Kirimova 2021 J. Phys. Conf. Ser. 1889 052033

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ICMSIT-II 2021 IOP Publishing
Journal of Physics: Conference Series 1889 (2021) 052033 doi:10.1088/1742-6596/1889/5/052033
Risk identification of calibration laboratories
K V Kirimova1,3, O Y Sorochkina1 and K E Savvin2

1
Don State Technical University, 1 Gagarina square, Rostov on Don, Rostov region,
344002, Russia
2
OOO «Laboratorno-issledovatel'skij centr», 2, Menzhinskogo st., Rostov on Don,
Rostov region, 344065, Russia
3
E-mail: kv_kirimova@mail.ru
Abstract. The article is devoted to the identification, ranking and quantitative analysis of the
risks that affect the quality of calibration work in the calibration laboratory. The paper used the
brainstorming technique, the Ishikawa chart, and the ranking method for research. The results
are represented by the Pareto chart. The ranked list was compiled based on the statistical data of
the calibration laboratory. The ranked list was used as assessment criteria of risk.
1. Introduction
The new version of the GOST ISO / IEC 17025-2019 standard was adopted in 2019. A feature of the
implementation of the requirements of the standard in the new edition is the addition of a new process -
risk management, to the usual version of the organization's QMS. Moreover, all calibration laboratories
must adopt a risk-based mindset, which will affect how laboratories approach calibration processes.
Previously, the risk was mentioned only as the need to take it into account when making decisions, no
more. That is, it was mainly advisory in nature. In connection with these changes, it became necessary
to organize and implement risk management in the QMS [1].
The risk management policy also affects the laboratory policy, it dictates [2]:
• Statement of the fact of focus on risk management on the part of the laboratory management in
relation to the stated goals.
• Intention to implement risk management.
• Determining the authority of the personnel in relation to risk management [3].
• Obligation to ensure access of those responsible for risk management to the necessary resources
(personnel, time, training, finance).
• Commitment to maximum involvement of the company in maintaining risk management [4].
• Establishing indicators of the effectiveness of risk management.
• Allocation of resources for risk management.
• Ways to resolve conflicts.
• Striving to revise and improve the risk management system [5-7].
The purpose of the study is to identify the most common risks affecting the calibration process.
The relevance of the study is due to the need of the calibration laboratory to minimize the risks arising
during the calibration process.
Content from this work may be used under the terms of the Creative Commons Attribution 3.0 licence. Any further distribution
of this work must maintain attribution to the author(s) and the title of the work, journal citation and DOI.
Published under licence by IOP Publishing Ltd 1
Research problem:
• Identify risks and their consequences using the brainstorming method and Ishikawa diagram.
• To rank quantitative indicators of risks arising within one year.
• Identify the most common risks.
The process of calibration of measuring instruments in the calibration laboratory of OOO

«Laboratorno-issledovatel'skij centr» was chosen as the object of research.
2. Identification of risks
Risk is the factor that affects the final result, and influence will mean the deviation of events from the
expected result of the events that were influenced. Regarding to the calibration process, the end result is
understood as obtaining a reliable result with a given, i.e. certain accuracy [8].
To form the most complete list of risks, the brainstorming method was used, for this an expert group
of six people was created (GOST R 58771-2019 Risk management. Risk assessment technologies),
namely:
• Quality Director - Chief Metrologist.

• Director of the Department of Measuring Technology.
• Leading Metrology Engineer.
• Quality specialist.
• Head of the laboratory of precision mechanics and measuring instruments for geometric
quantities.
• Metrology engineer.
Brainstorming allows you to establish the relationship between the end result and the problems that
affect the ability to produce a valid calibration result.
To enhance the effectiveness of the application, the brainstorming method was used simultaneously
with the construction of the Ishikawa chart. This made it possible not only to identify risks, but also to
make a preliminary ranking of factors. With a causal diagram, it is easy to visualize the root causes that
generate specific consequences and are manageable [9], [10].
The Ishikawa chart is shown in figure 1.
Figure 1. Ishikawa chart.
Data analysis has identified five main groups of risk factors [8], [11]: Calibrating instruments,
Calibrator, Working place, Item of calibration, Quality measurement. These groups are shown in figure 2.
2
(a)
(b)
3
(c)
(d)
4
(i)
Figure 2. Five main groups of risk factors.
3. Enumeration of risk register

