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Authorizations: HMIQP-1012 - Product Traceability

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317 views2 pages

Authorizations: HMIQP-1012 - Product Traceability

Uploaded by

AK
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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HMIQP-1012 - Product Traceability

Revision NEW

AUTHORIZATIONS
Title Signature Date

Document Owner Quality Manager Original On File 03/01/2016


Management Representative Production Manager Original On File 03/01/2016

1.0 PURPOSE
The purpose of this procedure is to define the controls used for product traceability. The procedure described herein
complies with AS9100 and ISO 13485.

2.0 SCOPE
This procedure applies from the time product arrives at Honeycutt Manufacturing, Inc. and lasts until the records are no
longer stored per Control of Records procedure.

3.0 GENERAL
The Quality Assurance Manager and Production Control Manager will oversee and manage product traceability. Where
traceability is a requirement Honeycutt Manufacturing, Incorporated records the unique serialization number of the product
per customer and regulatory specifications. Material is identified with form In-House Product Identification Tag - Lime
Green (QMSF-0016).

All control, review, and approval is controlled per the flow chart found at the end of this document.

4.0 REFERENCE DOCUMENTS


• Honeycutt Manufacturing, Inc. Quality System Manual (Sec. 7.5.3.2.1)
• AS9100
• ISO 13485
• QMSF-0016, In-House Product Identification Tag - Lime Green

5.0 RESPONSIBILITY
• Quality Assurance Manager
• Production Control

6.0 REVISION
Revision Date Change(s)
NEW 03/01/16 Initial Release

The information contained in this document is the property of Honeycutt Manufacturing, Inc. and is strictly confidential. This information is not to be shared with anyone
outside of Honeycutt Manufacturing, Inc. without prior written approval from management. Any dissemination, distribution, or copying of any of the information herein,
either in part or whole, is strictly prohibited.

Copyright © 2016 Honeycutt Manufacturing, Incorporated HMIQP-1012 - Product Traceability - Revision NEW
Page 1 of 2
HMIQP-1012 - Product Traceability
Revision NEW

Start

SH
Product is received

QA Product is inspected per Purchase


Order requirements

Verify reject; fill out


Product meet Purchase Order
Nonconformance Report
requirements
No (QMSF-0017) (NCR)

Yes

Serialize per Purchase Order


Product need serialization
requirements
Yes

No
SH
Product with Material Product
Identifier Tag QMSF-0023

Operators ensure Product Identifier


Tag and Work Order instructions match

Operator will complete process and


verify that all product is within
Start / End
conformance. All nonconforming
product is dealt with per Control of
Process Nonconforming Product Process
HMIQP-1007

Decision

SH Shipping Agent Operator will move all product and


paperwork to next operations or
material storage cage.
QA Quality Assurance Agent

Black circle icons indicate the process owner


or decision owner. They imply continuation of
ownership for all proceeding processes and
decisions until a process or decision with a
different owner is encountered while following
the chart flow.

End

Copyright © 2016 Honeycutt Manufacturing, Incorporated HMIQP-1012 - Product Traceability - Revision NEW
Page 2 of 2

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