Quality Management Procedure

KP 16. Corrective Action

1 Purpose

The purpose of this procedure is to eliminate non-conformities in the product, service,

environment and occupational safety system through error analyses and corrective measures
within the scope of TS EN ISO 14001 Environmental Management System, TS ISO 45001
Occupational Health and Safety, Energy Management System, and TS EN ISO IEC 17025
Laboratory Management System.

2 Area of Validity

This procedure applies to all possible deviations caused by conditions established by Quality
Management Plans, character of the product, and the quality, environment, occupational health
and safety system.
This procedure applies to all problems occurred during test and calibration studies.
Prepared within the scope of TS EN ISO 9001, TS EN ISO 14001, TS ISO 45001 item 10.2, and
TS EN ISO 17025 8.7 Corrective Actions.

3 Concepts

 Correction: Instantaneous activity carried out to eliminate detected non-conformities.

 Corrective action: A systematic activity for the purpose of eliminating detected non-
conformities or resolve any other unwanted situation.
 Hypothesis: The most appropriate solution among other solutions for a problem.
 Problem: Non-conformity with the management system, ISO standard requirements, test and
calibration specifications, accredited company demands, or customer demands.

4 Application

.1 In case of a non-conformity during process, quality, environment, occupational health and

safety system, material entry, design, production, assembly, and tests or any non-conformity
or defect has been detected during commissioning and operation at customer facilities, their
reasons must be investigated and proper corrective measure should be taken in order to
prevent them from repeating. Detected non-conformities are reported by a “Non-conforming
product report.” An “Assembly Report” is prepared and documented if such non-conformity
or defect has occurred during commissioning at customer facilities. Each documentation
must be reported to relevant departments and archived.

4.1.2 Causes of a defect are investigated after occurrence and scope of such defect has been
detected. For this purpose, meetings are held in participation of quality assurance and
relevant departments.

Due to time constraints, alterations and corrections required for product units sent by
supplier can be carried out after reaching an agreement with the supplier. The supplier must
be notified of related costs along with a report. Regarding materials sent by suppliers, the
supplier would be obliged to take necessary measures. In addition, BEST personally audits
the status of these measures if deemed necessary. It is discussed whether actions were in
conformity with

 Work instructions and norms

 Design documents
 Test and control reports,
 Procedures,
 Quality records,

during these meetings. Emphasis should be placed on error analyses and error tipping
points.

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 Quality Management Procedure

KP 16. Corrective Action

.3 After identifying causes of errors, “corrective actions” are determined and written on the
meeting minutes. If causes of errors cannot be found through analyzing the erroneous unit, it
should be investigated whether
- Corrective measures are feasible from a technical and financial standpoint,
- Non-conformities can be prevented from reoccurring, i.e. effectiveness of measures,
during this meeting through production methods, design controls, quality records etc.

.4 Proper monitoring (auditing) measures are taken in order to ensure that stipulated corrective
measures are implemented in an excellent and effective manner. These are verified through
repeating measurements, examinations and experiments as well as system, method, and
product inspections.

.5 Corrective actions that would prevent possible error from occurring through analyzing current
documents and processes are carried out.

.6 In case of ineffectiveness of the measures taken, causes of the non-conformity are analyzed
again to take new measures and non-conformity must be prevented from repeating.

.7 For repeating non-conformities related to laboratory activities, test manager, laboratory

manager, or laboratory officer have the authority to initiate corrective actions. Actions to be
taken are established after identifying the root cause of the non-conformity that is subject to
CPA. Based on the scope of the activity, a monitoring period is specified on the CPA form
and CPA is shut down if the activities have been effective at the end of this period. Test
manager and laboratory manager are authorized to shut down actions. CPA may be initiated
again if the actions have been found to be insufficient.

.8 The departments responsible must make changes that are necessary due to corrective actions
on documents such as

 Processes
 Pictures
 Work plans
 Production Instructions
 Test instructions
 Specifications
 Procedures

as soon as possible and notify relevant departments.

.9 Each corrective action must be documented and monitored for effectiveness.

.10 A scientific approach must be adopted and cause-effect must be conducted when solving
problems. The Plan, Apply, Control, Take Measures (PACT) cycle must be modeled.

PLAN: Project owner of the corrective action policy must conducts a root cause
analysis for the problem. Various approaches can be used in root cause analysis based on
circumstances. The “5N” approach is the preferred approach. Why did the problem occur?
Why was the problem allowed to continue. Effective use of this approach will prevent the
problem from repeating.

