SABLON ZA PROCEWDURE

ORAO PROCEDURE

Mandatory implementation as of: 01.04.2013.QUALITY MANAGEMENT SYSTEM CORRECTIVE AND PREVENTIVE ACTIONSTotal 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

Prepared byApproved by Decision no.Date

IVName Mirko PantiMilan Buha051/67-0301.04.2013.

IssueSignature

AmendmentName

no.1Signature

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TABLE OF VALID PAGESPage no.123456789101112

Amendment

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TABLE OF DISTRIBUTION OF COPIESopy no.45678910111213141516171819202122

Quantity111111 111 11 1 11

CONTENTS:

Page

0. INTRODUCTION

2

1. SCOPE AND AREA OF APPLICATION

2

2. DEFINITIONS

2

3. RESPONSIBILITY

2

4. DESCRIPTION OF ACTIVITIES

3

4.1 Corrective action

3

4.2 Preventive action

55. RELATION TO STANDARDS AND OTHER PROCEDURES - DOCUMENTS

6

6. ANNEXES

77. ABBREVIATIONS

7

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

21DESCRIPTION TABLE OF MODIFICATION - AMENDMENTModification

no.Brief description of modificationDateModification carried out byModification verified by

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. SCOPE AND AREA OF APPLICATION

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.

4. DESCRIPTION OF ACTIVITIES

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 NonconformityReexamination 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 NonconformityAnalysis 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.

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 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.

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. RELATION TO STANDARDS AND OTHER PROCEDURES -

DOCUMENTS

1. Quality Manual OS-Q.1

2. Quality Handbook of Laboratory for Testing Materials/Products Division OS-Q.2

3. Quality Handbook Metrology Laboratory Division OS-Q.3

4. 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

6. ANNEXES

1. Algorithm of Corrective Action

- Annex 1

2. Corrective Action Log OQZ13 046

- Annex 2

3. Corrective Action Request OQZ13 030

- Annex 3

4. Corrective Action Plan OQZ14 081

- Annex 4

5. Report on Analysis of Implemented Corrective Actions OQZ14 082

- Annex 5

6. Corrective Action Request to Supplier OQZ13 048

- Annex 6

7. Algorithm of Preventive Action

- Annex 7

8. Preventive Action Plan OQZ14 088 - Annex 89. 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. ABBREVIATIONS

FMEA

- Failure Mode and Effects Analysis)

QMD

- Quality Monitoring Department

DQRD

- Department for Quality Research and Design

OQZ

- "ORAO' quality record

RDD

- Research and Development Division

ANNEX 1

ALGORITHM OF CORRECTIVE ACTION

-

1. Decision on the implementation of corrective action

2. Adoption of proposal and plan of implementation

3. Verification of achieved results

ANNEX 2

OQZ13 046

C O R R E C T I V E A C T I O N L O G

No.Request submitter

DateWU/Division to which nonconformity statement is directed

Form of noticed nonconformityCorrective actionPerson/position/ responsible for

performance deadlineDate of the completion of action and evaluation of efficiency

123456

ANNEX 3

CORRECTIVE ACTION REQUESTOQZ13 030BUSINESS SECRET

Internal

Sent to:

(1)

Requested by:

(2)Request no.

(3)

Noticed nonconformity of product, process and quality management system: (4)

Root cause of nonconformity :

(5)

Person/position:

_________________

Date:

(signature)

Opinion of authorized person on nonconformity:

(6)

Date:

______________

(signature)

Nonconformity effect on QMS:

(7)

Quality Manager

_________________________

Date:

(signature)

Corrective action decision:

(8)

Quality Manager

_________________________

Date:

(signature)

CORRECTIVE ACTION REQUESTOQZ13 030

BUSINESS SECRET

Internal

Sent to:

(1)

Requested by:

(2)Request no

Plan no.: (3)

ACTIVITIES ON CORRECTIVE ACTION IMPLEMENTATION:

Responsible person:

Date:

(9)

Checking corrective action implementation:

(10)

The activity is in the process of implementation

Monitoring of implemented corrective action:Responsible personDate: (11)

Submitted to:

- Request submitter 1x

- Corresponding division 1x

- OPK-a 1xDate:

Date:Quality Manager

(12)

______________

(signature)

AGREED:

Executive Director for Quality andlaboratories

Addendum with Annex 3Explanation 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;

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 byQuality 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 actionField (12)- Signed after completion of corrective action.

Consent on performed corrective action shall be given by the Executive

Director for Quality and Laboratories.

ANNEX 4

ORAOa.d.

