QUALITY MANAGEMENT SYSTEM

CORRECTIVE AND PREVENTIVE

ACTIONS

ORAO PROCEDURE

Mandatory
implementation
of: 01.04.2013.

as

Total pages 21

OQM-07.017
Descriptors: Corrective action, preventive action, noncompliance, correction,
amendment improvement.

Business secret
Internal

The procedure has been made in accordance with the requirements of the standard ISO
9001/2008, BAS ISO/IEC 17025:2006, SORS 9000/05, EN 9100 Standards, Quality
Manual OS-Q.1, Quality Handbook of the Laboratory for Testing Materials OS-Q.2 and
Quality Handbook of Meteorological Laboratory OS-Q.3
TABLE OF VALID ISSUE/AMENDMENTS
IV
Issue

Name

Amendment

Name

no.1
Amendment
no.2
Amendment
No.3
Amendment
no.4

Prepared by

Approved by

Decision no.

Date

Mirko Panti

Milan Buha

051/67-03

01.04.2013.

Signature
Signature

Name
Signature

Name
Signature

Name
Signature

TABLE OF VALID PAGES

Page no.

14

15

16

17

18

19

20

21

10

11

12

Amendment
Page no.

13

Amendment
Page no.
Amendment

TABLE OF DISTRIBUTION OF COPIES

opy no.

10

11

12

13

14

Quantity

15

16

17

18

19

20

21

22

CONTENTS:

Page

0. INTRODUCTION

1. SCOPE AND AREA OF APPLICATION

2. DEFINITIONS

3. RESPONSIBILITY

4. DESCRIPTION OF ACTIVITIES
4.1 Corrective action
4.2 Preventive action

3
3
5

5. RELATION TO STANDARDS AND OTHER PROCEDURES - DOCUMENTS

6. ANNEXES

7. ABBREVIATIONS

8. DISTRIBUTION LIST (distribution of copies - only with original and standard)

21

DESCRIPTION TABLE OF MODIFICATION - AMENDMENT

Modification
no.

Brief description of modification

Date

Modification
carried out by

Modification
verified by

ISSUE IV
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0. INTRODUCTION
Corrective and preventive actions in ORAOa.d. are the part of active management,
wherewith it is ensured that the capability and promptness of responding to causes and
possible causes of noncompliance (nonconformity) of product/process and quality
system management is more important than noncompliance itself.

1 . S C O P E AN D AR E A O F AP P L I C ATI O N
Procedure stipulates documented management system for corrective and preventive
actions in ORAOa.d.
In addition to establishing the responsibility and authority for taking corrective and
preventive actions, the procedure also defines the method of evaluation of importance,
investigation of possible causes, problem analysis, taking emergency actions, process
control, removal of nonconforming product units and stipulating the system of
modifications which originate from corrective and preventive actions.
Stipulated and taken corrective and preventive actions include all the functions of
ORAOa.d.

2. DEFINITIONS
All the definitions and concepts in the procedure are taken from standard SRPS ISO
9000:2007, as well the definitions of concepts which are quoted authentically because of
area being worked on:
Preventive action is an action for the elimination of the cause of possible
noncompliance or some other potential undesired situation. Preventive action is
taken to prevent occurrence (SRPS ISO 9000/2007, Item 3.64);
Corrective action is an action for the elimination of the cause of noncompliance.
Corrective action is taken to prevent repeating the occurrence (SRPS ISO
9000/2007, Item 3.65).

3. RESPONSIBILITY
Executive Director for Quality and Laboratories and Quality Manager for Laboratories in
corresponding laboratory shall be responsible for the application and maintenance of
documented system of corrective and preventive actions.
Executive Director for Quality and Laboratories, or Quality Manager for Laboratories
shall define and set responsibility and authorities for the implementation of established
corrective and preventive actions.
Quality Monitoring Department or Quality Manager for Laboratories shall manage the
documentation about corrective and preventive actions.

