Control of Nonconforming Product

Company Name / Control of Nonconforming Product
Division or Address / Doc. No. / Rev. No.
Division or Address / Date: / Page XXX of x

ISO Procedure

Control of Nonconforming Product

Approved: ______

title Name

Approved: ______

title Name

Approved: ______

title Name

Approved: ______

title Name

Approved: ______

title Name

Change Record

Rev / Date / Responsible Person / Description of Change
A / Name / Initial Release

Distribution List

(list the departments that receive controlled copies)

1. 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.

2. 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 non-conformities 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.

<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 Holding Area

receiving
inprocess
final
other

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)

<Job title/team> dispositions defective materials following <name of procedure>.

<Frequency>, the <team>, composed of <job titles> performs the following activities:

• <activity>

To handle emergencies, <describe what happens>.

The following describes the possible dispositions:

Disposition Description

(i.e., Use As Is) / Parts are used exactly as they are with no anticipated effect on product quality.
(i.e., Not Usable) / Parts can not be used in their present state. Scrap.
(i.e., Rework) / 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>

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.

<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

Document and Data Control

Purchasing

Process Control

Inspection and Testing

Corrective and Preventive Action

Servicing

Controlled Copy, Do Not Duplicate For Internal Use Only