Company Name
Division or Address
Division or Address
Control of Nonconforming Product
Doc. No.
Rev. No.
Date: 6/28/2016
Page 1 of x
ISO Procedure
Control of Nonconforming Product
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
1.
2.
Control of Nonconforming Product
Doc. No.
Rev. No.
Date: 6/28/2016
Page 2 of x
Purpose
•
To evaluate defective products and products of questionable integrity.
•
To evaluate the cause of defects and rework the part where possible.
•
To create a permanent solution that prevents recurrence of problems.
Scope
This procedure applies to the review and subsequent disposition of material
purchased for or assembled by <COMPANY> and to defective products returned
for repair or evaluation.
3.
Responsibilities
It is every employee's responsibility to identify nonconforming material as
discrepant when it is noticed during normal work assignments.
<Job title> analyzes the product deficiencies to determine the cause.
<Job title> oversees the <team> activities and handles discrepant materials from
incoming inspection and repair and:
•
Makes periodic sweeps of the production areas to remove any
accumulation of discrepant material to the <location>.
•
When requested, responds to unique situations where unexpected
nonconforming material threatens to disrupt production and assists in the
segregation of this material.
•
Determines if an audit of stock or staging areas is necessary to head off
additional nonconforming material from reaching production areas. If
audits are necessary, removes any additional nonconforming material to
the <location>.
•
Dispositions material as to type of discrepancy. Returns minor nonconformities to production for rework. Vendor discrepant material is
segregated on pallets or suitable containers. Scrap material is segregated
from vendor discrepant material.
<Job title> inspects incoming product for conformance and completes the <name
of Inspection Report>.
<Job title> evaluates customer returns and determines if the product is to be
repaired.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Control of Nonconforming Product
Doc. No.
Rev. No.
Date: 6/28/2016
Page 3 of x
<Job title> ensures that nonconforming material does not accumulate in
production areas, conducts or delegates authority for surveillance and purges, and
notifies <department> if unexpected occurrences of nonconforming material are
noticed.
4.
Procedure
4.1
Identify Discrepant Material
<Job title> is responsible for removing nonconforming materials removed
from production lines.
<Job title> attempts to rework and reinspect the defective material. <Job
title> reinspects the material. The rework is recorded onto <name of
form>.
<Job title> marks defective items with <marking>. <Job title> completes
the <name of report> indicating <items>.
4.2
Holding Area
The following identifies where defective materials are held:
Work Area
receiving
inprocess
final
other
Holding Area
The holding area is restricted and <describe characteristics>.
<Job title> logs items in the holding area into <name of log>.
4.3.
Investigate
<Job title> inspects holding areas and classifies items in the holding area
as follows:
Classification
Description
(i.e., affects safety or performance, MRB)
(i.e., unfit for sale, inspection)
(i.e., can be reworked)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Control of Nonconforming Product
Doc. No.
Rev. No.
Date: 6/28/2016
Page 4 of x
<Job title/team> dispositions defective materials following <name of
procedure>.
<Frequency>, the <team>, composed of <job titles> performs the
following activities:
•
<activity>
•
<activity>
•
<activity>
To handle emergencies, <describe what happens>.
The following describes the possible dispositions:
Disposition
(i.e., Use As Is)
(i.e., Not Usable)
(i.e., Rework)
Description
Parts are used exactly as they are with no
anticipated effect on product quality.
Parts can not be used in their present state.
Scrap.
Parts are reworked and reinspected.
(i.e., Hold for Evaluation)
other
<Job title> completes the <name of form> indicating the disposition.
<Job title> approves the rework.
If an item cannot be reworked, the following occurs: <activity>.
<Job title> investigates the vendor upon receipt of defective incoming
parts.
<Job title> contacts the vendor and completes the <name of form>. <Job
title> reviews the vendor’s corrective action.
<Job title> investigates nonconforming inprocess materials and analyses
•
<activity>
•
<activity>
•
<activity>
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Control of Nonconforming Product
Doc. No.
Rev. No.
Date: 6/28/2016
Page 5 of x
If necessary, a method of waivers is used to release nonconforming
product. <Job title> authorizes the waiver. <Job title> notifies the
customer of the waiver.
<Job title> maintains the <name of record> indicating the product waived
for release and stores the <name of record> in <location> for <length of
time>.
4.4
Rework
If so dispositioned for rework, <job title> defines the rework and
retesting requirements and completes the <name of form>.
<Job title> approves the rework for internal work. <Job title> approves
the rework for external rework.
For external rework, <job title> sends <documentation> to the vendor.
For internal rework, the reworked material is moved to <location>. <Job
title> inspects the reworked material and completes the <name of form>.
<Job title> stores the <name of form> in <location> for <length of time>.
If the reworked product does not conform to requirements <job title>
notifies the customer and completes the <name of form>. <Job title>
approves the <name of form>. The completed <name of form> is filed as
a Quality Record in <location>.
4.5
Recall
If recommended, <job title> locates recalled units by reviewing <name of
records>. Customers and inventory are notified of a recall by <activity>.
<Name of record> indicates the recall of finished parts. <Job title> is
responsible for maintaining the records.
<Product> must product pass regulatory and safety requirements from
<agencies>.
Finished product is reviewed in the field to determine whether to recall
the product based on safety and customer satisfaction. <Job title>
performs the review and completes the <name of form>.
4.6
Return Authorization
A customer can return product for evaluation and repair, if necessary by
contacting <department>.
<Job title> issues an authorization number.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Control of Nonconforming Product
Doc. No.
Rev. No.
Date: 6/28/2016
Page 6 of x
<Job title> receives the returned item and enters the information onto
<name of record> to indicate the receipt of the product into the facility.
<Job title> inspects the item to determine the problem, to verify the
customer’s complaint, and determine if the goods are acceptable for
inventory. <Job title> completes the <name of form>.
<Job title> dispositions the returned item.
<Job title> notifies the customer of labor and material costs. If the
product is not under warranty, the customer authorizes payment by
<activity>.
<Job title> is responsible for the repair.
<Job title>creates the work orders for the repair.
The repair is performed at <location> and inspected prior to shipment.
<Job title> inspects the item and completes the <name of record>. The
<name of record> is stored <location> for <length of time>.
5.
Related Documentation
<Deviation Notice>
<Engineering Change Notice>
<Rework Form>
<Accept/Reject tag>
Document and Data Control
Purchasing
Process Control
Inspection and Testing
Corrective and Preventive Action
Servicing
<list work instructions>
Controlled Copy, Do Not Duplicate
For Internal Use Only