QUALITY MANAGEMENT SYSTEM PROCEDURE MANUAL

Nonconformity
1.

Introduction & Purpose

The purpose of this procedure is to establish the process for identifying, documenting and analyzing nonconformities
and mitigating their impacts by implementing corrective and preventive actions. Your Companys quality management
system is geared toward the proactive elimination of actual and potential deficiencies. Nonconformities in products,
services or the management system are investigated and action implemented to prevent their reoccurrence.

2.

References

Standard

Title & Description

Clause

ISO 9001:2008

Quality management components

8.3

3.

Terms & Definitions

Term

Definition

Nonconformity

Non-fulfilment of a requirement

Preventive Action

Action taken to eliminate a potential non-conformity

Corrective Action

Action taken to eliminate the cause of a non-conformity

4.

Application & Scope

This procedure is applicable to all corrective and preventive actions that are related to non-conformities in products,
services and audit results. Any corrective action taken to eliminate the causes of actual non-conformities is appropriate
to the magnitude of the problem whilst also being in proportion to the risks presented by the non-conformity. Root
causes of non-conformities in products and services, as well as, management system process defects are investigated
and actions implemented to prevent their recurrence.

5.

Requirements

Personnel & Process Owners are required to:

Report potential and actual non-conformities to their Line Manager/Supervisor

Follow this procedure upon detection of a non-conformity

The Management Representative is required to:

Determine the causes of non-conformities

Maintain a system for reporting and record keeping

Implement necessary actions to achieve resolution

Review the effectiveness of corrective actions taken

6.

Process

6.1

Identifying Nonconformities

It is the responsibility of all employees to bring suspected nonconformities to the attention of the Management
Representative or their Line Manager or Supervisor, or other nominated representative. Nonconformities are
identified through the following activities:

Product nonconformities are identified through inspection activities; subsequent reporting details the nature
of the nonconformity as per 8.3. This is done quickly to allow containment and correction action.

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Process nonconformities are based on the analysis of trends in monitoring and measurement data as per
8.2.3. Corrective action is taken and the process is monitored for stability.

Management system and process nonconformities are identified by auditing as per 8.2.2. Competent auditors
describe the nature of the problem, the requirement, including its source and appropriate evidence.

Potential nonconformities trigger the preventive action process as per 8.5.3. Any potential problem is
described in terms of its nature, the requirement and evidence that the requirement will not be fulfilled
unless the system is changed.

6.2

Controlling Nonconformities

By whichever means nonconformity is identified, the underlying cause(s) of the nonconformity is investigated and
appropriate corrective action(s) are taken according to the nature of the nonconformity.
1.

Any non-conforming materials are immediately quarantined in a segregated area

2.

Subsequent investigation and verification activities are undertaken to determine the cause(s)

3.

Any nonconforming materials maybe disposed of to prevent delivery to the customer or re-worked where it is
deemed appropriate by the Management Representative

4.

Preventive action, such as implementing modifying or enforcing procedures or other controls, is taken to
avoid repetition of the nonconformity

5.

Any corrective or preventive action taken to address the causes of the nonconformity must be appropriate to
the magnitude of problems and commensurate with the impact encountered is documented

6.

The organization has implemented and maintained a system for reporting and record keeping for
nonconformity, corrective and preventive action

7.

Any changes to quality management system procedures, as a result of corrective or preventive action, are
recorded

8.

The nonconformity report details the nature and scale of the nonconformity as well as proposals for
corrective and preventive actions, as appropriate

9.

A repeated nonconformity of the same nature or significant deviations from procedures (e.g. disregard of the
procedures or absence of required verification documentation) are reported to the Management
Representative for action and resolution

6.3

Review

A report is submitted by the Management Representative as part of the management review process where any
significant deviations from the policies and objectives are reported. Where preventive actions involve long term
programming, these are considered in the setting of objectives or targets.

6.4

Forms & Records

All records that are generated by this process are managed in accordance with the document and data control and the
control of records procedure.
Ref.

Title & Description

F04-1

Nonconformity Report

F04-2

Nonconformity Report Log

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7. Process Map
Management
Representative

Input

Production Team

Customer
Product nonconformity reported

Product/material nonconformity detected

Quarantine
product/material

Investigate nature of
non-conformity

Activity

Generate nonconformity report

Re-work
material/product

Validate re-work

No

Investigate causes

Update customer with

Verify non-conformity
& determine impact

If material/product
conforms use as is

Is disposition of
material/product
required?

Yes

Offer return, refund or

Yes

Output

Identify batches as
scrap & dispose of

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Close-out nonconformity report and

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