Non-Conforming Material Procedure

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Non-Conforming Material Procedure
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Microscan systems, Inc. – Confidential
Form Name: QMS Procedure Format, Version 5
04-000015-01 Non-Conforming Material Procedure
Version: 3
Page 2 of 6
Contents
CONTENTS .................................................................................................... 2
PURPOSE ...................................................................................................... 2
Scope..................................................................................................2
DEFINITIONS/ACRONYMS ............................................................................... 2
REFERENCES ................................................................................................ 3
PROCEDURE ................................................................................................. 3
SECTION A. DISCREPANT M ATERIAL FROM RECEIVING INSPECTION ................. 3
SECTION B. DISCREPANT M ATERIAL FROM STORES........................................ 3
SECTION C. DISCREPANT M ATERIAL FROM PRODUCTION ................................ 4
SECTION D. REVIEW AND DISPOSITION OF DISCREPANT MATERIAL ................. 4
SECTION E. DISCREPANT M ATERIAL FROM SERVICE ....................................... 5
SECTION F. QUALITY RECORDS - DISCREPANCY NOTICE ................................ 6
Purpose
The purpose of this procedure is to establish a method for identification, segregation and disposition of nonconforming material intended for manufacturing use. Items include: purchased parts, components and material
assembled at Microscan or by suppliers.
Scope
Nonconforming material is defined as a deficiency in characteristic that renders the quality of a product or service
unacceptable, indeterminate or not according to specified requirements. This can include but not limited to
o
materials that fail to conform to Engineering Drawing Specifications
o
materials that fail to conform to specifications on Purchase Orders
o
materials that fail to conform to Quality/Workmanship Standards
Definitions/Acronyms
MRB – Material Review Board; The purpose of this board is to provide directions aimed at minimizing the
manufacturing scheduling and economic impact incurred as a result of nonconforming material.
PPQD – Purchased Part Quality Database
DN – Discrepancy Notice
UAI – Use As Is
RTV – Return to Vendor (Return to Supplier), Warehouse location
DVR – Drawing Variance Record
SCAR – Supplier Corrective Action Request
CAR – Corrective\Preventative Action Request
RT – Rejection/ Red Tag
PO – Purchase Order
ECR – Engineering Change Record
IAW – In Accordance With
MR – Material Review, Warehouse location for MRB
ESDS – Electrostatic Discharge Sensitive
Part – Refers to a “purchased” level component used in a sub-assembly.
NR assembly – Refers to the sub-assembly or “70-level assembly that is Non-Re-workable.
R assembly – Refers to the “70-,” “90-,” or “FIS” level assembly that is Re-workable.
04-000015-01 Non-Conforming Material Procedure
Version: 3
Page 3 of 6
GEMBA – Gemba is a Japanese term meaning "the place where the truth can be found." Others may call it
"the value proposition." In quality management, gemba means the manufacturing floor and the idea is that if
a problem occurs, the engineers must go there to understand the full impact of the problem, gathering data
from all sources.
80/20 rule – Also known as the Pareto principle, states that for many situations approximately 20% of the
bugs cause 80% of the problems. Therefore, we should concentrate on the few bugs that cause most of the
problems.
References
04-000024
Corrective/Preventive Action Request Procedure
04-000267
Production Planning and Work Order Procedure
04-110014
Engineering Change Procedure (ECN)
04-000018
Electrostatic Discharge Control Procedure
04-200016
Stock Purge Procedure
Procedure
Section A. Discrepant Material from Receiving Inspection
Responsibility Action
Quality
A-1
A non-conformance is identified on material in Receiving Inspection.
Generate a Discrepancy Notice (DN) per A-2;
a) If material is immediately needed for production, notify Quality representative for
disposition.
b) If there is no immediate need for non-conforming material, move the parts to the MRB
holding area for MRB Review and Disposition.
A-2
A Discrepancy Notice (DN) is created through the “DN Entry” module of the Purchased
Part Quality Database (PPQD). A copy of the DN form is printed and attached to the
discrepant material.
A-3
Inventory Transaction to the discrepant material location is performed in Visual.
Section B. Discrepant Material from Stores
Responsibility Action
Quality
B-1
In case of identification of a nonconformity that can be presented in current stock, a stock
purge is performed in accordance with Stock Purge Procedure (04-200016-01).
B-2
Purged material is delivered to the MRB holding area. A DN is created per section A2.
B-3
Material is held in the MRB holding area for MRB Review and Disposition.
04-000015-01 Non-Conforming Material Procedure
Version: 3
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Section C. Discrepant Material from Production
Responsibility Action
When non-conforming Parts or Non-Re-workable assembly (NR assembly) material is
Manufacturing C-1
found in manufacturing, place in ESD safe bag. Mark the nonconforming material with
rejection tag (RT), place in red bin.
When non-conforming Re-workable assembly material is found in manufacturing; mark
Manufacturing C-2
part with rejection tag, and place in rework bin.
Note: Re-workable assemblies must be dismantled to a “Part” or “NR assembly” marking
with rejection tag, and placing in red bin).
Stores
C-3
Removes non-conforming material from manufacturing red bins, transaction material to
“Scrap” and place parts in MRB red bins.
