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
AmendmentName
no.2Signature
AmendmentName
No.3Signature
AmendmentName
no.4Signature
TABLE OF VALID PAGESPage no.123456789101112
Amendment
Page no.131415161718192021
Amendment
Page no.
Amendment
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