HMIQP-1007 - Control of Nonconforming Product

Revision NEW - January 1, 2016

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 process for Control of Nonconforming Product. The procedure described
herein complies with AS9100 and ISO 13485.

2.0 SCOPE
This procedure applies to nonconforming product purchased and/or manufactured by Honeycutt Manufacturing,
Incorporated.

3.0 GENERAL
The Quality Assurance Manager or his/her designee will oversee and manage the control of nonconforming product. All
nonconforming product is tagged at time of first discovery. Parts will remain tagged until they can be assessed as scrap or
repairable. Form Nonconformace Report (QMSF-0011) will be created at this time. Scrap parts will be physically altered
so that they can’t be mistaken as a conforming part. Parts that can be repaired will be repaired immediately or split onto
a rework work order.

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

4.0 DEFINED TERMS

Nonconforming: The non-fulfillment of a specified requirement

Rework: Action taken on a nonconforming product so that the product will fulfill the requirements of the product
requirement.

5.0 REFERENCE DOCUMENTS

• Honeycutt Manufacturing, Inc. Quality System Manual (Sec. 8.3)
• AS9100
• ISO 13485
• QMSF-0011, Nonconformance Report

6.0 RESPONSIBILITY
• Quality Assurance Manager

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-1007 - Control of Nonconforming Product - Revision NEW
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 HMIQP-1007 - Control of Nonconforming Product
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7.0 REVISION
Revision Date Change(s)
NEW 03/01/16 Initial Release

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 HMIQP-1007 - Control of Nonconforming Product
Revision NEW - January 1, 2016

Start Product that has been delivered

to customer and rejected for
nonconformance
SA
Receive Non-conforming Material
Report (NCR) from customer

Internally distribute NCR information to

the appropriate personnel

Generate Return Merchandise

Authorization (RMA) in Enterprise
Resource Planning system (ERPS)

QA
Verify non-conformance of returned
product

SA
Notify customer that returned parts
Returned product conforms to
are acceptable and do not require
manufacturing requirements
Yes corrective action

No

Create Non-conformance Report

(QMSF-0017)

Start / End

Form Corrective-Preventive Action Create CPAR per Corrective-

Process Report (QMSF-0019) (CPAR) is Preventive Action Procedure
required Yes (HMIQP-1009)
Decision
No

SA Sales Agent Review and report on customer NMRs

in Management Review meeting

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

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Start Nonconforming product

detected before delivery
to customer

O
Identify, tag, and segregate
nonconforming product. Notify Quality
Agent if final production quantity will be
less than the minimum quantity
required on the work order

QA
Create Nonconformance Report
(QMSF-0017) (NCR)

Have the Material Review Board

(MRB) meeting

Split parts to rework work order in

Part(s) can be reworked to conform to
Enterprise Resource Planning (ERP)
all requirements
system
Yes

Start / End
Corrective/Preventive Action Report
Create CPAR
(QMSF-0019) (CPAR) is required
Yes
Process
No
Decision

O Originating Agent

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

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 HMIQP-1007 - Control of Nonconforming Product
Revision NEW - January 1, 2016

Start Nonconforming product that

was purchased complete
from supplier

QA
Identify, tag, and segregate
nonconforming product during
receiving inspection. Notify Quality
Manager

Create Nonconformance Report

(QMSF-0017) (NCR)

PA
Product needs to be returned for Contact supplier to obtain return
replacement or rework authorization (RMA)
Yes

No

SH

Return product to vendor

Start / End QA
Corrective/Preventive Action Report
Create CPAR
(QMSF-0019) (CPAR) is required
Yes
Process

No
Decision
Review and report on CPAR (if
required) in a Management Review
(MR) meeting
PA Purchasing Agent

QA Quality Assurance Agent

SH Shipping 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

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