OPERATIONAL QUALIFICATION

M/C

M/C

OPERATIONAL QUALIFICATION

1. Objective
2. Verification of Operating Procedure
3. Operational Testing
4. Acceptance Criteria

OPERATIONAL QUALIFICATION
M/C

1.0

OBJECTIVE:

Process of obtaining and documenting evidence that installed equipment operates

within predetermined limits when used in accordance with its operational
procedures The purpose of this study is to qualify and certify the operational
performance of M/C.
This study:
Verifies the equipment consistently operates within a specified set of
parameters under normal operational conditions.
Assures that the equipment performance is adequate to support the process for
which the equipment is intended.
Demonstrate the completeness and adequacy of operating procedure /
Preventive Maintenance.
Checking of various parameters like Intact seal for a specified seal width, No
channels or open seals, No punctures or tears, No material delamination or
separation.

2.0 VERIFICATION OF OPERATING PROCEDURE:

Operating Procedure Title

Operation of Vacuum Packing and Sealing

Machine

Operating Procedure No.

As per machine Manual

Verification Date

OPERATIONAL QUALIFICATION
M/C
3.0 OPERATIONAL TESTING:
Operating
Personnel / Dept.
1) Assemblly &
testing

2) QC dept.

Observation

Comments

Operating personnel
understand and follow the
operating Procedure and
requirements

Verified

Operating Procedure provides

adequate direction and control
to ensure uniform equipment
operation

Verified

Signed

Date

Checked By:
(QC Incharge)
Verified By:
(Works Manager)

4.0 ACCEPTANCE CRITERIA:

Criteria
All acceptance criteria set forth in the Operational
Qualification were met.
All applicable data sheets were signed as checked and
verified.
Calibration of instrumentation verified.

Observation
Accepted
Accepted
Accepted

OPERATIONAL QUALIFICATION
M/C
Operating procedure / Preventive Maintenance
procedure were verified for completeness and accuracy.
Sealing at Low Temperature (Recommended from
Supplier of Packing Material)
Sealing at High Temperature (Recommended from
Supplier of Packing Material)
Peeling Test at Low Temperature Sealing
Peeling Test at High Temperature Sealing
Temperature (T) determined for the PQ (Average
between lower limit and upper limit is the ActualTemperature during the test)

Accepted
Accepted
Accepted
Accepted
Accepted

No
Major Deviations (if any)
Acceptable

Acceptable / Not acceptable

If not acceptable, action taken

Signed

Checked By:
(QA Incharge)
Verified By:
(Works Manager)

Date