Cotton inserter-Performance Verification protocol

This article contains about Performance Verification protocol for Cotton inserter.

Performance Verification protocol for Cotton inserter

Objective:

To ensure that the Cotton Inserter is capable of inserting the cotton pieces as per set length.

 Scope:

Applicable to Cotton insertion by using cotton inserter machine in container packing line.

Site of Study:

Packing Department

Location -To be recorded in validation protocol.

Validation Team:

Representatives from:

Packing                  :

Quality Assurance   :

Engineering             :

(Individual name to be mentioned in the Report)

Description of the Equipment to be Validated / used:

Equipment                        : Cotton Inserter

Code No.                          : Details to be recorded in the validation Report.

Make                                : Details to be recorded in the validation Report.

Qualification date             : Details to be recorded in the validation Report.

 Standard Operating Procedure (SOP) to be followed:

Reference SOP No.  : To be recorded in the validation Report.

 Control:

Requirements:

1. Cotton in roll form.
2. Speed of machine.
3. Standard weight of cotton to be inserted.
4. Size of container.

Calibration:

Calibration of pressure gauges to be recorded in the validation report.

 Training :

Training details of personnel involved to be recorded in the report.

 Precautions :

Ensure proper safety aspects are followed.

Validation Procedure:

• Put ‘ON’ the machine..
• Place the containers on the conveyor and adjust the gating system.
• Load the cotton through the cotton supporter in to the rollers.
• Comparison of length with weight of cotton.
• Set the cotton length and number of pieces to be inserted
• Operate the machine as per SOP.
• Check the quantity of cotton initially and after every 1 hour for 5 containers and record the same in validation report.
• Mention the balance code no. & its calibration details.

 Acceptance criteria for Performance Verification of Cotton inserter :

• Weight of cotton should be within the limit.
• Product should not get damaged.

Non Compliance:

 Details of deviations (including justification of acceptance) done to successfully carried out the validation exercise should be recorded (Attach the details to the validation report).

Type of Validation:

Concurrent Validation.

 Frequency for Performance Verification of Cotton inserter :

One Validation exercise every two years.

Results:

During the study observations and results should be recorded in the validation report.

 Summary of Finding of experiments (inference):

Summarize the finding of the validation study to draw an inference.

Recommendation (including requirements of any additional documentation):

Record the recommendations based on the interpretation of the results in validation report.

 Team Approval:

The individuals who have performed the Validation study, Supervised the Validation, completed the records, performed the testing of the product should approve the validation report.

 Review (Inclusive of follow up action, if any):

The plant Quality Assurance and plant Head should review the validation report. The report should include any follow-up action if required.

Approved by:

Plant Quality Assurance and Plant Head should finally approve the validation report.

 Annexures:

Annexures (if any) attached to the validation report should be recorded.

 Abbreviations:

SOP         : Standard Operating Procedure

OOS        : Out Of  Specification

No.           : Number