This presentation is on basic requirement on Claibtration to meet Quality management system in the manufacturing area.

1. ISO 9001:2000
CalIbratIOn
Dr. A. Amsavel

2. Introduction : Calibration

3. Introduction
 Calibration requirement
 Purpose / Importance of Calibration
 Definitions
 ISO 9001:2000 requirement
 Calibration of MMDs
 Documents & Records

4. Calibration Requirement
Requirement by QMS & cGMP
 ISO 9001:2000
 7.6 Control of monitoring and measuring devices
 cGMP: Q7A
 5.0 Process Equipment : 5.3 Calibration
 6.6 Laboratory Control Records
 USFDA: 21 CFR Part 210/211

5. Definition: Calibration
 Set of operations that establish, under specified conditions, the
relationship between values of quantities indicated by a
measuring instrument or measuring system, or values
represented by a material measure or a reference material, and
the corresponding values realized by standards.
Notes:
 1. The result of a calibration permits either the assignment of value
measurands to the indications or the determination of corrections with
respect to indications.
 2. A calibration may also determine other metrological properties such as
the effect of influence quantities.
 3. The result of a calibration may be recorded in a document, sometimes
called a calibration certificate or a calibration report.

6. Calibration! What is it ?
 A set of operations, performed in accordance
with a definite procedure, that compares the
measurements performed by an instrument to
those made by a more accurate instrument or a
standard for the purpose of detecting and
reporting, or by adjustment, errors met in the
instrument tested.

7. Purpose of Calibration
To ensure readings from an instrument are consistent
with other instruments and to determine the accuracy
of the instrument i.e. that it can be trusted for its
observed/displayed measured value.
The value of calibration for industry
 To ensure that products are manufactured to specifications.
 To demonstrate that the industry operates a quality system
and technically competent and are able to generate
technically valid results.
 To increase quality & value of product.
 The calibrated measuring instruments (working standards)
have the assurance of an unbroken chain of
national/international measuring standards.

8. Definitions (ISO 10012:1997)
 Maximum / Limits of permissible error (of a
measuring instrument)
Extreme values of error permitted by specifications, regulations,
etc. for a given measuring instrument.
 Measurement process:
Set of interrelated resources, activities and influences which
produce a measurement.
 Notes:
 “Influences” are all factors such as those caused by the
environment which may or may not be controlled or controllable
and which add to the variability or the bias of the process.

9. Definitions (cont..)
 Measuring equipment:
 All of the measuring instruments, measurement
standards, reference materials, auxiliary apparatus and
instructions that are necessary to carry out a
measurement.
Notes:
 1. This term includes measuring equipment used in the
course of testing and inspection, as well as that used in
calibration.
 2. In the context of this part of ISO 10012, the term
“measuring equipment’ is taken to encompass
“measuring instruments” and “measurement standards”.
Moreover, a “reference material” is considered to be a
type of “measurement standard”.

10. Uncertainty of measurement:
 Uncertainty- How accurate are the measurements ?
It is a measure of the quality of a measurement & provides the
means to assess & minimize the risks and possible
consequences of poor decision.
Parameter, associated with the result of a measurement
that characterizes the dispersion of the values that could
reasonably be attributed to the measurand.
 Notes:
1. The parameter may be, for example, a standard deviation (or a given multiple
of it), or the half-width of a interval having a stated level of confidence.
2. It is understood that the result of the measurement is the best estimate of the
value of the measurand, and that all components of uncertainty, including
those arising from systematic effects, such as components associated with
corrections and reference standards, contribute to the dispersion.

11. Abbreviation
 Metrology is the science of measurement.
Metrology includes all theoretical and practical
aspects of measurement.
 NIST:
National Institute of Standards and Technology
(USA),
 BIPM:
International Bureau of Weights and Measures
 NABL: National Accreditation Board for Testing
and Calibration Laboratories

12. Indicator, Monitoring device and
Measuring equipment
What is the difference?
 For example, a pressure gauge may be used:-
 as an indicator (e.g. to ensure that the pressure is
present);
 as a monitoring device (e.g. to ensure that the
pressure is stable and the process is under control);
and
 as measuring equipment (e.g. where the accurate
value of the pressure is important for the quality of
product).

