company Name]'s QMS Manual.

3. Related Procedures and Other Documentation:

Procedure No. Description of Procedure

QSP 4.2-3 Control of Records

QSP 8.1-5 Quality Failure Code Reporting and Feedback

QSP 8.5-1 Corrective Action

Document No. Description of Document

QSF 8.3-1.1 Nonconforming Material Report (NCMR)

Supersedes
None / Date Issued
10/01/02 / Page
7 of 7 / Procedure No.
QSP 8.3-1

4. Procedure:

4.1 When nonconforming (or suspect) material or product is discovered, the employee who identified the material initiates a Nonconforming Material Report (NCMR) by completing items 1 through 8 and the first two digits of the failure code (item 4) on the NCMR Form, QSF 8.3-1.1.

NOTE 1: This employee is referred to as the NCMR initiator.

NOTE 2: The failure code is used as input to the Quality Failure Analysis and Coding Technique (Q-FACT) system as a means to analyze defect data and drive a prioritized reduction plan through corrective action. See Quality Failure Code Reporting and Feedback QSP 8.1-5.

4.2 The NCMR initiator notifies one or more employees who have been given the responsibility and authority to perform nonconforming product review and disposition (see NOTE 3).

4.2.1 If the nonconforming product has left the facility, go to step 4.3.

4.2.2 If the review and appropriate disposition of the nonconforming product will occur immediately upon its discovery, proceed to step 4.5.

4.2.3 Otherwise, go to 4.4.

NOTE 3: The above personnel are designated by the department manager as having the knowledge to perform nonconforming product review and disposition. These authorized employees (referred to as the review personnel) are responsible for obtaining the information, other knowledgeable personnel, etc., necessary for determining the appropriate disposition.

4.3 The review personnel contacts the customer who received the nonconforming product, documents the correspondence on the NCMR, and sends a copy of the NCMR to Quality Assurance (QA). Proceed to step 4.5 when the department responsible is ready to continue review.

NOTE 4: Quality Assurance may initiate Corrective Action QSP 8.5-1 and/or take other action appropriate to the effects, or potential effects, of the nonconforming product provided to the customer. The NCMR stays with the department responsible for review until its disposition is determined.

4.4 The review personnel identifies the nonconforming product with a Nonconforming Product Tag, writes the NCMR number on the tag, moves the material to the "Bond Area" of the department in which the nonconformance was found, and sends a copy of the NCMR to Quality Assurance (QA). Proceed to step 4.5 when the department responsible is ready to continue review.

NOTE 5: The NCMR stays with the department responsible for review until its disposition is determined.

4.5 The review personnel examines the nature of the nonconformance and determines disposition by addressing the following questions in the order listed:

a) Does the nonconformance affect product performance?

b) Can the product be “reworked” to meet the specified requirements and eliminate the detected nonconformity?

c) Can the product be “used as is” with concession?

d) Can the product be “repaired” with concession?

e) In the case of rejected/scrapped product, can the product be re-graded for alternative applications?

4.5.1 If the disposition decision involves the product being “used as is” or “repaired” with concession, then go to step 4.6.

4.5.2 If the disposition decision involves visible rework on the exterior of the product, then go to step 4.7.

4.5.3 If neither of the above apply, go to step 4.8.

4.6 The review personnel obtains and documents concession from the parties responsible for specifying the product requirements (Customer, End-user, Regulatory body, Engineering, etc.), and documents the actual condition of the product to be put into use. Go to step 4.8.

NOTE 6: If the nonconforming product has already been received by the customer, product recall is initiated.

4.7 The review personnel obtains and documents approval from the customer, end-user, regulatory body, or other body before performing any rework. (See NOTE 6)

4.8 The review personnel completes the disposition portion (the last two digits of item 4 and items 9-14, 16 & 17) of the NCMR, and notifies any functions that may be affected by the nonconforming product and/or decisions on its disposition.

4.9 The review personnel compares the intended disposition - with regard to both product and process specifications - to the currently approved plan which resulted from the Production Part Approval Process.

4.9.1 If there are no differences between the intended disposition and the approved plan, then go to step 4.11.

4.10 The review personnel obtains written authorization from the customer prior to proceeding with disposition and identifies (on the shipping container) any material shipped with authorization.

NOTE 7: This requirement applies to products or services from suppliers as well as in-house production.

NOTE 8: The authorization shall record the quantity authorized and/or expiration date.

4.11 The review personnel sends the pink copy of the NCMR to QA, and ensures the blue copy of the NCMR remains with the material until completion of the action to be taken, and other copies of the NCMR are delivered to the appropriate departments’ personnel for initiation of the disposition action to be taken.

4.12 Designated personnel carry out the appropriate disposition action and complete line 18 on the NCMR.

4.12.1 If the disposition does not involve repair or rework, then go to step 4.14.

4.13 The employee who has been given the authority and responsibility for inspection by the department manager re-inspects the reworked or repaired product in accordance with the documented procedures / work instructions.

4.13.1 If the product does not pass re-inspection, go to step 4.2.

4.14 The inspection personnel initials item number 15 on the NCMR, and ensures that the product is returned to the activity in which the nonconformance was discovered.

4.15 After “disposition” and “action to be taken” are completed, the Department Manager closes out the NCMR, stores the white copy of the NCMR in the department's “Completed NCMR”, and forwards a copy of the closed out NCMR to QA.

NOTE 9: All “Completed NCMRs” are maintained according to Control of Records QSP 4.2-3.

4.16 QA reviews the completed NCMRs on a weekly basis for correctness and completeness of all information and enters the NCMR information into the Q-FACT system according to Quality Failure Code Reporting and Feedback, QSP 8.1-5.

END OF PROCEDURE.

SAMPLE NONCONFORMING MATERIAL REPORT

(17) Route To:  Engineering

 Stock/Receiving Serial No. XXXXX

 Purchasing

 Other ______Date _____(1)_____

NONCONFORMING MATERIAL REPORT

(NCMR)

Part No. _____(2)_____ Failure code __ __ (4) __ ___

Part Name _____(3)_____ Quantity ______(5)______

Job No. _____(6)_____

Supplier/Customer Name ______(7)______

Description of Problem (8)______

______

DISPOSITION

(9)  Rework Quantity _____Insp. by ___(15)___

(10)  Deviate from Spec.  Use as is  Repair Quantity _____Insp. by ______

(11)  Scrap/Reject  Regrade Quantity _____Insp. by ______

Requested by _____(12) _____ Date _____

Authorized by _____(13) _____ Date _____

Assigned to _____(14) _____ Date _____

______

ACTION TO BE TAKEN

Description of Action to be Taken (16)

______

Action Completed by ______(18) ______Date ______