APPLY: Possible hypotheses must be established and evaluated experimentally.

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 Quality Management Procedure

KP 16. Corrective Action

CONTROL: Experimental results must be evaluated against hypotheses. Quality

Manager or his/her proxy must monitor the experiment at proper times and periods in order
to determine whether the hypothesis is effective.

TAKE MEASURES: After completion of this process in a satisfactory manner, steps

should be taken to adapt the hypothesis as a new standard work and personnel should be
notified.

4.11 Environmental Management Program activities planned in accordance with environmental

goals and objectives are monitored by the management Representative.
4.12 OHS program activities planned in accordance with occupational health and safety goals and
objectives are monitored by the Management Representative.

4.13 Management of Internal Environmental, Occupational Health and Safety Management

System audits and monitoring of non-conformities detected during such audits and external
audits must be in accordance with the Internal Audit Procedure.

4.14 Corrective actions aiming at reducing or eliminating any indoor or outdoor negative impact
of the factory on the environment as well OHS deficits are carried out by unit supervisors
and/or their representative. Unit supervisors take the issues below when deciding on a
corrective action in case of an environmental accident, work accident, or emergencies that
have a negative impact on the environment: relevant procedures and instructions, and
whether the material with negative effects on the environment is classified as waste. If the
issue is related to chemicals being used, check information on Material Safety Data Sheet
and whether the incident is related to legal regulations.

4.15 Decision to prevent an activity or accident that has a negative impact on the environment or
occupational safety from repeating and as well as corrective actions regarding elimination of
areas, operating unit, or machinery with environmental or occupational risks and this risk
may be discussed during meetings within the scope of Management Review Procedure.

4.16 Corrective actions are monitored through the corrective actions monitoring table.

4.17 In cases where urgent Corrective Actions or a defect in operation of any current corrective
action are identified, the identifying individual informs the Management Representative and
the Management meets in order to discuss the issue again or initiate a new action.

4.18 Corrective Actions are initiated by a Corrective Action Form and monitored by the
Management Representative. Any BEST A.Ş stakeholder may request any corrective action
or they may be requested as a result of official relations.

4.19 The Management Representative reports all Corrective Actions and their results in
Management Review Procedure meetings and a final decision is made.

4.20 Training efforts within the scope of the Training Procedure may be initiated, procedures
and/or documents may be modified, or new machinery-equipment investment may be made
as a result of corrective actions. Machinery and equipment constructions are modified,
studies on the settlement plan are made, and the supplier is warned whenever necessary.

4.21 658 Predictive Maintenance Activity form is used to monitor corrective actions regarding the
Energy Management System and maintenance activities. Only the maintenance department
personnel may fill out this form, maintenance department supervisors and the department
manager are responsible for carrying out the activities.

5 Responsibility

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 Quality Management Procedure

KP 16. Corrective Action

All relevant departments are responsible for implementing the method described above.
All personnel is authorized to and responsible for initiating a corrective action when a non-
conforming product or work is created, a deviation has been made in the policy and management
system procedures, or a technical operation is complete.

Project manager of the corrective action should notify the Quality Manager and/or the
Management Representative. The Quality Manager and/or the Management Representative must
examine the situation and initiate corrective actions. Corrective actions are closed by the
Management representative.

6 Documents

 Non-conforming product report - Form 052

 Inspection Report (System inspection, product inspection, process inspection)
 Corrective action - Form 171
 Environmental non-conformity report - Form 025
 658 Predictive Maintenance Activity form

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 Quality Management Procedure
Detecting the
Non-conformityKP 16. Corrective Action

Non-
Explaining the conformity
Inputs Non-conformity Outputs
Report Responsibility
Documents, Workflow Records, Made by Working Receiving
Others Others
together informatio
n

Quality Relevant Relevant

Control Units Units

Root Cause
Analysis
Quality Relevant Relevant
Assurance Units Units
Is the real
cause found?
No

Yes
Quality
Establish Assurance
Measures

“medium / Quality
Implementation Assurance
long term
and measures”
Control
Quality
Effectiveness Assurance
Control

Is the
Measure No
Effective?
Yes Quality
Assurance/
Documenting Manageme
nt
Representa
tive

APPROVED:

(the original is signed) (the original is

signed)

Kübra Kıvrak Korkut Ergül

Quality Assurance Systems Officer Quality and Testing Director

First Release 06.2008 Rev 06/01.04.2021 Page 5/5

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subject to changes.