ISSUE IV
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4 . D E S C R I P T I O N O F AC T I V I T I E S
4.1 Corrective Action
Algorithm of corrective action is shown in Annex 1 and explained hereinafter.
File on corrective actions is defined with Corrective Action Log OQZ13 046 (Annex 2)
File on corrective actions for suppliers is defined with Corrective Action Log for
Suppliers OQZ13 049 (Annex 10)
4.1.1 Reexamination of Nonconformity
Reexamination of nonconformity of product, process and quality management system
shall be carried out after the following is obtained:
Users complaints expressed in any way (claims, letters, phone calls and personal
contacts);
Customers challenge;

Reports on quality checks;

Reports on reexaminations by management;

Conclusions from management meetings;

Information and data obtained during repairs and finishing the products;

Defects of monitoring and measuring equipment;

Records (technological examination list, testing list, reports on laboratory testing,

reports on laboratory standardization and reports on testing before verification and
validation);
Corrective action request OQZ13 030 (Annex 3).
Reexamination of nonconformity is performed by QMD, Quality Manager for Laboratories
and personnel whose work is influenced by nonconformity or other persons authorized
by the Executive Director for Quality and Laboratories.
Reexamination of nonconformity shall be completed by verification thereof.
4.1.2 Analysis of the Causes of Nonconformity
Analysis implies research and determining the causes of nonconformity. Analysis is
carried out by the Executive Director for Quality and Laboratories, Quality Manager for
Laboratories, personnel of QMD, as well as other persons authorized by the Executive
Director for Quality and Laboratories. In analysis, all information about the detection of
nonconformity and actions taken to eliminate the nonconformity are used. When
considering the cause of nonconformity, its influence to production costs, quality costs,
functioning, reliability, safety, process capability and user satisfaction should be
discussed.
Frequently, the fundamental cause is not noticeable so that careful analysis of the
specified requests of product, process and quality management system is required. If the
fundamental cause of nonconformity is a mistake in product design, the Executive
Director for Quality and Laboratories shall make decision on forming a commission for
investigation and determining the cause. The commission is composed as follows:
- Quality technologist from QMD;
- Person from the division where the cause of nonconformity is present, but who is not directly
responsible for the occurrence of nonconformity, or a person from RDD, who is not a project
leader;
- Person from any other division who knows the problem.
Analysis of the causes of nonconformity shall be completed with preparation of plan or
proposal for the elimination of the cause of nonconformity.

ISSUE IV
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4.1.3 Implementation of Corrective Actions

When defining and implementing corrective actions, causes of nonconformity shall be
eliminated to level which corresponds to an acceptable risk for ORAOa.d., whereas the
detection and removal of fundamental cause of product nonconformity shall be carried
out disregarding resources spent for its removal.
Implementation of corrective actions is defined with corrective action plan and order
which follows Corrective Action Request OQZ13 030. Implementation plan of corrective
action is prepared in free-form, while the Executive Director for Quality and Laboratories
gives consent for its use. This plan can be an integral part of monthly work schedule of
ORAOa.d. The plan defines activities, activity holders, control points and performance
deadlines.
Implementation plan of corrective actions in Metrology Laboratory Division and
Laboratory for Testing Materials/Products Division is defined by the record Corrective
Action Plan OQZ14 081, Annex 4.
4.1.4 Analysis of the Implementation of Corrective Actions
With an order, or corrective action plan, evaluation methods of the effectiveness and
efficiency of actions being taken can be specified.
Monitoring of corrective actions which have been taken is the responsibility of the
Executive Director for Quality and Laboratories, Quality Manager of Laboratories and
other authorized persons.
Analysis of the effectiveness and efficiency of corrective actions is performed in
Corrective Action Request OQZ13 030 or in a way defined with the Corrective Action
Plan or in some other way.
In order to check the effectiveness of corrective actions in Metrology Laboratory Division
and Laboratory for Material/Product Testing Division, analysis of implemented corrective
actions shall be performed which is formalized with record Report on Analysis of
Implemented Corrective Actions OQZ14 082 (Annex 5).
Verification of corrective actions is done by the Quality Manager, while the Executive
Director for Quality and Laboratories gives consent on Corrective action request
OQZ13 030 or with the certification of Corrective Action Implementation Report.
If corrective action does not give expected results, or the corrective action is not closed,
the Executive Director for Quality and Laboratories defines special actions in order to
eliminate the nonconformity root causes. The analysis is done at least once a year
during Quality Management System reviewing, and if necessary, within monthly analyses
of corrective actions.
When it is ascertained that the supplier is liable for (the cause of) nonconformity, the
Executive Director for Quality and Laboratories requests corrective actions to be taken
with the supplier on the record Corrective Action Request to Supplier OQZ13 048,
Annex 6. In addition, the Executive Director for Quality and Laboratories is responsible
for the analysis of the implementation of corrective actions for the supplier, as well as for
their final verification.
Corrective Action Plan OQZ14 081 (Annex 4) and Report on the Analysis of
Implemented Corrective Actions OQZ14 082 (Annex 5) can be also used in other
WU/divisions in the process of deciding on corrective actions.
QMD manages all the corrective action records.
4.1.5. Analysis of results of implemented corrective actions
In order to check results of implemented corrective actions in Metrology Laboratory
Division and Laboratory for Material/Product Testing Division the analysis of results of
implemented corrective actions shall be performed which is formalized with record

