1.0 OBJECTIVE : To lay down the procedure for the calibration of the standard weights / stones used for the calibration & routine function check of the weighing balance.
2.0 SCOPE : This SOP is applicable for the calibration of the standard weights / stones used in Quality Control, Quality Assurance, Manufacturing (OSD), Manufacturing (MDI) and Warehouse department for the purpose of calibration & routine function check of the weighing balances.
3.0 RESPONSIBILITY
3.1 Individual Department Head will be responsible to get the standard weights / stones calibrated from BSTI (Bangladesh Standards And Testing Institution) or OTS (Pvt.) Limited or by the certified Engineer of the supplier (i.e. Bangladesh Scientific Instrument Company) or internally by Engineering department within due time.
3.2 Overall responsibility for training, implementation & follow-up with the Heads of each department.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 During regular use the standard weights / stones should be handled with care to avoid any tapping, breakage etc. to avoid weight loss or gain.
5.2 Small weights should be handled with forceps to avoid hand contact.
6.0 PROCEDURE
6.1 General procedure
6.1.1 Identify the weights of Standard Weights / Stones used for calibration of Analytical or Precision Balances with specific weight box number and calibration certificate should be issued against the box number of the weight set in each box.
6.1.2 The stones used for calibration of the commercial balances should be kept in boxes divided in multiple sets based on usage under control and should be identified with individual box number. Calibration certificate should be issued against the weight set in each box.
6.1.3 In case of large stones/weights, if there is more than one piece of same weight exist, each stone should be embossed with identification mark (e.g. 1,2,3, ….) and the identification mark should be mentioned in the calibration certificate for traceability.
6.2 Calibration by BSTI or OTS (Pvt.) Ltd. or by Supplier’s Engineer
6.2. 1. Calibration of standard weights/Stones should preferably be done through the technical support of BSTI or OTS (Pvt.) Ltd. or by the Supplier’s Engineer as per the approved procedure.
6.2. 2. In the calibration report (e.g. Calibration Certificate), the calibration performer will document the calibration data of the weights / stones.
6.2. 3 The calibration agency should issue the calibration certificate with sign & date.
6.2. 4 After receiving the calibration certificate (s), respective department head will review the certificate (s) and will sign & date.
6.2. 5 Based on the calibration certificate, the respective Department Head will issue calibration sticker (FRM No. FQA/053).
6.2. 6 The calibration sticker must have the information like Name of the instrument / Equipment, Code No., Date of Calibration, Next Calibration due on etc. with appropriate sign & date for checking and approval.
6.2. 7 During calibration of one set of weights / stones, the daily function check of the balances shall be done using the available calibrated weight sets in the factory.
6.3 Internal Calibration by Engineering Department
6.3.1 In case, BSTI or Supplier of the weighing stones cannot provide support for the calibration within due time, the calibration of the stones has to be done internally by the engineering department as per the procedure mentioned below.
6.3.2 Use Calibrated reference stone for the calibration of the in-house weighing stones.
6.3.3 Take weight of the calibrated reference stone in a calibrated weighing balance and record the weight.
6.3.4 Immediately take weight of the stone to be calibrated in the same balance and record the weight.
6.3.5 Repeat the process of 6.3.3 & 6.3.4 for 10 times & record all the weights in the format of Annexure – I.
6.3.6 Calculate the deviation of weight of the test stone from the standard stone & uncertainty of measurement.
6.3.7 Attach all the weighing records and the calculations with the calibration documents.
6.3.8 Review the document critically by a second personnel and sign.
6.3.9 If the stone meet the calibration requirement, get the calibration record approved by QA.
6.3.10 If the stone fails to meet the calibration requirement, discard the stone and replace it with a new stone.
6.3.11 Issue calibration sticker (FRM No. FQA/053) and attach it on the box containing the stones.
6.4 palibration Frequency
6.4.1 Once in a year ± 10 days