13. Calibration and verification
 Calibration system determines the
accuracy of measurement and verification
system determines the integrity of devices.

14. ISO Standard
 ISO 5725: 1994 (P-1,2 &6) Guide on precision of the test
methods: Principle and applications (IS:5420 p-1)
 ISO 5725: 1994 (P-4) Guide on precision of the test
methods: Inter Laboratory testing (IS:5420 p-2)
 ISO 5725: 1994 (P-3 &5) Accuracy & precision
 ISO 9001: 2000 & ISO 9004 : 2000
 ISO 10012: 1992 (p-1): Quality Assurance requirement
for measuring equipment: Meteorological confirmation
system for measuring equipment.
 ISO 10012: 1997 (p-2): Quality Assurance for measuring
equipment: Guidelines for control of measurement
processes
 ISO guide 30 & 33

15. Quality management system

16. ISO Clauses
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality Management System (4.1-4.2)
5. Management Responsibility (5.1-5.6)
6. Resource Management (6.1-6.4)
7. Product Realization (7.1-7.6)
8. Measurement, analysis and improvement (8.1-8.5)

17. 
Training
Services
4.1 Control Our Processes
4.2 Control Our Documentation
5.3 Policy Objectives 5.4
5.2 Customer Focus Determine & Communicate
5.5
Authority & Responsibilities
Customer 5.1 Committed Review 5.6
8.2.1
Satisfaction 5. Managed
8.2.2 System
8. Measure GOOD 6. Provide Resources
8.2.3 Processes
Analyse COMPANY People 6.2
8.2.4 Product Improve ISO Buildings, Equipment,
Machinery, etc 6.3
8.3 Non-conforming 7. Do What the Environment 6.4
Product Customer Wants
8.4 Data & Info Planning 7.1
Corrective Selling 7.2
8.5.2 Action Designing 7.3
Purchasing 7.4
8.5.3 Preventive
Doing It 7.5
Action
Calibrating 7.6
22

18. ISO 9001: 2000 refers where?
6.0 Resource Management
6.3 Infrastructure
Determine, provide and maintain
infrastructure needed
7.5.1 Control of production and service
provision
7.6 Control of monitoring and measuring
devices (MMD)

19. 7.6 Control of monitoring and measuring
devices (MMD)
Determine Monitoring and measurements to be made
and measurement and monitoring devices needed to
provide evidence of conformity of product.
 Calibrate of verify measuring and monitoring devices
(MMD) at specified intervals or prior to use against
international or national standards. Where no such standard
exist record to the basis.
 Adjust or Re-Adjust necessary.
 safeguarded from adjustments that would invalidate the
measurement result
 protected from damage and deterioration during handling,
maintenance and storage.

20. 7.6 Control of monitoring and measuring
devices (MMD)
 When the equipment (MMD) is found not to conform
to requirements, the organization shall assess and
record the validity of the previous measuring results.
 The organization shall take appropriate action on the
equipment and any product affected.
 Records of the results of calibration and verification
shall be maintained.
 When computer software used in the monitoring and
measurement, the ability of to satisfy the intended
application shall be confirmed.

21. How can we do to meet the requirement?
 Selection of Instrument
 Least count / Resolution required
 Calibration
 Frequency of calibration

22. Indicator, monitoring and measuring
devices
For example, in some industries, a pressure gauge
may be used:-
 as an indicator (e.g. to ensure that the pressure
is present);
 as a monitoring device (e.g. to ensure that the
pressure is stable and the process is under
control); and
 as measuring equipment (e.g. where the
accurate value of the pressure is important for
the quality of product).

23. Least count /Resolution requirement
Least count /Resolution requirement is as required for
process
Eg-1. Temperature measurement 51 -55°C
 Assume Least count is 1°C
 Measurement accuracy is ± 1°C
 Measurement : 51,52,53,54,55
 ie 2 out of 5 value likely to out of range 2/5=40%
Eg-2. Temperature measurement 51 -70°C
 Assume Least count is 1°C
 Measurement accuracy is ± 1°C
 Measurement : 51,52,53.. 69,70
 ie 2 out of 20 value likely to out of range 2/20=10%

24. Least count /Resolution requirement
Ideal tolerance limit is 1/10 = 10%
 For case-1
 51-55 or 53 ± 2°C
 1/10th of 2 is ± 0.2°C or at least 1/5th ± 0.4°C
 For case-1
 51-70 or 60.5 ± 9.5°C
 1/10th of 10 is ± 0.95°C or
 at least 1/5th ± 1.95°C

25. Acceptance criteria / permissible limit
 Instrument accuracy can be / acceptance
criteria = measurement accuracy or finer
but not higher.


