ISO13485：2016忠告性通知控制程序-英文版

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.

Title

Signature Date

Document Owner

Production Manager

Original On File 03/01/2016Management Representative

Sales Manager

Original On File

03/01/2016

AUTHORIZATIONS

1.0 PURPOSE

The purpose of this procedure is define the actions taken for an advisory notice & recall. The procedure described herein complies with AS9100 and ISO 13485.

2.0 SCOPE

This procedure starts at the time of nonconforming product discovery. The procedure will continue until all product issues are resolved and/or all product is replaced with product that conforms to customer and regulatory requirements.

3.0 GENERAL

The Quality Assurance Manager and Sales Manager will oversee and manage the advisory notice and recall procedure. An advisory notice and recall may be issued when a nonconforming product is discovered after shipment. The Quality Assurance Agent will determine the nature and seriousness of the nonconformity. The nonconformance report and corrective action will be started by a Quality Assurance Agent. The Quality Assurance Manager will draft an advisory notice. A Sales Manager will send an advisory notice to all affected customers.

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

4.0 REFERENCE DOCUMENTS

• Honeycutt Manufacturing, Inc. Quality System Manual (Sec. 8.5.1)• AS9100•

ISO 13485

5.0 RESPONSIBILITY

• Quality Assurance Manager •

Sales Manager

6.0 REVISION

Revision Date Change(s)NEW

03/01/16

Initial Release

QA Quality Assurance Agent

Decision

Start / End Process

O

Originating 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.

SM Sales Manager

QM Quality Manager Start

Nonconformity of product is discovered and Quality Assurance Agent is notified

Determine nature and seriousness of the hazard or non-conformity and

the failure to meet regulatory requirements (as applicable)

Create Nonconformance Report

Form (QMSF-0017)

Advisory Notice is required

Yes

No

End

Corrective action is required

Yes

Follow procedure Corrective Action

(HMIQP-1009)

Record applicable information and file relevant paperwork on network (as

required)

Indicate why corrective action is unnecessary on in-process Nonconformance Report Form

(QMSF-0017)

Issue Advisory Notice and distribute to Sales Agent

Send Advisory Notice to customer

QA

O

SM

QM