Metrology Laboratory Division/ Laboratory for Testing Materials/Products DivisionCORRECTIVE ACTION PLAN

_______________________________________OQZ14 081

BUSINESS SECRET

No: ___________

Date: _________

NoReference documentTaskResponsible personCooperatesDeadlineCertificationNote

12345678

Page X of Y

ANNEX 5

ORAOa.d.

Metrology Laboratory Division/ Laboratory for Testing Materials/Products DivisionREPORT ON ANALYSIS OF IMPLEMENTED CORRECTIVE ACTIONS

______________________OQZ14 082

BUSINESS SECRET

No: ___________

Date: _________

Responsible person:

Deadline:

CORRECTIVE ACTION

ACTIVITIES ON THE PERFORMANCE OF CORRECTIVE ACTION:

Activity

Executor

Date of activity completion

Corrective action status:

Date of completion

Quality Manager ML/LIM

Page X of Y

ANNEX 6

OQZ13 048

CORRECTIVE ACTION REQUEST TO SUPPLIER

Supplier:

Representative for quality:Register no.:

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:

Suppliers measures:

Cause of system deviation:

_______________________________________________________________________

_______________________________________________________________________

________________________________________________________________________

Corrective actions and verification:

______________________________________________

______________________________________________

______________________________________________

______________________________________________Responsible person:

____________

____________

____________

____________Date:

__________

__________

__________

__________

Executive Director for Quality and Laboratories: ________________________________

ANNEX 7

ALGORITHM OF PREVENTIVE ACTION

-

1. Decision on implementation of preventive action

2. Adoption of proposal and Plan of implementation

3. Verification of achieved results

ANNEX 8 ORAOa.d.

Metrology Laboratory Division/ Laboratory for Testing Materials/Products Division PREVENTIVE ACTION PLAN

_______________________________________OQZ14 088

BUSINESS SECRET

No: ___________

Date: _________

NoReference documentTaskResponsible personCooperatesDeadlineCertificationNote

12345678

ANNEX 9 ORAOa.d.

Metrology Laboratory Division/ Laboratory for Testing Materials/Products DivisionREPORT ON ANALYSIS OF IMPLEMENTED PREVENTIVE ACTIONS

______________________OQZ14 089

BUSINESS SECRET

No: ___________

Date: _________

Responsible person:

Deadline:

PREVENTIVE ACTION

ACTIVITIES ON THE PERFORMANCE OF PREVENTIVE ACTION:

Activity

Executor

Date of activity completion

Preventive action status:

Date of completion

Quality Manager ML/LIM

Page X of Y

ANNEX 10

CORRECTIVE ACTION LOG FOR SUPPLIERS

No.Request submitterDateSupplierCorrective action Suppliers quality representative DeadlineCompletion date

Actions and efficiency score

123456

ANNEX 11 ORAOa.d.

Metrology LaboratoryREPORT 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

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 copiesWU/ WU/Division/PositionSignatureDate

1 originalInvestment Development Department

2 standardQuality Monitoring Department

3 copyHolder of Work

4 copyDirector

5 copyExecutive Director for Technical Operations

6 copyExecutive Director for Economic Operations

7 copyExecutive Director for Quality and Laboratories

8 copyManager of Overhaul WU

9 copyManager of Manufacture WU

10 copyManager of Laboratories WU

11 copyManager of Research and Development Division

12 copyManager of Maintenance Division

13 copyManager of Commercial Division

14 copyManager of Marketing Division

15 copyManager of Accounting and Finance Division

16 copyManager of Division for General Operations

17 copyManager of Quality Division

18 copyManager of Division for Personal and Legal Operations

19 copyManager of Department for Development and Design of Quality

20 copyManager of Organizational Division

21 copyExecutive Director for Personnel, Legal and General Operations

22 copyManager of Galvanic-chemical Treatment Division

Working copy

NOTE: Distribution of copies to be carried out per users

Manager of QMD

Requested answer shall be given 5 days after the receipt of returned parts

ANALYSIS OF IMPLEMENTATION

IMPLEMENTATION

3

PROPOSAL OR

PLAN

ANALYSIS OF

NONCONFORMITY

1

REEXEMINATION OF NONCONFORMITY

START

ANALYSIS OF IMPLEMENTATION

IMPLEMENTATION

2

PREVENTIVE ACTION PLAN

ANALYSIS OF PROBABLE NONCONFORMITIES AND POTENTIAL PROBLEMS

3

1

ESTABLISHING POTENTIAL NONCONFORMITY

END

START

2

END