26. CONTROL OF MMDs
What we do,
 Identify the instruments, Equipments used for
process, analysis and etc,
 List with equipment code
 Record the resolution, limit of permissible error
etc
 Calibration frequency & Schedule
 Calibration – External / Internal
 Record the calibration activity.

27. CONTROL OF MMDs at MDPL
 SOPs for calibration
 List the Standards used for calibration
 Statuary requirement if any
 Traceability to standard / master used
 Maintain relevant record
 SOP for OOC

28. CONTROL OF MMDs at MDPL
 Calibration to cover the entire range of
MMD
 At least 5 to 6 points to establish linearity
 Additional points at operational range
 Record the calibrated spare installed
during calibration of MMD if any

29. Record for calibration
 Format for raw data / certificate
 Refer Standard used
 Review / Compare result with permissible error
 Value before and after calibration
 Readjusted if any
 Remark: Correction required / error is to be
added with the value / reading
 Enter the Status :Passes / fails
 Inform the user to add correction
 Status Label.

30. Evaluation of External Agency
 Service provider to be evaluated / audited
 NABL accreditation
 System / standard followed
 SOP and standards
 Masters
 NIST
 Qualification & Competence of person
 Maintain audit report , approved service provider
list, contract etc

31. Verification of External certificate
Have a check list for verification
 Is agency SOP reviewed & accepted
 Is followed as per SOP & referred
 Is it in the specified format
 Covered the range of MMD
 Check for all info like Code no, range resolution,
correction, status …..
 Review evidence – stamp and sign & date.


32. Q7A: 5.3 Calibration
 Control, weighing, measuring, monitoring, and testing
equipment critical for ensuring the quality should be calibrated
according to written procedures and an established schedule.
 Equipment calibrations should be performed using standards
traceable to certified standards, if they exist.
 Records of these calibrations should be maintained.
 The current calibration status of critical equipment should be
known and verifiable.
 Instruments that do not meet calibration criteria should not be
used.
 Deviations from approved standards of calibration on critical
instruments should be investigated to determine if these could
have had an effect on the quality of product manufactured
using this equipment since the last successful calibration.

33. Q7A: 6.6 Laboratory Control Records
 Periodic calibration of laboratory
instruments, apparatus, gauges, and
recording devices

34. 4.2 Documentation (ISO 10012-2: 1997)
 Document should be specific. It should state responsibility
and action to be taken. Document the Performance of the
Measurement processes.
 Guidance:
 Specification of measuring instrument
 Measurement procedure
 Instruction for the operator
 Validation report
 Verification report
 Measurement uncertainty
 Limits of permissible error
 Details of and/ or listing of computer program used

35. 4.3 Measurement processes
(ISO 10012-2: 1997)
 The performance characteristic required for the intended
use should be characterized
 Eg.
 Uncertainty in use
 Stability
 Range
 Resolution
 Repeatability
 Reproducibility
 Skill level of the operator.
Should specify master used, condition of use, other
factor affecting the reliability of measurement.

36. 4.10 Indicated failure of a controlled
measurement processes.
 When Indicates failure to meet the
specification, take necessary corrective action
and document.
 Decreasing the interval between the check
 Repairing or eli9minating unstable or unreliable instrument
 Extending the time span over which the measurement made
 Decreasing the uncertainty acceptable or increasing the
accuracy required for instrument
 Increasi8ng the number of influence quantities being
checked
 Upgrading the operator competence

37. 4.13. Records of control of
measurement processes.
 Sufficient records should be maintained to
demonstrate compliance
 Full description: Identification of Equpt., code, Standard
used, operating condition, operator
 Relevant data / values including measurement
uncertainty
 Action taken Readjusted if any
 Date of activity, verification program
 Identification of verification and document
 Person performed the activity
 Qualification of person.