ISSUE IV
-4-

Report on Analysis of Results of Implemented Corrective Actions OQZ14 090 (Annex

8).
The above mentioned record can be used in the process of solving other corrective
actions.
4.2 Preventive Action
Algorithm of preventive action is shown in Annex 7, and it is explained hereinafter.
4.2.1 Determining Potential Nonconformity
Determining potential nonconformities of product, process and quality management
system is carried out through the review by management, meetings of Quality Council,
contract reviewing, verification and validation of project stages, monitoring the quality of
products, monitoring and measurements.
4.2.2 Investigation of Potential Causes and Problem Analysis
Investigation of potential causes and problem analysis is performed by personnel of
QMD as well as other persons authorized by the Executive Director for Quality and
Laboratories. Analysis is conducted based on the requirements of the Executive Director
for Quality and Laboratories.
Investigation of potential causes of nonconformity in the calibration process and/or
testing process in Metrology Laboratory Division and Laboratory for Material/Product
Testing Division is performed by managers, technologists and metrologists of Metrology
Laboratory Division and Laboratory for Material/Product Testing Division according to
the procedure OCQ-06.065 Procedure for Non-conforming calibration/testing.
Results of the report on performed quality checks (internal and external checks),
numerical and non-numerical tools of quality (primarily FMEA method) and like are used
in the analysis. In analysis of potential causes, all the corrections and reworks of product
carried so far, as well as the actions taken to eliminate the nonconformity should be
mandatory used.
Frequently, the fundamental cause is not noticeable so that careful analysis of product
specification and all relevant processes, operations, records, reports on servicing and
users complaint are required. In analysis, statistical methods can be also used
especially in the analysis of records, reworks and corrections performed so far. When
considering the cause of nonconformity, its influence to production costs, quality costs,
functioning, reliability, safety, process capability and user satisfaction should be
discussed.
If the fundamental cause of product nonconformity is nonconformity of quality
management system or a mistake in product design, the Executive Director for Quality
and Laboratories shall make decision on forming a commission for investigation and
determining the cause.
The commission is composed as follows:
- Quality technologist from QMD or DQRD;
- Person from the division where the possible cause of nonconformity is present, but who is not
directly responsible for the occurrence of nonconformity, or a person from RDD, who is not a
project leader;
- Person from any other division who knows the problem.

