The purpose of this procedure is
- To determine testing, monitoring, measuring requirements and the equipments needed to provide evidence of conformity.
- To ensure that testing, measurement and monitoring equipment is calibrated and maintained and that the equipment is used in a manner that is consistent with monitoring and measurement requirements.
- To establish the criteria to calibrate process control instruments, weighing equipments, laboratory equipments and calibration equipments in accordance with the relevant specifications and national / international standards.
This procedure is applicable to all the following systems and standards
- ISO 29001: 2020/ API Spec Q1, 9th edition
- API Spec ….
- API Spec …..
- API Spec …..
- API Spec …..
- API Spec ……
Applies to all processes which has an influence on product quality.
- QA/QC Engineer
- All concerned Personnel
- All MMEs
- Calibration procedure & Specifications,
- Calibration schedule/ Calibration methods
- Competent & Experience Manpower, XXX Procedures/QIPs/ Work instructions
- Advance Instruments / equipment for carrying out Inspection & Testing,
- In-house Masters for Internal calibration
- It is the responsibility of the QA/ QC Engineer to ensure that all test equipments are adequately calibrated traceable to National/International Standards.
- It is the policy of XXX to maintain the accuracy and reliability of its inspection and measuring equipment/ tools at a level acceptable within the calibration appropriate to their tolerances by calibrating them as scheduled.
4.1 CALIBRATION PLAN
- QA/QC Engineer verifies the Master list of Monitoring and Measuring Instruments to ensure the frequency, date of calibration, due date of calibration and status of all the equipments requiring calibration.
- Calibration interval is identified for all the measuring equipments as per the international standard requirements.
|Sl. No.||Equipment/or Instrument||Calibration Interval||Mode of Calibration|
|1||Vernier Caliper||Every six months||Internal|
|2||External Micrometer||Every six months||Internal|
|3||Internal Micrometer||Every six months||Internal|
|4||Depth Micrometer||Every six months||Internal|
|5||Vernier Height Gauges||Every six months||Internal|
|6||Dial Indicator||Every six months||Internal|
|7||Surface Table||Every six months||Internal|
|8||Engineer’s Level||Every six months||Internal|
|9||Electrode Oven||Every six months||Internal|
|10||Slip Gauges||Every One year||External|
|11||Pressure Gauges and Recorder||Every three months or before use||External/Internal|
|12||Temperature Recorders||Every three months or before use||External|
|13||API Thread Ring & Plug Gauges||First Re-calibration after 1000 engagements and subsequent every after 500 engagements||Internal/External|
|14||API Thread Plug Gauges||First Re-calibration after 1000 engagements and subsequent every after 500 engagements||Internal/External|
|15||Tong Tester||Every One year||External|
|16||Precision Level||Every six months||Internal|
|17||Bore Gauge||Every six months||External|
|18||Ball Trammel Gauge||Every six months||Internal|
|19||MPI Yoke||Every six months||Internal|
|20||Noise Meter||Every One year||External|
|21||PWHT Temperature Controller K-Type||Every Three Months||External|
|22||Snap Gauge||Every One year||External|
|23||Bevel Protractor||Every six months||External|
|24||Hilo Gauge||Every One year||External|
|25||Weld Gauge||Every One year||External|
|26||Dew Point Meter||Every One year||External|
|27||Infrared Thermometer||Every One year||External|
|28||Hardness Tester||Every One year||External|
|29||Lux Meter||Every One year||External|
|30||Measuring Tape||Every One year||External|
|31||Welding Rectifier||Every six months||Internal|
|32||PWHT Furnace||Every One year||Internal|
|33||Yoke Calibration Block||Every One year||External|
|34||Digital Thermometer||Every One year||External|
|35||Digital Thermocouple||Every One year||External|
|36||Step Block||Every One year||External|
|37||Humidity Meter||Every One year||External|
|38||Micrometer Setting Rod||Every One year||External|
|39||Ultrasonic Thickness Gauge||Every One year||External|
|40||Drift||Every six months||Internal|
|41||Dial Caliper||Every six months||Internal|
|42||Paint/Foil thickness Gauge||Before use||Internal|
|43||API Taper Gauges||Every after 1000 engagements||Internal|
|44||Master Gauges Plug and Ring||Every after 250 engagements||External|
|45||External Dial Caliper||Every six months||Internal|
|46||Internal Dial Caliper||Every six months||Internal|
|47||API Profile Gauges||Every after 1000 Connections||Internal|
As per API Spec. 7-2 Sec.10.3.1.5.2 – Regional and reference master gauges are retested for mating and interchange standoff at least once each seven years, and certified on a certificate of retest as being acceptable for further use. API working gauges setting rods and others shall be segregated into adjustable and non-adjustable as per API 5CT clause 8.2 para 4.
4.2 GENERAL CALIBRATION REQUIREMENTS:
- Unless, otherwise specified, monitoring and measuring equipment is calibrated to manufacturer’s specifications. If no specifications are available, the equipment is calibrated based on intended use.
