Nonconformity &

Corrective Action
ISO 9001:2015 & ISO 14001:2015

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 Nonconformity & Corrective
Insert your company’s name or logo.
Action
ISO 9001:2015 & ISO 14001:2015

Contents
1 Nonconformity & Corrective Action Procedure _________________________________________________________ 3

1.1 Introduction & Purpose _______________________________________________________________________________ 3

Process Activity Map _______________________________________________________________________________ 3
References _________________________________________________________________________________________ 3
Terms & Definitions ________________________________________________________________________________ 3

1.2 Application & Scope __________________________________________________________________________________ 4

1.3 Roles, Responsibilities & Authorities ________________________________________________________________ 4

Roles & Responsibilities ___________________________________________________________________________ 4
1.3.1.1 Employees _______________________________________________________________________________________ 4
1.3.1.2 Process Owners __________________________________________________________________________________ 4
1.3.1.3 Supervisors ______________________________________________________________________________________ 5
1.3.1.4 Operations Manager ____________________________________________________________________________ 5
1.3.1.5 Purchasing Manager ____________________________________________________________________________ 5
1.3.1.6 EQMS Manager __________________________________________________________________________________ 5
1.3.1.7 Supplier __________________________________________________________________________________________ 6

1.4 Document the Corrective Action _____________________________________________________________________ 6

General _____________________________________________________________________________________________ 6
Process Nonconformances ________________________________________________________________________ 6
Customer Returns __________________________________________________________________________________ 7
Supplier Returns ___________________________________________________________________________________ 7

1.5 Problem Solving _______________________________________________________________________________________ 8

General _____________________________________________________________________________________________ 8
Define the Problem ________________________________________________________________________________ 8
Establish a Problem-solving Team _________________________________________________________________ 9
Implement Containment Action __________________________________________________________________ 10
Undertake Root-cause Analysis ___________________________________________________________________ 10
Implement Corrective Action _____________________________________________________________________ 13
Verify the Effectiveness ___________________________________________________________________________ 13
Close-out the Corrective Action __________________________________________________________________ 13

1.6 Monitor & Review ___________________________________________________________________________________ 13

Key Performance Indicators ______________________________________________________________________ 14
Status of Corrective Actions ______________________________________________________________________ 15

1.7 Documentation ______________________________________________________________________________________ 15

1.8 Corrective Action Process Map _____________________________________________________________________ 16

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 Nonconformity & Corrective
Insert your company’s name or logo.
Action
ISO 9001:2015 & ISO 14001:2015

6. Review the effectiveness of corrective actions taken.

1.3.1.7 Supplier
All Suppliers are required to respond to SCAR initiator with timelines indicated on SCAR form as to the
feasibility of completion. Follow the description on the form on how to complete SCAR.

1. Utilize quality tools – e.g.: 5Why, Ishikawa - to assist with root-cause Analysis;
2. Follow up and communicate progress on CA(s) and their verification method to SCAR initiator;
3. Implement verified permanent corrective actions;
4. Return completed SCAR (or 8D) form to SCAR Initiator;
5. Handle any charge-back requests as a result of nonconformance in a timely manner.

1.4 Document the Corrective Action

1.4.1 General
Your organization’s nonconformity and corrective action process combines organizational management
techniques with individual tools to create a robust closed-loop process in order to:

Define the Verify and report

Identify the root- Identify Implement
problem and the effectiveness
cause(s) corrective actions corrective action
establish team of corrective
actions

Implement Verify and Close-out

containment approve corrective action
action implementation report

The EQMS Manager reviews any issues raised by each nonconformity to identify root-cause and level of action
required. Repeated nonconformities of the same nature or which are significant deviations from procedures or
policies are reported to Top management for action and resolution.

1.4.2 Process Nonconformances

Noncompliances are failures within the management system and usually relate to differences between how
duties are being carried out and those set out in procedures.

Where problems exist in our process or in our management system, employees are authorized to report the
issue to the EQMS Manager via the Corrective Action Report (CAR) form or the Internal Audit Report form.

The EQMS Manager reviews the problem and decides whether to implement any process or system changes
necessary using any specialists as required.

The EQMS Manager reviews any issue raised by the nonconformity, including those arising from complaints,
to identify root-cause and the level of action required.

Repeated nonconformities of the same nature or which are significant deviations from procedures or policies
are reported to Top management for action and resolution. Corrective action is taken as a result of:

1. In-process concerns;
2. Internal and external audits;
3. Concerns about management system stability.

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 Nonconformity & Corrective
Insert your company’s name or logo.
Action
ISO 9001:2015 & ISO 14001:2015

1.5 Problem Solving

1.5.1 General
Your organization ensures the focus of the corrective action process will stop the recurrence of serious
nonconformities, by removing their root-causes. A nonconformance will require formal root-cause analysis and
corrective action when:

1. There is an adverse impact on the quality of products:

a. No easy/specific method of correction/is complex;
b. Safety impact (product/personal);
c. Customer complaints;
d. Product strength, performance, and/or reliability issue;
e. Critical limits and tolerance exceeded;
f. High impact on production/maintenance operations:
i. Stop the line; prevent the next operation from occurring, etc.;
ii. Regulatory authorities and/or Customer dissatisfaction;
iii. Costs issue generated to the Customer or organization;
iv. Disruption of Supplier’s process or Customer’s operations.
g. Recurring (based on valid analytical methods);
h. Severe and continuous;
i. Repetitive problems to one part or similar operations and processes;
j. Difficult to detect;
k. By Customer request;
l. A design issue;
m. A manufacturing/processing issue.
2. There is potential for the nonconformance to recur somewhere else in the quality system;
3. There are reports of problems with procedures, processes, forms, work instructions, or guidelines:
Your organization ensures that root-cause analysis is considered when undesirable conditions, defects, and
failures are detected and the cause is unknown, not obvious, or inconclusive. The decision to apply or not to
apply the process is made by the Operations Manager and the EQMS Manager based on the risk level and
whether the associated risk is acceptable.

1.5.2 Define the Problem

Senior Management will be actively involved in any major corrective actions, ensuring that all actions agreed
by any multi-functional teams are carried out entirely. Major corrective actions and improvements are placed
onto the continual improvement programme and reported on at Top management review meetings.

Corrective Action Report (CAR) form is issued for repetitive, ongoing problems during our production processes
and issues having a major impact on Customer end product delivery and quality management system
noncompliances. Other nonconformities outside these criteria are controlled through the remedial action
system. All corrective action reports raised are categorized as having major or minor effects:

• Major: Where the procedure contradicts working practices and/or working practices do not reflect
standard requirements or Customer complaints which require additional corrective action;
• Minor: Where the system procedure or process is not being fully adhered to, equipment breakdown
or failures which do not affect operational activities. A nonconformance that does not have an
immediate impact on the stability of the management system.

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