ISSUE IV
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4.2.3 Implementation of Preventive Actions

When defining and implementing preventive actions, causes of nonconformity shall be
eliminated to the level which corresponds to an acceptable risk for ORAOa.d...
Implementation of preventive actions is defined with preventive action plan.
Implementation plan of preventive action is prepared in free form, while the Executive
Director for Quality and Laboratories gives consent for its use. This plan can be an
integral part of monthly work schedule of ORAOa.d. The plan defines activities, activity
holders, control points and performance deadlines.
Preventive action implementation plan in Metrology Laboratory Division and Laboratory
for Material/Product Testing Division is defined with the record of Preventive Action Plan
OQZ14 088.
Preventive action plan is usually a plan which results from reexamination of quality
management system.
4.2.4 Analysis of the Implementation of Preventive Actions
The Executive Director for Quality and Laboratories is competent for monitoring the
preventive actions being taken. Analysis of effectiveness and efficiency is carried out in a
way specified by the Executive Director for Quality and Laboratories.
Verification of preventive actions is carried out by the Executive Director for Quality and
Laboratories by certification of Preventive Action Implementation Report.
QMD manages all the preventive action records.
In order to check effectiveness and purposefulness of preventive actions in Metrology
Laboratory Division and Laboratory for Material/Product Testing Division the analysis of
results of implemented preventive actions shall be performed which is formalized with
record Report on Analysis of Results of Implemented Preventive Actions OQZ14 089.

5 . R E L ATI O N T O S TAN D AR D S AN D O T H E R P R O C E D U R E S DOCUMENTS

1.
2.
3.
4.

Quality Manual OS-Q.1

Quality Handbook of Laboratory for Testing Materials/Products Division OS-Q.2
Quality Handbook Metrology Laboratory Division OS-Q.3
SORS 9000/05 Requirements for Quality Provision in Design, Development and Production
of NGO Means
5. ISO 9001/2008 Quality Management System Requirements
6. SRPS ISO 9000:2007 Quality Management Systems Basics and Vocabulary
7. BAS EN ISO/IEC 17025:2006 General Requests for Competence of Testing and Calibration
Laboratories
8. ISO 9004/2008 Quality Management System Instructions for Performance Improvement
9. EN 9100
10. Documentation Management ORAOa.d. OQM-01.004
11. Quality Checks OQM-01.016
12. Decision on Complaints/Claims OQA-08.045

ISSUE IV
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6 . AN N E X E S
1.
2.
3.
4.
5.
6.
7.
8.
9.

Algorithm of Corrective Action

- Annex 1
Corrective Action Log OQZ13 046
- Annex 2
Corrective Action Request OQZ13 030
- Annex 3
Corrective Action Plan OQZ14 081
- Annex 4
Report on Analysis of Implemented Corrective Actions OQZ14 082
- Annex 5
Corrective Action Request to Supplier OQZ13 048
- Annex 6
Algorithm of Preventive Action
- Annex 7
Preventive Action Plan OQZ14 088
- Annex 8
Report on Analysis of Results of Implemented Preventive Actions OQZ14 089
- Annex 9
10. Corrective Action Log for Suppliers OQZ13 049
- Annex 10
11. Report on Analysis of Results of Implemented Preventive Actions OQZ14 090
-Annex 11

7 . AB B R E V I ATI O N S
FMEA
QMD
DQRD
OQZ
RDD

- Failure Mode and Effects Analysis)

- Quality Monitoring Department
- Department for Quality Research and Design
- "ORAO' quality record
- Research and Development Division

ISSUE IV
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ANNEX 1

ALGORITHM OF CORRECTIVE ACTION

START

REEXEMINATION OF
NONCONFORMITY

ANALYSIS OF
NONCONFORMITY

PROPOSAL OR
PLAN

IMPLEMENTATION

ANALYSIS OF
IMPLEMENTATION

END

1. Decision on the implementation of corrective action

2. Adoption of proposal and plan of implementation
3. Verification of achieved results

ISSUE IV
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ANNEX 2
OQZ13 046
C O R R E C T I V E AC T I O N LO G

No.

Request
submitter
Date

WU/Division to which
nonconformity statement
is directed
Form of noticed
nonconformity

Corrective action

Person/position/
responsible for
performance
deadline

Date of the
completion of
action and
evaluation of
efficiency

ISSUE IV
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ANNEX 3
OQZ13 030
CORRECTIVE ACTION REQUEST

Sent to:

(1)

Requested by:

(2)

BUSINESS SECRET
Internal

Request no.