- The specifications for calibration must be reviewed, planned and validated by QA/QC Engineer.
- Environmental Condition to be maintain as per requirement.
- Temperature Range: 23°C±5°C
- Humidity Range: 20 to 80 % RH
- Calibration requirements are documented in the calibration certificates for the individual instrument / instrument type.
4.3 INSTRUMENT RECEIPT:
- All monitoring and measuring equipment must be received, reviewed, verified, and approved by QA/QC Engineer before it can be used in production or inspection reject/accept decisions.
4.4 INSTRUMENT IDENTIFICATION:
- All inspection, measuring and test equipment are have a unique identification number and details relating to each piece of equipment is recorded in the Master list of Monitoring and Measuring Equipment.
- All master equipment for calibration also has a unique Identification Number and has the calibration traceable to National/ International Standard (e.g. NAMAS). Calibration reports of master equipment are maintained separately with the list of Monitoring and Measuring Instruments.
- Identification is made either by engraving the unique identification on the equipment or by labeling (fixing the identification number by a label/sticker).
- Upon completion of the calibration, the status of calibration is identified by fixing a calibration sticker. Calibration sticker has the date of calibration, calibration due and certificate number.
- All non-conforming instrument/equipment is identified by red sticker and is segregated.
- In order to identify the Product inspected by a particular Equipment/instrument, that equipment/instrument is logged in a register with the following information:
- Date of use
- Job/contract number
- Operator Name
- All instruments (not fitted with equipment/machines) are stored in the gauge room and the calibrated equipment/instruments are stored separately without mixing with the instruments not calibrated.
4.5 HANDLING & STORAGE:
- Personnel handling, transporting, or storing monitoring and measuring equipment must ensure that care is taken to prevent damage or deterioration to the equipment. If personnel are not familiar with the use or application of equipment, they are responsible for asking their supervisor and/or QA personnel for training.
- In case the QA personnel not available, the users should follow the user manual provided with the equipment for doing monitoring and measurement activities.
4.6 OUTSIDE SUPPLIERS:
- For calibration preference of suppliers is to those who hold ISO/IEC 17025 certification, but is made based on their technical competence. QA/QC Engineer is responsible for ensuring that outside calibration service providers are on Approved Supplier List.
4.7 CALIBRATION PROCEDURE (Internal)
- All measuring and test equipment which can be calibrated internally (within XXX) have calibration procedure and is demonstrated accordingly (Level III – Quality Internal Procedures).
- Trained/Qualified personnel are conducted the calibration to safe guard the inspection, measuring and test facilities from adjustments, which would invalidate the calibration setting.
- XXX operates detailed Level III procedures, which specifies the process employed for the calibration of inspection, measuring and test equipment including detail of equipment type unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory.
4.8 CALIBRATION PROCEDURE (External)
- On receipt of the calibration recall instruction from the Quality System Manager, the QC Engineer checks the calibration status of the all measuring and monitoring devices.
- A list to be prepared for devices which are due for calibration by the QC Engineer and the measuring and monitoring devices are collected and delivery note is prepared by the store keeper. The physical condition of the measuring and monitoring devices to be checked by QC Engineer before sending them for calibration.
- The measuring and monitoring devices is sent to the approved calibration providers through Machine shop driver.
- The driver is responsible for delivering the measuring and monitoring devices to the calibration provider and bring acknowledgement of the same.
- Once the measuring and monitoring devices are calibrated, it is collected by the driver along with original invoice.
- The driver is responsible for delivering the measuring and monitoring devices and their calibration certificates to the QC Engineer.
- It is the responsibility of QC Engineer to check the accuracy and correctness of the calibration certificates and if any deviations report immediately to the service provider. Also the QC Engineer will examine the physical condition of the measuring and monitoring devices once it is back from calibration.
- Original calibration certificates are to be filed in the calibration certificates files and a copy to be maintained with the QC Engineer. Accordingly the master list of measuring and monitoring instruments to be updated by the QC Engineer.
- Then the measuring and monitoring devices is send to the production with calibration sticker.
- The same methodology is followed for customer provided measuring and monitoring devices.
4.9 CALIBRATION RECORDS:
- All calibrated instruments (externally or internally) have a calibration certificate issued by the authority (internal or external). In house calibration is recorded in the in-house calibration certificate. (Refer XXX / QA / 16).
- Calibration certificate have the following:
- Date of calibration
- Equipment details
- Reference procedure with issue and revision status
- Master equipment used/traceability (measurement standard)
- Environmental Condition.
- Calibration data (any out of specification reading as received for calibration/verification and an assessment of the impact of out of specification)
- Name and Signature of the calibration performed
- Status of calibration is recorded in the Master list of Monitoring and Measuring Instruments.
- Where inspection measuring and test equipment is found to be nonconforming but still within its calibration period, the equipment is labeled with ‘Red sticker’ and held as segregated.
