SOP For Calibration Management

Document Title		Calibration Management
SOP NO.	UGINE-SOP-CAL-01	Version No.
		Page No.
Effective Date		Next Review Date

	Name	Department	Sign/Date
Prepared By
Reviewed By
Approved By

1.       Objective :-  Calibration Procedure of Manufacturing Instrument.

2.       Scope:- This procedure is applicable for QC instruments, production equipment, utility service and all other equipment used for measurement. And All User Department Related to Process and Manufacturing

3.       Responsibility:- All Department Related to Production Process.

4.       DEFINITIONS:- 

4.1    Calibration ;- Calibration is the process of comparing a reading on one piece of equipment or system, with another piece of equipment that has been calibrated and referenced to a known set of parameters. The equipment used as a reference should itself be directly traceable to equipment that is calibrated according to ISO/IEC 17025

4.2    Acceptance Criterion: Numerical limits, ranges, or other suitable measures for acceptance of test results or values.

4.3    Accuracy: Accuracy refers to the level of agreement between the actual measurement and the absolute measurement

4.4    Calibration Range: Measurement range of the instrument for which calibration has been / is to be carried out.

4.5    Least Count :- Measurable Small Unit is Least Count.

4.6    Impact Assessment: The process of evaluating the impact of operating, controlling, alarming and failure conditions of a system on the quality of a product

4.7    Like to like instrument:  The instrument which has same specification like Least Count, Accuracy, Range, and Process connection.

4.8    Calibration Instrument List :- Calibration List Which is Mention Instrument Id , Instrument Name ,And Other Parameter and Detail.

4.9    Calibration Schedule: - The schedule which defines the frequency  after which the instrument should be calibrated.

4.10  Measurement: “Measurement” is the act of determining a target's size, length, weight, capacity, or other aspect. There are a number of terms similar to “measure” but which vary according to the purpose (such as “weight,” “calculate,” and “quantify.”) In general, measurement can be understood as one action within the term “instrumentation.”

4.11    Out of Calibration:-  Instrument is Working Condition and Found Instrument Out Side the Accuracy ,Beyond the Limit.

 5.0  Procedure :-

5.1 Identification of Equipment’s/ Instruments

5.1.1  Instrument ID Assign to as per Equipment and Instrument Numbering System SOP.

5.1.2   All instrumentation shall be assigned a unique number.

                     

5.2  Instrument Criticality Assessment

5.2.1 Instrument Criticality Assign to as Per Production/ Process Parameter.

      5.2.2 Instrument Criticality Assessment should be required as Per Define Instrument

      Process Parameter and Based on Product Impact.

5.3 Instruments Categorization: - Instrument Categorization Divided into Three Categories.

5.3.1 Critical Instrument: - Instruments, Which Directly impact on quality of the product and Process Parameter.

                     

5.3.2 Non Critical Instrument: - Instruments, which do not impact Directly and Indirectly on  the  quality of the product and Process Parameter.

5.3.3 For Information Instrument: - Instruments, which do not impact Directly and Indirectly on  the  quality of the product and Process Parameter, this Instrument Only Showing Value for Indication it is Called For Information Instrument

5.4    Instrument Calibration Frequency:-  Calibration of the instruments shall be carried out at the frequency detailed below

5.4.1 Internal Process and Production Instrument

Category	Calibration Frequency	Tolerance
Critical	6 Month	+/- 14 Days
Non Critical	12 Month	+/- 30 Days
For Information	NA	No Need As Requirement

5.4.2 For External Calibration (Master Instrument)

Category	Calibration Frequency	Tolerance
Critical	24 Month	+/- 60 Days

5.5    Prepare Instrument Calibration List :-

                      5.5.1 Prepare Calibration Manufacturing List and added Desire Content or Point

                                A. Sr. No.

                                B. Instrument ID

                                C. Instrument Location

                                D. Accuracy

                                E. Acceptance Criteria       

                                F. Category

                                G. Remark

                                H. History

                                I. Remark

      5.5.2 If any Instrument Added and Delete and Modified, Prepare the Addendum of                          Instrument Manufacturing List With Respect to Change Control.

       5.5.3 Instrument List Shall be Revised in Once in a year.

5.6   Prepare Instrument Calibration Schedule :-

                      5.6.1 Prepare Calibration Manufacturing List and added Desire Content or Point

                                A. Sr. No.

                                B. Instrument ID

                                C. Schedule Date

                                D. Schedule Tolerance Date

                                E. Done Date       

                                F. Sign Remark

                                G. Remark

                               

5.6.2 If any Instrument Added and Delete and Modified, Prepare the Addendum of Instrument Manufacturing Schedule With Respect to Change Control.

      5.6.3 Instrument Schedule Shall be Revised in Once in a year.

      5.7 Like to Like :- If any Instrument Found During Calibration Out of Calibration and Out of Order, Instrument Category is Critical Rise the Incident and Change the Instrument of Same Specification (Change Control Required). No Need for Non Critical and For Information Instrument and Replace the Like to Like.

5.8 Instrument Found Out of Calibration and Out Of Order :-

5.6.1 In case of instrument which fails in calibration, the Plant ENGINEERING shall initiate steps to repair / replace the instrument and an “OUT OF CALIBRATION / PERFORMANCE” status label shall be displayed on the instrument.

    5.6.2 For critical instruments calibration failure shall be intimated to the User department, Quality Assurance and shall be addressed through incident.

    5.6.3 The replaced instrument shall be included in the CALIBRATION MASTER LIST & calibration schedule.

  5.6.4 The details of failed instrument and replaced instrument shall be “History log for instruments replacement” Shall BE Entered.

5.7  When instrument is found to be out of schedule:-

5.7.1 If calibration is not performed within the scheduled due date, an Incident notification shall be raised & investigation shall be carried out and details of investigation shall be documented.

                5.8 Instrument unavailable for calibration :-

    5.8.1 If an equipment/instrument is under validation/Major maintenance/Breakdown etc. then Calibration shall not be performed & calibration order shall be locked with reference document / notification number.