HA 1 Stop Rigid Box Manufacturer Sdn. Bhd.

Standard Operation Procedure

Doc. No. SOP-QA-01 Effective Date 01/03/17
Calibration process
Revision 00 Pages 1 of 2

Revision History Table

Rev. No. Rev. Date Changes Description Author

- - Initial Release HP Lai

 Document No. SOP-QA-01 Effective Date 01/03/17
Calibration process
Revision 00 Pages 2 of 2

Responsibilities Process Flow Description Quality Records

1. Plan and generate yearly calibration schedule for new/  Yearly
Calibrationand document to QA-01.
existing equipment Calibration
QA Manager Schedule
2. The calibration frequency is determined base on Schedule [QA-01]
equipment stability, purpose and degree of usage.

 External
3. Recall equipment
Performthat has expired on calibration date Calibration
and to send to the external accredited calibration.
Calibration certificate
QA Manager 4. Equipment is calibrated against the Standards and/or
Masters whose calibration is certified as traceable to
nationally or internationally recognized standards.

5. Verify and review the calibration certificate to validate

No the obtained calibration result.  External
QA ManagerVerif Calibration
y? 6. In event of any equipment are identified as
certificate
nonconforming during calibration, remove equipment
from point of use and to disposition accordingly.
7. To re-evaluate the previous documented inspection,
Remove from use measuring and test result generated from the
equipment to assess the validity of the results
Yes obtained. The re-evaluation is to be documented and,
when required, corrective action is initiated as per QSP
– 05, Corrective & Preventive Action procedure.
8. In the event of equipment is identified to be
nonconforming for usage, all the product that verified
by using the equipment shall be tracked back using the
inspection records and re-verified.
9. While in use, the equipments are safeguarded from
Equipment User Protect
adjustment &
that would invalidate the measurement
Safeguard
results and must be protected against damages or
deterioration during handling and maintenance.
10.Equipment are to be removed immediately from use
and forwarded to QA Department for verification or
calibration when;
 failure in operation occurs;
 there is evidence of physical damages;
 accuracy and precision of the equipment is suspected;
 calibration performed is believed to be imprecise; and
 the calibration due date is expired.

11. Calibration records are to be maintained throughout  Yearly

the life of each equipment. Calibration
File and
12. File and maintain
maintain the equipment calibration records Schedule [QA-01]
QA Manager accordingly to QSP – 02, Control of QMS Records
records  External
procedure.
Calibration
certificate

Prepared by Review by Approved by

Date : Date: Date: