Doc No: SOP 03

Revision No: NEW

Revision Date:

Prepared By:

SECTION TITLE: STANDARD OPERATING PROCEDURES Approved By:

DOCUMENT TITLE: SCALE CHECK & CALIBRATION Pages: 1

PURPOSE: This SOP outlines the procedure for monitoring the accuracy of the scales used in production.

PERSON RESPONSIBLE

FREQUENCYMONITORING

ACTIVITYCORRECTIVE ACTIONS RECORDS

QA DesignateAccording to QA Audit Schedule /As Required

Daily GMP Audit / Monthly GMP Audit

When findings deviate from written standards the QA designate will document findings on the Daily / Monthly GMP Audit Form and notify the General Manager of the deviation.

Short term action will be initiated and recorded on the Daily / Monthly GMP audit form. Long term action required, will be discussed by management and corrective actions / responsibilities and time frames will be agreed and documented.

Daily GMP Audit Monthly GMP Audit Daily scales check Form.

MATERIALS REQUIRED: 1kg Standard Weight

PROCEDURE DESCRIPTION:

1. Every day, check the accuracy of the scales on production lines and ingredient weigh-up area.

2. “Zero” the scale and then place 1 kg standard weight on the scale and record the reading.

3. If standard weight reads more than 2 grams outside its stated weight then corrective action must be taken.

4. If the scale reads within the limits specified in step 2, then the scale passes and is fit for use.

5. If the scale does not pass, make whatever corrective action is required (if necessary, refer to the manufacturer’s manual or in the case of the Excell 986 scales use the following calibration procedure). Record the corrective action on the Daily Scales Calibration Check Form.

Calibration of the Excell 986 Scales:

1. While the power is OFF, press “On/Zero” key (don’t release) and press “Tare” key three times to enter offset mode.

2. Press “On / Zero” key to enter the Calibration Mode.

3. Put the full capacity mass on the scale (2 kg) and press “On / Zero” key to show “CAL 1”, then the display will show “the capacity”, (i.e. if the scale is 2Kg, it will show “2000g”). At this time, the calibration is finished. Then, remove the mass from the scale.

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Calibration of ACS Weighing Scales:

While the power is on, keep pressing (CAL) for about 4 seconds. Calibrate after the weight window displays “CAL”.

Press (SET), the weight window displays the weight calibrated last time.

Press () and (ENTER) to input the weight you want to load. Then load the corresponding weight. Press (ENTER) to make sure the calibration finished.

Note: The high limit and low limit set in the weighing model are saved in the scale. Different unit s corresponding to different alarm range and methods. The value inputted by pressing () cannot be more than the full scale.

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