Further according to the provided diagram during the year, the identified risk factors were counted and
their further registration in the register. The frequency of occurrence and possible consequences on the
calibration process and the issuance of a calibration document to the customer were determined. The
proportion of cases of occurrence of adverse factors was calculated. Table 1 shows the quantitative risk
indicators obtained after observations [12-15].
Table 1. Ranked list of risks, according to the frequency of occurrence.
percentage of cases,
№ basic risk consequences of risk incident count
%
Calibrating instruments
Temporary inability to
1.1 Equipment failure perform calibration of 86 10.54
measuring instruments
1 Depreciation of Temporary inability to 179 21.94
1.2 equipment. functional perform calibration of 52 6.37
obsolescence measuring instruments
Contaminating impurity
1.3 Equipment failure 41 5.02
of equipment
A high probability of a
Substandard work negative result of the
2.1 49 6.00
servicing calibration of measuring
instruments
2 84 10.29
Late performance negative result of the
2.2 35 4.29
servicing of equipment calibration of measuring
instruments
5
perform calibration of
Violation of calibration measuring instruments
3.1 36 4.41
schedules of equipment Failure to meet deadlines
calibration was performed
User dissatisfaction
3 69 8.46
Non-compliance of Temporary inability to
metrological perform calibration of
characteristics of measuring instruments
3.2 33 4.04
measuring instruments Failure to meet deadlines
in the scope of calibration was performed
accreditation User dissatisfaction
Supply downtime or
negative result of the
4 poor in quality 11 1.35
calibration of measuring
consumable products
instruments.
Calibrator
Non-compliance with the
Increase staff workload
planned deadlines for the
1 due to an increase scope 116 14.22
execution of works.
of work
User dissatisfaction
Technical errors of the Nonconforming works
2 80 9.80
working staff User dissatisfaction
Increase other staff
Departure of a staff on
3.1 workload due to an increase 7 0.86
leave of absence
scope of work
3 10 1.23
Increase other staff
Sickness absence of a
3.2 workload due to an increase 3 0.37
staff
scope of work
Behavioral risks Voluntary waste and loss of
4 8 0.98
(conscious. motivated) the organization's property
Nonconforming works.
Employee turnover
5 Negative effect on the 6 0.74
image of organization
Skilled personnel Nonconforming works on
6 shortage calibration of measuring 5 0.61
(incompetence) instruments
Working place
Technical problems in Failure to meet performance
1.1 the operation of time. 42 5.15
information systems User dissatisfaction
1 48 5.88
Loss of data (calibration Inability to issue calibration
1.2 status of measuring results to the customer of 6 0.74
instruments) measuring instruments
Outage along deficiency

of standard test
conditions
2 perform calibration of 24 2.94
(temperature. humidity.
pressure. power supply
voltage)
Performance impairment of
Contamination of the
3 3.1 calibration of measuring 23 14 2.82 1.72
room
instruments
6
Emergency condition of
3.2 perform calibration of 9 1.10
the service room
Item of calibration
Absence of
accompanying Increasing the time required
1 documents when to prepare measuring 56 6.86
accepting measuring instruments for calibration
instruments
Breakage to calibration
objects because of
2 User dissatisfaction 23 2.82
mishandling. storage.
transportation
Adequacy of the
measuring instrument Refusal to provide
3 9 1.10
with the scope of calibration services
accreditation
Quality measurement
Lack of regulatory Increased calibration time
1.1 documents for due to the search for the 19 2.33
calibration work necessary documentation
Adjustment of the scope Increased calibration time
of accreditation due to due to making changes to
1.2 12 1.47
changes in regulatory the quality management
documents system
1 Non-compliance of the 46 5.64
purchased equipment Complaint costs.
(measuring instruments. Temporary inability to
1.3 8 0.98
consumables. auxiliary perform calibration of
equipment and supplies) measuring instruments
with the requirements
Calibration methods are
Increase of risk of non-valid
1.4 not verified and 7 0.86
result
validated
Ineffectiveness of Increased calibration time
control of human due to making changes to
2.1 14 1.72
resources system / the quality management
equipment system
Violation of the Lack of verification of
schedule for conducting calibrators ' qualifications.
2 2.2 a quality calibration Possibility of incorrect 19 5 2.33 0.61
audit calculations and calibration
results
Negative result of inter- Re-entry into participation
laboratory comparison in inter-laboratory
2.3 in the field of ensuring comparison. 0 0.0
the uniformity of Reporting of negative result
measurements to the accreditation body
The processing of the information received made it possible not only to group particular risk factors
around the main ones. but also to identify patterns of manifestation.
4. Recommendations and conclusions

After completing the risk ranking process. it is necessary to identify the risk groups that have the greatest
impact on the calibration process. This task is solved by constructing a Pareto chart (figure 3). which
allows you to demonstrate the quantitative ratios of various groups of risks in descending order of
7
frequency of occurrence. The 80/20 Pareto Principle clearly shows which factors are key in managing
emerging risks.
400 100,0
350
80,0
300
250 60,0
200
150 40,0
100
20,0
50
0 0,0
calibrating working place quality measurement
instruments
number of cases percentage of cases, %

cumulative total
Figure 3. Pareto chart.
It can be seen from the Pareto chart that the most common risks will be the risks of the «Calibration
resources» and «Personnel (Calibrator)» groups. In further researches. a system for influencing the risk
group «Calibration resources» will be developed. which includes the development of a corrective action
plan for risk management in the calibration laboratory. and the determination of the numerical
characteristics of the identified risks.
As a result of the study. the risks that may arise during the calibration process were identified and
ranked. Identified those that have the greatest impact on the process. The results obtained will be useful
not only for calibration laboratories. but for any organizations working in the field of ensuring the
uniformity of measurements. because the assessment methods used are available and allow them to be
effectively applied in the transition of calibration laboratories to risk-based thinking.
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PAPER • OPEN ACCESS You may also like

This content was downloaded from IP address 223.190.82.111 on 24/02/2024 at 07:36

Risk identification of calibration laboratories

K V Kirimova1,3, O Y Sorochkina1 and K E Savvin2

The process of calibration of measuring instruments in the calibration laboratory of OOO

• Quality Director - Chief Metrologist.

Figure 1. Ishikawa chart.

3. Enumeration of risk register

Outage along deficiency

4. Recommendations and conclusions

number of cases percentage of cases, %

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