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OP-7.5.3 Product Identification and Traceability

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Operational Procedure MIYOSHI PRECISION (MALAYSIA) SDN BHD

Product Identification and Traceability


Operational Procedure : OP-7.5.3 Revision: 7 Page 1/6

Revision History

Rev No Details of Revision Date


00 Initial Release 01.01.02
01 Update documents to reflect current practice 03.11.03
02 To update the procedure and to add-in TS16949 requirement as 28.02.07
a current practice. Additional clause for Control plan table
03 To update the procedure and to add-in Revision History as a 30.08.07
front page for procedure.
04 To update the procedure clause 2.2 “All control run or risk run 12.03.08
parts shall be identified with a labels, and properly segregated”.
And clause 3.1 “Final products are identified by their part name,
part number or model number. The identification is a product
label and/or is printed on the product packaging. As for control
run or risk run parts, an additional label shall be used to indicate
the purpose of the control run and risk run and quantity.

05 Upgrade to ISO 9001:2008 requirement 14.10.10

06 Changes at approval Authorities and other minor amendments 13.12.10

07 Changes at approval Authorities 03.05.11

Approval Authorities

Prepared Reviewed Reviewed By Reviewed Approved


By By By By

Name Kala Allan Teen Nicole Lee Johnas S.G.Tan

Date 03.05.11 03.05.11 03.05.11 03.05.11 03.05.11

Designation Doc. Cont. EMR OSHMR QMR GM

Signature
Product Identification and Traceability
Operational Procedure : OP-7.5.3 Revision: 7 Page 2/6

Responsible Outline of Procedure Interface

Store/Receiving personnel Receiving of purchased Purchase Order, Delivery Order


products

Store/Receiving personnel Material spec.


Identification of
QA Inspector purchase products Part Number

Storage area in
Store Personnel production/store Delivery Note

Production Personnel Part/material issued Material Requisition Form


to production
Customer Drawing

Set-up
Production Personnel/QA Inspector Set-up Inspection

Production Personnel/QA Inspector Production inspection


Mass Production start
QA In-Process Inspection

Operator Production Traveler Tag, 2ND. Process tag,


output/packing
Packing Instruction

QA Inspector Lot Passed Label In-process, Out going Insp.

Production / Store Personnel Next process or store Quality Plan


LOT PASSED Label
Product Identification and Traceability
Operational Procedure : OP-7.5.3 Revision: 7 Page 3/6

I PURPOSE

The purpose of this procedure is to provide for a system and instructions for product
identification and traceability.

II APPLICATION

This procedure applies to materials, components, parts, subassemblies, and other


products intended for incorporation into the final products, and to the final products
themselves.

III RESPONSIBLE

This procedure concerns Store, Production and Quality Assurance departments.

IV PROCEDURE

1. Identification of purchased products

1.1 Purchased materials and parts are identified with unique part numbers, thickness or
names. The identification is the same as used in drawings, specifications, bills of
materials, part lists, purchase orders, etc.

1.2 Materials and parts identified by marking, labeling or tagging the packaging
or containers holding them and, when appropriate and practical, by labeling the
products themselves. Products may be also identified by general identification of the
area dedicated for storage of particular product.

1.3 Materials and parts identification is maintained while the products are in storage
and/or are staged for production.

2. Identification during production

2.1 During all stages of production, in-house manufactured parts and subassemblies are
usually identified by the Shop Schedule, traveler tags, product labels and other
documents and records created during manufacturing, assembly, and inspection or
testing of a product. These documents and records are kept in the area where the
product is being processed or is staged for the next processing step.Tooling were
identified by permanently marked part numbers

2.2 All control run or risk run parts shall be identified with a labels, and properly
segregated.

2.3 When the products need to do rework or sorting at any stages in production or QA,
they shall be labeled with the Non Conformance label.
Product Identification and Traceability
Operational Procedure : OP-7.5.3 Revision: 7 Page 4/6

3. Identification of final product

3.1 Final products are identified by their part name, part number or model number. The
identification is a product label and/or is printed on the product packaging. As for
control run or risk run parts, an additional label shall be used to indicate the purpose
of the control run and risk run and quantity.

3.2 When traceability is required, products are identified with their lot numbers and/or
carton labels.

4. Part number and product configuration records

4.1 Quality Assurance maintains records correlating each issued part number to
corresponding drawings, specifications, technical data, and other documentation
defining the part.

4.2 For products that are assembled from numerous parts, Quality Assurance will be
issuing the product specification to production. The specification correlates the lot
number and/or carton labels of products, or individual products with the parts lists
used in their manufacture and assembly

5. Traceability

5.1 Traceability is maintained when specified by customers, governmental regulations,


or internal requirements. The extent of traceability is defined in accordance with the
stated requirements.

5.2 When required, purchased products are traceable to their purchase orders and thereby
to their original inspection, testing or other such quality records supplied with the
products.

5.3 During production, traceability are maintained using Shop Schedule Lot No.,
inspection records, Traveler Tag/2ND. Process tag and other such documents and
records established during the manufacture, assembly, inspection, and testing of a
product.

V RECORDS

1.1 When traceability is required, Production and Quality Assurance maintains (or
coordinates) the traceability record. The record usually consists of Lot No.; parts and
components used; process data; and product inspection and testing reports. The exact
scope of the required traceability record for a given product is documented in
manufacturing specifications or the production Shop Schedule.

1.2 Whenever possible and practical, traceability information is recorded directly on the in-
Product Identification and Traceability
Operational Procedure : OP-7.5.3 Revision: 7 Page 5/6

process inspection report. For each relevant operation, inspectors record, equipment,
process parameters and other such traceability information, as required.

Refer to Control Plan

Process Relevant records Identification Traceability Identification


means means means (non
(conforming conforming
items) items)

Receiving DO, PO, Receive Stamp Receiving date, NA


material Invoice on D/O supplier name

In Coming D/O, IQC Inspection QA Plan. Non


Inspection Disposition Tag, Conformance
Report, Material IQC Accept Tag, IQC
Certificate Stamp Rejected Stamp.

Storage FIFO Sticker, NA Inspection NA


Label Disposition Tag,
IQC Accept
Stamp

Material Material NA Material / Part NA


Issuance Request Form label

In process IPQC Inspection IPQC Inspection QA Plan Non


Report, Report Conformance
Drawing, FA periodically Tag
Report inspection
report

Out Going OQC Inspection OQC Accepted QA Plan Non


Report Stamp Conformance
Tag

Ware House FIFO Sticker NA Daily Finish NA


Good Sent To
(Storage) Inventory Tag Store
Passed Label

Delivery Delivery Order NA Passed Label NA


Product Identification and Traceability
Operational Procedure : OP-7.5.3 Revision: 7 Page 6/6

VI ASSOCIATED DOCUMENTS

 Operational Procedure OP-7.5.1: Production Work Order – Shop Schedule


 Operational Procedure OP-7.4.3: Verification of Purchased Product
 Operational Procedure OP-7.5.5: Product Handling, Preservation and Shipping

V APPENDIX
Nil

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