Quality or Mfg C-4
Performs “GEMBA” of MRB red bins, and reviews non-conforming material. Use 80/20 rule
Engineer
to determine if non-conforming material should be reviewed by MRB.
Quality
C-5
Non-conforming material designated for review shall be transferred from “scrap” to the
“MR” location, and DN issued. Remaining non-conforming material shall be discarded in
recycle bin (note, no DN required).
Section D. Review and Disposition of Discrepant Material
Discrepant material will be reviewed and disposition by the Materials Review Board (MRB) which consists of members
from Manufacturing Engineering, Project Engineering (as required.), Purchasing, Quality and
Manufacturing/Production Control.
Responsibility Action
Quality
D-1
DN’s are reviewed for completeness, repetition, the need to contact suppliers, or the need
to perform a stock purge.
Designated Quality personnel will have the authority to execute a “Return To Supplier”
disposition for non-conforming material provided the return is coordinated with
Manufacturing/Production Control. In these cases, Quality and Purchasing will sign the
DN. Material shall be returned in accordance with the Material Return and PO Update
Procedure.
The Quality representative will have the authority to execute a “Scrap” disposition on
discrepant material from Production provided the cost associated with the DN does not
exceed $100. In these cases, Quality signature is the only required disposition sign-off
approval in a DN.
D-2
All other dispositions shall be handled through the MRB and shall require disposition signoff approval from Quality, Manufacturing Engineering
(or Project Engineer), Purchasing, and Manufacturing/Production Control. Note: The
Project Engineer approves disposition on engineering material.
Calls MRB Meeting to review and disposition discrepant material. This meeting is
generally convened weekly. The MRB review may include drawing requirements, material
planning requirements, and related or similar vendor issues.
04-000015-01 Non-Conforming Material Procedure
Materials
Review Board
(MRB)
D-3
Quality
D-4
D-5
D-6
Version: 3
Page 5 of 6
Material are disposition as “Return to Supplier,” “Rework at Microscan,” “Scrap,” or “Use as
Is.” The DN remains at a pending status until all members agree upon the final disposition
and disposition approval signatures are obtained. If identified as part of the disposition, the
MRB team will review the nonconformity, determine if nonconforming product has been
delivered to the customer, and if so, inform Manufacturing Manager for impact assessment
and appropriate action.
Return to Supplier
Discrepant material may be “returned to supplier” for rework, replacement or credit.
Material and transactions will be processed in accordance with the Materials Return and
PO Update Procedure (04-040010) Note: A copy of the completed DN will remain with the
material for return.
Rework at Microscan
Discrepant material may be reworked. If necessary Rework Instructions will be created
defining the scope and detail of the rework to be performed otherwise verbal instruction are
acceptable. The rework instruction will require a verification of the rework upon
completion. If the rework requires repair activity, the rework instructions will require
engineering approval.
Rework shall be executed by one of two means:
1. A rework work order in accordance with the Production Planning and Work Order
Procedure (04-000267-01).
2. For very simple rework (i.e. Part marking or packaging issues), rework may be
performed and verification of the rework will be documented on the associated DN.
Scrap
Disposition material “scrap” if the discrepancy is irreparable or the cost of rework exceeds
the cost of replacement. Material that is scrapped will be disposed of. Inventory
transactions will be performed in accordance with the Inventory Transactions and
Adjustments Procedure. Note: All “scrap” material of a single part number that exceeds
$250 shall have an additional sign off by VP of Operations or designated personnel.
Use As Is
“Use as Is” shall document material accepted for use in its current condition. A DVR
(Drawing Variation Record) and ECR (Engineering Change Record) as required will
support such action. Inventory transactions will be performed in accordance with
Procedure 04-120003.
Update the Disposition of the DN in the Purchased Part Quality Database.
If MRB determines a Supplier Corrective Action Request (SCAR) is required, quality
representative will generate and send in accordance with the Corrective\Preventive Action
Request Procedure (04-000024-01) and/or inform the supplier of the DN.
File hard copy of the DN by DN Number.
Section E. Discrepant Material from Service
Responsibility Action
Service
E-1
When non-conforming RTS (return to stock) Products or any ELF (early life failure) material
is found in service: input failure data to defect tracking software and place in ESD safe
Box.
E-2
Complete a stock transfer record moving the product from RTN to MRB and deliver box
and transfer record to stores.
Stores
E-3
Inventory transaction to the discrepant material location is performed.
Material is physically taken to MRB discrepant material shelf.
Quality
E-4
Discrepant material is reviewed by MRB (material review board) and disposition as
appropriate.
04-000015-01 Non-Conforming Material Procedure
Version: 3
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Section F. Quality Records - Discrepancy Notice
Responsibility Action
Quality
F-1
Collected:
F-2
F-3
F-4
F-5
F-6
Indexed/Filed:
Storage:
Access:
Retention:
Disposal:
Hard Copy signed, completed forms are maintained in the “MRB closed”
file in the Q.A. file cabinet. Electronic copy located in the PPQD.
Filed by Discrepancy Notice number.
Hard copy In Q.A. file cabinet. Electronic copy in the PPQD.
Open to all Microscan employees, available to customers by requests.
A minimum of three (3) years from the date of closure.
Discrepancy Forms may be disposed or recycled after the retention
period.
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