Noticed nonconformity of product, process and quality management system:

(3)
(4)

Root cause of nonconformity :

(5)
Person/position:
_________________
(signature)

Date:
Opinion of authorized person on nonconformity:
Date:

(6)
______________
(signature)

Nonconformity effect on QMS:

(7)

Date:
Corrective action decision:

Quality Manager
_________________________
(signature)
(8)

Date:

Quality Manager
_________________________
(signature)

ISSUE IV
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ISSUE IV
-11-

Sent to:

(1)

ACTIVITIES
ON
IMPLEMENTATION:

OQZ13 030
CORRECTIVE ACTION REQUEST
BUSINESS SECRET
Internal
Requested by:
(2) Request
Plan no.:
(3)
no
CORRECTIVE

ACTION Responsible
person:

Date:

Checking corrective action implementation:

(9)

(10)

The activity is in the process of implementation

Monitoring of implemented corrective action:

Submitted to:

Date:

- Request submitter 1x
- Corresponding division 1x
- OPK-a 1x

Date:

Responsible
person

Date:

(11)

Quality Manager
(12)
______________
(signature)
AGREED:
Executive Director for Quality
and laboratories

Addendum with Annex 3

Explanation for filling in the form "Corrective Action Request"
Field (1) specifying the name of sector where the corrective action should be taken;
Field (2) first and last name of the person who requests corrective action;
Field (3) register number of the record to be inserted;
Field (4) type of nonconformity to be specified;

ISSUE IV
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Field (5) textual description of the root cause with as much data and information as
possible. If needed, root cause can be given in additional sheet
accompanying the request.
Field (6) Based on the investigation of causes and problem analysis, justification of
request is ascertained. If the request is justified, short and accurate opinion
is given about corrective measure. The opinion is signed by authorized
person.
Field (7) potential effects of noncompliance to the existing QMS
Field (8) -Decision on taking or not-taking the corrective action. Decision is made and
signed by Quality Manager.
Field (9) Signing the activities eliminating corrective actions, holders of primary
responsibilities, deadlines for carrying out activity. The activities are defined
after the meeting on noncompliance reviewing.
Field (10) Brief observations of persons/positions responsible for the implementation of
corrective action and signature of the person who checked the corrective
action
Signing and approving performed activities shall be carried out after
coordination of the holder of primary responsibility and the person who
performed the corrective action.
Field (11) Brief observations of persons/positions responsible for
Monitoring of implemented corrective action
Field (12)- Signed after completion of corrective action.
Consent on performed corrective action shall be given by the Executive
Director for Quality and Laboratories.

ISSUE IV
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ANNEX 4

ORAOa.d.
Metrology Laboratory
Division/ Laboratory
for Testing
Materials/Products
Division

OQZ14 081
BUSINESS
SECRET
No: ___________
Date: _________

CORRECTIVE ACTION PLAN

_______________________________________

No

Reference
document

Task

Responsible
person

Cooperates

Deadli
ne

Certific
ation

Note

Page X of Y

ISSUE IV
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ANNEX 5

ORAOa.d.
Metrology Laboratory
Division/ Laboratory
for Testing
Materials/Products
Division

REPORT ON ANALYSIS OF IMPLEMENTED CORRECTIVE

ACTIONS
______________________

Responsible person:

OQZ14 082
BUSINESS
SECRET
No: ___________
Date: _________

Deadline:

CORRECTIVE ACTION

ACTIVITIES ON THE PERFORMANCE OF CORRECTIVE ACTION:

Activity

Corrective action status:

Executor

Date of completion

Date of activity completion

Quality Manager ML/LIM

Page X of Y

ISSUE IV
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ANNEX 6

OQZ13 048

CORRECTIVE ACTION REQUEST TO SUPPLIER

Supplier:

Register no.:

Representative for quality:

Date:

Part No:
Part name:
Drawing No.:
Release:

Order no.:
Date of delivery:
Quantity:

Deviation (description of deviation):

Decision in accordance with refused parts/material:

Requested answer shall be given 5 days after

the receipt of returned parts

Suppliers measures:

Cause of system deviation:

_______________________________________________________________________
_______________________________________________________________________
________________________________________________________________________
Responsible
person:

Corrective actions and verification:

______________________________________________
______________________________________________
______________________________________________
______________________________________________

____________
____________
____________

Date:
__________
__________
__________
__________

____________

Executive Director for Quality and Laboratories: ________________________________

ISSUE IV
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ANNEX 7

ALGORITHM OF PREVENTIVE ACTION

START

ESTABLISHING
POTENTIAL
NONCONFORMITY

ANALYSIS OF PROBABLE
NONCONFORMITIES AND
POTENTIAL PROBLEMS

PREVENTIVE ACTION
PLAN

IMPLEMENTATION

ANALYSIS OF
IMPLEMENTATION

END

1. Decision on implementation of preventive action

2. Adoption of proposal and Plan of implementation
3. Verification of achieved results

ISSUE IV
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ANNEX 8

ORAOa.d.
Metrology Laboratory
Division/ Laboratory
for Testing
Materials/Products
Division

OQZ14 088
BUSINESS
SECRET
No: ___________
Date: _________

PREVENTIVE ACTION PLAN

_______________________________________

No

Reference
document

Task

Responsible
person

Cooperat
es

Dead
line

Certifica
tion

Note

ISSUE IV
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ANNEX 9

ORAOa.d.
Metrology Laboratory
Division/ Laboratory
for Testing
Materials/Products
Division

REPORT ON ANALYSIS OF IMPLEMENTED PREVENTIVE

ACTIONS
______________________

Responsible person:

OQZ14 089
BUSINESS
SECRET
No: ___________
Date: _________

Deadline:

PREVENTIVE ACTION

ACTIVITIES ON THE PERFORMANCE OF PREVENTIVE ACTION:

Activity

Preventive action status:

Executor

Date of completion

Date of activity completion

Quality Manager ML/LIM

Page X of

ISSUE IV
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ANNEX 10
CORRECTIVE ACTION LOG FOR SUPPLIERS

No.

Request
submitter
Date

Supplier

Corrective action

Suppliers
quality
representative
Deadline

Completion date
Actions and
efficiency score

ISSUE IV
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ANNEX 11

ORAOa.d.
Metrology Laboratory

REPORT ON ANALYSIS OF RESULTS OF IMPLEMENTED

CORRECTIVE ACTIONS
______________________

OQZ14 090
BUSINESS
SECRET
No: ___________
Date: _________

CORRECTIVE ACTION

Responsible person:

Implementation date:

MONITORING OF IMPLEMENTED CORRECTIVE ACTION EFFECTIVENESS

Observation

Executor

Date

ANALYSIS OF RESULTS OF IMPLEMENTED CORRECTIVE ACTIONS

CONCLUSION

Date

Quality Manager SML

ISSUE IV
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8. DISTRIBUTION LIST (Distribution of copies only with original

and standard)
PROCEDURE: CORRECTIVE AND PREVENTIVE ACTIONS OQM-07.017, release IV,
(name and designation, release, modification-amendment)

RB copies WU/ WU/Division/Position

1 original
2 standard
3 copy
4 copy
5 copy
6 copy
7 copy
8 copy
9 copy
10 copy
11 copy
12 copy
13 copy
14 copy
15 copy
16 copy
17 copy
18 copy
19 copy
20 copy
21 copy
22 copy

Signature

Date

Investment Development Department

Quality Monitoring Department
Holder of Work
Director
Executive Director for Technical Operations
Executive Director for Economic Operations
Executive Director for Quality and Laboratories
Manager of Overhaul WU
Manager of Manufacture WU
Manager of Laboratories WU
Manager of Research and Development
Division
Manager of Maintenance Division
Manager of Commercial Division
Manager of Marketing Division
Manager of Accounting and Finance Division
Manager of Division for General Operations
Manager of Quality Division
Manager of Division for Personal and Legal
Operations
Manager of Department for Development and
Design of Quality
Manager of Organizational Division
Executive Director for Personnel, Legal and
General Operations
Manager of Galvanic-chemical Treatment
Division

Working
copy

NOTE: Distribution of copies to be carried out per users

Manager of QMD

ISSUE IV
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