- An assessment of the equipment is undertaken and appropriate rectification is taken
- Any inspection, measuring and test equipment found to be suspected, the suspected equipment is automatically segregated and re-inspected to re-establish conformance in accordance to the inspection requirements
- It is the responsibility of the QA/ QC Engineer or his Designated Engineer to arrange recall of the units due for calibration.
- All calibration records are maintained with Quality Assurance Department.
- All calibration records of monitoring and measuring equipment is maintained by the QA/QC Engineer and retained for a minimum of 5 years.
4.10 OUT OF TOLERANCE CONDITIONS:
- If any monitoring and measuring equipment is found to be out of tolerance during calibration, the monitoring and measuring equipment is reviewed for possible impact on measured product since the equipment’s last known acceptable calibration/verification.
- The QA/QC Engineer, or delegate, must make a determination as to the appropriate action required concerning use of the equipment and any product potentially affected by its prior use (use as it is, scrap, recall, etc.)
- A notation of actions taken on equipment and product is maintained in the calibration files.
- The QA/QC Engineer must provide a copy of the equipment’s calibration history at the time of review.
- Equipments which are considered as out of calibration/damaged/lost will be recorded in the Non-calibrated / Scrap equipment Record.
4.11 NON-CONFORMING MEASURING EQUIPMENT:
- Any confirmed measuring equipment that is suspected or known to be damaged, malfunctioning in such a way to invalidate its intended use, producing incorrect measurement results, safeguard broken or damaged, or otherwise considered unfit for use must be removed from service and segregated or identified in such a way to prevent its use.
- This is done by performing the following:
- By marking the instruments inactive in the calibration files.
- Record the date, reason for defect, replacement status, and whether any product has been affected and why.
- Place a Not in Use on the non-conforming equipment until disposition.
- Equipment cannot be returned to service until the reasons for its nonconformity have been eliminated and its full function has been confirmed, or it is designated for ‘limited use’ only. If the instrument is sent out for repair, the supplier also calibrates the equipment.
- Accompanying documents is reviewed upon its receipt to ensure that calibration was completed.
- If the instrument is replaced, a new entry with a new instrument number is created in the calibration list. The nonconforming instrument remains inactive.
4.12 LIMITED USE:
- If any equipment is not functioning to its full capabilities, but is acceptable for limited or other use, this information must be clearly identified and apparent for the operator/user. For example, this could be used for ‘reference only’ measurements.
4.13 LOST INSTRUMENTS:
- Any instrument that cannot be located at the calibration due date require the notification of the process In-charges. Instruments that cannot be located for a period exceeding 2 months requires notification of the QA/QC Engineer.
All calibrations are traceable to the International Standards.
- Master list of all Monitoring and Measuring Equipment’s (MMEs) is established containing the following:
- Equipment Description
- Identification Number
- Acceptance Criteria
- Interval of Calibration/verification
- Calibration/verification responsibility (External or In-house)
- The interval of calibration/verification is determined based on the type of MME and frequency of usage.
- The MMEs are calibrated either in-house or by the approved external laboratories. In case of in-house calibration/verification, the calibration/ verification is carried out as per work instructions.
- All newly procured MMEs are submitted to QA/QC Engineer for registering in the Master list. The QA/QC Engineer ensures the availability of the calibration certificate for the new MME or otherwise ensures issuance only after calibration
- If the deviation of the measurement is affecting the product quality, the components produced using this MME are traced and is re-inspected. In case the components/ products are already dispatched, the customer is intimated regarding the same and the necessary action is taken.
4.15 MONITORING AND MEASUREMENT OF THE PROCESS
- The QA/QC Engineer verifies timeliness of re-calibration / verification to check the process effectiveness.
- When the equipment is provided from a source external, including third-party, proprietary, employee and customer-owned equipment, XXX / QC verifies that the equipment is suitable and provides evidence of conformity to the requirements of this section.
- XXX maintains a registry of Monitoring and Measuring Equipment of the required testing, measurement and monitoring equipment used to determine product conformity to requirements
- Calibration certificates file (Internal/External)
- Calibration history card
- Calibration Sticker
6.0 KEY PERFORMANCE INDICATOR:
Completion of calibration as per schedule
7.0 ASSOCIATED DOCUMENTS & RECORDS
|Master list of Monitoring & Measuring Instruments||XXX / QA / D02||QA/QC Engineer|
|In-House Calibration Certificate||XXX / QA / 16||QA/QC Engineer|
|In-House Calibration Certificate (Pressure Gauges)||XXX / QA / 35||QA/QC Engineer|
|Calibration History Card||XXX / QA / 36||QA/QC Engineer|
|Yoke In-house Calibration Certificate||XXX / QA / 37||QA/QC Engineer|
|Non-calibrated/Scrap equipment Record||XXX / QA / 43||QA/QC Engineer|