SOP for Coding and Calibration of Standard Weight

1.0 Scope: The SOP is applicable for the Coding and Calibration of Standard Weight including analytical balance in the various departments at the plant.

2.0 Responsibility:

• QA officer is responsible for coding and calibration of standard weight used in different departments.
• Head production, engineering, warehouse, and quality control ensure compliance with this standard operating procedure.
• Head quality assurance is responsible for overall compliance with this SOP.

3.0 Precautions:
3.1 Check the validity of the calibration certificate of standard weight to be used for the calibration.
3.2 The balance should not be used if it is out of working range.

4.0 Frequency:
4.1 Calibration of standard analytical weight- annual.
4.2 Calibration of standard weight- annual.

5.0 Procedure:

• Make a list of all the analytical balances available at the site.
• Allocate alphanumeric code to all analytical weight sets as follows:
• XX/AWB/YY
• XX- Stands for department code
• /- slash
• AWB- Analytical weight box(set)
• YY- Running serial numbers for several weight boxes present in departments.

6.0 Procedure: For departments, follow these codes:

• EX- External preparation.
• LQ- Liquid oral
• OH- oral hygiene
• QC- Quality control
• TB- Tablet
• WH- warehouse

For example:

• QC/AWB/01 -Analytical weight set number 1 in quality control.
• QC/AWB/02 – Analytical weight set number 2 in quality control.
• Mark the alphanumeric code to all the analytical weight sets.

7.0 Coding of standard weight:

7.1 Make a list of all standard weights:

7.2 Allocate an alphanumeric number to all the standard weight sets as follows:

• XX/SW/YY
• XX- Stands for department code
• / -slash
• SW- Standard weight set
• YY- Running serial number for weight box present in the departments

7.3 Allocate an alphanumeric number to all the standard weight sets as follows:

• PP/YY/ZZ
• P- Standard weight
• /-slash
• YY- Is for weight in Kg
• ZZ- is a serial number of a particular weight( 01.02.03…..etc.)

For example:

• P/20/01- First 20 kg standard weight
• P/10/01- First 10 kg standard weight

8.0 Yearly Calibration of Analytical Standard Weight:
8.1 Certification of weight by the Electronics Test and Department Center (ETDC), Government of India, or its authorized agency.
8.2 Make a list of the analytical weight box with a weight ID number for sending to ETDC or its authorized agency for calibration.
8.3 Prepare a returnable gate pass and send the analytical weight box to ETDC or its authorized agency for calibration.
8.4 After the calibration weight is received from ETDC or its authorized agency, check for any damage and quantity of weights.
8.5 Ensure that the certificate for calibration is received from ETDC or its authorized agency, and review the certificate for completeness

8.6 Tolerance Limit: ± 0.1%.
8.7 Discard the weight falling out of the tolerance limit and intend to purchase new weights.

9.0 Yearly Calibration and Stumping of Standard Weight:
9.1 Intimate the government agency (for weight and measure) for calibration of all standard weights.
9.2 Make a list of the standard weight box to be sent to ETDC or its authorized agency and send it to ETDC for calibration.
9.3 After the calibration weight is received from ETDC or its authorized agency, check for any damage and quantity of weights.
9.4 Ensure that a certificate for calibration is received from ETDC or its authorized agency, review the certificate for completeness, and store the calibration certificate of standard weight in the custody of the QA Head.
9.5 The calibration weight should fall within tolerance limits ± 0.1%. Those weights falling out of the tolerance limits of ± 0.1% should be discarded.
9.6 Discard the weight falling out of the tolerance limit and intend to purchase new weights.

Related: SOP for acceptable quality level

10.0 Abbreviations:

• QA – Quality Assurance
• Kg – Kilogram
• g – gram
• IPQA -in-process Quality Control
• No. -Number
• pg. -page
• SOP -Standard operating procedure